On May 19, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported additional clinical data for lifileucel alone and in combination with pembrolizumab in patients with advanced melanoma (Press release, Iovance Biotherapeutics, MAY 19, 2021, View Source [SID1234580279]). The data are available in two ASCO (Free ASCO Whitepaper) abstracts, with additional updates to be provided at the upcoming ASCO (Free ASCO Whitepaper) 2021 Annual Meeting, to be held June 4-8, 2021 .

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Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics, stated, "We are very excited that our latest clinical datasets demonstrate the broad potential for lifileucel in advanced melanoma. For the first time we are reporting results for lifileucel as an earlier treatment for advanced melanoma in combination with pembrolizumab, demonstrating an overall response rate (ORR) of 86% in patients who are naïve to anti-PD-1 therapy. We are impressed with the results for this combination regimen, particularly since pembrolizumab alone demonstrated a 33% ORR in a comparable patient population. In addition, in a post-PD1 advanced melanoma patient population in Cohort 2 in the C-144-01 study, shorter duration of prior anti-PD-1 therapy maximizes Duration of Response (DOR) to lifileucel treatment."

Lifileucel in Combination with Pembrolizumab in Advanced Melanoma (IOV-COM-202 Study)
Early data suggest the response rate of lifileucel plus pembrolizumab may be additive 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 up to 12 patients who are naïve to ICI, or anti-PD-1, therapy. Six of the initial seven patients had a confirmed objective response, representing an 86% ORR (1 Complete Response (CR) and 5 Partial Responses (PR), with one best response of stable disease (abstract data extraction: February 2021). The longest duration of response was 16.8 months.

The Treatment-Emergent Adverse Event (TEAE) profile was consistent with the underlying disease and known Adverse Event (AE) profiles of pembrolizumab, NMA-LD and IL-2. These encouraging data confirm the potential feasibility and activity of lifileucel in combination with pembrolizumab in early-line treatment of patients with advanced melanoma. Updated results for the initial seven patients will be available in the upcoming ASCO (Free ASCO Whitepaper) poster.

Lifileucel Following anti-PD-1 therapy in Advanced Melanoma (C-144-01 clinical study)
As previously reported, 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. DOR was not reached at 28.1 months of median study follow up and ORR remained at 36.4 percent.

New data in the ASCO (Free ASCO Whitepaper) abstract suggest that DOR was positively associated with shorter cumulative duration of prior anti-PD-1 therapy. In responders, the median cumulative duration and median prior lines of anti-PD-1 therapy was 4.4 months (range: 1.4-22.5 months) and 1.5 lines (range: 1-4). These results support earlier use of lifileucel following anti-PD-1 therapy instead of retreatment with anti-PD-1 based – regimens.

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 adverse events emerging over time. Updated results for Cohort 2 with longer duration of follow up will be part of the oral presentation during ASCO (Free ASCO Whitepaper) 2021.

Iovance Presentation and Poster 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

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