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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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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.
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.
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.
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.
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.
GSK paid ~$445M upfront for co-development of bintrafusp alfa (M7824), bifunctional TGF-beta/anti-PD-L1.
Bintrafusp alfa failed in NSCLC Phase III, biliary tract Phase II, and other indications. Mutual termination.
Three clinical failures. GSK lost ~$445M upfront with no milestones earned. No further obligations.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| GlaxoSmithKline plc / Merck KGaA (this deal) | 2019 | $4.2B | 29 |
| GlaxoSmithKline plc / Theravance, Inc. | 2012 | $213M | 82 |
| GlaxoSmithKline plc / Tesaro Inc. | 2018 | $5.1B | 79 |
| GlaxoSmithKline plc / Pfizer Inc. (Consumer Healthcare Division) | 2018 | $12.7B | 76 |
| GlaxoSmithKline plc / Novartis Consumer Healthcare JV | 2018 | $13.0B | 74 |
| GlaxoSmithKline plc / ID Biomedical Corporation | 2005 | $1.4B | 64 |
| GlaxoSmithKline plc / Vir Biotechnology Inc. | 2020 | $595M | 51 |
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