Amivantamab

Final overall survival data for RYBREVANT plus chemotherapy in EGFR exon 20 insertions and tolerability updates for subcutaneous RYBREVANT FASPRO with prophylactic strategies.

OrigAMI-4 showed 42% response rate with >1/3 complete responses; FDA review shortened to ~6 months; drug targets EGFR and MET and is co-formulated with hyaluronidase.

Phase 1b/2 OrigAMI-4: subcutaneous amivantamab + hyaluronidase achieved 42% ORR (15% CR) in pretreated recurrent/metastatic HNSCC; median DOR not reached (11.8 mo FU); manageable safety.

European Commission approves subcutaneous RYBREVANT® for flexible dosing in advanced EGFR-mutated NSCLC, offering reduced clinic time and fewer reactions.

The OrigAMI-4 study shows amivantamab with immunotherapy offers durable antitumor activity in recurrent/metastatic head and neck cancer, improving outcomes over current treatments.