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Soo Park, MD
Soo Park, MD
Posted: Friday, July 19, 2024
With no U.S. Food and Drug Administration–approved treatments for immune checkpoint inhibitor–resistant metastatic melanoma, clinical outcomes for this patient population remain poor. Sapna Pradyuman Patel, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues assessed the efficacy and safety of SX-682—an oral, first-in-class CXCR1/2 inhibitor—in combination with the PD-1 inhibitor pembrolizumab in patients whose disease progressed on anti–PD-1 and anti–CTLA-4 therapies. The results of this study, presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9508), showed this treatment regimen to be well tolerated, with clinically meaningful disease control.
This phase I trial enrolled 51 patients with metastatic melanoma whose disease progressed on prior anti–PD-1 therapy. Participants were administered escalating doses of SX-682, from 25 mg to 400 mg by mouth twice daily in a 21-day cycle, plus pembrolizumab.
The median patient age was 65, and 45% of participants received at least three prior lines of therapy. No dose-limiting toxicities were reported, and a maximum tolerated dose was not identified. Most patients reported any-grade treatment-related adverse events (75%), and grade 3 or 4 events affected 43%; 20% of patients discontinued therapy because of treatment-related adverse events.
The objective response rate among patients given 200 mg of SX-682 was 21% (n = 19), consisting of four partial responses and no complete responses. The disease control rate was 63%, including eight cases of stable disease. Of note, the disease control rate significantly correlated with SX-682 dosing; the rates were higher at 150 mg (50%; P = .0440) and 200 mg (63%; P = .0028). Median overall survival was also longer among patients who received 200 mg of SX-682 than among those treated with 100 mg or less (14.7 vs 7.4 months).
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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