Akeso lung cancer drug cuts death risk 34% in landmark trial
▼ Summary
– Akeso’s ivonescimab reduced the risk of death by 34% in a phase three trial for advanced squamous non-small cell lung cancer, with median survival of 27.9 months versus 23.7 months for the standard therapy.
– Ivonescimab is the first China-originated oncology drug selected for ASCO’s plenary session in the society’s 61-year history.
– The drug is a first-in-class bispecific antibody combining PD-1 blockade and anti-VEGF inhibition, and no prior therapy had beaten PD-1 regimens in a head-to-head phase three trial for this cancer.
– The global NSCLC market was estimated at $20.2 billion in 2024, and Summit Therapeutics holds licensing rights for ivonescimab in the US, Canada, Europe, and Japan.
– Akeso’s Hong Kong-listed shares fell 1.86% on the results day due to profit-taking, though analysts view the data as a potential new standard of care.
Akeso, the Chinese biotech firm whose experimental therapy ivonescimab was once hailed as “biotech’s DeepSeek moment,” has delivered a major clinical win. New phase three data show the drug reduced the risk of death by 34% in patients with advanced squamous non-small cell lung cancer (NSCLC). The results, disclosed in a Hong Kong stock exchange filing on Monday, have earned ivonescimab a spot at the plenary session of the American Society of Clinical Oncology (ASCO). This marks the first time in 61 years that a China-originated investigational oncology drug has been selected for that prestigious platform.
The trial, known as HARMONi-6, enrolled 532 patients with locally advanced or metastatic squamous NSCLC, with roughly 92% already in late-stage disease. Squamous cell lung cancer is strongly tied to smoking, accounting for 80% of cases in men and 90% in women, according to the US National Library of Medicine.
The numbers tell a compelling story. Patients who received ivonescimab plus chemotherapy achieved a median overall survival of 27.9 months, nearly four months longer than the 23.7 months seen with tislelizumab plus chemotherapy. Tislelizumab, marketed by global oncology developer BeOne, generated $737 million in global sales in 2025, up 18.6% year on year. At the two-year mark, 64.7% of ivonescimab patients were still alive, compared with 48.6% in the control group.
Ivonescimab is a first-in-class bispecific antibody that combines PD-1 immune checkpoint blockade with anti-VEGF angiogenesis inhibition in a single molecule. No other therapy had previously challenged the dominance of PD-1-based regimens in a head-to-head phase three trial for this cancer type. The DeepSeek comparison, which first emerged when earlier ivonescimab data surfaced, reflects a pattern where Chinese-originated innovation is disrupting fields long dominated by Western incumbents.
The global non-small cell lung cancer market was valued at $20.2 billion in 2024 and is projected to reach $53.9 billion by 2034, according to Global Market Insights. Ivonescimab already has two approved uses in China: for lung cancer patients with epidermal growth factor receptor (EGFR) mutations (approved 2024) and as a first-line treatment for PD-L1 positive NSCLC (approved 2025).
The US pathway runs through Summit Therapeutics, which licensed exclusive rights for the United States, Canada, Europe, and Japan from Akeso in a 2022 deal worth up to $5 billion in upfront and milestone payments. Summit has already filed a Biologics License Application with the US FDA, which has set a target action date of 14 November 2026 for ivonescimab in EGFR-mutated NSCLC. The HARMONi-6 squamous NSCLC data would support a further label expansion.
Zhang Jialin, head of China healthcare research at Nomura, called the results “a big success not only for the company but also for the drug class, also a sentiment booster for the sector.” Akeso chairwoman Xia Yu said the ASCO selection “signifies the study’s potential to establish a new standard of care and reshape clinical guidelines and practices.”
Ivonescimab’s clinical success arrives as China’s broader biotech industry transitions from generic drug manufacturing to innovative drug development. Chinese technology companies including ByteDance are entering drug discovery with AI-designed therapies, and AI-driven drug discovery platforms are proliferating globally. Established pharmaceutical firms like Innovent Biologics recently signed a $10.5 billion deal with Pfizer for 12 cancer drug trials.
The Chinese drug regulator has accelerated approvals for domestically developed innovative medicines, creating a pipeline that is beginning to compete directly with Western pharmaceuticals in global markets. China’s innovation machine is producing globally competitive products across sectors from AI to biotechnology, a trend that is reshaping competitive dynamics for Western incumbents.
Despite the strong data, Akeso’s Hong Kong-listed shares fell 1.86% to HK$115.9 on Monday, bucking a broader market rally. Analysts attributed the decline to profit-taking after a sustained run-up ahead of the results. Several brokerages revised their target prices upward following the data release, with consensus moving toward ivonescimab becoming a backbone therapy in the NSCLC treatment landscape.
(Source: The Next Web)
