The approval for this population is based on results from a Phase III Study 309/KEYNOTE-775 trial
Eisai Co. and Merck & Co. (known as MSD outside the United States and Canada) have announced the FDA has approved a combination of Eisai’s Lenvima and Merck’s Keytruda. The combination has been approved as a treatment for patients with advanced endometrial carcinoma that isn’t microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for surgery or radiation.
The approval for this population is based on results from a Phase III Study 309/KEYNOTE-775 trial, in which the combination demonstrated statistically significant improvements in overall survival, reducing the risk of disease progression or death by 40%, versus chemotherapy. It also demonstrated statistically significant improvement in objective response rate, with an ORR of 30% versus 15% for patients who received chemotherapy, in addition to a complete response rate of 5% for the combination versus 3% for chemo and a partial response rate of 25% versus 13%, respectively.
Both components of the therapy can cause adverse reactions, some of which can be serious or fatal, and based on the type and severity of any reactions experienced, treatment may be interrupted, reduced or discontinued. Both therapies can also cause foetal harm when administered to pregnant women.
"When compared to the chemotherapies used in this trial, this combination treatment regimen was proven to extend the lives of certain patients diagnosed with previously treated, advanced endometrial cancer," said Dr Gregory Lubiniecki, VP, Oncology Clinical Research, Merck & Co. Research Laboratories. "Based on Phase 3 data, today's approval acts as the confirmatory trial to our previous accelerated approval of Keytruda plus Lenvima in patients with certain types of advanced endometrial cancer and reinforces the impact of our joint research with Eisai in exploring the potential of this combination to treat more patients with challenging types of cancer."
"This FDA approval of Lenvima plus Keytruda for the treatment of patients with certain types of advanced endometrial cancer is an important step forward towards helping this patient community that has had limited treatment options," said Dr Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. "This marks a culmination of our relentless pursuit to address unmet needs of people with cancer, and we owe our deepest gratitude to those who participated in our Study 309/KEYNOTE-775 trial, their families and clinicians, and to our employees, whose collective commitment made this meaningful milestone possible."
The combination therapy was previously approved under the FDA's accelerated approval process, as well as under the agency's Real-Time Oncology Review pilot program and its Project Orbis initiative, for the treatment of the same population. In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from the most recent trial.