64: Lifileucel TIL Cell Therapy in Patients With Advanced Melanoma After Progression on Immune Checkpoint Inhibitors (ICI) and Targeted Therapy: Tumor Tissue Procurement Data from the C-144-01 Study

Friday, March 24, 2023

11:34 AM – 11:44 AM

Location: Veterans Memorial Auditorium

Abstract Presenter(s)

Michael E. Egger, MD, MPH

Associate Professor
Unversity of Louisville
Louisville, Kentucky, United States

Disclosure(s): Iovance Biotherapeutics: Consultant (Ongoing); SkylineDx: Contracted Research (Ongoing)

First Author(s)

Michael E. Egger, MD, MPH

Associate Professor
Unversity of Louisville
Louisville, Kentucky, United States

Disclosure(s): Iovance Biotherapeutics: Consultant (Ongoing); SkylineDx: Contracted Research (Ongoing)

Author(s)

Martin McCarter, MD

Professor of Surgery
University of Colorado School of Medicine

Disclosure information not submitted.
Kelly Olino, MD (she/her/hers)

Assistant Professor of Surgical Oncology
Yale School of Medicine
New Haven, Connecticut, United States

Disclosure(s): No financial relationships to disclose
NK

Nikhil Khushalani, MD

Vice Chair for the Department of Cutaneous Oncology
H. Lee Moffitt Cancer Center, Tampa, FL, USA, United States

Disclosure information not submitted.
JC

Jason A. Chesney, MD, PhD

Professor of Medicine
University of Louisville, Louisville, KY, USA, United States

Disclosure information not submitted.
TM

Theresa Medina, MD

Assistant Professor, Medicine-Medical Oncology
University of Colorado Cancer Center – Anschutz Medical Campus, Aurora, CO, USA, United States

Disclosure information not submitted.
HK

Harriet Kluger, MD

Professor of Medicine (Oncology) and of Dermatology
Yale University School of Medicine, Smilow Cancer Center, New Haven Hospital, NewHaven, CT, USA, United States

Disclosure information not submitted.
FG

Friedrich Graf Finckenstein, MD

Chief Medical Officer
Iovance Biotherapeutics, Inc., San Carlos, CA, USA, United States

Disclosure information not submitted.
PH

Parameswaran Hari, MD

Senior Vice President
Iovance Biotherapeutics, Inc., San Carlos, CA, USA, United States

Disclosure information not submitted.
MJ

Madan Jagasia, MBBS, MD

Executive Vice President
Iovance Biotherapeutics, Inc., San Carlos, CA, USA, United States

Disclosure information not submitted.
XW

Xiao Wu, PhD

Executive Director, Biostatistics
Iovance Biotherapeutics, Inc., San Carlos, CA, USA, United States

Disclosure information not submitted.
WS

Wen Shi, MD, PhD

Vice President, Clinical Science
Iovance Biotherapeutics, Inc., San Carlos, CA, USA, United States

Disclosure information not submitted.
AS

Amod Sarnaik, MD

Associate Professor of Cutaneous Oncology and Immunology
H. Lee Moffitt Cancer Center, Tampa, FL, USA, United States

Disclosure information not submitted.

Disclosure(s):

Michael E. Egger, MD, MPH: Iovance Biotherapeutics: Consultant (Ongoing); SkylineDx: Contracted Research (Ongoing)

Kelly Olino, MD: No financial relationships to disclose

Introduction: Investigational tumor-infiltrating lymphocyte (TIL) cell therapy has demonstrated potential efficacy in multiple solid tumors. Surgeons are key contributors to multidisciplinary TIL cell therapy patient (pt) care because of their role in tumor resection, providing the starting material for TIL cell therapy manufacturing. We report surgical outcomes of lifileucel, a one-time autologous TIL cell therapy, in pts with advanced melanoma enrolled in the multicohort, open-label, Phase 2 C‑144-01 study.

Methods: All pts had progressed on ICI and targeted therapy (if appropriate). Pts had ≥1 lesion resected (~1.5 cm diameter) for 22-day lifileucel manufacturing. All pts received nonmyeloablative lymphodepletion, a single lifileucel infusion, and ≤6 doses of high-dose IL-2. The primary endpoint was independent review committee (IRC)-assessed ORR (RECIST v1.1).

Results: The full analysis set included 153 pts (Cohort 2: n=66; Cohort 4: n=87) treated with lifileucel, with a median of 3 prior lines of therapy and high baseline disease burden. Lifileucel was manufactured using tumor tissue resected from diverse sites, including lymph node/skin/subcutaneous (46%), visceral organ (28%), and other (26%; eg, muscle, soft tissue, bone, limb/extremity). No difference was seen in TIL dose manufactured across resection sites and target lesion sum of diameter reductions were seen regardless of TIL dose. Only 3% of resected pts had G3/4 tumor-resection AEs related to surgery, which included cellulitis and postsurgical site-related AEs (n=2 each), and nausea, abdominal pain, and hypoxia (n=1 each). No patient had surgery-related AEs that prevented TIL infusion. Treatment-emergent AEs were consistent with prior reports. ORR was 31% (8 CR; 40 PR), with responses observed across all resection sites. At a median 27.6-mo follow-up, median DOR was not reached (40% of responses ongoing at datacut).

Conclusions: Lifileucel showed potential efficacy, durable activity, and a favorable safety profile with minimal surgical morbidity in pts with heavily pretreated advanced melanoma, regardless of tumor resection site.

Learning Objectives:

To understand the efficacy and safety outcomes of lifileucel TIL cell therapy in patients with advanced melanoma who progressed post immune checkpoint inhibitor and targeted therapy (where appropriate)
To understand the surgical aspects of the favorable safety profile of lifileucel TIL cell therapy
To highlight the key role of the surgeon in the success of lifileucel TIL cell therapy