Johnson & Johnson has reported a 49% overall response rate in a colorectal cancer study with RYBREVANT (amivantamab-vmjw), in combination with chemotherapy.
The latest data from the Phase Ib/II OrigAMI-1 study indicates that RYBREVANT, along with chemotherapy, shows significant antitumor activity in metastatic colorectal cancer (mCRC).
This study focused on patients with RAS/BRAF wild-type (WT) mCRC who were not previously treated with anti-epidermal growth factor receptor (EGFR) therapy.
RYBREVANT is a fully-human bispecific antibody targeting anti-EGFR and MET, approved in various regions, including the US and Europe, for certain types of non-small cell lung cancer (NSCLC).
The OrigAMI-1 study is assessing its safety and efficacy combined with chemotherapy regimens mFOLFOX6 or FOLFIRI in patients with mCRC.
Patients eligible for the study had no mutations in the KRAS, NRAS, or BRAF genes and no ERBB2/HER2 gene amplification.
The primary endpoint was to evaluate the safety and determine the appropriate dose of the combination.
The study recruited patients who were either treatment-naïve or had undergone one prior line of treatment, excluding prior EGFR inhibitor therapy.
In the trial, 43 patients received RYBREVANT with FOLFOX (20 patients) or FOLFIRI (23 patients), with a median follow-up period of 7.3 months.
Results showed an overall response rate of 49%, with a median duration of response of 7.4 months and a median progression-free survival of 7.5 months.
Disease control was achieved in 88% of subjects, and the treatment demonstrated significant intrahepatic antitumor activity, with a 53% response rate in patients with liver metastases.
The safety profile was manageable and consistent with the known effects of the individual treatments, with no new safety signals or additive toxicity observed. The most common treatment-emergent adverse events included neutropenia, rash, stomatitis, infusion-related reactions, and diarrhoea.
Johnson & Johnson Innovative Medicine Clinical Development, Solid Tumors vice-president Kiran Patel said: “Confirmation that RYBREVANT has activity beyond lung cancer, given its unique multi-targeted approach in inhibiting EGFR and MET, is a potentially important step forward for patients with EGFR inhibitor-naïve metastatic colorectal cancer.”
Looking ahead, Johnson & Johnson plans to initiate pivotal Phase III registration trials to further evaluate RYBREVANT-based regimens as first- and second-line treatments for colorectal cancer.
RYBREVANT is also being investigated in multiple clinical trials for other indications.
