Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating patients with unresectable stage III or IV melanoma who have experienced disease progression after anti-PD-(L)1 treatment.
The multi-center Phase II trial, conducted across seven countries with 184 enrolled patients, aimed to demonstrate the anti-tumor activity and overall response rate (ORR) for the combination regimen and each molecule as a single agent. The trial successfully met the primary efficacy outcome measure, showing a significant improvement in ORR for patients treated with the combination therapy. Both BNT111 and Libtayo also demonstrated clinical activity when used as monotherapies.
The study is ongoing to assess secondary endpoints, which include duration of response (DOR), disease control rate (DCR), overall survival (OS), safety, and tolerability. BNT111, developed by BioNTech, utilizes a liposome delivery formulation and encodes four mRNAs targeting melanoma tumor-associated antigens (TAAs) such as NY-ESO-1, tyrosinase, MAGE-A3, and TPTE. The combination therapy with Libtayo has received the US FDA’s Fast Track designation for anti-PD-1-refractory/relapsed, unresectable Stage III or IV melanoma and Orphan Drug designation (ODD) for the treatment of stage IIB through IV melanoma.- Flcube.com
