The EC approvals for Keytruda plus Lenvima are based on results from CLEAR/KEYNOTE-581 trial and Phase 3 KEYNOTE-775/Study 309 trial


Merck Research Laboratories in South San Francisco, California. (Credit: Coolcaesar/Wikipedia.)

The European Commission (EC) has approved Merck’s Keytruda (pembrolizumab), in combination with Eisai’s Lenvima (lenvatinib) for two different indications.

Keytruda is an anti-PD-1 therapy, and Lenvima is an orally available multiple receptor tyrosine kinase inhibitor, also called Kisplyx in the European Union (EU).

The EC approved the combination as first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

The approval is based on results from the Phase 3 CLEAR/KEYNOTE-581 trial in 497 adult patients with advanced RCC.

In the study, Keytruda plus Lenvima showed statistically significant improvements the progression-free survival (PFS) and overall survival (OS).

The treatment using the drug combination has reduced the risk of disease progression or death by 61% and the risk of death by 34%, compared to sunitinib.

Also, the drug regimen resulted in a superior objective response rate (ORR), complete response (CR) rate, and partial response (PR) rate than sunitinib.

The most adverse reactions include diarrhoea, hypertension, fatigue, hypothyroidism, decreased appetite, nausea, stomatitis, proteinuria, dysphonia and arthralgia.

Earlier this year, the US Food and Drug Administration (FDA) approved the Keytruda plus Lenvima combination to treat advanced RCC in adults.

Merck Research Laboratories clinical research vice president Gregory Lubiniecki said: “Today’s approval of Keytruda plus Lenvima brings a new treatment option to patients with advanced renal cell carcinoma in Europe.”

The EC has also approved the same combination to treat advanced or recurrent endometrial carcinoma in adults, who were and not eligible for curative surgery or radiation.

According to Merck, Keytruda plus Lenvima is the first combination of immunotherapy and a tyrosine kinase inhibitor, to be approved in Europe for endometrial carcinoma patients.

The EC approval is based on results from the Phase 3 KEYNOTE-775/Study 309 trial, in 827 patients with advanced endometrial carcinoma.

In the study, the drug combination showed statistically significant improvements in OS and PFS.

Keytruda plus Lenvima reduced the risk of death by 38%, and the risk of disease progression or death by 44%, compared to chemotherapy.

The EC approval enables marketing of Keytruda plus Lenvima in all 27 EU member states in addition to Iceland, Liechtenstein, Norway and Northern Ireland.

Eisai oncology business group clinical research vice president Corina Dutcus said: “Until recently, women in Europe with advanced or recurrent endometrial cancer have faced a difficult prognosis and had few treatment options.

“The approval of Keytruda plus Lenvima in this setting reflects the progress that we have made in our collaboration with Merck in developing solutions for those diagnosed with difficult-to-treat cancers.”