Ana Oaknin, MD, PhD, on Cervical Cancer: New Findings on Cemiplimab in Recurrent or Metastatic Disease
ESMO Congress 2022
Ana Oaknin, MD, PhD, of Barcelona’s Vall d’Hebron University Hospital, discusses an analysis of long-term survival from the EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial. Cemiplimab-rwlc is the first immunotherapy to demonstrate an overall survival benefit as a second-line monotherapy for patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy but not immunotherapy. The benefit was sustained in this population (Abstract 519MO).
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
EMPOWER-Cervical 1 is a Phase III open-label randomized clinical trial in patients with recurrent metastatic cervical cancer who have progress after platinum therapy. 608 patients were randomized to anti-PD1 agent cemiplimab of investigator choice chemotherapy. The main stratification factors were geography regions, previous use of bevacizumab, histology, and ECOG. Patients received therapy until progression and acceptable toxicity on 96 weeks.
The primary endpoint of the study was overall survival, and secondary endpoint was PFS and overall response rate. Regarding baseline characteristics, the majority of patients had a squamous cell carcinoma less, than half had previous use of bevacizumab, and approximately 50% of the patients had received more than one prior line of therapy for the recovering and metastatic setting. The trial met its primary endpoint and the final analysis of survival, with 30 months of follow-up show that median overall survival was significantly longer with cemiplimab compared with chemotherapy in the squamous cell carcinoma population, also, in the overall population.
Regarding the results, according the PDL-1 status, we can state that overall survival was longer for both populations, PDL-1-positive and PDL-1-negative. In addition, higher overall respond rates were observed with cemiplimab compared with chemotherapy in all the population, namely PDL-1-positive and PDL-1-negative. In terms of safety, there is no new safety signal. The safety profile of cemiplimab was consistent with that other anti PDL-1 regimen.
So, we can conclude saying that cemiplimab, a second-line therapy after platinum failure statistically and clinically meaningful prolongation of overall survival compared with chemotherapy in squamous cell carcinoma population, and in the overall population. In the PDL-tested population, cemiplimab was associated with the clinical-meaningful improvement of overall survival compared with chemotherapy in both populations, namely PDL-1-positive and PDL-1-negative.
In summary, cemiplimab was associated with a prolongation on overall survival for the patients who have progress after platinum therapy, regardless of PDL-1 status. I can summarize saying that with a median follow-up of three months, the final overall survival data for the EMPOWER-Cervical trial showed that cemiplimab was associated with significantly prolongation of overall survival for our patients with metastatic recurrent cervical cancer who have progress after platinum therapy.
Nizar M. Tannir, MD, of The University of Texas MD Anderson Cancer Center, discusses phase III findings from the PIVOT-09 study, which compared bempegaldesleukin plus nivolumab with the investigator’s choice of a tyrosine kinase inhibitor (either sunitinib or cabozantinib) in patients with previously untreated advanced renal cell carcinoma (Abstract LBA68).
Gérard Zalcman, MD, PhD, of France’s Bichat-Claude Bernard Hospital, Assistance Publique–Hôpitaux de Paris, discusses phase III results from the IFCT-1701 trial, which explored the questions of whether to administer nivolumab plus ipilimumab for 6 months or whether to prolong the treatment in patients with advanced non–small cell lung cancer (Abstract 972O).
Marinde J.G. Bond, PhD Candidate, of the University Medical Center, Utrecht, discusses phase III findings from the CAIRO5 study of the Dutch Colorectal Cancer Group, the first such trial in defined subgroups of patients with initially unresectable colorectal cancer liver metastases and left-sided and RAS/BRAF V600E wild-type tumor. The study compared FOLFOX/FOLFIRI plus either bevacizumab or panitumumab (Abstract LBA21).
Martin Reck, MD, PhD, of Germany’s Lung Clinic Grosshansdorf, details two trials that included patients with advanced non–small cell lung cancer: 3-year survival outcomes in the EMPOWER-Lung 1 study of continued cemiplimab-rwlc beyond disease progression with the addition of chemotherapy, and phase III results from the IFCT-1701 trial of nivolumab plus ipilimumab 6-month treatment vs treatment continuation (LBA54 and Abstract 972O).
Christelle de la Fouchardiere, MD, of France’s Centre Léon Bérard, discusses phase III findings from the PRODIGE 65–UCGI 36–GEMPAX UNICANCER study, which evaluated whether the combination of gemcitabine and paclitaxel improves overall survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma after FOLFIRINOX failure or intolerance (Abstract LBA60).