Pharma BD Deal Intelligence

GlaxoSmithKline plc / Merck KGaA

2019 · Co-Development · $4.2B · Complete

A $4.2B co-development alliance for bintrafusp alfa, GSK and Merck KGaA's TGF-beta trap/anti-PD-L1 fusion protein bet across NSCLC and other solid tumors, collapsed in 2021 after the molecule failed in the clinic—a bust that ended the partnership entirely.

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The coverage arc

Sep 30, 2021 Bearish

GSK $4.2B bet on Merck KGaA bintrafusp alfa goes up in smoke as pharmas cut ties after series of clinical trial flops in lung cancer indications.

Apr 24, 2026 BioPharm International Bullish

GSK and Merck KGaA partnered in a $4.2 billion cancer immunotherapy deal centered on M7824, with Merck receiving EUR 300 million upfront and potential…

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GSK and Merck KGaA entered a global alliance to co-develop bintrafusp alfa (M7824), a bifunctional TGF-beta trap/anti-PD-L1 fusion protein. Deal terminated in 2021 after clinical failures.

Key facts

Disease & market context

Non-Small Cell Lung Cancer

Competitive Landscape

Bintrafusp alfa (M7824, GSK/Merck KGaA) is a TGF-beta-trap/anti-PD-L1 bifunctional fusion protein whose pivotal 1L NSCLC program failed in January 2021 (INTR@PID Lung 037 did not beat pembrolizumab monotherapy), leading GSK to terminate development. Anti-PD-1/PD-L1 monoclonals (dominant 1L and 2L MOA class): pembrolizumab (Keytruda, Merck) held 1L monotherapy (TPS >=50%) and combination-with-chemo labels and reported ~$25B FY2023 global sales per Merck 10-K; nivolumab (Opdivo, BMS) plus ipilimumab (Yervoy) with or without chemotherapy, atezolizumab (Tecentriq, Roche), durvalumab (Imfinzi, AstraZeneca), cemiplimab (Libtayo, Regeneron), and tremelimumab (Imjudo) combinations cover NSCLC segments. PD-1/VEGF bispecifics (emerging threat): ivonescimab (SMT112/AK112, Summit/Akeso) beat Keytruda on PFS in 1L PD-L1+ NSCLC per HARMONi-2 (China) and is in US Phase 3 HARMONi. Targeted therapies (biomarker-selected): osimertinib (Tagrisso, AstraZeneca) in EGFR, alectinib (Alecensa, Roche) in ALK, sotorasib (Lumakras, Amgen) and adagrasib (Krazati, BMS) in KRAS G12C. Anti-VEGF: bevacizumab (Avastin, Roche) and ramucirumab (Cyramza, Lilly) as combination biologics. Commercial framing: the TGF-beta-trap class failed NSCLC registration; the 1L battle has moved to bispecifics (ivonescimab) and chemo-I-O combinations.

Cervical Cancer

Competitive Landscape

Bintrafusp alfa (M7824, GSK/Merck KGaA) is a TGF-beta-trap/anti-PD-L1 bifunctional fusion protein whose cervical cancer development was discontinued following the GSK 2021 strategic review after Phase 2 data did not support registration. Anti-PD-1 monoclonals (dominant MOA class in recurrent/metastatic cervical): pembrolizumab (Keytruda, Merck) is FDA-approved 1L in combination with chemotherapy plus or minus bevacizumab for PD-L1 CPS >=1 per KEYNOTE-A18 and KEYNOTE-826 (OS HR 0.63), and as adjuvant with chemoradiation for high-risk locally advanced disease per KEYNOTE-A18; cemiplimab (Libtayo, Regeneron) is FDA-approved 2L after platinum per EMPOWER-Cervical 1; nivolumab (Opdivo, BMS) holds FDA accelerated approval for PD-L1+ recurrent/metastatic disease. Antibody-drug conjugates (tissue-factor targeted): tisotumab vedotin (Tivdak, Pfizer/Genmab) received FDA full approval April 2024 for 2L+ recurrent/metastatic cervical cancer per innovaTV 301 (OS HR 0.70). Anti-VEGF: bevacizumab (Avastin, Roche) plus paclitaxel/cisplatin is the legacy 1L backbone per GOG-240. Chemo-radiation: cisplatin-based chemoradiation remains locally advanced standard. Emerging HPV E6/E7-directed T-cell therapies: lifileucel (Amtagvi, Iovance TIL) and HPV-targeted TCR-T assets are investigational. Commercial framing: Keytruda-chemo owns 1L; Tivdak and Libtayo split 2L; the TGF-beta-trap MOA class has not gained traction in cervical.

Biliary Tract Cancer

Competitive Landscape

Bintrafusp alfa (M7824, GSK/Merck KGaA) is a TGF-beta-trap/anti-PD-L1 bifunctional fusion protein whose biliary tract cancer (BTC) program was discontinued after the 2021 Phase 2 INTR@PID BTC 047 failed to meet primary endpoint versus historical control; GSK terminated the program in 2023. Anti-PD-L1/PD-1 monoclonals plus gemcitabine/cisplatin (current 1L standard of care): durvalumab (Imfinzi, AstraZeneca) plus gemcitabine/cisplatin is FDA-approved (September 2022) per TOPAZ-1 (OS HR 0.80); pembrolizumab (Keytruda, Merck) plus gem/cis is FDA-approved (October 2023) per KEYNOTE-966 (OS HR 0.83). FGFR2-targeted TKIs (biomarker-selected, ~10-15% intrahepatic cholangiocarcinoma): pemigatinib (Pemazyre, Incyte) is FDA-approved 2L for FGFR2 fusion/rearrangement per FIGHT-202; futibatinib (Lytgobi, Taiho) received FDA approval September 2022 per FOENIX-CCA2; infigratinib (Truseltiq, QED/Helsinn) was withdrawn in 2022. IDH1-mutant (~15-20% ICC): ivosidenib (Tibsovo, Servier) is FDA-approved 2L+ per ClarIDHy. HER2-amplified: trastuzumab deruxtecan (Enhertu, Daiichi/AstraZeneca) and zanidatamab (Ziihera, Jazz/BeiGene, FDA-approved November 2024 for HER2+ BTC per HERIZON-BTC-01). Commercial framing: the TGF-beta bispecific class has not delivered in BTC; durvalumab+chemo and pembrolizumab+chemo own 1L, while pemigatinib, ivosidenib, and zanidatamab split the biomarker-enriched 2L market.

Deal timeline

Related deals — scored

DealYearValueOutcome
GlaxoSmithKline plc / Merck KGaA (this deal)2019$4.2B29
GlaxoSmithKline plc / Theravance, Inc.2012$213M82
GlaxoSmithKline plc / Tesaro Inc.2018$5.1B79
GlaxoSmithKline plc / Pfizer Inc. (Consumer Healthcare Division)2018$12.7B76
GlaxoSmithKline plc / Novartis Consumer Healthcare JV2018$13.0B74
GlaxoSmithKline plc / ID Biomedical Corporation2005$1.4B64
GlaxoSmithKline plc / Vir Biotechnology Inc.2020$595M51

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