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

Bladder Cancer
Immunotherapy

Jonathan E. Rosenberg, MD, on Urothelial Cancer: Results From EV-103, Cohort K on Enfortumab Vedotin and Pembrolizumab

Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses recent findings on the safety and antitumor activity of enfortumab vedotin-ejfv given intravenously as monotherapy or in combination with pembrolizumab to previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (Abstract LBA73).

Colorectal Cancer

Myriam Chalabi, MD, PhD, on Colon Cancer: New Findings on Neoadjuvant Immune Checkpoint Inhibition

Myriam Chalabi, MD, PhD, of The Netherlands Cancer Institute, discusses data from the NICHE-2 study, which confirms previously reported pathologic responses to short-term neoadjuvant nivolumab plus ipilimumab in patients with locally advanced mismatch repair–deficient colon cancer. Survival data suggest neoadjuvant immunotherapy may become standard of care and allow further exploration of organ-sparing approaches. (Abstract LBA7).

Colorectal Cancer
Immunotherapy

Julien Taïeb, MD, PhD, on Colorectal Cancer: Recent Findings on Avelumab vs Standard Second-Line Chemotherapy

Julien Taïeb, MD, PhD, of Paris Descartes University, discusses phase II results from the SAMCO-PRODIGE 54 trial, which shows the efficacy and safety of avelumab in the second-line treatment of patients with deficient DNA mismatch–repair microsatellite-instability metastatic colorectal cancer. According to Dr. Taïeb, the study indirectly suggests this population should be treated as soon as possible with an immune checkpoint inhibitor (Abstract LBA23).

Gynecologic Cancers

Ana Oaknin, MD, PhD, on Cervical Cancer: New Findings on Cemiplimab in Recurrent or Metastatic Disease

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).

Skin Cancer

Neil D. Gross, MD, on Cutaneous Squamous Cell Carcinoma: Recent Findings on Cemiplimab

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).

Advertisement

Advertisement




Advertisement