Merck's Keytruda Plus Platinum Chemotherapy Achieves Positive Phase 3 Results in First-Line Treatment of Cervical Cancer, Significantly Improving OS and PFS
Jun 23, 2021 03:31
CST Updated
03:31
MSD
Pharmaceutical R&D and Manufacturer
June 22, 2021 /BioonBIOON/ -- MSD (Merck & Co.) recently announced data evaluating the anti-PD-1 therapy KEYTRUDA® (pembrolizumab)First-Line Treatment for Cervical CancerResults of the pivotal Phase 3 KEYNOTE-826 trial (NCT03635567). The trial enrolled 617 adult patients with persistent, recurrent, or metastatic cervical cancer (including squamous cell carcinoma, adenosquamous carcinoma, and adenocarcinoma) who had not previously received systemic chemotherapy and were no longer candidates for curative therapy (such as surgery and/or radiation therapy). It evaluated the efficacy and safety of Keytruda versus placebo, in combination with platinum-based chemotherapy (paclitaxel plus cisplatin, or paclitaxel plus carboplatin) with or without bevacizumab, as first-line treatment. The primary endpoints of the study were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included: objective response rate (ORR), duration of response (DOR), and safety.
The results showed that,The trial met the primary endpoints of OS and PFS.Based on an interim analysis conducted by the Independent Data Monitoring Committee (IDMC),Regardless of the patientTumorRegardless of PD-L1 status, the Keytruda regimen (Keytruda + the same platinum-based chemotherapy, with or without bevacizumab) demonstrated statistically significant and clinically meaningful improvements in OS and PFS compared with the control regimen (placebo + platinum-based chemotherapy, with or without bevacizumab).
Based on the results of this trial,Keytruda is the first anti-PD-1/PD-L1 therapy to demonstrate this.In this trial, the safety profile of Keytruda was consistent with that reported in previous studies. The trial results will be presented at the upcoming medical...Meetingpublished on, and will be submitted to the regulatory authorities.
Dr. Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at MSD Research Laboratories, stated: "Despite advances in prevention and screening, cervical cancer remains a significant health issue that often affects young and middle-aged women. Women diagnosed with metastatic cervical cancer face a particularly poor prognosis, underscoring an urgent need for new treatment options."KEYNOTE-826 is the first study to demonstrate positive results for immunotherapy in the first-line treatment of persistent, recurrent, or metastatic cervical cancer., we look forward to sharing these findings at the upcoming conference and discussing them with regulatory authorities. We thank the patients, their caregivers, and the researchers for their participation in this important study.”
The Phase 3 KEYNOTE-826 trial is also the confirmatory trial for the accelerated approval of Keytruda for the treatment of cervical cancer. In June 2018, Keytruda received accelerated approval from the U.S. FDA for the second-line treatment of patients with recurrent or metastatic cervical cancer, specifically: disease progression during or after chemotherapy, followingFDAVerification of Approved Test MethodsTumorWomen with recurrent or metastatic cervical cancer expressing PD-L1 (combined positive score [CPS] ≥ 1).
Based on this accelerated approval,Keytruda becomes the first PD-1 immunotherapy approved for the treatment of advanced cervical cancer.This approval also marks Keytruda's first indication in gynecologic cancers. Data from the Phase II KEYNOTE-158 cohort E showed that in PD-L1-positive (CPS ≥1) patients, the overall response rate (ORR) with Keytruda was 14.3%, while no response was observed in PD-L1-negative (CPS <1) patients.
Cervical cancer is the fourth leading cause of cancer-related death among women worldwide. Although it can occur in women of any age, it is most frequently diagnosed in those aged 35 to 44. Nearly all cases are caused by human papillomavirus (HPV) infection, with approximately 80% classified as squamous cell carcinoma (SCC, originating from cells at the base of the cervix) and the majority of the remainder being adenocarcinoma (originating from glandular cells in the upper part of the cervix).
Despite advances in routine medical screening and prevention (HPV vaccination), cervical cancer remains prevalent. It is estimated that over 600,000 new cases of cervical cancer are diagnosed worldwide annually, with more than 340,000 deaths. Cervical cancer is generally curable when detected early and treated effectively; however, treatment options for advanced, recurrent, or metastatic cervical cancer are limited, and survival rates remain low. In the United States, forDiagnosisFor cervical cancer patients whose cancer has spread to distant parts of the body, the estimated 5-year survival rate is approximately 17%. (Bioon.com)