Merck, known as MSD outside the United States and Canada, has received FDA approval for its anti-PD-1 therapy, KEYTRUDA, in combination with chemoradiotherapy (CRT) for treating patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. This marks the third indication for KEYTRUDA in cervical cancer and the 39th in the U.S. The approval is based on positive results from the Phase 3 KEYNOTE-A18 trial, demonstrating a 41% reduction in the risk of disease progression or death compared to placebo plus CRT. Median progression-free survival (PFS) was not reached in either group.
KEYTRUDA, an immune checkpoint inhibitor, has gained prominence in the advanced cervical cancer landscape. The FDA approval for its use in combination with CRT provides a new anti-PD-1-based treatment option for patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer. Dr. Bradley Monk, an oncologist and professor of obstetrics and gynecology, emphasized the significance of this approval in offering patients an innovative treatment approach.
FDA Approval of KEYTRUDA and CRT Combo Marks a Milestone in Cervical Cancer Care
The KEYNOTE-A18 trial, involving 1,060 patients, explored the efficacy of KEYTRUDA plus CRT in comparison to placebo plus CRT. The results revealed a statistically significant improvement in PFS in the overall population, particularly in patients with FIGO 2014 Stage III-IVA disease. The 12-month PFS rate was 81% for KEYTRUDA plus CRT, demonstrating its potential to reduce the risk of disease progression or death compared to CRT alone.
While the median duration of exposure to KEYTRUDA was 12.1 months, fatal adverse reactions occurred in 1.4% of patients receiving KEYTRUDA in combination with CRT. Serious adverse reactions, including urinary tract infection, urosepsis, and sepsis, were observed in 30% of patients. Common adverse reactions among KEYTRUDA recipients included nausea, diarrhea, vomiting, urinary tract infection, and fatigue.
A Significant Milestone in Addressing Unmet Medical Needs
The approval expands the range of treatment options for cervical cancer patients, providing an anti-PD-1-based regimen irrespective of PD-L1 expression. KEYTRUDA’s established role in advanced cervical cancer, along with this new approval, reinforces its position as a pivotal therapeutic agent. Dr. Gursel Aktan, Vice President of Global Clinical Development at Merck Research Laboratories, highlighted the importance of this milestone in addressing the unmet medical needs of cervical cancer patients.
As the pharmaceutical landscape continues to evolve, KEYTRUDA’s diverse indications contribute to its prominence in advancing cancer care. The FDA’s approval signifies a step forward in harnessing the potential of immunotherapy in treating cervical cancer, offering renewed hope for patients facing this challenging condition.
Resource: Merck, January 12, 2024
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