Pharma BD Deal Intelligence

GSK plc / Merck KGaA

2019 · Co-Development · $4.2B · Terminated

A failed alliance despite a $4.2B potential deal value. GSK and Merck KGaA's bintrafusp alfa collaboration for NSCLC and biliary tract cancer collapsed after multiple clinical trial failures, with the partnership terminated in September 2021—less than three years after signing.

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Top 25 biggest flops we track

Ranks computed across 828 graded deals (Critic + Outcome Score both present).

The coverage arc

Sep 30, 2021 Fierce Biotech Bearish

GSK's $4.2B bet on Merck KGaA's cancer drug goes up in smoke as pharmas cut ties.

Oct 01, 2021 BioSpace Bearish

GSK and Merck KGaA break up their $4 billion oncology collaboration after multiple clinical trial failures of bintrafusp alfa, ending a partnership that had…

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GSK and Merck KGaA formed a global immuno-oncology alliance to co-develop and co-commercialize bintrafusp alfa (M7824), a bifunctional TGF-beta trap/anti-PD-L1 fusion protein. GSK paid EUR 300M upfront with up to EUR 500M in development milestones and EUR 2.9B in approval/commercial milestones. The collaboration was terminated September 2021 after multiple clinical trial failures.

Key facts

Disease & market context

Non-Small Cell Lung Cancer (IO)

200K US cases/yr · $30.0B Global IO/NSCLC Market (2024)

Disease Overview

NSCLC accounts for ~85% of lung cancers with ~200,000 new US cases/year. Immuno-oncology (checkpoint inhibitors) has transformed treatment. Bintrafusp alfa attempted to combine TGF-beta trapping with PD-L1 blockade but failed to improve on existing PD-1/PD-L1 monotherapies.

Deal Outcome

The GSK/Merck KGaA bintrafusp alfa alliance was terminated in September 2021 after multiple Phase III failures in NSCLC (INTR@PID Lung 037) and biliary tract cancer. The bifunctional approach failed to demonstrate superiority over pembrolizumab in first-line NSCLC. This was a significant setback for the TGF-beta combination hypothesis.

Biliary Tract Cancer

12K US cases/yr · $1.5B Global BTC Market (2024) · ~20% 5-Year Survival Rate

Disease Overview

Biliary tract cancers (cholangiocarcinoma, gallbladder cancer) are rare, aggressive malignancies with limited treatment options. Approximately 12,000 new cases occur annually in the US. Immunotherapy and targeted therapies (FGFR inhibitors, IDH inhibitors) are expanding options.

Treatment Landscape

Standard first-line: gemcitabine/cisplatin + durvalumab (TOPAZ-1). Targeted: pemigatinib/futibatinib (FGFR2 fusions), ivosidenib (IDH1 mutations). Bintrafusp alfa failed in BTC, but the TOPAZ-1 trial established immunotherapy as standard of care. Approximately 40% of BTC has actionable molecular targets.

Deal timeline

Related deals — scored

DealYearValueOutcome
GSK plc / Merck KGaA (this deal)2019$4.2B29
GSK plc / SmithKline Beecham2000$12.0B79
GSK plc / Pfizer Inc.2018$0.0M77
GSK plc / Novartis AG2014$16.0B76
GSK plc / Hansoh Pharmaceutical Group Co. Ltd.2023$1.7B74
GSK plc / Nuvalent, Inc.2026$10.6B70
GSK plc / Sierra Oncology Inc.2022$1.9B70

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