Ivonescimab: PD-1/VEGF Bispecific Landscape vs Pembrolizumab

Ivonescimab is an experimental antibody that blocks two targets at once, PD-1 and VEGF. Summit Therapeutics is developing it outside China, and Akeso, its originator, already sells it in China as Yi Da Fang. It matters to competitive intelligence because several companies are now racing to prove that this PD-1 x VEGF design can beat pembrolizumab (Keytruda), the incumbent in lung cancer.

Mechanism at a glance

Ivonescimab is a bispecific antibody. One arm binds PD-1, the same “brake” on T cells that pembrolizumab targets. The other binds VEGF, a signal tumors use to grow blood vessels, which is also the target of the older drug bevacizumab. The idea is to combine immune activation and blood-vessel blockade in one molecule. It is given by intravenous infusion.

Why it matters

As of November 4, 2026, ivonescimab is not approved in the US. Summit’s first FDA application covers ivonescimab plus chemotherapy for EGFR-mutated, non-squamous non-small cell lung cancer (NSCLC) after treatment with an EGFR tyrosine kinase inhibitor. It rests on the global HARMONi trial, where the company-reported independent-review median progression-free survival was 6.8 months versus 4.4 months with placebo plus chemotherapy (HR 0.52). Overall survival was a co-primary endpoint. In July 2026 Summit reported an updated overall survival hazard ratio of 0.76 in the full population, and said it shared the analysis with the FDA. This application is not a head-to-head comparison with pembrolizumab, which is the test that matters most for the wider market.

On the FDA date: Summit’s own Q2 2026 report states that “The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.” We found no report of a change or extension as of November 4. November 14 is a Saturday, and the FDA does not always wait for the goal date.

Competitive pressure points

• Pumitamig (BNT327): a PD-L1 x VEGF bispecific from BioNTech and Bristol Myers Squibb. Its Phase 2/3 first-line NSCLC study compares it plus chemotherapy with pembrolizumab plus chemotherapy (NCT06712316, estimated primary completion January 2029). BioNTech said on November 3, 2026 that pumitamig is in seven pivotal ROSETTA trials, five of them started in 2026.
• PF-08634404 (from SSGJ-707): Pfizer’s PD-1 x VEGF bispecific, licensed from 3SBio. Its Phase 3 “Symbiotic-Lung-01” study compares it plus chemotherapy with pembrolizumab plus chemotherapy in advanced NSCLC (NCT07222566, 1,410 patients planned, estimated primary completion February 2029).
• LM-299: Merck, which owns pembrolizumab, licensed this PD-1 x VEGF bispecific from LaNova in November 2024 for $588 million upfront. We could not verify its current clinical stage.
• Head-to-head risk for Summit: HARMONi-7 pits ivonescimab alone against pembrolizumab in high PD-L1 NSCLC (NCT06767514, 780 patients planned). A head and neck trial, ILLUMINE, also uses pembrolizumab as the comparator.
• The incumbent: see our pembrolizumab landscape.

What to watch

• Whether the FDA acts on the EGFR-mutated NSCLC application by or near November 14, and what the label says about overall survival.
• HARMONi-3, the first-line trial against pembrolizumab plus chemotherapy. An interim analysis in the squamous group did not reach its threshold in April 2026, and the trial continues.
• Whether the strong overall survival result Akeso reported in China (HARMONi-6, against tislelizumab) carries over in Western populations.
• How the EGFR-mutated setting compares with osimertinib-based treatment; see our osimertinib landscape.

Recent developments

Updated November 4, 2026. Items are drawn from company announcements, regulators and trade press; links go to the sources.

• Nov 3, 2026: BioNTech reported third-quarter results. Pumitamig is in seven pivotal ROSETTA trials, and ESMO 2026 included data from ROSETTA Lung-107 (pumitamig plus docetaxel in second-line NSCLC), described by the company as showing encouraging antitumor activity. BioNTech also announced a supply agreement with Gilead for a Phase 3 in first-line triple-negative breast cancer. (BioNTech Q3 report)
• Jul 23, 2026: Summit reported an updated HARMONi overall survival hazard ratio of 0.76 (0.76 in both Western and Asian subgroups), and said that enrollment is complete in both HARMONi-3 cohorts. (Summit Q2 report)
• Apr 30, 2026: Summit disclosed that the interim progression-free survival analysis in HARMONi-3’s squamous cohort did not hit; the trial continues unchanged. Summit has not said how far the result fell short. (ApexOnco)
• Jan 2026: The FDA accepted Summit’s application and set the November 14, 2026 goal date. (CancerNetwork)
• Nov 14, 2024: Merck announced its LM-299 license from LaNova. (Merck)

Upcoming catalysts

• Nov 14, 2026: FDA goal date for Summit’s ivonescimab application.
• Second half of 2026: primary progression-free survival analysis in the squamous cohort of HARMONi-3, with an early interim overall survival analysis (company guidance).
• First half of 2027: HARMONi-3 non-squamous progression-free survival, and a separate squamous overall survival interim analysis (company guidance).

Bottom line

The November 14 FDA date still holds as far as we can verify. It would be a first US decision for the PD-1 x VEGF class, but in a narrow setting and with a mixed overall survival story. The bigger question for the field is whether any of these bispecifics beats pembrolizumab in first-line lung cancer, and those answers are still years away for most rivals.

For how we track assets like these, see our guide to oncology pipeline tracking.

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This article is for informational and competitive-intelligence purposes only and is not medical advice. Approvals, labels and trial results change; verify details against current prescribing information and primary sources.