Johnson & Johnson (JNJ) said Sunday that data from a phase 1b/2 study showed its experimental therapy, subcutaneous amivantamab and hyaluronidase-lpuj, achieved a 42% confirmed overall response rate in patients with recurrent or metastatic head and neck squamous cell carcinoma previously treated with immunotherapy and platinum-based chemotherapy.
The primary endpoint was overall response rate, with the more than one-third of responders achieving complete responses, the company said.
Median duration of response had not been reached at a median follow-up of 11.8 months, the company said.
The company in the 102-patient study cohort, median progression-free survival was 6.8 months and median overall survival was 12.5 months.
A supplemental Biologics License Application seeking approval for subcutaneous amivantamab in head and neck cancer has been submitted to the U.S. Food and Drug Administration (FDA), it added.
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