Johnson & Johnson announces new data from Phase 1b/2 OrigAMI-1 study

Johnson & Johnson announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT combined with chemotherapy demonstrated promising rapid and durable antitumor activity in patients with RAS/BRAF wild-type metastatic colorectal cancer who have not previously received anti-epidermal growth factor receptor therapy. These data were presented in a mini-oral presentation at the European Society of Medical Oncology 2024 Congress. In the study, patients receiving RYBREVANT plus chemotherapy were either in their first or second line of treatment for mCRC and had not been treated with specific anti-EGFR therapies. Patients receiving FOLFOX were oxaliplatin-naive and patients receiving FOLFIRI were irinotecan-naive. Response was assessed by the investigator per RECIST v1.1. Forty-three patients were treated with RYBREVANT along with either FOLFOX or FOLFIRI. The median follow-up period was 7.3 months for RYBREVANT plus FOLFOX and RYBREVANT plus FOLFIRI. Patients treated with RYBREVANT plus chemotherapy achieved an overall response rate of 49 percent, median duration of response of 7.4 months and median progression-free survival of 7.5 months. Disease control was observed in 88 percent of patients. Clinically meaningful intrahepatic antitumor activity was observed among patients with liver metastases treated with RYBREVANT plus chemotherapy, demonstrating a significant reduction in liver tumors. Notably, nine patients were able to proceed to curative-intent surgery due to strong antitumor activity. The safety profile of RYBREVANT plus FOLFOX/FOLFIRI was manageable and consistent with each of the individual components, without any additive toxicity. No new safety signals were observed. The most frequent treatment-emergent adverse events were neutropenia, rash, stomatitis, infusion-related reactions and diarrhea. All IRRs were Grade 1 or 2 and there were no Grade 3 or higher IRR events reported. Treatment-related discontinuations of RYBREVANT were 10% for RYBREVANT plus FOLFOX and nine percent for RYBREVANT plus FOLFIRI. Pivotal Phase 3 registration trials evaluating RYBREVANT-based regimens as first- and second-line treatment in colorectal cancer are planned.