What's Happening?
OncoC4, a biopharmaceutical company based in Rockville, Maryland, has announced that China's National Medical Product Administration (NMPA) has granted Breakthrough Therapy Designation for its anti-CTLA-4
antibody candidate, gotistobart (BNT316/ONC-392). This designation is for the treatment of patients with squamous non-small cell lung cancer (sqNSCLC) who have not responded to prior standard immuno-oncology therapies. Gotistobart is being developed in collaboration with BioNTech and is currently undergoing a Phase 3 clinical trial, PRESERVE-003, which evaluates its efficacy and safety as a monotherapy compared to standard chemotherapy. The trial involves approximately 600 patients across 12 countries, including the United States.
Why It's Important?
The Breakthrough Therapy Designation is significant as it allows for expedited development and regulatory review of gotistobart, potentially accelerating its availability to patients. SqNSCLC is a particularly aggressive form of lung cancer with limited treatment options, especially for those who have progressed on first-line therapies. The designation indicates that gotistobart may offer substantial improvements over existing treatments, addressing a critical unmet need in oncology. This development could have a profound impact on the treatment landscape for lung cancer, offering new hope to patients and potentially improving survival rates.
What's Next?
With the Breakthrough Therapy Designation, OncoC4 and BioNTech can expect more frequent interactions with the NMPA, which may facilitate the collection of necessary data to support the drug's development. If the criteria are met, gotistobart could also qualify for priority review, further speeding up its path to market. The results from the ongoing Phase 3 trial will be crucial in determining the next steps, and detailed data is expected to be presented at a medical conference in December 2025.
