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Soo Park, MD
Soo Park, MD
Posted: Tuesday, July 16, 2024
The early efficacy, durability, and safety of a drug combination to address immune checkpoint inhibitor–naive unresectable or metastatic melanoma all seem to support the treatment’s further evaluation in a phase III trial, according to Sajeve Samuel Thomas, MD, of Orlando Health Cancer Institute, Florida, and colleagues. The team is evaluating lifileucel, an autologous tumor-infiltrating lymphocyte cell therapy, plus the PD-1 inhibitor pembrolizumab in the phase II trial IOV-COM-202. They presented the updated results of the study’s cohort 1A during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9505).
The endpoints were objective response rate and incidence of grade ≥ 3 treatment-emergent adverse events. The analysis included 22 patients (median age, 48.5) who received pembrolizumab, nonmyeloablative lymphodepletion (cyclophosphamide and fludarabine), a single lifileucel infusion (ranging from 1 × 109 cells to 150 × 109 cells), six or fewer doses of interleukin-2 (600,000 IU/kg intravenously), and continued pembrolizumab until disease progression or unacceptable toxicity for up to 24 months. Eight patients had V600 BRAF mutations, and three had had prior BRAF/MEK inhibitor treatment.
“All response-evaluable patients demonstrated regression of target lesions,” noted Dr. Thomas and co-investigators, and the median time to initial response was 2.5 months. At a median follow-up of 17.2 months, they noted, the median duration of response was not reached. Further, 71.4% of the responders had an ongoing response, and 36.4% had a response lasting at least 12 months. The confirmed objective response rate was 63.6%, including 22.7% complete responses and 40.9% partial responses; 27.3% had stable disease.
Grade ≥ 3 treatment-emergent adverse events “were consistent with the underlying disease and known safety profiles of pembrolizumab, nonmyeloablative lymphodepletion, and interleukin-2,” confirmed the researchers. The most common adverse events were thrombocytopenia (68.2%), neutropenia (50.0%), and anemia (45.5%).
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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