Akeso and Summit Therapeutics reported Tuesday that their drug ivonescimab met a key survival goal in a late-stage trial for first-line treatment of non-small cell lung cancer, adding to a growing body of evidence that the experimental therapy can outperform the standard-of-care treatment Keytruda.
Trial Results Show Survival Benefit
In the HARMONi-2 study, an independent monitoring committee determined that ivonescimab produced both statistically and clinically meaningful improvement in overall survival compared to Merck & Co.’s Keytruda, according to a joint announcement from the companies. The randomized, double-blind trial enrolled patients with locally advanced or metastatic NSCLC whose tumors expressed the PD-L1 biomarker at levels of 1% or higher.
Earlier results from the same trial, using a May 2024 cutoff, showed patients receiving ivonescimab lived a median of 11.14 months without their cancer worsening versus 5.82 months for those given Keytruda. Akeso described HARMONi-2 as the first Phase III randomized controlled trial to demonstrate a significant positive outcome against Keytruda in this patient population.
Dr Yu Xia, president and chief executive of Akeso, said the company was pleased that the fourth Phase III study of an ivonescimab-based regimen had demonstrated statistically significant benefit in both survival and progression-free survival. The results reinforce the clinical value of the drug in lung cancer treatment, she added in the announcement.
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Detailed findings from the interim survival analysis will be presented at an upcoming international medical conference and submitted for publication in a peer-reviewed journal.
Broader Development Pipeline
Ivonescimab works as a bispecific antibody targeting both PD-1 and VEGF, combining immunotherapy with anti-angiogenesis mechanisms in a single molecule. The drug has now achieved positive results in overall survival and progression-free survival across multiple Phase III head-to-head trials against existing PD-1 and PD-L1 therapies.
Beyond lung cancer, the drug is being studied in additional tumor types. In August 2026, Akeso and Summit announced that the HARMONi-GI1 trial in patients with advanced biliary tract cancer also met its overall survival goal. A separate Phase III study called HARMONi-7 is evaluating ivonescimab specifically in patients with high PD-L1 expression (TPS ≥50%) in NSCLC.
If the survival benefit observed in HARMONi-2 holds up in final analysis, it would represent a meaningful advancement for patients who currently have limited options beyond established checkpoint inhibitors. The magnitude of that benefit matters considerably for oncologists weighing treatment choices, though analysts at Citi and Evercore have told investors they expect the survival improvement to exceed 30% based on the data trends. This potential survival improvement could translate to a significant increase in the number of patients who achieve a durable response and live longer with their disease.
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Regulatory Status and Commercial Potential
Chinese health authorities approved ivonescimab for NSCLC in May 2024, giving Akeso an early foothold in the world’s largest cancer drug market. The United States regulatory review is ongoing, with a Prescription Drug User Fee Act (PDUFA) decision date set for November 14.
Summit secured the rights to commercialize ivonescimab in the United States, Europe, Canada, Japan, Latin America, the Middle East and Africa under a deal announced in 2022. The agreement obligated Summit to pay Akeso up to $5 billion.
Industry analysts at GlobalData project the drug could achieve more than $9 billion in annual sales by 2032, placing it in the mega-blockbuster category. The forecast reflects expectations that positive survival data across multiple indications could support broad prescribing use. This potential commercial success could transform Summit’s financial system, providing significant revenue streams and solidifying its position as a major player in the oncology market.
