Conclusion: The Braftovi + Mektovi regimen has bolstered the role of BRAF + MEK inhibitor combinations in BRAF-mutated melanoma.
The Braftovi + Mektovi combination (Pfizer via Array BioPharma) gained approval in 2018 for patients with unresectable or metastatic melanoma with a BRAF mutation. It is the most recent combination of a BRAF and MEK inhibitor to be approved for this indication, following Novartis’s Tafinlar/Mekinist combination and Genentech’s Zelboraf/Cotellic.
The new combination offers moderate clinical benefit over the previous BRAF/MEK inhibitor combinations, showing an incremental benefit in PFS, but a strong survival benefit that underlies the improved mortality score in the Equinox unmet need framework. Although the new combination faces two well-established competitors and was relatively late to the party, its moderate level of clinical innovation (drugs with improvements of 5 – 10% typically compete reasonably well) suggests that it will capture a meaningful share of this market.
The Braftovi + Mektovi also combination appears to be priced appropriately, relative to the incremental clinical benefit it confers over Zelboraf + Cotellic. The figure below shows that, compared to our exemplar set of oncology drugs that have achieved good market access, it is in the cloud, suggesting the incremental price and benefit are in good balance; early sales reports confirm that the combination is achieving good access.
New Treatments on the Horizon
The pipeline for new melanoma treatments is robust, with many new combinations for both BRAF mutated and wild-type patients, including triplet regimens targeted to BRAF patients. Whether those triplets offer sufficient clinical benefit to justify their incremental costs remains to be seen.
Current major melanoma players (BMS, Merck, Novartis, and Roche) and other companies are investigating novel agents and combinations targeted to melanoma sub-populations. Analyzing those new agents and combinations through our lens can help development teams anticipate the commercial outlook of their programs under a range of plausible clinical outcomes.