HQ Team
January 13, 2024: The U.S. Food and Drug Administration (FDA) has granted approval for the expanded use of Merck & Co’s immunotherapy Keytruda in combination with chemoradiotherapy for newly diagnosed patients with advanced cervical cancer. This approval makes Keytruda the first anti-PD-1-based immunotherapy to receive FDA approval for this specific treatment.
Merck, also known as MSD, applauded the FDA’s approval of Keytruda in combination with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer. The approval, based on data from the Phase 3 KEYNOTE-A18 trial, marks a significant breakthrough, offering a new treatment option for patients who had not undergone surgery, radiation, or systemic therapy.
Clinical success of Keytruda
The approval comes on the heels of the Phase 3 KEYNOTE-A18 trial, demonstrating a remarkable improvement in progression-free survival (PFS). Patients treated with Keytruda plus CRT experienced a 41% reduction in the risk of disease progression or death compared to those who received a placebo plus CRT. This accomplishment solidifies Keytruda’s role in advancing the standard of care for cervical cancer patients.
Keytruda in cervical cancer
This approval marks the third indication for Keytruda in cervical cancer, reinforcing its position as an effective treatment option. Dr. Gursel Aktan, Vice President, Global Clinical Development at Merck Research Laboratories, emphasized the significance of Keytruda’s role in advanced cervical cancer and its potential to reduce the risk of disease progression or death.
Keytruda’s approval in combination with CRT is the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer, irrespective of PD-L1 expression. This revolutionary approach reflects Merck’s commitment to providing innovative treatment options for cancer patients.
With two additional approved indications in cervical cancer, Keytruda has established itself as a key player in the field. It is approved in combination with chemotherapy, with or without bevacizumab, and as a single agent for the treatment of recurrent or metastatic cervical cancer. This versatile range of indications underscores Keytruda’s efficacy across different stages of cervical cancer.
KEYNOTE-A18, a Phase 3 trial sponsored by Merck, demonstrated the effectiveness of Keytruda in combination with CRT. The trial, which enrolled 1,060 patients, showcased a statistically significant improvement in PFS.
Adverse reactions
The approval comes with a focus on safety, with the acknowledgment of immune-mediated adverse reactions. Early identification and management are crucial, ensuring the safe use of Keytruda. The drug’s potential to cause severe or life-threatening reactions, including infusion-related issues, necessitates vigilant monitoring and intervention.
Cervical cancer, despite declining rates due to screenings and prevention, remains a global concern. In the U.S. alone, it is estimated that there were approximately 13,960 new cases of invasive cervical cancer and about 4,310 deaths from cervical cancer in 2023. Keytruda’s approval signifies a significant stride in addressing this prevalent health issue.
