Fianlimab Combo Shows Activity in Advanced Melanoma Subtypes

Source: Cancer Network, October 2024

The safety profile of fianlimab/cemiplimab in a phase 1 trial was consistent with prior reports of cemiplimab monotherapy.

Significant clinical activity occurred among patients with advanced melanoma of various LAG-3 and PD-L1 expressions statuses when they received fianlimab plus cemiplimab-rwlc (Libtayo), according to post analysis data from a phase 1 trial (NCT03005782) presented at the 2024 European Society of Medical Oncology Congress (ESMO).

Tumor responses assessed by blinded independent central review (BICR) in a combined cohort of 98 patients showed that at a median follow-up of 23 months (interquartile range, 15-31), the overall response rate (ORR) was 57% (95% CI 47%-67%), including a complete response (CR) rate of 25% and a partial response (PR) rate of 33%. The rates of stable disease (SD) and progressive disease (PD) were 17% and 15%, respectively. Seven percent of patients were not evaluable (NE), and 3% of patients did not reach CR or PD. The disease control rate (DCR) was 78% (95% CI, 68%-85%). The median time to response was 1.5 months, and the median time to CR was 4.1 months.

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