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.
Neal D. Shore, MD, of Carolina Urologic Research Center/Genesis Care, discusses new data from the ENACT trial, which showed that patients with prostate cancer and the RNA biomarkers PAM50 and AR-A were likely to have better outcomes with enzalutamide treatment. The results suggest that such RNA biomarkers may help to identify patients who may benefit from enzalutamide treatment compared with active surveillance (Abstract 1385P).
Rahul Aggarwal, MD, of the University of California, San Francisco, discusses recent data from the PRESTO study, which showed that apalutamide plus androgen-deprivation therapy (ADT) for 12 months significantly prolonged PSA progression-free survival compared with ADT alone in patients with biochemically recurrent prostate cancer. These results provide support for the intensification of ADT in this setting. (Abstract LBA63).
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).
Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, and Laurence Albiges, MD, PhD, of France’s Gustave Roussy Cancer Centre, discuss results from two important trials presented at ESMO 2022: Cohort 1 of the LITESPARK-003 study of belzutifan plus cabozantinib as first-line treatment of advanced renal cell carcinoma (RCC), and the KEYNOTE-B61 study of pembrolizumab plus lenvatinib as first-line treatment for non–clear cell RCC (Abstracts 1447O and 1448O).
Marleen Kok, MD, PhD, of The Netherlands Cancer Institute in Amsterdam, discusses the initial results from the BELLINI trial, which tested whether short-term preoperative nivolumab, either as monotherapy or in combination with low-dose doxorubicin or novel immunotherapy combinations, can induce immune activation in patients with early-stage triple-negative breast cancer with tumor-infiltrating lymphocytes (Abstract LBA13).