On Saturday, Johnson & Johnson (NYSE:JNJ) shared new longer follow-up results from the Phase 1b/2 OrigAMI-1 study.
The trial is evaluating Rybrevant (amivantamab-vmjw) in combination with FOLFOX or FOLFIRI chemotherapy for RAS/BRAF wild-type metastatic colorectal cancer.
The company said that encouraging anti-tumor activity, durable responses, and low rates of treatment-related discontinuations observed in this study support further investigation in ongoing Phase 3 studies in first- and second-line colorectal cancer.
Results were presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
Detailed Study Results
At a median follow-up of 16 months, amivantamab plus FOLFOX (n=20) or FOLFIRI (n=23) achieved a confirmed overall response rate (ORR) of 51% across the study, with responses observed early and a median time to first response of 8.3 weeks, along with a median DOR of 9.3 months.
Median PFS was 9.2 months.
In the first-line subgroup, ORR was 73%, with a median DOR not yet reached at the time of data cutoff.
Among 11 patients treated in the first-line subgroup, four were able to proceed to curative intent surgery. In the second-line subgroup (n=32), ORR was 44% and median DOR was 7.4 months.
More than one-third of patients treated in the second-line setting remained on therapy for over one year, and three patients have stayed on amivantamab treatment for more than two years.
In patients with liver metastases (n=30), the study showed notable activity, with an ORR of 57% and a median PFS of 11.3 months.
The safety profile remained consistent with prior reports of amivantamab plus chemotherapy in colorectal cancer and with the known safety profiles of the individual agents.
Broader Pipeline and Regulatory Updates
Last week, Johnson & Johnson said topline results from the Phase 2b JASMINE study of nipocalimab in lupus patients met the primary endpoint, and key secondary and exploratory endpoints.
In December 2025, the U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously administered therapy for epidermal growth factor receptor-mutated non-small cell lung cancer.
Rybrevant Faspro is approved for all indications for which Rybrevant is approved.
JNJ Price Action: Johnson & Johnson shares were up 1.61% at $207.69 at the time of publication on Monday, according to Benzinga Pro data.
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