On June 6, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported updated clinical data for lifileucel from Cohort 2 in the C-144-01 clinical study in patients with advanced melanoma (Press release, Iovance Biotherapeutics, JUN 6, 2021, View Source [SID1234583614]). The data were presented in an oral presentation at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting.

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Omid Hamid, M.D., Chief of Research/Immuno-Oncology, The Angeles Clinic & Research Institute, stated, "Anti-PD-1 therapy is a mainstay class of treatment offering several therapeutic options for metastatic melanoma. For patients who progress on anti-PD-1 therapy, there is an unfulfilled need for efficacious and durable treatment options. The latest results with lifileucel suggest that early intervention with lifileucel TIL therapy, immediately upon progression on anti-PD-1 therapy, may offer better outcomes and longer duration of response. These data offer evidence that patients have had positive treatment experiences with lifileucel, and I believe TIL therapy has the potential to become an important option within the melanoma treatment landscape."

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "Our latest data for Cohort 2 in the C-144-01 clinical study are very exciting and continue to support the durability of responses after lifileucel in challenging to treat patients with melanoma. Median DOR has still not been reached at 33 months of median study follow up. We are also reporting the important observation that a shorter duration of prior anti-PD-1 therapy is associated with longer duration of response after lifileucel. We are committed to bringing lifileucel to patients as soon as we can."

The long-term follow-up data for Cohort 2 in the C-144-01 clinical study continue to demonstrate durability and depth of lifileucel TIL therapy response. Median DOR was not reached at 33.1 months of median study follow up (range: 2.2 to 38.5+ months) and Overall Response Rate, or ORR, remained at 36.4% (data extraction: April 2021). Responses deepened over time and one patient converted from partial to complete response at 24 months post lifileucel infusion.

A multivariable model showed that for every six-month decrease in cumulative duration of prior anti-PD-1 therapy, DOR to lifileucel will be nearly doubled. These results suggest that early intervention with lifileucel at the time of initial progression on anti-PD-1 therapy may maximize benefit.

All patients in Cohort 2 had high baseline disease burden and were heavily pretreated (3.3 mean prior therapies), including anti-PD1 and BRAF/MEK inhibitors if BRAFV600 mutation positive. The adverse event profile was consistent with the underlying advanced disease, lymphodepletion and IL-2 regimens, with no new safety risks identified for lifileucel during long-term follow-up.

Iovance Presentation at ASCO (Free ASCO Whitepaper) 2021
Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.
Authors: James M. G. Larkin, et al.
Session Title: Melanoma/Skin Cancers
Session Type: Oral Abstract Session
Abstract Number: 9505
Location: ASCO (Free ASCO Whitepaper) Meeting Library at View Source and View Source
Session Date and Time: Sunday, June 6, 2021 from 8:00 – 11:00 a.m. ET
Webcast and Conference Call
Iovance will host a webcast and conference call on Sunday, June 6, at 12:00 p.m. ET to discuss ASCO (Free ASCO Whitepaper) clinical data updates for lifileucel alone and in combination with pembrolizumab in patients with advanced melanoma. Iovance senior leadership, together with Dr. Hamid, will present a summary of the ASCO (Free ASCO Whitepaper) data from Cohort 1A in the IOV-COM-202 study as well as the oral presentation of updated Cohort 2 data from the C-144-01 clinical study.

The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and the access code is 4858337. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.