Median Duration of Response Not Reached at 18.7 Months of Median Study Follow Up
C-144-01 Study Contributes to Advancement in TIL Therapy Using Centrally Standardized Manufacturing, Allowing for Broadened Patient Access
SAN CARLOS, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), today announced that the Journal of Clinical Oncology has published a manuscript of clinical data for Cohort 2 in the C-144-01 study of lifileucel TIL therapy in metastatic melanoma. Online open access to the publication is available at https://ascopubs.org/doi/full/10.1200/JCO.21.00612.
Amod Sarnaik, Associate Professor of Cutaneous Oncology and Immunology at H. Lee Moffitt Cancer Center stated, “Effective treatment options are limited for patients with advanced melanoma who progress after immune checkpoint inhibitors and targeted therapies. Lifileucel represents a significant improvement in the treatment of advanced melanoma, particularly in the expanding post-immune checkpoint inhibitor patient population. The results from the C-144-01 clinical study, as well as the advancement of lifileucel using a centralized TIL manufacturing process, offer a new opportunity for accessible treatment for the most challenging to treat patients with metastatic melanoma.”
“With this publication we have summarized several years of our clinical development and TIL manufacturing as we strive to make TIL a broadly accessible cell therapy for patients with advanced melanoma,” said Maria Fardis, PhD, MBA, President and Chief Executive Officer of Iovance. “At the time of the data extract for publication, the overall response rate (ORR) was 36%, median duration of response (DOR) had not been reached at 18.7 months of median study follow up and median overall survival (OS) was 17.4 months. As a reference, patients treated with chemotherapy are expected to have an OS of approximately 7 months. I believe these results demonstrate the durability of one-time treatment with lifileucel. Importantly, durable responses were seen across all patient subgroups regardless of prior treatment or mutation status, including patients who were primary refractory to anti−PD-1 therapy. I would like to thank the investigators who contributed to this manuscript as well as the patients who participated in Cohort 2 of the C-144-01 clinical study.”
Publication Summary
In Cohort 2 of the C-144-01 clinical study, 66 patients received a mean of 3.3 prior therapies. As of the data extract for the publication (April 23, 2020), the ORR was 36% (2 complete responses and 22 partial responses), meeting the study primary endpoint in a patient population that had failed frontline anti−PD-1 therapy, the current standard of care. The median DOR was not reached after a median of 18.7 months of study follow-up (range 0.2 to 34.1 months) and 69% of patients had DOR of at least one-year. The median OS was 17.4 months, and one-year survival was 38% in patients with stable disease and 92% in patients with a partial or complete response.
Lifileucel also demonstrated similar ORR across Cohort 2 subgroups, including patients who were primary refractory to anti−PD-1 or anti−PD-L1 therapy (41%); patients who received anti−PD-1 or anti−PD-L1 combination as a frontline therapy (33%) or after failing frontline therapy (32%); and patients with primary resistance or acquired resistance to anti−PD-1 plus anti−CTLA-4 combination therapy (35% and 27%, respectively).
Responses to lifileucel were agnostic of PD-L1 status, BRAF mutation status, or prior anti−CTLA-4 therapy. Safety profile was consistent with known adverse events associated with advanced disease, non-myeloablative lymphodepletion, and IL-2.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient’s own immune cells to attack cancer. TIL cells are extracted from a patient’s own tumor tissue, expanded through a proprietary process, and infused back into the patient. Upon infusion, TIL reach tumor tissue, where they attack cancer cells. The company has completed dosing in pivotal programs in patients with metastatic melanoma and cervical cancer. In addition, the company’s TIL therapy is being investigated in a registration-supporting study for the treatment of patients with locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC). Clinical studies are also underway to evaluate TIL in earlier stage cancers in combination with currently approved treatments, and to investigate Iovance peripheral blood lymphocyte (PBL) T cell therapy for blood cancers. For more information, please visit www.iovance.com.
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Iovance Biotherapeutics, Inc:
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