Johnson & Johnson (JNJ) released encouraging long-term results over the weekend from its Phase 1b/2 OrigAMI-1 study, and the data suggests its cancer therapy Rybrevant might have real staying power in colorectal cancer treatment.
The trial is testing Rybrevant (amivantamab-vmjw) paired with either FOLFOX or FOLFIRI chemotherapy regimens in patients with RAS/BRAF wild-type metastatic colorectal cancer. Translation: this is for a specific genetic subset of advanced colorectal cancer patients whose tumors don't have certain common mutations.
The company says the anti-tumor activity, durable responses, and low treatment discontinuation rates from this study justify pushing forward with ongoing Phase 3 trials in both first-line and second-line colorectal cancer settings. The results were presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
The Numbers Tell an Interesting Story
After a median follow-up of 16 months, the combination therapy achieved a confirmed overall response rate of 51% across 43 patients treated with either amivantamab plus FOLFOX (20 patients) or FOLFIRI (23 patients). Responses showed up quickly, with a median time to first response of just 8.3 weeks, and the median duration of response lasted 9.3 months. Median progression-free survival came in at 9.2 months.
But the real standout was the first-line subgroup, where the response rate hit 73% and the median duration of response hadn't even been reached yet when researchers cut off the data. Even more promising: among the 11 first-line patients, four were able to proceed to curative intent surgery, which is ultimately what you're hoping for in cancer treatment.
The second-line setting (32 patients who had already tried other treatments) showed a 44% response rate with a median duration of 7.4 months. What's particularly notable here is the durability—more than one-third of these second-line patients stayed on therapy for over a year, and three patients have now been on amivantamab treatment for more than two years.
For the 30 patients with liver metastases, which typically represent a tougher challenge, the therapy still showed meaningful activity with a 57% response rate and median progression-free survival of 11.3 months.
The safety profile remained consistent with previous reports of amivantamab combined with chemotherapy in colorectal cancer, matching what's already known about these individual agents.
Broader Developments at Johnson & Johnson
This colorectal cancer data comes on the heels of other positive news from Johnson & Johnson. Last week, the company announced that its Phase 2b JASMINE study of nipocalimab in lupus patients hit its primary endpoint along with key secondary and exploratory endpoints.
And in December 2025, the FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), marking the first subcutaneously administered therapy for epidermal growth factor receptor-mutated non-small cell lung cancer. The new formulation is approved for all the same indications as the original Rybrevant.
Johnson & Johnson shares were trading up 1.61% at $207.69 on Monday.
