Advertisement


Jean-Pascal Machiels, MD, PhD, on Head and Neck Cancer: Recent Data on Pembrolizumab and Chemoradiation Therapy

ESMO Congress 2022

Advertisement

Jean-Pascal Machiels, MD, PhD, of Belgium’s Cliniques universitaires Saint-Luc (UCLouvain), discusses the primary results of the phase III KEYNOTE-412 study of pembrolizumab plus chemoradiation therapy (CRT) vs placebo plus CRT for patients with locally advanced head and neck squamous cell carcinoma (Abstract LBA5).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
We presented at ASMO the result of the KEYNOTE-412 trial that compared chemoradiation with pembrolizumab versus chemoradiation plus placebo in patient with locally advanced squamous cell carcinoma of the head and neck. The standard therapy for this group of patient when they're unresected is high-dose cisplatin combined with radiation therapy. With this treatment, the 5-year of our survival is around 50%. We clearly need to improve that. We know that pembrolizumab improves survival in the recurrent and metastatic setting. We have also preclinical model that demonstrate when you gave radiation therapy or cisplatin, that you increase the PD-L1 expression on the tumor, and there are also in preclinical model data that suggests that combining radiotherapy plus anti-PD-1 could improve the outcome. In this study, we select patients unresected, so locally advanced squamous cell carcinoma, and we include patients with locally advanced disease, meaning stage 3 and stage 4 patient. For p16-positive oropharyngeal cancer, we include only T4 or N3 disease. The patients were randomized, so we include 804 patient, randomized 1:1 fashion between chemoradiation plus placebo versus chemoradiation plus pembrolizumab. We gave one dose of placebo or pembrolizumab one week before the cycle of chemoradiation, and in total, we gave 17 cycles. The primary endpoint was event-free survival. The primary endpoint in this trial on the intent-to-treat population was not met, but we observe a favorable trend in favor of improved event-free survival in the group of patients that received chemoradiation plus pembrolizumab. The hazard ratio was 0.83 and the p-value, 0.04, but the efficacy boundary was 0.02 in this study. The 2-year event-free survival with was 56% in placebo and 63% in pembrolizumab. After that, we performed an exploratory analysis where we look at patient with a high expression of PD-L1 on their tumor, CPS 20 or higher. In this group of patients, the 2-year event-free survival was, in placebo, 62%, and in pembrolizumab, 71%. For this group of patients, we also observe a favorable of overall survival benefit, with a 3-year of a survival rate of 73% in control and 79% in pembrolizumab. So we conclude by saying that this trial did not meet the primary endpoint, although there is a favorable trend in favor of pembrolizumab with chemoradiation. This study gave important information, because probably we need to select the patient altered exploratory. It seemed that patients with high CPS score on the tumor could benefit of this approach. So future trials should probably try to select patient with a tumor that express PD-L1. Maybe also in the future, we should try to combine differently chemoradiation with pembrolizumab. Probably the adjuvant setting or the neoadjuvant setting will be better than the concomitant treatment.

Related Videos

Breast Cancer

Matthew P. Goetz, MD, on Breast Cancer: Interim Survival Results With Abemaciclib Plus a Nonsteroidal Aromatase Inhibitor

Matthew P. Goetz, MD, of Mayo Clinic, discusses recent data from the MONARCH 3 trial of patients with advanced hormone receptor–positive, HER2-negative breast cancer. The study, a second interim analysis, showed that longer overall survival was observed in both the intention-to-treat group as well as in the subgroup with visceral disease. However, neither met the threshold for statistical significance, and further analyses are planned when more data can be reported. (Abstract LBA15).

Kidney Cancer

Nizar M. Tannir, MD, on RCC: Data on Bempegaldesleukin Plus Nivolumab vs Tyrosine Kinase Inhibitors in Untreated Disease

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).

Kidney Cancer
Immunotherapy

Robert J. Motzer, MD, on Renal Cell Carcinoma: New Results With Nivolumab and Ipilimumab

Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III results of the CheckMate 914 trial, which explored the efficacy of adjuvant nivolumab plus ipilimumab vs placebo in the treatment of patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (Abstract LBA4).

Prostate Cancer

Neal D. Shore, MD, on Prostate Cancer: Biomarker Analysis, Enzalutamide, and Active Surveillance

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).

Lung Cancer
Immunotherapy

Martin Reck, MD, PhD, on NSCLC: New Findings on Cemiplimab, Nivolumab, and Ipilimumab

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).

Advertisement

Advertisement




Advertisement