Immunotherapy combination improves response in unresectable melanoma
Click Here to Manage Email Alerts
An immunotherapy combination improved outcomes compared with historical control for certain patients with advanced melanoma, according to a topline data announcement.
BNT111 (BioNTech) — an investigational immunotherapy — uses a fixed combination of mRNA-encoded, tumor-associated antigens designed to activate a precise and strong immune response against cancer.
The randomized phase 2 BNT111-01 trial included patients with anti-PD-1/PD-L1-refractory or relapsed unresectable stage III or stage IV cutaneous melanoma.
Researchers assigned half of the patients to BNT111 plus the PD-1 checkpoint inhibitor cemiplimab (Libtayo, Regeneron Pharmaceuticals). The other half of patients received either BNT111 monotherapy or cemiplimab monotherapy.
Treatment in all groups continued for up to 24 months.
Overall response rate served as the primary endpoint. Duration of response, disease control rate, OS, safety and tolerability served as additional endpoints.
The trial met its primary endpoint, showing a significantly higher ORR among patients assigned BNT111 plus cemiplimab compared with a historical control for this indication.
“These phase 2 results mark a significant step toward our vision of personalized cancer medicine. We envision mRNA as a centerpiece in future treatment paradigms for cancer, helping to address unmet medical needs, such as for patients with [anti-PD-1/anti-PD-L1] refractory or resistant melanoma,” Özlem Türeci, MD, chief medical officer and co-founder of BioNTech, said in a company-issued press release.
The combination of BNT111 and cemiplimab exhibited a safety profile consistent with prior trials that evaluated BNT111 with anti-PD-1/anti-PD-L1-containing treatments.
The trial will continue for further assessment of secondary endpoints that remained immature at the time of primary analysis.
Complete data from the BNT111-01 trial will be presented at a medial conference.
Read more about
Click Here to Manage Email Alerts