BioNTech Achieves Early Success in Advanced Melanoma

In an open-label Phase II trial, 184 patients with anti-PD-(L)1 refractory or relapsed, unresectable advanced melanoma were randomized into three cohorts. Half received the combination of BNT111 and Libtayo, while the remaining participants were divided equally to receive either BNT111 or Libtayo alone.

The trial results revealed a statistically significant improvement in the overall response rate for the combination therapy arm, leading to the achievement of the study’s primary endpoint. Both monotherapy arms also showed clinical activity, with Libtayo performing consistently with historical control data.

The combination therapy was well-tolerated, with no unexpected safety concerns. BioNTech and Regeneron plan to discuss the results with regulators as they consider further development. The combination of BNT111 and Libtayo holds FDA fast-track status for the melanoma population studied.

Competing with Major Players

BioNTech and Regeneron’s success positions them against Merck and Moderna, who are advancing their investigational cancer vaccine mRNA-4157/V940 in combination with Keytruda (pembrolizumab) for advanced melanoma. Merck and Moderna’s combination recently reported a significant reduction in disease recurrence or death in their Phase IIb trial for stage III/IV melanoma patients.

Insights into BNT111

BNT111 is an investigational off-the-shelf mRNA cancer immunotherapy developed using BioNTech’s proprietary FixVac platform. It encodes four melanoma-associated proteins: NY-ESO-1, MAGE-A3, tyrosinase, and TPTE, which are found in over 90% of cutaneous melanoma cases.

In earlier studies, BNT111 has shown promise in enhancing the immune system’s anti-tumor response and priming T cells against the antigens for up to a year with monthly vaccinations. Phase I data published in July 2020 in Nature demonstrated significant activity against cancer cells, with six out of 17 patients showing partial response when treated with both BNT111 and an anti-PD-1 agent.

Future Plans

BioNTech CMO and co-founder Özlem Türeci highlighted the significance of these findings, marking a crucial step toward developing personalized cancer therapies. Türeci envisions mRNA playing a central role in future cancer treatment paradigms, addressing unmet medical needs, especially for patients with anti-PD-(L)1 refractory or resistant melanoma.

BioNTech and Regeneron are set to share detailed data at an upcoming medical congress and will submit their findings for peer-reviewed publication. The companies will continue to share development costs equally and maintain full commercial rights over their respective products, recording revenues separately.

As BioNTech and Regeneron prepare to advance their combination therapy, the competition with Merck and Moderna in the field of advanced melanoma treatments intensifies, with both partnerships striving to bring innovative solutions to patients with this challenging disease.

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