Dr. Thomas on the Safety Profile of Lifileucel Plus Pembrolizumab in Advanced Melanoma

Sajeve Samuel Thomas, MD, medical oncologist and hematologist, Orlando Health Cancer Institute, Orlando Health, assistant professor, Florida State University College of Medicine and University of Central Florida College of Medicine, discusses the safety profile of lifileucel (LN-144) plus pembrolizumab (Keytruda) in advanced melanoma.

The results of the ongoing phase 2 IOV-COM-202 trial (NCT03645928), which were presented during the 2021 ASCO Annual Meeting, demonstrated early efficacy signals with the combination of lifileucel, a tumor-infiltrating lymphocyte cellular therapy, and pembrolizumab in patients with checkpoint inhibitor–naïve advanced melanoma.

Regarding safety, lifileucel plus pembrolizumab was generally well tolerated among patients, Thomas says. The majority of adverse effects (AEs) were related to non-myeloablative lymphodepletion with cyclophosphamide and fludarabine or IL-2 administration, Thomas says. The toxicities observed with pembrolizumab were consistent with the known safety profile of the agent, including fatigue and itchy skin, Thomas says.

Lymphodepletion- and IL-2–related AEs were also consistent with previous reports and were mostly transient, Thomas says. After treatment discontinuation or dose interruption, most AEs resolved within 2 to 4 weeks, Thomas says. However, patients required prolonged hospital stays to monitor for blood-count recovery and potential infections, Thomas says.

Common any-grade AEs included thrombocytopenia, chills, nausea, pyrexia, vomiting, fatigue, febrile neutropenia, hypertension, neutropenia, alopecia, cough, decreased appetite, and peripheral edema. Additionally, over time, the incidence of AEs decreased, suggesting that one-time administration of lifileucel could be optimal, concludes Thomas.