Early stage results of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma

Regeneron is ready with LAG-3 update at ESMO 2022!

Sep 07, 2022 | DelveInsight

The ability to effectively treat melanoma will increase with the development of a combination of LAG-3 and PD-1 inhibitors. Regeneron Pharmaceuticals’ fianlimab is one of the players in the space, which is all set to present data from its Phase I trial in combination with LIBTAYO (cemiplimab). Multiple clinical trials are underway to evaluate LAG-3–directed agents in combination with anti–PD-1 and/or anti–CTLA-4 therapy. Positive data from the Phase I trial of fianlimab in combination with Libtayo in advanced melanoma presented at the American Society of Clinical Oncology (ASCO) Annual Meeting indicate that the journey of fianlimab has been rosy so far. The company is also conducting a Phase III trial of fianlimab in first-line metastatic melanoma. Regeneron plans to file its offering, fianlimab in combination with LIBTAYO (cemiplimab) for advanced melanoma in 2024.

Checkpoint inhibition has revolutionized the treatment of advanced melanoma over the past decade. Infact, the LAG-3 next-generation therapies market is expected to grow in the upcoming years owing to the potential entry of major LAG-3 candidates and their readily uptake, increase in incident cases of various solid tumors, increase in PD-1/PD-L1 relapsed/refractory cases in various cancers, label-expansion in multiple cancer types, robust and unique pipeline (anti-LAG-3 monoclonal, bispecific antibodies and, soluble LAG-3 molecule), and improvement in the outcome of patients.

Relatlimab (in combination with nivolumab) became the first LAG-3-blocking antibody to demonstrate a benefit in a Phase III study and received approval by the US FDA for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma in March 2022. Meanwhile, competition is not far behind, as other immuno-oncology approaches are hotting up.

Fianlimab + cemiplimab combination showed clinical activity for patients with advanced melanoma that is similar to anti–PD-1 + CTLA-4 combination therapy, but with lower demonstrated rates of TEAEs. This year the company is all set to provide updated data from this trial at the ESMO 2022 annual conference. Although it is too early to predict, it will be interesting to see over time if the fianlimab and Libtayo combination will improve overall survival, when compared with nivolumab and relatlimab.  As per Delveinsight’s forecast, if approved, fianlimab and Libtayo combination is estimated to grab more than USD 550 million in revenue in the year 2035 in 7 Major Markets

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