Regeneron Pharmaceuticals’ investigational melanoma combination therapy shows continued response after two years in a Phase I trial.
The company presented longer-term data from the Phase I trial (NCT03005782) at the European Society for Medical Oncology (ESMO) Annual Meeting from 13 to 17 September.
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The trial investigated fianlimab, a LAG-3 inhibitor, plus Libtayo (cemiplimab), an anti-PD-L1 treatment, in 98 adults with advanced melanoma who were split into three cohorts, an initial cohort, a confirmatory cohort and a neo/adjuvant experienced cohort who received treatment for 12 months.
After 23 months, with three cohorts combined, there was a 25% complete response (CR) rate and a 57% objective response rate (ORR).
In the first cohort, there was a 23% CR rate and a 60% ORR. In the confirmatory cohort, there was a 25% CR rate and a 63% ORR. Finally, in the cohort with prior neoadjuvant or adjuvant systemic therapy, there was a 28% CR rate and a 39% ORR.
The median time to response and CR were 1.5 months and 4.1 months, respectively. The median duration of response was not reached, and the overall median progression-free survival was 24 months.
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By GlobalDataThe safety profile of the combination in melanoma patients remained consistent with the safety profile of Libtayo monotherapy and other anti-PD-L1 agents, except for higher rates of treatment-related adrenal insufficiency.
This data builds on results presented at the American Society of Clinical Oncology (ASCO) 2023.
Dr Meredith McKean, director of the Melanoma and Skin Cancer Research Program at Sarah Cannon Research Institute, told the Clinical Trials Arena that this data bodes well for other ongoing studies for the combination therapy.
McKean said: “There’s certainly a lot of excitement based on the doubling of the objective response rate with fianlimab and Libtayo compared to other anti-PD1’s. There is an ongoing, randomised Phase III trial in frontline metastatic melanoma that is anticipated to read out in 2025 and there’s a lot of other discussions ongoing about where this immune therapy regimen may also go.”
The company is running four Phase III studies of the combination therapy, including one of the therapies versus Keytruda (pembrolizumab) in previously untreated unresectable locally advanced or metastatic melanoma (NCT05352672).
Additional trials are in the adjuvant (NCT05608291) and perioperative settings (NCT06190951), as well as against other first-line, standard-of-care LAG3 and PD-1 combinations (NCT06246916).
