Johnson & Johnson’s Rybrevant (amivantamab), in combination with chemotherapy, has demonstrated positive responses in patients with RAS/BRAF wild-type metastatic colorectal cancer (mCRC) in new trial results.
The phase 1b/2 OrigAMI-1 study evaluated Rybrevant alongside either FOLFOX or FOLFIRI chemotherapy. Among patients with RAS/BRAF wild-type mCRC, it demonstrated anti-tumour activity and durable responses.
The safety profile of the combination treatment regimen was consistent both with the drugs’ individual safety profiles and with previous reports on Rybrevant plus chemotherapy in CRC. No new safety signals were observed.
CRC is a leading cause of cancer-related death and the third most commonly diagnosed form of cancer globally. Incidence of CRC is rising among younger populations, and over half of patients will eventually see their disease metastasise, highlighting the importance of developing new treatments.
Patients with RAS/BRAF wild-type metastatic colorectal cancer – involving mutations in the RAS and BRAF genes – often see poorer outcomes overall, and second-line treatment options for this patient group remain limited.
Rybrevant is approved for a variety of indications in the US and Europe, both as a monotherapy and alongside chemotherapy, primarily for various forms of non-small cell lung cancer (NSCLC).
Studies of Rybrevant are ongoing in indications including NSCLC, CRC and recurrent/metastatic head and neck squamous cell carcinoma.
Dr Filippo Pietrantonio, head of the Gastrointestinal Oncology Unit, IRCCS Foundation, National Cancer Institute, Italy, said: “These results show the potential of Rybrevant combined with chemotherapy to deliver meaningful and durable benefit for people with advanced colorectal cancer, including for those with liver metastases who have historically faced poorer outcomes.
“Seeing patients maintain responses for extended periods, some beyond two years, is a powerful sign of progress in a disease where sustained efficacy has been hard to achieve, and speaks to the promise of this treatment approach.”
Kiran Patel, vice president, global head, Solid Tumour Clinical Development and Companion Diagnostics at Johnson & Johnson, said: “Treatment for metastatic colorectal cancer has remained largely unchanged for many years, underscoring the need for new strategies.”
Results were presented during a poster session at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium.