Ana Oaknin, MD, PhD, on Cervical Cancer: Safety and Efficacy Results With Nivolumab and Ipilimumab
ESMO Congress 2022
Ana Oaknin, MD, PhD, of Barcelona’s Vall d’Hebron University Hospital, discusses findings from the CheckMate 358 trial, which showed that chemotherapy-free immunotherapy with nivolumab alone or in combination with ipilimumab may provide durable tumor regression with manageable toxicity in patients with recurrent or metastatic cervical cancer, regardless of tumor PD-L1 expression (Abstract 520MO).
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
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.
Richard S. Finn, MD, of the Geffen School of Medicine at the University of California, Los Angeles, discusses primary phase III results from the LEAP-002 study of pembrolizumab, an anti–PD-1 therapy, plus lenvatinib, the orally available multiple receptor tyrosine kinase inhibitor, vs lenvatinib monotherapy in patients with advanced hepatocellular carcinoma (Abstract LBA34).
Neil D. Gross, MD, of The University of Texas MD Anderson Cancer Center, discusses data from a phase II study, which showed that neoadjuvant cemiplimab-rwlc in patients with stage II–IV (M0) resectable cutaneous squamous cell carcinoma is active and may enable function-preserving surgery in some cases (Abstract 789O).
Bernd Kasper, MD, PhD, of Germany’s Mannheim Cancer Center, discusses phase III data from the DeFi trial, the largest study conducted to date for patients with desmoid tumors. The trial showed that the gamma secretase inhibitor nirogacestat demonstrated improvements in all primary and secondary efficacy endpoints. Although considered benign because of their inability to metastasize, desmoid tumors can cause significant morbidity and, occasionally, mortality in patients (Abstract LBA2).
Antonio Marra, MD, of Memorial Sloan Kettering Cancer Center, discusses a mutational signature analysis that reveals patterns of genomic instability linked to resistance to endocrine therapy with or without CDK4/6 inhibition in patients with estrogen receptor–positive/HER2-negative metastatic breast cancer (Abstract 210O).
Sapna P. Patel, MD, of The University of Texas MD Anderson Cancer Center, discusses the latest findings from the SWOG S1801 trial, which showed that using single-agent pembrolizumab as neoadjuvant therapy improved event-free survival compared to adjuvant therapy in high-risk resectable stage III–IV melanoma (Abstract LBA6).