Nivolumab and Ipilimumab in Melanoma: OpACIN Trial Follow-up
Posted: Wednesday, November 13, 2019
At 3-year follow-up of the early-phase OpACIN trial, no new safety events occurred, and none of the patients with melanoma who had a pathologic response to neoadjuvant ipilimumab and nivolumab have suffered relapses. Study author Christian U. Blank, MD, PhD, of the Netherlands Cancer Institute in Amsterdam, and colleagues suggest that pathologic response may be useful as a surrogate marker for relapse-free and overall survival. These results were presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona (Abstract 1313PD).
A total of 20 patients with stage IIIB/IIIC melanoma with palpable nodal disease were treated from August 2015 to October 2016. Patients were randomly assigned to receive 3 mg/kg of ipilimumab plus 1 mg/kg of nivolumab either as four courses of adjuvant therapy or split with two courses of neoadjuvant and two courses of adjuvant treatment.
None of the seven patients who achieved a pathologic response in the neoadjuvant arm relapsed after a median follow-up of 36.7 months. The two nonresponding patients in the neoadjuvant arm have relapsed, compared with four patients who have relapsed disease in the adjuvant arm. One patient from the neoadjuvant group died, and three patients died in the adjuvant group. The estimated 3-year relapse-free survival rates were 80% and 50% in the neoadjuvant and adjuvant arms, respectively. In addition, the 3-year overall survival rate was 90% in the adjuvant arm and 67% in the neoadjuvant arm.
A total of 18 patients had developed at least one grade 3 or 4 adverse event, and almost all have recovered to grade 1 or lower. The eight patients who had grade 2 endocrine toxicities needed hormonal supplementation, which is still ongoing.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.