On May 29, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported long-term interim data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma during an oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program (Press release, Iovance Biotherapeutics, MAY 29, 2020, View Source [SID1234558709]).

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"We are very pleased to present the long term follow up data for lifileucel in melanoma at the ASCO (Free ASCO Whitepaper) Scientific Program," said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics. "The median duration of response has not been reached at 18.7 months of study follow up supporting potential benefit of the one-time treatment of lifileucel TIL therapy in advanced melanoma patients. The latest data at ASCO (Free ASCO Whitepaper) also demonstrate durable responses with lifileucel across the broad spectrum of our study population, including a wide age range of metastatic melanoma patients who have received prior anti-CTLA-4 and BRAF targeted treatments, and equally in patients with PD-L1 high and low status."

Jason Chesney, MD PhD, Director, James Graham Brown Cancer Center, University of Louisville and C-144-01 study investigator stated, "One of the greatest challenges oncologists face today is the treatment of melanoma patients who have progressed on immune checkpoint and BRAF/MEK inhibitors. The preliminary results of the C-144-01 study demonstrate that autologous tumor infiltrating lymphocytes (TILs; lifileucel) induce durable clinical responses in a significant percentage of this moribund population. Importantly, this new study opens the door for trials of TILs in many other cancer types and in combination with our growing repertoire of immunomodulatory agents."

Updated interim results from Cohort 2 are now available from 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." As of the April 23, 2020 data extract for the oral presentation, lifileucel shows a 36.4% overall response rate (2 complete responses and 22 partial responses) and a disease control rate of 80% (n=66). Median duration of response (DOR) was not reached at 18.7 months of median study follow up (2.2 to 26.9+ months).

The Cohort 2 patients had heavily pretreated metastatic melanoma 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.

Michael Kaplan, President and CEO of the Melanoma Research Alliance, stated, "While the last decade has brought incredible progress in delivering new treatments for melanoma, we know that more than half of patients with advanced melanoma are still in need of additional options. It is particularly exciting to see a new treatment approach, like lifileucel, that can offer hope and real results for some for whom checkpoint immunotherapy alone has yet to prove successful. The Melanoma Research Alliance is excited that Iovance has taken a significant step forward in ensuring more treatment options for patients who once had very few."

The oral abstract session is 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