The LEAP-015 trial comes as part of a series of trials run between MSD and Eisai combining Keytruda and Lenvima. Credit: Shutterstock / sebra

MSD and Eisai have announced mixed results from a Phase III trial of a Keytruda (pembrolizumab) combination as a first-line treatment for patients with metastatic human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma.

MSD and Eisai’s data from the LEAP-015 trial (NCT04662710), examining the anti-PD-1 therapy alongside oral multiple receptor tyrosine kinase inhibitor (TKI) Lenvima (lenvatinib) met one of the dual primary endpoints of progression-free survival (PFS). However, the randomised, open-label trial did not meet one of its two primary endpoints of overall survival (OS).

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The combination therapy trial also met a secondary endpoint tracking objective response rate (ORR) compared with chemotherapy. Full results and analysis from the trial are set to be announced at an upcoming meeting.

MSD’s Keytruda is an anti-PD1 monoclonal antibody and is one of the company’s flagship oncology drugs, making $25bn in sales in 2023. The drug was first approved by the US Food and Drug Administration (FDA) in September 2014.

Eisai’s Lenvima was first approved by the FDA in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).

Eisai and MSD launched their collaboration for the LEAP trials series (LEnvatinib And Pembrolizumab) in 2015. The companies are also investigating the combination in other indications across the hepatocellular carcinoma and oesophageal cancer spaces.

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Gregory Lubiniecki, vice president of global clinical development at Merck Research Laboratories, said: “Locally advanced unresectable or metastatic gastroesophageal adenocarcinoma remains a challenging disease to treat and a leading cause of cancer death worldwide. These study results add to our understanding of this combination and will inform our future research as we strive to improve outcomes for more patients with cancer.”

The combination of Keytruda and Lenvima has been approved in regions such as the US and EU for the treatment of advanced renal cell carcinoma (RCC) and other types of advanced endometrial carcinoma. Besides patients living with metastatic HER2-negative gastroesophageal adenocarcinoma, the LEAP-015 trial also included patients with locally advanced unresectable variants of the disease.

Corina Dutcus, senior vice president of oncology global clinical development at Eisai, said: “While the LEAP-015 trial did not show a statistically significant increase in OS, we were pleased to observe an improvement in PFS and ORR for patients treated with Keytruda plus Lenvima in combination with chemotherapy.”

In 2023, MSD and Eisai announced data from the Phase III trials LEAP-003 and LEAP-017, evaluating Keytruda and Lenvima, both of which failed to meet their primary endpoints.