SITC 2019: Avelumab Plus FOLFOX and Cetuximab in Metastatic Colorectal Cancer
Posted: Monday, November 18, 2019
Combination treatment of FOLFOX (leucovorin, fluorouracil, oxaliplatin) with cetuximab plus avelumab produced a high rate of responses in patients with microsatellite-stable metastatic colorectal cancer within the first 8 weeks of treatment. This work was presented at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, Maryland (Abstract O16), by Eray Goekkurt, MD, of the Hematology-Oncology Practice Hamburg, Germany. The German investigators believe this combination therapy warrants further evaluation in a randomized trial.
The phase II AVETUX trial enrolled 43 patients with RAS/BRAF-wild type metastatic colorectal cancer. Patients were treated with 10 mg/kg of avelumab starting on cycle 2 of standard modified FOLFOX6 and cetuximab therapy. The median age of patients treated was 61 years, 33% of patients were women, and 70% had liver metastases. A total of 2 patients had high microsatellite instability, 1 had low microsatellite instability, and 40 had microsatellite-stable cancers. The intention-to-treat population included 39 patients.
The overall response rate to the combination therapy was 79.5%, which included 6 complete responses and 25 partial responses. An additional five patients had stable disease at the time of analysis, two patients had progression of disease, and one patient was not evaluable. The disease control rate was estimated to be 92.3%. The early tumor shrinkage rate, signifying a decrease in tumor size of more than 20% after 8 weeks, was 79.5%.
The treatment regimen was reported to be well tolerated, and avelumab was not associated with additional adverse events beyond those expected with standard FOLFOX and cetuximab treatment. Four patients experienced an immediate and otherwise unexplained fever.
Disclosure: For full disclosures of other study authors, visit sitcancer.org.