Ana Oaknin, MD, PhD, on Cervical Cancer: Safety and Efficacy Results With Nivolumab and Ipilimumab

CheckMate 358 is an ongoing Phase I/II study analyzing the role of nivolumab and nivolumab/ipilimumab combination in virus-associated cancer, including cervical cancer, regardless of PDL1 status. In the cervical cancer cohort, recovering metastatic cervical cancer patients were randomized into two arms, nivolumab plus ipilimumab in two different regimens: NIVO 1 IPI 3, or NIVI 3 IPI 1. These combinations were analyzed in the first-line setting and the second-line. The primary objective of the study was overall response rate and secondary objective progression-free survival, overall survival, and duration of response. The two-treatment combination show promising overall response rate, and remarkably, we observe greater responses when the patient received this combination of first-line therapy. Interestingly, the combination show responses regardless of PDL1 status. And when we saw the response rate in this combination were greater that we saw with nivolumab monotherapy. In addition, PFS and overall survival were really, really promising. When we look at the median overall survival for those patients treated with NIVO 1 IPI 3, was around 20 months and interestingly 48% of the patients were alive up to NGS. However, this data should be interpreted with caution because the trial is not fully randomized and the population was a mixed population. The safety profile of the combination in this study was aligned with the previous reported data. We need to say that some adverse events, such as hepatitis and colitis seem to be higher for those patients treated with nivolumab 1 ipilimumab 3. But in conclusion, I can say that outcome from the NIVO 3 combination show very, very promising outcome, and it may be considered as a kind of chemotherapy free regimen for our patient with metastatic recurrent cervical cancer.