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Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy (CRT) Reduced Risk of Death by 33% Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
Merck & Co., Inc., a leading global biopharmaceutical company, has recently announced groundbreaking results from its Phase 3 KEYNOTE-826 trial. The study evaluated KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of newly diagnosed high-risk locally advanced cervical cancer. The findings, which have been presented at the European Society for Medical Oncology (ESMO) Congress 2023, underscore a significant advancement in the treatment paradigm for this patient population.
KEYTRUDA® Plus CRT: A New Hope for Cervical Cancer Patients
The KEYNOTE-826 trial demonstrated that the addition of KEYTRUDA® to CRT significantly reduced the risk of death by 33% compared to CRT alone. This outcome positions the combination therapy as a potentially transformative approach to managing locally advanced cervical cancer, which remains a significant global health challenge.
Understanding the Trial Design
The Phase 3, randomized, double-blind KEYNOTE-826 trial enrolled 823 patients from 20 countries. Participants were randomly assigned to receive either KEYTRUDA® 200 mg every three weeks plus CRT (n=410) or placebo plus CRT (n=413). The dual primary endpoints were overall survival (OS) and progression-free survival (PFS). The secondary endpoint focused on safety and tolerability. The study also assessed health-related quality of life and various exploratory endpoints, including pharmacokinetics and immunogenicity of KEYTRUDA®.
Impressive Results and Statistical Significance
After a median follow-up of 27.4 months, the combination of KEYTRUDA® and CRT showed a statistically significant improvement in both OS and PFS. Notably, the median OS was not reached in the KEYTRUDA® plus CRT arm versus 16.3 months in the placebo plus CRT arm, reflecting a 33% reduction in the risk of death (HR=0.67; 95% CI, 0.54-0.84; p<0.001). The median PFS was 19.1 months in the KEYTRUDA® plus CRT arm versus 10.7 months in the placebo plus CRT arm, indicating a 35% reduction in the risk of disease progression or death (HR=0.65; 95% CI, 0.53-0.80; p<0.001).
Safety Profile and Tolerability
The safety profile of KEYTRUDA® plus CRT was consistent with the known profiles of each therapy. Grade 3-5 adverse events occurred in 80.2% of patients in the KEYTRUDA® plus CRT arm and 75.5% in the placebo plus CRT arm. The most common adverse events (≥20%) in the KEYTRUDA® plus CRT arm versus the placebo plus CRT arm were anemia (49.5% vs. 45.9%), neutropenia (35.1% vs. 29.8%), and nausea (25.9% vs. 25.1%). These findings suggest that the addition of KEYTRUDA® to CRT does not substantially increase the treatment burden for patients.
Impact on Clinical Practice
The results of the KEYNOTE-826 trial mark a pivotal moment for patients with newly diagnosed high-risk locally advanced cervical cancer. The demonstrated survival benefits of the KEYTRUDA® plus CRT regimen underscore the potential for immunotherapy to transform the standard of care in this setting. As the medical community continues to explore the vast potential of immunotherapy across various cancer types, findings like these offer hope for more effective and durable treatment options.
Looking Ahead: The Future of Cervical Cancer Treatment
Merck’s commitment to advancing oncology research and improving outcomes for patients with cancer is evident in the success of the KEYNOTE-826 trial. As the company continues to investigate KEYTRUDA® across a wide range of cancers and in various treatment settings, the hope is that more patients will benefit from immunotherapy in the future. The positive outcomes observed in the KEYNOTE-826 trial set a promising precedent for ongoing and future studies exploring the potential of KEYTRUDA® and other immunotherapies in cervical cancer and beyond.
For the latest updates on Merck’s oncology research and the KEYTRUDA® clinical development program, visit Merck.com.
Disclaimer: This article is based on press releases and conference presentations. The information provided is for educational purposes only and is not a substitute for professional medical advice. Always consult your healthcare provider for personalized medical guidance.
