OpACIN Trial: Ipilimumab Plus Nivolumab in Stage III Melanoma
Posted: Monday, January 7, 2019
Based on updated data from the OpACIN study, researchers reported that patients with high-risk stage III melanoma who received neoadjuvant ipilimumab plus nivolumab experienced high response rates and “promising” long-term survival outcomes. In fact, none of the patients who achieved a pathologic response upon neoadjuvant therapy have relapsed. These findings were presented at the European Society for Medical Oncology Immuno-Oncology Congress 2018 (Abstract LBA3) as well as published in the Annals of Oncology.
“OpACIN was the first trial investigating [neoadjuvant ipilimumab plus nivolumab] in [patients] with macroscopic stage III melanoma, thus having the longest [follow-up],” concluded Elisa A. Rozeman, MD, of the Netherlands Cancer Institute in Amsterdam, and colleagues. “Pathologic complete response could become a primary read-out for subsequent neoadjuvant immunotherapy trials as well as a surrogate marker for [relapse-free survival] and [overall survival].”
The study enrolled 20 patients with high-risk stage III melanoma between August 2015 and October 2016. All patients received ipilimumab at 3 mg/kg plus nivolumab at 1 mg/kg. They also were randomly assigned to receive the treatment either over 4 adjuvant courses or split into 2 neoadjuvant plus 2 adjuvant courses. The investigators evaluated patients for achievement of pathologic response, defined as fewer than 50% viable tumor cells.
Of the 7 patients who achieved pathologic response in the neoadjuvant arm, none had relapsed at a median follow-up of 31.6 months. However, the two patients who did not achieve pathologic response did relapse. At 30 months, the overall survival rate for this arm was 90%, and the relapse-free survival rate was 80%. In the adjuvant arm, four patients relapsed. At 30 months, the relapse-free survival rate was 60%, and the overall survival rate was 67%.
Disclosure: The study authors’ disclosure information can be found at academic.oup.com.