Pharma BD Deal Intelligence

Merck & Co. Inc. / Eisai Co., Ltd.

2017 · Co-Development · $5.8B · Complete

A partial win: Lenvima's Keytruda-combo alliance grew into a steady ~$1B/year revenue line for Merck, anchored by real FDA approval in endometrial cancer with confirmed 5-year survival benefit. But the broader "LEAP" expansion into liver, skin, and lung cancers largely failed, with multiple late-stage trials missing survival endpoints and getting discontinued.

CALLED IT — OFF BY 18

Lenvima became a durable ~$1B/year alliance revenue line for Merck, but the ambitious "LEAP" program to extend Keytruda+Lenvima across 6+ tumor types mostly failed — a partial win riding on one real approval (endometrial cancer) amid a long trial-failure streak.

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The coverage arc

Mar 08, 2018 Fierce Pharma Bullish

Evercore ISI's Umer Raffat noted 'Merck has been extremely focused on flawless trial execution with IO-chemo and has added two important small molecule…

Sep 21, 2021 Fierce Pharma Bullish

Analysts at the time of CLEAR data viewed KEYTRUDA-LENVIMA as the leading IO-TKI combo in RCC on cross-trial comparisons vs Bristol Myers' Opdivo+Cabometyx,…

Aug 03, 2022 Fierce Pharma Bearish

LEAP-002 missed in 1L HCC, leading Merck and Eisai to scrap that ambition; analysts framed the readout as a setback that ceded ground to Roche's…

Source summaries from our enrichment pipeline; follow links for originals.

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Merck and Eisai entered a global strategic oncology collaboration to co-develop and co-commercialize lenvatinib (LENVIMA) as monotherapy and in combination with KEYTRUDA (pembrolizumab). Eisai received $300M upfront, up to $650M in option exercise rights through 2020, $450M in R&D reimbursement, plus up to $385M in clinical/regulatory milestones and up to $3.97B in sales-based milestones (~$5.76B aggregate). Eisai books global sales; gross profits split 50/50.

Did it work? Outcome assessment

Lenvima became a durable ~$1B/year alliance revenue line for Merck, but the ambitious "LEAP" program to extend Keytruda+Lenvima across 6+ tumor types mostly failed — a partial win riding on one real approval (endometrial cancer) amid a long trial-failure streak.

Strategic verdict
Partially Achieved

Key facts

Disease & market context

Renal Cell Carcinoma, Hepatocellular Carcinoma, and Endometrial Carcinoma (LENVIMA + KEYTRUDA combinations)

82K US cases/yr · $1.5B Global lenvatinib market $1.48B in 2024 (CAGR 8.2% to 2033)

Disease Overview

Lenvatinib (LENVIMA) is a multi-receptor tyrosine kinase inhibitor (VEGFR1-3, FGFR1-4, RET, KIT, PDGFR-α) approved across thyroid cancer, renal cell carcinoma (in combination with everolimus or pembrolizumab), hepatocellular carcinoma (1L monotherapy), and endometrial carcinoma (with pembrolizumab). The Merck-Eisai collaboration centered on combining lenvatinib's anti-angiogenic activity with KEYTRUDA's PD-1 blockade to drive synergistic responses across multiple solid tumors with limited durable IO activity as monotherapy.

Competitive Landscape

In advanced RCC at deal time, the standard of care was sunitinib (Pfizer's Sutent) and pazopanib (Votrient); the LENVIMA+KEYTRUDA combination went on to deliver superior PFS/OS vs sunitinib in CLEAR (KEYNOTE-581), supporting a first-line approval in 2021 and competing directly with Bristol Myers' Opdivo+Cabometyx (CheckMate-9ER) and Opdivo+Yervoy combinations (Fierce Pharma, https://www.fiercepharma.com/marketing/data-favor-merck-eisai-s-keytruda-lenvima-as-winner-kidney-cancer-but-window-still-open). In 1L HCC, lenvatinib monotherapy received FDA approval August 2018 based on REFLECT (non-inferior to sorafenib/Nexavar), then was leapfrogged by Roche's atezolizumab+bevacizumab (Tecentriq+Avastin) and AstraZeneca's Imjudo+Imfinzi. In endometrial cancer, KEYTRUDA+LENVIMA established a new standard of care in pMMR advanced disease via KEYNOTE-775 (BioPharma Dive, https://www.biopharmadive.com/news/eisai-merck-lenvima-approval-indication-deal-cancer/530461/). Several Phase 3 readouts disappointed (LEAP-002 HCC, LEAP-006/007 NSCLC, LEAP-010 head & neck, LEAP-012 NSCLC, LEAP-015 GE adenocarcinoma) — a reminder that the combination thesis didn't generalize universally, but the validated indications anchored multi-billion-dollar franchise sales.

Related deals — scored

DealYearValueOutcome
Merck & Co. Inc. / Eisai Co., Ltd. (this deal)2017$5.8B57
Merck & Co. Inc. / Acceleron Pharma Inc.2021$11.5B90
Merck & Co. Inc. / Peloton Therapeutics Inc.2019$2.2B88
Merck & Co. Inc. / AstraZeneca PLC2017$8.5B87
Merck & Co. Inc. / Moderna, Inc.2022$250M86
Merck & Co. Inc. / Moderna, Inc.2016$250M84
Merck & Co. Inc. / Eisai Co., Ltd.2018$5.8B83

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