On April 9, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma (Press release, Iovance Biotherapeutics, APR 9, 2021, View Source [SID1234577772]). These data will be part of an oral presentation in a Clinical Trials Plenary Session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting.

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"We are very excited to report our latest Cohort 2 melanoma data in an oral presentation at AACR (Free AACR Whitepaper)," said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics. "The long term follow up data show that median duration of response was not reached at 28.1 months of median study follow up. Furthermore, overall response rate remained at 36.4 percent and we saw a continued deepening of response in 17 percent of the patients. The data continue to demonstrate durability and depth of our lifileucel TIL therapy response after a one-time treatment, in a difficult to treat patient population with advanced melanoma. We are honored that AACR (Free AACR Whitepaper) has chosen our melanoma Cohort 2 data to be featured in a clinical trials plenary session."

Jason Chesney, M.D., Ph.D., Director, James Graham Brown Cancer Center, University of Louisville and C-144-01 study investigator stated, "Melanoma patients who have progressed on immune checkpoint and BRAF/MEK inhibitors are among the most challenging patients for oncologists to treat. The updated results of the C-144-01 study continue to demonstrate that autologous tumor infiltrating lymphocytes (TILs; lifileucel) induce durable clinical responses in 36 percent of patients in the study. This study also creates opportunities for additional trials of TILs in many other cancer types and in combination with immunomodulatory agents."

The Cohort 2 data are available in the abstract titled, "Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced (unresectable or metastatic) melanoma: durable duration of response at 28-month follow up." Data highlights as of the December 14, 2020 data cut extract used for the abstract submitted to AACR (Free AACR Whitepaper) were as follows:

Lifileucel showed a 36.4% overall response rate (4.5% complete responses and 31.8% partial responses) and median duration of response (DOR) was not reached at 28.1 months of median study follow up as assessed by investigators (n=66).
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-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 additional adverse events emerging over time.
The abstract is available in the AACR (Free AACR Whitepaper) Online Meeting Planner at www.aacr.org and on the Iovance website at www.iovance.com/our-science/publications. The data from the abstract will be highlighted in additional detail at the AACR (Free AACR Whitepaper) 2021 Annual Meeting. Details of the oral presentation are as follows:

Abstract Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced (unresectable or metastatic) melanoma: durable duration of response at 28-month follow up
Authors: Jason Alan Chesney, MD, PhD, et al.
Abstract Number: 5329
Presentation Number: CT008
Session Title: Immunooncology and Cell Therapy Trials
Session Date and Time: Saturday, April 10, 2021, 4:45 PM – 5:00 PM ET
Location: AACR (Free AACR Whitepaper) Virtual Annual Meeting 2021 at www.aacr.org
In addition to the oral presentation, three Iovance poster presentations at AACR (Free AACR Whitepaper) will highlight the design of clinical trials in progress in solid tumors and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). These posters are intended to educate physicians about study design and will not include clinical data. Posters will be available from 8:30 a.m. ET on Saturday, April 10 through Monday, June 21, 2021 in the Virtual ePoster Hall at www.aacr.org and on the Iovance website at www.iovance.com/our-science/publications.

Abstract Title: A Phase 2, multicenter study of autologous tumor infiltrating lymphocytes (TIL) (LN-144/LN-145/LN-145-S1) in patients with solid tumors (IOV-COM-202)
Authors: Scott Gettinger, MD, et al.
Abstract Number: CT235
Abstract Title: A Phase 1/2 study evaluating the safety and efficacy of IOV-2001 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (IOV-CLL-01)
Authors: Meixiao Long, MD, PhD, et al.
Abstract Number: CT244
Abstract Title: A phase 2 multicenter study of autologous tumor infiltrating lymphocytes (TIL; LN-145) cell therapy in patients with metastatic non-small cell lung cancer (IOV-LUN-202)
Authors: Erminia Massarelli, MD, PhD, et al.
Abstract Number: CT246