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Durable, sustained clinical benefit was also observed with Opdivo plus Yervoy or Opdivo alone across relevant subgroups, including in patients with BRAF mutation, wild-type tumors, and baseline liver metastases. Among patients with BRAF-mutant tumors, the rate of OS at 6.5 years was 57% in patients who received Opdivo plus Yervoy, 43% for Opdivo alone, and 25% for Yervoy alone. In patients with BRAF wild-type tumors, the rate of OS was 46% in patients who received Opdivo plus Yervoy, 42% for Opdivo alone and 22% for Yervoy alone. The rate of OS among patients with liver metastases was 38% for those who received Opdivo plus Yervoy, 31% for Opdivo alone, and 22% for Yervoy alone. Median duration of response (DoR) was not reached for those who received Opdivo plus Yervoy nor Opdivo,while the DoR for Yervoy-treated patientswas 19.2 months.

“The sustained overall survival and progression-free survival benefit shown with nivolumab-based treatment, particularly the nivolumab plus ipilimumab combination, has changed the way we look at long-term efficacy outcomes for patients with advanced melanoma,” said Jedd D. Wolchok, M.D., Ph.D., FASCO, Chief, Immuno-Oncology Service, Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center. “These new results from the CheckMate -067 trial, with nearly half of patients treated with the nivolumab and ipilimumab combination surviving to six-and-a-half years, confirm the durable, sustained benefit of the combination in patients with advanced melanoma.”

The safety profile for Opdivo plus Yervoy was consistent with prior findings, with no new safety signals observed and no additional treatment-related deaths occurring since the five-year analysis. Grade 3/4 treatment-related adverse events were reported in 59% of patients in the combination group, 24% of patients in the Opdivo group, and 28% of patients in the Yervoy group.

“These results build upon our decade-long legacy in treating melanoma, which began when the average life expectancy following a diagnosis of metastatic melanoma was roughly six months and less than 10% of patients survived beyond five years,” said Gina Fusaro, development lead, melanoma, Bristol Myers Squibb. “With some of the longest follow-up with immunotherapies to date, Opdivo and Yervoy have consistently demonstrated durable, long-term survival benefits for patients diagnosed with advanced melanoma.”

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -067 clinical trial. The 6.5-year CheckMate -067 data (Abstract #9506) will be presented in an oral abstract session on Sunday, June 6, 2021 from 8:00 a.m. to 11:00 a.m. EDT at the American Society of Clinical Oncology (ASCO) Annual Meeting 2021 from June 4-8.

Dr. Wolchok has provided consulting services to Bristol Myers Squibb.

About CheckMate -067

CheckMate -067 is a Phase 3, double-blind, randomized trial that evaluated the combination of Opdivo plus Yervoy or Opdivo monotherapy versus Yervoy monotherapy in 945 patients with previously untreated advanced melanoma. Patients in the combination group (n=314) received Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks (Q3W) for four doses followed by Opdivo 3 mg/kg every two weeks (Q2W). Patients in the Opdivo monotherapy group (n=316) received Opdivo 3 mg/kg Q2W plus placebo. Patients in the Yervoy monotherapy group (n=315) received Yervoy 3 mg/kg Q3W for four doses plus placebo. Patients were treated until progression or unacceptable toxic effects. Overall survival (OS) and progression-free survival (PFS) were dual endpoints of the trial. Secondary endpoints included objective response rates (ORR), descriptive efficacy assessments and safety.

Sobre el melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has been increasing steadily for the last 30 years. In the United States, 106,110 new diagnoses of melanoma and about 7,180 related deaths are estimated for 2021. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanoma is mostly curable when treated in its very early stages; however, survival rates decrease if regional lymph nodes are involved.

Bristol Myers Squibb: crear un futuro mejor para los enfermos de cáncer

Bristol Myers Squibb se inspira en una única visión: transformar la vida de los pacientes a través de la ciencia. El objetivo de la investigación oncológica de la empresa es suministrar medicamentos que ofrezcan a cada paciente una vida mejor y más saludable y que hagan posible la curación. Sobre la base de un legado en una amplia gama de cánceres que ha cambiado las expectativas de supervivencia para muchos, los investigadores de Bristol Myers Squibb están explorando nuevas fronteras en la medicina personalizada, y a través de plataformas digitales innovadoras, están convirtiendo los datos en conocimientos que agudizan su enfoque. Los profundos conocimientos científicos, las capacidades de vanguardia y las plataformas de descubrimiento permiten a la empresa observar el cáncer desde todos los ángulos. El cáncer puede tener una influencia implacable en muchas partes de la vida de un paciente, y Bristol Myers Squibb se ha comprometido a tomar medidas para abordar todos los aspectos de la atención, desde el diagnóstico hasta la supervivencia. Porque como líder en la atención al cáncer, Bristol Myers Squibb trabaja para que todas las personas con cáncer tengan un futuro mejor.

Acerca de Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

INDICACIONES

OPDIVO® (nivolumab), como agente único, está indicado para el tratamiento de pacientes con melanoma irresecable o metastásico.

OPDIVO® (nivolumab), en combinación con YERVOY® (ipilimumab), está indicado para el tratamiento de pacientes con melanoma irresecable o metastásico.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), en combinación con YERVOY® (ipilimumab) y 2 ciclos de quimioterapia con doblete de platino, está indicado para el tratamiento de primera línea de pacientes adultos con cáncer de pulmón no microcítico (CPNM) metastásico o recurrente, sin aberraciones tumorales genómicas EGFR o ALK.

OPDIVO® (nivolumab) está indicado para el tratamiento de pacientes con cáncer de pulmón no microcítico (CPNM) metastásico con progresión en o después de la quimioterapia con platino. Los pacientes con aberraciones tumorales genómicas EGFR o ALK deben tener una progresión de la enfermedad con el tratamiento aprobado por la FDA para estas aberraciones antes de recibir OPDIVO.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), en combinación con YERVOY® (ipilimumab), está indicado para el tratamiento de primera línea de pacientes con carcinoma de células renales (CCR) avanzado de riesgo intermedio o bajo.

OPDIVO® (nivolumab), en combinación con cabozantinib, está indicado para el tratamiento de primera línea de pacientes con carcinoma de células renales (CCR) avanzado.

OPDIVO® (nivolumab) está indicado para el tratamiento de pacientes con carcinoma de células renales (CCR) avanzado que han recibido una terapia antiangiogénica previa.

OPDIVO^® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) está indicado para el tratamiento de pacientes con carcinoma de células escamosas de cabeza y cuello (SCCHN) recurrente o metastásico con progresión de la enfermedad en o después de una terapia basada en platino.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), en combinación con YERVOY® (ipilimumab), está indicado para el tratamiento de adultos y pacientes pediátricos de 12 años o más con cáncer colorrectal metastásico de alta inestabilidad de microsatélites (MSI-H) o deficiente en la reparación de emparejamientos (dMMR) que haya progresado tras el tratamiento con una fluoropirimidina, oxaliplatino e irinotecán. Esta indicación está aprobada bajo aprobación acelerada basada en la tasa de respuesta global y la duración de la respuesta. La continuación de la aprobación para esta indicación puede depender de la verificación y descripción del beneficio clínico en ensayos confirmatorios.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab), en combinación con YERVOY® (ipilimumab), está indicado para el tratamiento de pacientes con carcinoma hepatocelular (CHC) que han sido tratados previamente con sorafenib. Esta indicación está aprobada bajo aprobación acelerada basada en la tasa de respuesta global y la duración de la respuesta. La continuación de la aprobación para esta indicación puede depender de la verificación y descripción del beneficio clínico en los ensayos confirmatorios.

OPDIVO^® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO® (nivolumab) está indicado para el tratamiento de pacientes con carcinoma esofágico de células escamosas (CCE) avanzado, recidivante o metastásico no resecable después de una quimioterapia previa a base de fluoropirimidina y platino.

OPDIVO® (nivolumab), en combinación con quimioterapia que contiene fluoropirimidina y platino, está indicado para el tratamiento de pacientes con cáncer gástrico avanzado o metastásico, cáncer de la unión gastroesofágica y adenocarcinoma de esófago.

INFORMACIÓN IMPORTANTE DE SEGURIDAD

Reacciones adversas inmunomediadas graves y mortales

Las reacciones adversas inmunomediadas enumeradas aquí pueden no incluir todas las posibles reacciones adversas inmunomediadas graves y mortales.

Las reacciones adversas inmunomediadas, que pueden ser graves o mortales, pueden ocurrir en cualquier sistema de órganos o tejidos. Aunque las reacciones adversas inmunomediadas suelen manifestarse durante el tratamiento, también pueden producirse tras la interrupción de OPDIVO o YERVOY. La identificación y el tratamiento tempranos son esenciales para garantizar un uso seguro de OPDIVO y YERVOY. Vigilar los signos y síntomas que puedan ser manifestaciones clínicas de reacciones adversas inmunomediadas subyacentes. Evaluar la química clínica, incluyendo las enzimas hepáticas, la creatinina, el nivel de la hormona adrenocorticotrópica (ACTH) y la función tiroidea al inicio y periódicamente durante el tratamiento con OPDIVO y antes de cada dosis de YERVOY. En los casos de sospecha de reacciones adversas inmunomediadas, iniciar los estudios apropiados para excluir etiologías alternativas, incluyendo la infección. Establezca un tratamiento médico con prontitud, incluyendo la consulta a un especialista cuando sea necesario.

Interrumpir o suspender permanentemente OPDIVO y YERVOY en función de la gravedad (véase la sección 2 Posología y administración en la Información de prescripción completa adjunta). En general, si es necesario interrumpir o suspender OPDIVO o YERVOY, administrar un tratamiento con corticosteroides sistémicos (1 a 2 mg/kg/día de prednisona o equivalente) hasta que mejore hasta el Grado 1 o menos. Una vez que la mejoría sea de grado 1 o menos, iniciar la reducción de los corticosteroides y continuar la reducción durante al menos 1 mes. Considerar la administración de otros inmunosupresores sistémicos en pacientes cuyas reacciones adversas inmunomediadas no se controlan con el tratamiento con corticosteroides. A continuación se comentan las pautas de gestión de la toxicidad para las reacciones adversas que no requieren necesariamente corticoides sistémicos (por ejemplo, endocrinopatías y reacciones dermatológicas).

Neumonitis inmunomediada

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

En Checkmate 205 y 039, se produjo neumonitis, incluida la enfermedad pulmonar intersticial, en el 6,0% (16/266) de los pacientes que recibieron OPDIVO. Se produjo neumonitis inmunomediada en el 4,9% (13/266) de los pacientes que recibieron OPDIVO, incluyendo Grado 3 (n=1) y Grado 2 (n=12).

Colitis inmunomediada

OPDIVO y YERVOY pueden causar colitis inmunomediada, que puede ser mortal. Un síntoma común incluido en la definición de colitis fue la diarrea. Se ha notificado la infección/reactivación del citomegalovirus (CMV) en pacientes con colitis inmunomediada refractaria a los corticosteroides. En los casos de colitis refractaria a los corticosteroides, considere la posibilidad de repetir el estudio infeccioso para excluir etiologías alternativas. En los pacientes que recibieron monoterapia con OPDIVO, se produjo colitis inmunomediada en el 2,9% (58/1994) de los pacientes, incluyendo Grado 3 (1,7%) y Grado 2 (1%). En los pacientes que recibieron OPDIVO 1 mg/kg con YERVOY 3 mg/kg cada 3 semanas, se produjo colitis inmunomediada en el 25% (115/456) de los pacientes, incluyendo Grado 4 (0,4%), Grado 3 (14%) y Grado 2 (8%). En los pacientes que recibieron OPDIVO 3 mg/kg con YERVOY 1 mg/kg cada 3 semanas, se produjo colitis inmunomediada en el 9% (60/666) de los pacientes, incluyendo Grado 3 (4,4%) y Grado 2 (3,7%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%) and Grade 2 (5%).

Hepatitis inmunomediada y hepatotoxicidad

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO monotherapy in Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients. In patients receiving OPDIVO 1 mg/ kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%) and Grade 2 (2.5%).

OPDIVO en combinación con cabozantinib puede causar toxicidad hepática con mayor frecuencia de elevaciones de ALT y AST de grado 3 y 4 en comparación con OPDIVO solo. Considere la posibilidad de un control más frecuente de las enzimas hepáticas en comparación con la administración de los fármacos como agentes únicos. En los pacientes que recibieron OPDIVO y cabozantinib, se observaron aumentos de ALT o AST de grado 3 y 4 en el 11% de los pacientes.

Endocrinopatías inmunomediadas

OPDIVO y YERVOY pueden causar insuficiencia suprarrenal primaria o secundaria, hipofisitis inmunomediada, trastornos tiroideos inmunomediados y diabetes mellitus de tipo 1, que puede presentarse con cetoacidosis diabética. Suspender OPDIVO y YERVOY en función de la gravedad (véase la sección 2 Dosificación y administración en la Información de prescripción completa adjunta). En caso de insuficiencia suprarrenal de grado 2 o superior, iniciar un tratamiento sintomático, incluyendo la sustitución hormonal según esté clínicamente indicado. La hipofisitis puede presentarse con síntomas agudos asociados al efecto de masa, como dolor de cabeza, fotofobia o defectos del campo visual. La hipofisitis puede causar hipopituitarismo; iniciar la sustitución hormonal según esté clínicamente indicado. La tiroiditis puede presentarse con o sin endocrinopatía. El hipotiroidismo puede seguir al hipertiroidismo; iniciar la sustitución hormonal o el tratamiento médico según esté clínicamente indicado. Vigilar a los pacientes para detectar hiperglucemia u otros signos y síntomas de diabetes; iniciar el tratamiento con insulina según esté clínicamente indicado.

En los pacientes que recibieron monoterapia con OPDIVO, se produjo insuficiencia suprarrenal en el 1% (20/1994), incluyendo Grado 3 (0,4%) y Grado 2 (0,6%). En los pacientes que recibieron OPDIVO 1 mg/kg con YERVOY 3 mg/kg cada 3 semanas, se produjo insuficiencia suprarrenal en el 8% (35/456), incluyendo Grado 4 (0,2%), Grado 3 (2,4%) y Grado 2 (4,2%). En los pacientes que recibieron OPDIVO 3 mg/kg con YERVOY 1 mg/kg cada 3 semanas, se produjo insuficiencia suprarrenal en el 7% (48/666) de los pacientes, incluyendo Grado 4 (0,3%), Grado 3 (2,5%) y Grado 2 (4,1%). En los pacientes que recibieron OPDIVO y cabozantinib, se produjo insuficiencia suprarrenal en el 4,7% (15/320) de los pacientes, incluyendo Grado 3 (2,2%) y Grado 2 (1,9%).

En los pacientes que recibieron monoterapia con OPDIVO, se produjo hipofisitis en el 0,6% (12/1994) de los pacientes, incluyendo Grado 3 (0,2%) y Grado 2 (0,3%). En los pacientes que recibieron OPDIVO 1 mg/kg con YERVOY 3 mg/kg cada 3 semanas, se produjo hipofisitis en el 9% (42/456), incluyendo Grado 3 (2,4%) y Grado 2 (6%). En los pacientes que recibieron OPDIVO 3 mg/kg con YERVOY 1 mg/kg cada 3 semanas, se produjo hipofisitis en el 4,4% (29/666) de los pacientes, incluyendo Grado 4 (0,3%), Grado 3 (2,4%) y Grado 2 (0,9%).

En los pacientes que recibieron monoterapia con OPDIVO, se produjo tiroiditis en el 0,6% (12/1994) de los pacientes, incluyendo Grado 2 (0,2%). En pacientes que recibieron OPDIVO 3 mg/kg con YERVOY 1 mg/kg cada 3 semanas, se produjo tiroiditis en el 2,7% (22/666) de los pacientes, incluyendo Grado 3 (4,5%) y Grado 2 (2,2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%).

En los pacientes que recibieron monoterapia con OPDIVO, se produjo hipotiroidismo en el 8% (163/1994) de los pacientes, incluyendo Grado 3 (0,2%) y Grado 2 (4,8%). En los pacientes que recibieron OPDIVO 1 mg/kg con YERVOY 3 mg/kg cada 3 semanas, se produjo hipotiroidismo en el 20% (91/456) de los pacientes, incluyendo Grado 3 (0,4%) y Grado 2 (11%). En los pacientes que recibieron OPDIVO 3 mg/kg con YERVOY 1 mg/kg cada 3 semanas, se produjo hipotiroidismo en el 18% (122/666) de los pacientes, incluyendo Grado 3 (0,6%) y Grado 2 (11%).

En los pacientes que recibieron monoterapia con OPDIVO, se produjo diabetes en el 0,9% (17/1994) de los pacientes, incluyendo Grado 3 (0,4%) y Grado 2 (0,3%), y 2 casos de cetoacidosis diabética. En los pacientes que recibieron OPDIVO 3 mg/kg con YERVOY 1 mg/kg cada 3 semanas, se produjo diabetes en el 2,7% (15/666) de los pacientes, incluyendo Grado 4 (0,6%), Grado 3 (0,3%) y Grado 2 (0,9%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, Grade 2-5 immune-mediated endocrinopathies occurred in 4% (21/511) of patients. Severe to life-threatening (Grade 3-4) endocrinopathies occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate (Grade 2) endocrinopathy occurred in 12 patients (2.3%), including hypothyroidism, adrenal insufficiency, hypopituitarism, hyperthyroidism and Cushing’s syndrome.

Nefritis inmunomediada con disfunción renal

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).

Reacciones adversas dermatológicas inmunomediadas

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/ exfoliative rashes.

Suspender o interrumpir permanentemente OPDIVO y YERVOY en función de la gravedad (véase la sección 2 Posología y administración en la Información de prescripción completa adjunta).

En los pacientes que recibieron monoterapia con OPDIVO, se produjo una erupción inmunomediada en el 9% (171/1994) de los pacientes, incluyendo Grado 3 (1,1%) y Grado 2 (2,2%). En los pacientes que recibieron OPDIVO 1 mg/kg con YERVOY 3 mg/kg cada 3 semanas, se produjo una erupción inmunomediada en el 28% (127/456) de los pacientes, incluyendo Grado 3 (4,8%) y Grado 2 (10%). En los pacientes que recibieron OPDIVO 3 mg/kg con YERVOY 1 mg/kg cada 3 semanas, se produjo una erupción inmunomediada en el 16% (108/666) de los pacientes, incluyendo Grado 3 (3,5%) y Grado 2 (4,2%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated rash occurred in 15% (76/511) of patients, including Grade 3-5 (2.5%) and Grade 2 (12%).

Otras reacciones adversas inmunomediadas

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

Algunos casos de IMAR ocular pueden asociarse a un desprendimiento de retina. Pueden producirse varios grados de deficiencia visual, incluida la ceguera. Si la uveítis se produce en combinación con otras reacciones adversas inmunomediadas, considere un síndrome similar al de Vogt-Koyanagi-Harada, que se ha observado en pacientes que reciben OPDIVO y YERVOY, ya que esto puede requerir un tratamiento con corticosteroides sistémicos para reducir el riesgo de pérdida permanente de la visión.

Reacciones relacionadas con la infusión

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

In separate Phase 3 trials of YERVOY 3 mg/kg and 10 mg/kg monotherapy, infusion-related reactions occurred in 2.9% (28/982) of patients.

Complicaciones del trasplante alogénico de células madre hematopoyéticas

En los pacientes que reciben un trasplante alogénico de células madre hematopoyéticas (TCMH) antes o después de ser tratados con OPDIVO o YERVOY pueden producirse complicaciones mortales y otras graves. Las complicaciones relacionadas con el trasplante incluyen la enfermedad de injerto contra huésped (EICH) hiperaguda, la EICH aguda, la EICH crónica, la enfermedad venooclusiva hepática (EVO) tras el acondicionamiento de intensidad reducida y el síndrome febril que requiere esteroides (sin una causa infecciosa identificada). Estas complicaciones pueden ocurrir a pesar del tratamiento intermedio entre OPDIVO o YERVOY y el HSCT alogénico.

Seguir de cerca a los pacientes en busca de evidencias de complicaciones relacionadas con el trasplante e intervenir con prontitud. Considerar el beneficio frente a los riesgos del tratamiento con OPDIVO y YERVOY antes o después de un HSCT alogénico.

Toxicidad embriofetal

Basándose en su mecanismo de acción y en los resultados de los estudios en animales, OPDIVO y YERVOY pueden causar daño fetal cuando se administran a una mujer embarazada. Es probable que los efectos de YERVOY sean mayores durante el segundo y tercer trimestre del embarazo. Aconsejar a las mujeres embarazadas sobre el riesgo potencial para el feto. Aconsejar a las mujeres con potencial reproductivo que utilicen métodos anticonceptivos eficaces durante el tratamiento con OPDIVO y YERVOY y durante al menos 5 meses después de la última dosis.

Aumento de la mortalidad en pacientes con mieloma múltiple cuando se añade OPDIVO a un análogo de la talidomida y a la dexametasona

En ensayos clínicos aleatorios en pacientes con mieloma múltiple, la adición de OPDIVO a un análogo de la talidomida más dexametasona dio lugar a un aumento de la mortalidad. El tratamiento de pacientes con mieloma múltiple con un anticuerpo bloqueador de PD-1 o PD-L1 en combinación con un análogo de la talidomida más dexametasona no se recomienda fuera de los ensayos clínicos controlados.

Lactancia

No hay datos sobre la presencia de OPDIVO o YERVOY en la leche humana, los efectos en el niño amamantado o los efectos en la producción de leche. Debido al potencial de reacciones adversas graves en los niños amamantados, se aconseja a las mujeres que no den el pecho durante el tratamiento y durante los 5 meses siguientes a la última dosis.

Reacciones adversas graves

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 9ER, serious adverse reactions occurred in 48% of patients receiving OPDIVO and cabozantinib (n=320). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. Fatal intestinal perforations occurred in 3 (0.9%) patients. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=154). The most frequent serious adverse reactions reported in ≥2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, pneumonia, and anemia. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in ≥4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in ≥2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). In Checkmate 649, serious adverse reactions occurred in 52% of patients treated with OPDIVO in combination with chemotherapy (n=782). The most frequent serious adverse reactions reported in ≥ 2% of patients treated with OPDIVO in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). Fatal adverse reactions occurred in 16 (2.0%) patients who were treated with OPDIVO in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation.

Reacciones adversas comunes

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 743, the most common adverse reactions (≥20%) in patients receiving OPDIVO plus YERVOY were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 9ER, the most common adverse reactions (≥20%) in patients receiving OPDIVO and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough (14%) and dyspnea (14%) at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent (n=74), the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=154) were fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO with YERVOY (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%), decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Attraction-3, the most common adverse reactions (≥20%) in OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%). In Checkmate 649, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%).

In a separate Phase 3 trial of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Consulte la información de prescripción completa de OPDIVO y YERVOY en los Estados Unidos.

Ensayos clínicos y poblaciones de pacientes

Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 227–previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 025–previously treated renal cell carcinoma; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma, as a single agent or in combination with YERVOY; Checkmate 238–adjuvant treatment of melanoma; Attraction-3–esophageal squamous cell carcinoma; Checkmate 649–previously untreated advanced or metastatic gastric or gastroesophageal junction or esophageal adenocarcinoma.

Acerca de la colaboración entre Bristol Myers Squibb y Ono Pharmaceutical

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

Acerca de Bristol Myers Squibb

Bristol Myers Squibb es una empresa biofarmacéutica mundial cuya misión es descubrir, desarrollar y suministrar medicamentos innovadores que ayuden a los pacientes a vencer enfermedades graves. Para más información sobre Bristol Myers Squibb, visítenos en BMS.com o síganos en LinkedIn, Twitter, YouTube, Facebook e Instagram.

Celgene y Juno Therapeutics son filiales al cien por cien de Bristol-Myers Squibb Company. En algunos países fuera de los Estados Unidos, debido a las leyes locales, Celgene y Juno Therapeutics se denominan Celgene, una empresa de Bristol Myers Squibb, y Juno Therapeutics, una empresa de Bristol Myers Squibb.

Advertencia sobre las declaraciones prospectivas

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that Opdivo plus Yervoy may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such combination treatment for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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Source: Bristol Myers Squibb