Keytruda is Merck’s an anti-programmed death receptor-1 (PD-1) therapy that hinders the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
It increases the ability of the body’s immune system to detect and fight against tumour cells.
Discovered and developed by Eisai, Lenvima is an orally available multiple receptor tyrosine kinase inhibitor.
It inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).
The combination therapy is indicated for patients with unresectable, advanced, or recurrent endometrial carcinoma that continued to progress after receiving cancer chemotherapy.
The MHLW approval marks the first time for Keytruda plus Lenvima combination to be approved in the country.
Now, the combination treatment is approved in the US, Europe, and Japan to treat certain advanced endometrial carcinoma types.
Merck Research Laboratories Clinical Research vice president Dr. Gregory Lubiniecki said: “Rates of endometrial carcinoma have been steadily increasing in Japan each year, and there are limited options for patients who are diagnosed at an advanced stage or find their disease has returned.
“With today’s approval, patients in Japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy.”
The regulatory approval was based on the data obtained from the pivotal Phase III KEYNOTE-775/Study 309 study, which was conducted in 827 patients suffering with advanced endometrial carcinoma.
In this trial, the combination therapy showed statistically significant improvements in overall survival (OS), with a 38% reduction in risk of death and improved progression-free survival (PFS), by reducing the risk of disease progression or death by 44%, compared with chemotherapy.
The most common adverse reactions seen in the trial were nausea, hypothyroidism, fatigue, arthralgia, proteinuria, hypertension, diarrhoea, vomiting, and others.
Furthermore, Merck and Eisai continue to study the Keytruda plus Lenvima combination across many other cancer types with over 20 trials