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Iovance Reports Pivotal Cohort 4 Data for Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel from C-144-01 Clinical Study in Advanced Melanoma
Cohort 4 Early Data Shows 32.4% ORR by Investigator Assessment at 5.3 Months of Median Study Follow up Cohort 2 Median Duration of Response Not Reached at
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"Cohort 4 Early Data Shows 32.4% ORR by Investigator Assessment at 5.3 Months of Median Study Follow up\n Cohort 2 Median Duration of Response Not Reached at 18.7 Months of Median Study Follow Up and 36.4% ORR SAN CARLOS, Calif., May 27, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced initial data from pivotal Cohort 4 and updated long-term data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma. “We are very pleased to announce our pivotal Cohort 4 early data from the C-144-01 clinical study in advanced melanoma today,” said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics. “The data from the first 68 patients in Cohort 4, with a 32.4% overall response rate (ORR) at 5.3 months of median study follow up, is highly consistent with what we have observed in Cohort 2 with comparable study follow up. For Cohort 2, median duration of response has not been reached at 18.7 months of study follow up. Available care for metastatic melanoma patients enrolled into our program is chemotherapy, which has been reported to offer a 4-10% response rate with a very short median duration of response. Together, these early data continue to support the potential benefit of the one-time administration of lifileucel TIL therapy in advanced melanoma patients.” Interim Pivotal Cohort 4 ResultsInitial results from the pivotal Cohort 4 in the C-144-01 clinical study is available for 68 patients with two radiological assessments, as determined by investigator. Primary endpoint for the C-144-01 Cohort 4 study is ORR by independent review committee and secondary endpoint is ORR by investigator. Lifileucel shows a 32.4% overall response rate (1 complete response and 21 partial responses, 2 of which are yet to be confirmed with follow up visits) and a disease control rate of 72.1% as of the data cut off of 16 Mar 2020. This data is consistent with what was noted in Cohort 2 at 6 months of median study follow up. The ORR was 33% as reported in SITC 2018 abstract. The Cohort 4 metastatic melanoma patients have a similar patient characteristic profile to Cohort 2 with high baseline disease burden. They have progressed on multiple prior therapies, including anti-PD-1 and BRAF/MEK inhi...