India, May 31 -- Johnson & Johnson (JNJ) announced pivotal results from the Phase 1b/2 OrigAMI-4 study, which evaluated subcutaneous amivantamab with hyaluronidase-lpuj in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy. The regimen delivered durable responses, with a confirmed overall response rate of 42 percent. Notably, more than one-third of responders achieved complete responses. Median duration of response was not yet reached at a median follow-up of 11.8 months.
A supplemental Biologics License Application (sBLA) seeking approval for subcutaneous amivantamab in head and neck cancer has been submitted to the U.S. Food and Drug Administration (FDA), following its Brea...