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A $500M upfront, up to $5B licensing deal that gave Summit Therapeutics ex-China rights to Akeso's ivonescimab—now validated by Phase III data (HARMONi-6 OS HR 0.66) and an FDA BLA acceptance with a November 2026 PDUFA date, though the pivotal US HARMONi-3 readout against pembrolizumab is still pending.
Summit Therapeutics partners with Akeso in a deal worth up to $5 billion to in-license ivonescimab for development and commercialization in the US, Canada,…
Summit committed an upfront payment of $500 million for ivonescimab rights with potential deal value up to $4.5 billion.
At ASCO 2026, HARMONi-6 (1L advanced squamous NSCLC) showed ivonescimab+chemo improved OS vs tislelizumab+chemo (HR 0.66, ~28 vs ~24 mo median OS);…
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Summit Therapeutics licensed exclusive rights to ivonescimab, a PD-1/VEGF bispecific antibody, from Akeso for markets outside Greater China (US, Canada, Europe, Japan) in a December 2022 collaboration worth $500M upfront and up to $5B with milestones (deal closed January 2023). Development has since advanced materially: the U.S. FDA accepted Summit's BLA on January 29, 2026 for ivonescimab plus chemotherapy in EGFR-mutated NSCLC post-3rd-generation TKI (Phase III HARMONi, PFS HR 0.52), with a PDUFA goal action date of November 14, 2026. At ASCO 2026, the Akeso-run Phase III HARMONi-6 showed a statistically significant overall-survival benefit versus tislelizumab plus chemotherapy in first-line squamous NSCLC (OS HR 0.66). The global HARMONi-3 trial (first-line non-squamous NSCLC vs pembrolizumab) is the pivotal US readout, with final PFS data expected in the second half of 2026.
Ivonescimab (Summit/Akeso PD-1/VEGF bispecific) is in Phase 2/3 development for small cell lung cancer (SCLC), an indication with historically poor outcomes and limited I-O responsiveness. No PD-1/VEGF bispecific is FDA-approved in SCLC. Anti-PD-L1 monoclonals plus platinum/etoposide (current 1L extensive-stage SoC): atezolizumab (Tecentriq, Roche) plus carboplatin/etoposide is FDA-approved per IMpower133; durvalumab (Imfinzi, AstraZeneca) plus platinum/etoposide is approved per CASPIAN. Anti-PD-1 monoclonals (2L+ and limited-stage): nivolumab (Opdivo, BMS) and pembrolizumab (Keytruda, Merck) hold narrower labels; durvalumab (Imfinzi) received FDA approval in December 2024 for limited-stage SCLC consolidation post-chemoradiation per ADRIATIC. DLL3-directed bispecifics (emerging MOA class, high differentiation): tarlatamab (Imdelltra, Amgen DLL3/CD3 BiTE) received FDA accelerated approval May 2024 for 2L+ extensive-stage SCLC (ORR 40% per DeLLphi-301) and is the principal class-shifting competitor; BI 764532 (Boehringer Ingelheim DLL3 BiTE, Phase 1/2) and HPN328 (Harpoon/Merck DLL3 TriTAC, Phase 1/2) are pipeline threats. Anti-Trop-2 ADCs: sacituzumab govitecan (Trodelvy, Gilead) is in SCLC trials. Commercial framing: tarlatamab's DLL3 mechanism has redefined 2L SCLC competitively; ivonescimab must demonstrate incremental value over Imfinzi/Tecentriq 1L and differentiate from Imdelltra in relapsed disease.
Ivonescimab (Summit/Akeso PD-1/VEGF bispecific) is in Phase 2/3 development for metastatic colorectal cancer (mCRC). No PD-1/VEGF bispecific is FDA-approved in mCRC. Anti-PD-1 monoclonals (MSI-H/dMMR subset, ~5% of mCRC): pembrolizumab (Keytruda, Merck) is 1L FDA-approved for MSI-H/dMMR mCRC per KEYNOTE-177; nivolumab plus ipilimumab (Opdivo/Yervoy, BMS) is FDA-approved 1L for MSI-H/dMMR per CheckMate-8HW. Anti-VEGF agents (dominant biologic class in mCRC, all MSS): bevacizumab (Avastin, Roche), ziv-aflibercept (Zaltrap, Regeneron/Sanofi), and ramucirumab (Cyramza, Lilly) are FDA-approved; fruquintinib (Fruzaqla, Takeda/Hutchmed oral VEGFR TKI) received FDA approval November 2023 for refractory mCRC. Anti-EGFR monoclonals (RAS/BRAF wildtype): cetuximab (Erbitux, Lilly) and panitumumab (Vectibix, Amgen) plus FOLFOX/FOLFIRI backbones. BRAF V600E-targeted: encorafenib (Braftovi, Pfizer) plus cetuximab is FDA-approved. Refractory-line oral agents: regorafenib (Stivarga, Bayer) and trifluridine/tipiracil (Lonsurf, Taiho) plus bevacizumab. Commercial framing: ivonescimab's value proposition in MSS mCRC (95% of patients) depends on moving the anti-VEGF/anti-PD-1 combination into earlier lines where Avastin+chemo dominates; MSI-H segment is already crowded by Keytruda and Opdivo+Yervoy.
Ivonescimab (SMT112, Summit/Akeso) is a PD-1/VEGF bispecific antibody in Phase 3 HARMONi-7 and HARMONi-HN for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). No bispecific PD-1/VEGF agent is FDA-approved in HNSCC. Anti-PD-1/PD-L1 monoclonals (dominant standard-of-care, direct share competitors): pembrolizumab (Keytruda, Merck) is 1L approved as monotherapy or with platinum/5-FU per KEYNOTE-048 and generated ~$25B FY2023 global sales per Merck 10-K; nivolumab (Opdivo, BMS) holds 2L approval post-platinum; cemiplimab (Libtayo, Regeneron) is in late-stage HNSCC trials. EGFR-targeting agents (historical backbone): cetuximab (Erbitux, Eli Lilly) is FDA-approved in combination with radiation or platinum/5-FU and remains widely used. Emerging bispecific/combination competitors: volrustomig (MEDI5752, AstraZeneca PD-1/CTLA-4 bispecific, Phase 3) and rilvegostomig (AZD2936, AstraZeneca PD-1/TIGIT) are the primary bispecific rivals; petosemtamab (MCLA-158, Merus EGFR/LGR5 bispecific) reported 37% ORR in 2L HNSCC. Chemotherapy doublets (platinum/5-FU, platinum/docetaxel) remain benchmarks. Commercial framing: Keytruda's entrenched 1L position is the defining barrier; ivonescimab must demonstrate OS superiority over pembrolizumab head-to-head or carve a post-Keytruda niche to justify premium pricing.
Ivonescimab (SMT112/AK112, Summit/Akeso) is a PD-1/VEGF bispecific approved in China (May 2024) for EGFR-mutant NSCLC post-TKI per HARMONi-A and under FDA Phase 3 HARMONi and HARMONi-2 (beat pembrolizumab monotherapy on PFS in 1L PD-L1+ NSCLC per Akeso's 2024 WCLC presentation). PD-1/VEGF and PD-1/CTLA-4 bispecifics (direct MOA class): ivonescimab is first-in-class PD-1/VEGF; volrustomig (MEDI5752, AstraZeneca PD-1/CTLA-4, Phase 3) and cadonilimab (Akeso PD-1/CTLA-4, China-approved in cervical cancer) are the principal bispecific competitors. Anti-PD-1/PD-L1 monoclonals (incumbents, ~$35B combined 2023 global sales): pembrolizumab (Keytruda, Merck) holds 1L NSCLC monotherapy (PD-L1 TPS >=50%) and combination with chemo labels; nivolumab plus ipilimumab (Opdivo/Yervoy, BMS) is FDA-approved 1L with or without chemo; atezolizumab (Tecentriq, Roche), durvalumab (Imfinzi, AstraZeneca), cemiplimab (Libtayo, Regeneron), and tremelimumab (Imjudo) combinations cover additional segments. Anti-VEGF biologics (combination partners): bevacizumab (Avastin, Roche) and ramucirumab (Cyramza, Lilly). Commercial framing: Summit's HARMONi-2 PFS win over Keytruda is the market-defining event; FDA 1L NSCLC approval would directly threaten ~$10B+ of Keytruda's lung revenue and reset the bispecific category.
Ivonescimab (Summit/Akeso PD-1/VEGF bispecific) is in Phase 2/3 development for triple-negative breast cancer (TNBC). No PD-1/VEGF bispecific is FDA-approved in TNBC. Anti-PD-1 plus chemo combinations (1L PD-L1+ metastatic and neoadjuvant standards): pembrolizumab (Keytruda, Merck) is FDA-approved with chemotherapy in 1L PD-L1-positive (CPS >=10) metastatic TNBC per KEYNOTE-355, and as neoadjuvant/adjuvant with chemo per KEYNOTE-522; atezolizumab (Tecentriq, Roche) had a 1L TNBC label that was withdrawn in 2021. Anti-Trop-2 antibody-drug conjugates (dominant 2L+ MOA class): sacituzumab govitecan (Trodelvy, Gilead) is FDA-approved for pretreated metastatic TNBC per ASCENT (OS HR 0.48), with Gilead reporting ~$1.3B FY2023 net sales per 10-K; datopotamab deruxtecan (Dato-DXd, Daiichi Sankyo/AstraZeneca) is in Phase 3 TROPION-Breast02 and received FDA BLA submission. PARP inhibitors (germline BRCA-mutant subset): olaparib (Lynparza, AstraZeneca/Merck) and talazoparib (Talzenna, Pfizer). HER2-low TNBC: trastuzumab deruxtecan (Enhertu, Daiichi Sankyo/AstraZeneca) per DESTINY-Breast04. Commercial framing: ivonescimab enters a segment where Keytruda dominates 1L PD-L1+ and Trodelvy/Dato-DXd are rewriting 2L+; differentiation requires PFS/OS head-to-head versus Keytruda-chemo or positioning post-ADC progression.
Summit licensed ivonescimab (PD-1/VEGF bispecific) from Akeso for ex-China markets. $500M upfront with up to $5B total.
BLA submitted for ivonescimab+chemo in 2L+ EGFRm NSCLC. FDA accepted with PDUFA Nov 14, 2026. China approval May 2024.
FDA accepted for filing the BLA for ivonescimab + chemotherapy in EGFR-mutated NSCLC post-3rd-gen-TKI, based on Phase III HARMONi (PFS HR 0.52). PDUFA goal action date November 14, 2026 — the first US regulatory milestone for the licensed asset.
At ASCO 2026, the Akeso-run Phase III HARMONi-6 (1L advanced squamous NSCLC, China) showed ivonescimab + chemo cut risk of death 34% vs tislelizumab + chemo (OS HR 0.66; median OS ~27.9 vs ~23.7 mo) — ivonescimab's first Phase III OS benefit over an active PD-1 comparator.
BLA under FDA review. 14 Phase III studies ongoing/completed. Territory expanded to LATAM, Middle East, Africa.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Summit Therapeutics plc / Akeso Inc. (this deal) | 2023 | $4.5B | 79 |
| AstraZeneca PLC / Daiichi Sankyo Company, Limited | 2019 | $6.9B | 100 |
| Novartis AG / Endocyte, Inc. | 2018 | $2.1B | 96 |
| Astellas Pharma Inc. / Seagen Inc. | 2009 | $4.5B | 95 |
| Bristol-Myers Squibb Company / Medarex Inc. | 2009 | $2.4B | 92 |
| Servier / Agios Pharmaceuticals (oncology) | 2020 | $2.0B | 91 |
| Servier Pharmaceuticals LLC / Agios Pharmaceuticals Inc. | 2020 | $2.0B | 91 |
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