ASCO20: Immunotherapy Duo Plus Chemotherapy in Microsatellite-Stable Metastatic CRC
Posted: Wednesday, June 24, 2020
For patients with RAS-mutated, microsatellite-stable, metastatic colorectal cancer, first-line treatment with durvalumab and tremelimumab in combination with modified FOLFOX6 appears to be safe and effective, according to François Ghiringhelli, PhD, of the Center GF Leclerc, Dijon, France, and colleagues. The researchers presented the results of the intermediate safety and efficacy analyses of the MEDETREME trial during the ASCO20 Virtual Scientific Program (Abstract 3006).
In this single-arm, phase Ib/II study, 57 patients were enrolled to receive six cycles of the modified FOLFOX6 chemotherapy regimen—fluorouracil, leucovorin, and oxaliplatin—in combination with durvalumab at 150 mg intravenously every 2 weeks and tremelimumab at 75 mg intravenously every 4 weeks. After six chemotherapy cycles, patients were treated with durvalumab until disease progression.
The results of the intermediate efficacy analysis were calculated after 16 patients had received 6 months of treatment. At 6 months, progression-free survival was observed in 10 of the 16 patients (62.5%), including 5 complete responses, 5 partial responses, and 4 with stable disease. Median progression-free survival was not yet reached.
As for safety, the most common adverse events included asthenia (81.3%), neuropathy (87.5%), diarrhea (56.3%), and neutropenia (62.5%). Grade 3 and 4 adverse events included neutropenia (50%), elevated blood pressure (25%), asthenia (19%), and diarrhea (13%). Most of the adverse events were related to chemotherapy, noted Dr. Ghiringhelli and colleagues.
Disclosure: For full disclosures of the authors, visit coi.asco.org.