On June 4, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported clinical data for lifileucel in combination with pembrolizumab in patients with advanced melanoma (Press release, Iovance Biotherapeutics, JUN 4, 2021, View Source [SID1234583538]). The data are now available in an ePoster at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting.

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Antonio Jimeno M.D., Ph.D., Professor of Medicine/Oncology and Otolaryngology at the University of Colorado School of Medicine stated, "Anti-PD-1 therapy has become standard of care in frontline melanoma, yet we are still looking for ways to help more patients respond and to improve upon the depth and durability of responses. The 86% Overall Response Rate (ORR) for lifileucel in combination with pembrolizumab is remarkable and suggests a potential additive effect for early-line treatment of patients with melanoma. I look forward to investigating this treatment approach in additional patients with melanoma as well as in other tumor types such as head and neck squamous cancer."

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "We are very pleased with the initial efficacy and safety results for lifileucel in combination with pembrolizumab in patients who are naïve to anti-PD-1 therapy. We are particularly impressed by the complete response observations and noted conversion of several partial to complete responses over time. These data in melanoma also build upon our initial data for TIL in combination with pembrolizumab in head and neck cancer, supporting the broader potential for TIL in earlier anti-PD-1 naïve treatment settings across indications."

Early data suggest the response rate of lifileucel plus pembrolizumab may be additive and confirm the potential feasibility and activity of this combination in patients with immune checkpoint inhibitor (ICI)-naïve advanced melanoma. Cohort 1A in the IOV-COM-202 study is evaluating lifileucel in combination with pembrolizumab in patients who are naïve to ICI, or anti-PD-1, therapy. Initial patients (n=7) enrolled in Cohort 1A had high tumor burden at baseline, and 71.4% had not received any prior systemic therapy.

Six of the seven patients had a confirmed objective response, representing an 86% ORR (2 complete responses (CR), 1 unconfirmed CR (uCR) who had not yet reached the confirmatory CR assessment, and 3 partial responses (PR)), with one best response of stable disease. Responses deepened over time and the CR/uCR rate was 43%. Poster data extraction was in April 2021 and the median follow up was 8.2 months. ORR was investigator-assessed per RECIST 1.1. In a subsequent data cut in May 2021, all ongoing responses continued.

The Cohort 1A results also demonstrated that lifileucel can be safely combined with pembrolizumab. The treatment-emergent adverse event (TEAE) profile was consistent with the underlying disease and known adverse event (AE) profiles of pembrolizumab, non-myeloablative lymphodepletion (NMA-LD) and IL-2. The median number of doses of IL-2 and pembrolizumab were six and 10, respectively.

Iovance Poster at ASCO (Free ASCO Whitepaper) 2021
Title: Safety and efficacy of lifileucel (LN-144), an autologous, tumor infiltrating lymphocyte cell therapy in combination with pembrolizumab for immune checkpoint inhibitor naïve patients with advanced melanoma.
Authors: Sajeve Samuel Thomas, et al.
Session Title: Melanoma/Skin Cancers
Session Type: ePoster Session
Abstract Number: 9537
Location: ASCO (Free ASCO Whitepaper) Meeting Library at View Source and View Source
ePoster Viewing: on demand beginning Friday, June 4, 2021 at 9:00 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. Omid Hamid of The Angeles Clinic, will present a summary of the ASCO (Free ASCO Whitepaper) data from Cohort 1A in the IOV-COM-202 study as well as the upcoming 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.