Merck/Eisai's Keytruda Plus Lenvima Regime Shows Mixed Data In Esophagus Cancer Study

On Friday, Merck & Co Inc MRK and Eisai Co Ltd ESAIY ESALF announced results from the Phase 3 LEAP-015 trial of Keytruda (pembrolizumab) plus Lenvima (lenvatinib), in combination with chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma.

Gastroesophageal adenocarcinoma is a rare type of cancer that occurs in the esophagus, the passageway that connects the mouth and stomach.

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At an interim analysis, the Keytruda plus Lenvima-based regimen demonstrated a statistically significant improvement in progression-free survival (PFS), one of the study’s dual primary endpoints, and objective response rate (ORR), a key secondary endpoint, compared to standard of care chemotherapy.

The study continued, and at the final analysis, it did not meet its other primary endpoint of overall survival (OS).

The safety profile of the Keytruda plus Lenvima-based regimen was consistent with that observed in previously reported studies evaluating the combination.

A full evaluation of the data from this study is ongoing, and Merck and Eisai will present these results at an upcoming medical meeting.

Keytruda plus Lenvima is approved in the U.S., the EU, Japan and other countries for advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma.

In September last year, two Phase 3 trials, LEAP-006 and LEAP-008, evaluating Keytuda plus Lenvima in patients with certain types of metastatic non-small cell lung cancer failed to meet their dual primary endpoints of overall survival (OS) and progression-free survival (PFS).

In August, at the second analysis, Keytruda Lenvima did not demonstrate an improvement in overall survival (OS) in head and neck cancer compared to Keytruda plus placebo, and Merck and Eisai evaluated the likelihood of reaching the protocol-specified threshold for statistical significance for OS and deemed it low.

In April 2023, Merck and Eisai discontinued the Phase 3 LEAP-003 trial, which evaluated Keytruda plus Lenvima as the first-line treatment for adults with unresectable or metastatic melanoma.

The decision is based on the recommendation of an independent Data Monitoring Committee, which determined that Keytruda plus Lenvima did not demonstrate an improvement in overall survival (OS) compared to Keytruda alone. 

MRK Price Action: Merck stock is down 0.54% at $96.09 at publication Friday.

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