(November 07, 2022 08:01 ET | Source: Iovance Biotherapeutics, Inc. )
Clinically Meaningful and Durable Activity in Largest Cell Therapy Clinical Trial in Patients with Melanoma After Progression on Immune Checkpoint Inhibitors
31% Objective Response Rate (ORR) and Median Duration of Response (mDOR) Not Reached at 27.6 Months Median Study Follow Up in C-144-01 Trial (Cohorts 2 and 4)
SAN CARLOS, Calif., Nov. 07, 2022 (GLOBE NEWSWIRE) — Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced the publication of abstracts reporting clinical data and a trial in progress (TIP) for Iovance tumor-infiltrating lymphocyte (TIL) cell therapies for the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 8-12, 2022, in Boston, MA and virtually.
The abstract reports on pooled consecutive cohorts from the C-144-01 trial with efficacy data from a total of 153 patients with advanced melanoma enrolled in Cohort 2 (n=66) and Cohort 4 (n=87). All patients had progressed on or after immune checkpoint inhibitor therapy, and targeted BRAF/MEK therapy where appropriate. Patients were heavily pre-treated (median of 3 lines of prior therapy at baseline, range: 1-9) and had substantial disease burden at baseline. As previously reported, 100% of patients received prior anti-PD-1 therapy and more than 80% of patients received prior anti-CTLA-4 therapy.
The ORR assessed by an independent review committee (IRC) using RECIST v1.1 was 31% (95% CI: 24.1%-39.4%), with 8 complete responses (CRs) and 40 partial responses (PRs). mDOR was not reached, 42% of responses extended beyond 18 months, and 40% of responses were ongoing at the median study follow-up of 27.6 months. Median overall survival (mOS) was 13.9 months (95% CI: 10.6-17.8). In patients who achieved a response at their first assessment (6 weeks after lifileucel infusion), mOS had not been reached (95% CI: 22.5 months to NR). The treatment-emergent adverse event profile was consistent with the underlying disease and known adverse event profiles of nonmyeloablative lymphodepletion and interleukin-2 (IL-2). There are no currently approved treatments for the C-144-01 study population. Available care is chemotherapy, offering 4-10% ORR and OS of 7-8 months.1-4
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, “Adding to the initial positive data from our topline analysis, the analyses across pooled Cohorts 2 and 4 further demonstrate the clinical efficacy and durability of lifileucel in patients with advanced melanoma. The C-144-01 trial also validates the potential for lifileucel to become a broadly accessible TIL therapy using our centralized, scalable, 22-day manufacturing process. Our rolling BLA submission for lifileucel to the U.S. FDA is currently underway and on track to complete by the end of this year.”
Additional information and patient-level detail are available in the abstract. Analyses across pooled Cohorts 2 and 4, along with key individual cohort outcomes from an updated data analysis, will be presented during a rapid oral presentation at SITC.
Iovance Posters and Presentations at SITC Annual Meeting
Title: Lifileucel TIL cell monotherapy in patients with advanced melanoma after progression on immune checkpoint inhibitors (ICI) and targeted therapy: Pooled analysis of consecutive cohorts (C-144-01 study)
Authors: A. Sarnaik, et al
Presentation Type: Rapid Oral Abstract and Poster
Session Date and Time: November 10, 2022, 12:33 p.m. (Concurrent Session 105 11:55 a.m. – 12:55 p.m. ET) and Poster Hall (1:00 p.m. – 9:00 p.m. ET)
Abstract ID: 789
Title: Trial in progress: A phase 1/2 open-label study (IOV-GM1-201) of TALEN-mediated PD-1–inactivated autologous tumor-infiltrating lymphocytes (TIL; IOV-4001) in patients with advanced melanoma and NSCLC
Authors: A. Betof Warner, et al
Presentation Type: Poster
Session Date and Time: November 10, 2022, 9:00 a.m. – 9:00 p.m. ET, Poster Hall
Abstract ID: 783
Investor Webcast on Thursday, November 10, 4:30 p.m. ET
Iovance will host a webcast on Thursday, November 10 at 4:30 p.m. ET to discuss clinical data updates for lifileucel in advanced melanoma. Iovance senior leadership will be joined by key opinion leaders and principal investigators in Iovance clinical studies. To participate in the webcast, please register at: https://ir.iovance.com/events/event-details/sitc-investor-webcast. The live and archived webcast can be accessed in the Investors section of the company’s website at www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
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1Keytruda USPI accessed Mar 2022
2Weber et al., Lancet Oncol 2015
3Kirchburger et al., Eur J Cancer 2016
4Goldinger et al., J Clin Oncol 2018
Iovance Biotherapeutics, Inc.:
Sara Pellegrino, IRC
SVP, Investor Relations & Corporate Communications
650-260-7120 ext. 264
Director, Investor Relations & Public Relations