BERLIN (dpa-AFX) - BioNTech SE (BNTX) announced positive results on Tuesday for its Phase 2 trial of BNT111 aimed at treating unresectable stage III or IV melanoma through mRNA immunotherapy.
The trial achieved its primary goal, demonstrating a statistically significant increase in the overall response rate when BNT111 was used alongside Libtayo, compared to historical controls in patients with anti-PD-(L)1 relapsed/refractory advanced melanoma.
BNT111, developed using BioNTech's FixVac platform, while Libtayo is an anti-PD-1 monoclonal antibody being developed by Regeneron Pharma, Inc. (REGN).
The company stated that the Phase 2 trial will proceed as scheduled to evaluate further the secondary endpoints.
BioNTech and Regeneron intend to present detailed findings at an upcoming medical conference and will seek publication in a peer-reviewed journal.
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