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November 30, 2021updated 11 Jul 2022 9:48am

EC grants approval for Merck-Eisai’s combo therapy for endometrial cancer

The approval is based on positive data from the Phase III KEYNOTE-775/Study 309 trial of Keytruda plus Lenvima.

The European Commission (EC) has granted approval for Merck (MSD) and Eisai’s Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) to treat adults with advanced or recurrent endometrial cancer.

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The combination treatment is indicated for such patients who have progressed on or after previous platinum‑containing therapy in any setting and have not undergone curative surgical procedures or radiation.

Keytruda is an anti-PD-1 therapy developed by Merck while Lenvima is Eisai’s orally available inhibitor of multiple receptor tyrosine kinase.

Keytruda plus Lenvima is the first cocktail of immunotherapy and tyrosine kinase inhibitor to receive approval for treating advanced or recurrent endometrial cancer.

The EC approval is based on data obtained from the Phase III KEYNOTE-775/Study 309 trial.

The open-label, multicentre, randomised, active-controlled trial enrolled 827 advanced endometrial carcinoma patients.

These subjects were categorised into a 1:1 ratio to receive either the combination therapy or investigator’s choice of chemotherapy with doxorubicin or paclitaxel.

Findings showed that Keytruda plus Lenvima offered statistically significant improvements in overall survival (OS), lowering the mortality risk by 38% versus chemotherapy.

Furthermore, the combination treatment offered improvements in progression-free survival (PFS), indicating a 44% decline in disease progression or mortality risk.

The median OS and PFS were 18.3 months and 7.2 months for the Keytruda and Lenvima combination versus 11.4 months and 3.8 months in the chemotherapy arm.

The most common side effects were hypertension, diarrhoea, hypothyroidism, nausea, low appetite, vomiting and fatigue, among others.

Merck Research Laboratories Clinical Research vice-president Dr Gregory Lubiniecki said: “This approval is welcome news for patients in Europe and is based on the first Phase III study evaluating an immunotherapy and tyrosine kinase inhibitor combination that showed superior overall survival for patients with advanced or recurrent endometrial cancer compared to chemotherapy.

“Regardless of mismatch repair status, patients whose endometrial cancer progresses or returns after prior platinum-containing systemic therapies now have a combination treatment option in Keytruda plus Lenvima that demonstrated a 38% reduction in risk of death compared to chemotherapy alone.”

Separately, the EC approved Keytruda plus Lenvima as first-line therapy for adults with advanced renal cell carcinoma.

Last month, the EC approved Keytruda in combination with chemotherapy to treat individuals with breast cancer.

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