John Michael Kaczmar, MD, medical oncologist, associate professor, College of Medicine, Medical University of South Carolina (MUSC), MUSC Health, discusses future implications forthe use of fianlimab (formerly REGN 3767) in combination with cemiplimab-rwlc (Libtayo) for the treatment of patients with advanced melanoma.

, data from a phase 1 study (NCT03005782) revealed that the combination of the LAG-3 inhibitor fianlimab and cemiplimab elicited high and consistent tumor responses. These responses were similar in toxicity profile to PD-L1 inhibitor monotherapies in patients with advanced melanoma who had not previously received PD-L1 inhibitors in the advanced setting. These outcomes indicate that dual PD-1/LAG-3 inhibition is effective and safe, even among patients who have undergone previous adjuvant immunotherapy and those with unfavorable prognostic characteristics.

Looking to the future, investigators are continuing to examine the utility and benefit of fianlimab when given with cemiplimab vs pembrolizumab (Keytruda), as measured by progression-free survival, in patients with advanced melanoma in a phase 3 trial (NCT05352672). Additionally, researchers are currently investigating fianlimab plus cemiplimab vs pembrolizumab monotherapy in the adjuvant setting in a phase 3 trial (NCT05608291), and they are in the process of validating it through more extensive studies, Kaczmar states. This research could introduce another effective treatment option for patients with recurrent/metastatic melanoma and may emerge as a superior choice for patients in the adjuvant setting, Kaczmar explains.

Furthermore, exploring combinations in the neoadjuvant setting is crucial, Kaczmar continues. For various cutaneous malignancies, specifically in more advanced cases, there is a growing trend toward employing neoadjuvant therapies, he says. This trend is not solely pertinent to melanoma, as skin alterations also encompass other cancerous conditions, he notes. Consequently, oncologists anticipate an increasing emphasis on neoadjuvant therapies, as thissetting is often the most opportune moment to administer immune therapy, Kaczmar states. Notably, the tolerability of this approach, which is associated with minimal additional toxicity, renders it as a potential treatment applicable across different stages of the disease continuum, Kaczmar concludes.

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John Michael Kaczmar, MD, discusses future implications for the use of fianlimab in combination with cemiplimab for the treatment of patients with advanced melanoma.


John Michael Kaczmar, MD

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Dr Kaczmar on the Future Utility of Cemiplimab With Fianlimab in Advanced Melanoma