BioNTech and OncoC4 Initiate Pivotal P-III Trial of Gotistobart (BNT316/ONC-392) in Patients with Metastatic Non Small Cell Lung Cancer
Shots:
- The initiation of this trial is based on the positive results of P-I/II study evaluating gotistobart alone and in combination with pembrolizumab in patients with advanced solid tumors
- The first patient has been treated in P-III trial (PRESERVE-003) evaluating the safety and efficacy of gotistobart as monotx. vs docetaxel in the patient (n= ~600) with NSCLC that progressed under previous PDL1 inhibitors across the US, the EU, and others
- The trial is part of BioNTech’s strategy to initiate multiple pivotal trials in 2023 and 2024. The 1EP is OS while 2EPs are ORR, PFS, and AEs. In Mar 2023, both companies collaborated. Earlier it received FTD based on data of P-I/II for the monotx. in metastatic, immunotherapy-resistant NSCLC
Ref: Globenewswire | Image: Biontech
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
