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Merck and Eisai share crucial phase 3 trial results for advanced endometrial carcinoma treatment

The study evaluated the combination of Lenvima plus Keytruda versus chemotherapy for patients diagnosed with advanced, metastatic, or recurrent endometrial carcinoma


Merck – known as MSD outside of the US and Canada – announced in the New England Journal 2022 edition a publication of results from the phase 3 Study 309/KEYNOTE-775 trial.

The crucial study assessed the combination of Lenvima (lenvatinib) – a multiple receptor tyrosine kinase inhibitor administered orally as a pill, discovered by Eisai – with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) versus chemotherapy for patients with advanced, metastatic, or recurrent endometrial carcinoma following one prior platinum-based regimen. The study indicated that the chemotherapy used was down to the physician's choice of either paclitaxel or doxorubicin.

Included in the journal publication was previously recorded data, originally presented at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer. The results presented demonstrated that the combination of Lenvima plus Keytruda showed statistically significant improvements regarding the dual primary endpoints of progression-free survival and overall survival, compared to chemotherapy.

Speaking on the results of the trial, Dr Gregory Lubiniecki, vice president, Oncology Clinical Research at Merck Research Laboratories, commented: "While rates of endometrial carcinoma continue to rise globally, patients with advanced or recurrent disease have limited options available to them once the disease progresses following platinum-based chemotherapy.

"KEYNOTE-775/Study 309 is an important phase 3 study that supported recent approvals of Keytruda plus Lenvima for certain types of advanced endometrial carcinoma in the US and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients."

The New England Journal 2022 contains results for the all-comer population, including the mismatch repair deficient (dMMR) patient population for which Lenvima plus Keytruda, which has not yet been approved in the US.

"The phase 3 Study 309/KEYNOTE-775 trial demonstrates the ongoing commitment that Eisai and Merck share in addressing the unmet needs of people living with difficult-to-treat cancers, including advanced endometrial carcinoma," commented Corina Dutcus senior vice president, Clinical Research, Oncology Business Group at Eisai.

Ductus added: "The publication of this study in the New England Journal of Medicine reflects the importance of our joint research in exploring the potential of the Lenvima plus Keytruda combination."

Following the results taken from the phase 3 Study 309/KEYNOTE-775 trial, the combination of Lenvima and Keytruda has been given approval in the US for individuals living with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. The combination is approved in both the EU and Japan for specific patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status.

Merck and Eisai are evaluating the combination of Levima plus Keytruda via the LEAP – LEnvatinib And Pembrolizumab – clinical study in over ten different forms of tumours, across more than 20 clinical trials.

21st January 2022

From: Healthcare



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