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Merck, Eisai’s Keytruda/Lenvima regimen scores full approval in endometrial cancer

Keytruda plus Lenvima was previously approved under the FDA’s accelerated approval process

Merck & Co – known as MSD outside the US and Canada – and Eisai have announced that their immunotherapy combination Keytruda plus Lenvima has been approved in the US to treat endometrial cancer. 

The US Food and Drug Administration (FDA) has cleared checkpoint inhibitor Keytruda (pembrolizumab) plus tyrosine kinase inhibitor (TKI) Lenvima (lenvatinib) for the treatment of patients with advanced endometrial cancer that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The combination treatment is indicated for use for patients whose disease has progressed after systemic therapy in any setting, or who are not candidates for surgery or radiation.

In the phase 3 KEYNOTE-775 trial, Keytruda plus Lenvima demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS), reducing the risk of death by 32% and the risk of disease progression or death by 40%.

Keytruda plus Lenvima treatment also led to an objective response rate (ORR) of 30% versus 15% for patients receiving either doxorubicin or paclitaxel.

Patients receiving Merck and Eisai’s treatment had a complete response rate of 5% compared with 3% for doxorubicin or paclitaxel, and a partial response rate of 25% versus 13% respectively.

“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 Gregory Lubiniecki, vice president, oncology clinical research, Merck 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,” he added.

The Keytruda plus Lenvima was previously approved under the FDA’s accelerated approval process for the treatment of certain endometrial cancer patients.

Following the positive data from the KEYNOTE-775 confirmatory study, the requirements of the accelerated approval pathway have been met and the immunotherapy treatment regimen has full approval in the US.

In June, Merck and Eisai also announced that the Keytruda plus Lenvima combination treatment improved outcomes when compared to Pfizer’s Sutent (sunitinib) on a measure of health-related quality of life in a phase 3 first-line kidney cancer trial.

Previously, Merck and Eisai reported that Keytruda and Lenvima met the primary endpoint of improved progression-free survival (PFS) compared to Pfizer’s Sutent (sunitinib) in first-line advanced RCC patients.

The combination treatment also met key secondary endpoints of overall survival (OS) and objective response rate (ORR).

Article by
Lucy Parsons

22nd July 2021

From: Regulatory

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