Johnson & Johnson (NYSE: JNJ) unveiled comprehensive follow-up results from its Phase 1b/2 OrigAMI-1 trial assessing the therapeutic impact of Rybrevant (amivantamab-vmjw) combined with established chemotherapy regimens FOLFOX or FOLFIRI. The study targets patients diagnosed with RAS/BRAF wild-type metastatic colorectal cancer, a subgroup characterized by specific genetic tumor markers.
The updated data were shared on Saturday, coinciding with presentations at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, an event showcasing pivotal advances in gastrointestinal oncology.
Clinical Trial Findings: Depth and Duration of Response
The analysis incorporated a median follow-up period of 16 months during which patients received amivantamab plus one of the chemotherapy combinations—FOLFOX in 20 patients and FOLFIRI in 23 patients—resulting in a confirmed overall response rate (ORR) of 51%. This demonstrates that over half of the study participants experienced measurable tumor shrinkage.
Importantly, tumor responses manifested rapidly following treatment initiation, with a median time of 8.3 weeks to first response. The median duration of response (DOR) was recorded at 9.3 months, suggesting that responses were sustained for a significant period.
Additional progression metrics revealed a median progression-free survival (PFS) of 9.2 months across the entire study population, indicating the length of time during and after treatment in which the disease did not worsen.
Subgroup Analysis
- First-Line Patients: Among 11 patients receiving initial treatment, the ORR was notably higher at 73%. As of data cutoff, the median DOR had not yet been reached, hinting at potentially prolonged benefits. Additionally, four individuals in this cohort progressed to undergo surgeries with curative intent, reflecting meaningful clinical outcomes.
- Second-Line Patients: This group included 32 patients who had received prior therapies. Their ORR was 44%, and median DOR stood at 7.4 months. Notably, over one-third remained on therapy for longer than one year, with three patients continuing beyond two years on amivantamab treatment, emphasizing sustained disease control.
- Patients with Liver Metastases: In the subset of 30 patients presenting with liver metastatic involvement, the therapy exhibited significant activity, yielding an ORR of 57% and a median PFS of 11.3 months, suggesting meaningful responses in this challenging clinical scenario.
Safety Profile and Tolerability
The observed adverse events aligned with previously reported safety data for amivantamab combined with chemotherapy in colorectal cancer. No unexpected safety signals emerged, and the rates of treatment discontinuation related to adverse events remained low, supporting the regimen's tolerability.
Advances in Related Johnson & Johnson Programs
In a related development, Johnson & Johnson announced positive topline results from its Phase 2b JASMINE study assessing nipocalimab in patients with lupus, with the trial meeting its primary endpoint alongside key secondary and exploratory milestones.
Furthermore, in December 2025, the U.S. Food and Drug Administration approved Rybrevant Faspro, a formulation combining amivantamab with hyaluronidase-lpuj, notable as the first and only subcutaneous therapy for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer. This approval encompasses all indications for which Rybrevant is authorized, broadening patient accessibility.
Market Reaction and Stock Performance
Following the release of these updates, Johnson & Johnson shares experienced a positive movement on Monday, increasing by 1.61% to trade at $207.69 per share, as reported by Benzinga Pro data.
The encouraging clinical outcomes and regulatory milestones reinforce Johnson & Johnson's position within the oncology sector and may contribute to sustained investor interest.
Outlook
These findings underscore the potential of Rybrevant in combination therapies to improve outcomes for patients with metastatic colorectal cancer, particularly those harboring RAS/BRAF wild-type tumors. Ongoing Phase 3 studies will further elucidate its role in both first- and second-line treatment settings.