Dirk Arnold, MD, PhD, Director of the Asklepios Tumorzentrum Hamburg, discusses the OrigAMI-2 clinical trial in left-sided RAS/BRAF wild-type metastatic colorectal cancer (mCRC).
Approximately 50% of patients diagnosed with colorectal cancer have wild-type KRAS, NRAS, and BRAF genes. Standard of care therapy for these patients is doublet chemotherapy (FOLFOX or FOLFORI) combined with anti-EGFR therapy, but resistance is common. Amivantamab is an EGFR-MET bispecific antibody being evaluated in combination with FOLFOX or FOLFORI in patients with RAS/BRAF wild-type mCRC.
In the phase 1b/2 OrigAMI-1 study, amivanatamab plus FOLFOX or FOLFORI demonstrated rapid and durable antitumor activity regardless of tumor side. The OrigAMI-2 study (NCT06662786) is a randomized, multicenter, global, phase 3 clinical trial evaluating the efficacy of amivantamab compared to cetuximab, both in combination with FOLFOX or FOLFORI, as a first-line treatment in left-sided RAS/BRAF wild-type mCRC.
The study is planned to open across 216 sites in 21 countries. Eligibility criteria include wild-type for KRAS, NRAS, and BRAF by local testing, left-sided unresectable or metastatic colorectal cancer, and treatment-naïve for advanced disease. The study is looking to enroll 1000 patients who will be randomly assigned 1:1 to receive subcutaneous amivantamab or intravenous cetuximab, both in combination with FOLFOX or FOLFIRI.
The primary endpoint of the OrigAMI-2 clinical trial will be progression-free survival by blinded independent central review. Secondary endpoints will include overall survival, objective response rate, duration of response, and patient-reported outcomes.
For more information, click here.
To learn more about rare cancers, visit https://checkrare.com/diseases/cancers/