German biotech company BioNTech (Nasdaq: BNTX) rose 2.2% to $88.80 in pre-market trading after the company reported positive topline data from an ongoing Phase 2 clinical trial in patients with unresectable stage III or IV melanoma whose disease has progressed after treatment including an anti-PD-(L)1 antibody.
The randomized trial will evaluate the clinical activity and safety of Regeneron’s (Nasdaq: REGN) investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo (cemiplimab), an investigational anti-PD-1 monoclonal antibody, and evaluate the two single agents alone. The companies are investigating the combination under a 2020 collaboration.
BioNTech noted that the study met its primary efficacy endpoint, with a statistically significant improvement in ORR in patients receiving the combination of BNT111 and cemiplimab compared with the historical control arm in this indication and treatment setting. Clinical activity was seen in both randomized monotherapy arms. The ORR in the cemiplimab monotherapy arm was consistent with the historical control arms of anti-PD-(L)1 or anti-CTLA-4 therapy in this patient population. Treatment was well tolerated, and the safety profile of the BNT111 and cemiplimab combination in this study was consistent with previous clinical trials evaluating the combination of BNT111 with anti-PD-(L)1-containing therapy. The Phase II study will continue as planned to further evaluate secondary endpoints that were immature at the time of the primary analysis.
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