Amivantamab Combo Yields 73% ORR in First-Line Colorectal Cancer at 16-Month Follow-Up
Johnson & Johnson’s investigational bispecific antibody amivantamab-vmjw plus FOLFOX/FOLFIRI achieved a 73% confirmed ORR in first-line RAS/BRAF wild-type metastatic colorectal cancer with median duration of response not reached at 16-month follow-up. In liver-metastatic patients (n=30), ORR was 57% with median PFS of 11.3 months, supporting ongoing Phase 3 trials.
1. RYBREVANT® Shows Durable Anti-Tumor Activity in Metastatic Colorectal Cancer
Johnson & Johnson today reported extended follow-up from the Phase 1b/2 OrigAMI-1 study of amivantamab-vmjw (RYBREVANT®) plus FOLFOX or FOLFIRI in RAS/BRAF wild-type metastatic colorectal cancer. At a median follow-up of 16 months, the overall response rate (ORR) across both chemotherapy combinations was 51% (95% CI, 36–67) with a median duration of response (DOR) of 9.3 months (95% CI, 5.8–14.7). In the first-line subgroup, ORR reached 73% (95% CI, 53–86) and median DOR had not yet been reached. Notably, 70% of first-line patients maintained responses beyond 16 months, and four of 11 first-line patients proceeded to curative intent surgery. Patients with liver metastases (n=30) also experienced promising activity, with an ORR of 57% (95% CI, 37–75) and median progression-free survival of 11.3 months (95% CI, 5.9–16.4). Treatment-related discontinuations were low (9%) and safety remained consistent with known EGFR/MET inhibition profiles.
2. Johnson & Johnson Secures U.S. Tariff Exemptions in Exchange for Drug Price Reductions
In a landmark agreement with the U.S. administration, Johnson & Johnson has won exemptions from proposed import tariffs on its pharmaceutical portfolio by committing to pipeline-wide price concessions for American patients. Under the accord, the company will offer select branded medicines at cost price through a new federal portal and extend Medicaid pricing terms to Medicare beneficiaries for over 50 key products. The deal preserves uninterrupted supply of critical therapies while ensuring that J&J’s annual list-price increases remain capped at or below 2% through 2027. Company executives said the arrangement balances patient affordability with global supply chain stability, and could serve as a template for future industry-government collaborations on drug access and trade policy.