On May 27, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported 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 (Press release, Iovance Biotherapeutics, MAY 27, 2020, View Source [SID1234558544]).

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"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 Results

Initial 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 (Free SITC Whitepaper) 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 inhibitors. The adverse event profile was consistent with Cohort 2 and with the underlying advanced disease, lymphodepletion and IL-2 regimens. Cohort 4 dosed a total of 89 patients, and additional updates on Cohort 4 will be presented at upcoming medical meetings. Iovance remains on track to submit a biologics licensing application (BLA) for lifileucel in late 2020.

Updated Cohort 2 Results

Updated results from Cohort 2 will be presented at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program during an oral abstract session titled, "Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies." In this Cohort 2 data, lifileucel shows a 36.4% overall response rate (2 complete responses and 22 partial responses) and a disease control rate of 80% (n=66) as assessed by investigators. Median duration of response (DOR) was not reached at 18.7 months of median study follow up (2.2 to 26.9+ months). Durable responses have been observed across a wide age range in metastatic melanoma patients who have received prior anti-CTLA-4 and BRAF targeted treatments, regardless of BRAF mutation status, and equally in patients with PD-L1 high and low status.

The Cohort 2 melanoma patients are heavily pretreated with high baseline disease burden. They have progressed on multiple prior therapies (3.3 mean prior therapies), including anti-PD-1 and BRAF/MEK inhibitors. The adverse event profile was consistent with the underlying advanced disease, lymphodepletion and IL-2 regimens.

The oral abstract session at ASCO (Free ASCO Whitepaper)20 will be available on demand in the ASCO (Free ASCO Whitepaper) Meeting Library at View Source Details of the presentation are as follows:

Title: Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies

Authors: Amod Sarnaik, et al.

Session Title: Melanoma/Skin Cancers

Session Type: Oral Abstract Session

Abstract Number: 10006

Location: ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program at View Source

Date/Time: available for on-demand viewing starting at 8:00am ET on May 29, 2020

Furthermore, Iovance will provide results from Cohort 4 as well as Cohort 2 of the C-144-01 study in metastatic melanoma as part of the BLA package. Based on the pooled analysis of Cohort 2 plus 4 (n=134), the overall response rate was 34.3%, including three complete responses, 43 partial responses (two of which are yet to be confirmed with follow up visits) and a disease control rate of 76.1%. Median DOR was not reached at 10.6 months of median study follow up.