CHICAGO – A lung cancer drug developed by Chinese biotech company Akeso extended patients’ lives by about four months in a late-stage trial in China, results that will likely raise expectations for a closely watched new class of treatments.
The study included more than 500 patients with advanced cancer given either the experimental drug ivonescimab or a standard cancer therapy often used in China as a first line of treatment. Everyone in both groups also received chemotherapy.
Patients on ivonescimab had an overall survival of about 28 months, compared with almost 24 months for patients on the established drug, according to data presented at the American Society of Clinical Oncology annual meeting in Chicago.
The difference was statistically significant.
Ivonescimab is being developed by Akeso and its US partner, Summit Therapeutics, which licensed Akeso’s assets for US$500 million (S$638 million) upfront in late 2022.
The results could help dispel one of the big questions surrounding a new type of cancer treatment, which activates the immune system to fight tumours while cutting off their blood supply.
Numerous drugmakers, including Pfizer, Merck & Company, and Bristol-Myers Squibb, have pledged billions of dollars to gain the rights to these treatments, known as a PD-1/VEGF bispecific antibodies. They essentially merge the mechanisms of Merck’s blockbuster cancer therapy Keytruda and Roche Holding’s Avastin into a single drug.
The investment frenzy is based on the belief that combinations may become the gold standard over Keytruda, an immunotherapy used in many cancers that has been the world’s best-selling medicine.
Until now, the novel approach has offered little proof that it helps patients live longer.
“This is good incremental progress,” said Roy Herbst, an oncologist and deputy director of the Yale Cancer Center.
While the results will need to be verified in other studies outside of China, he said they were better than he expected and called the survival difference clinically meaningful.
A rival drug jointly developed by Germany’s BioNTech and Bristol-Myers also generated encouraging responses. The medicine, pumitamig, was originally developed by China-based Biotheus.
Patients had a robust response to treatment, including those with lower levels of the PD-L1 protein that helps tumours evade the immune system.
The results support its potential to benefit a broad range of patients with non-small cell lung cancer, said Solange Peters, lead investigator and director of oncology at the University Hospital of Lausanne.
Akeso’s positive, if not spectacular, result is almost certain to heighten interest among drugmakers in the dual-targeting approach, said Christine Lovly, chief of thoracic medical oncology at City of Hope in the Los Angeles area.
She said the type of lung cancer in the study is particularly hard to treat, making new methods welcome.
Numerous questions remained unanswered.
It is unclear which patients are most likely to benefit and whether the dual-acting drug will lengthen lives long term, as opposed to bumping up the median survival a bit.
“The data are intriguing, but still immature,” Lovly said in a phone interview.
The study also comes with an important caveat: It was conducted in China.
The Food and Drug Administration (FDA) typically wants to see trial results that involve US patients.
Summit is running a similar study that includes Americans and has applied for FDA approval of ivonescimab for those with a different form of lung cancer.
The trial presented at ASCO compared ivonescimab against Tevimbra, an immunotherapy marketed by BeOne Medicines that works similarly to Keytruda. It is approved in China as a first-line treatment for non-small cell lung cancer.
Akeso already showed its drug outperformed Tevimbra in delaying cancer progression.
The new study targeted squamous non-small cell lung cancer, a condition often linked with smoking.
Survival rates vary depending on when it is detected. According to Cleveland Clinic, about two-thirds of people diagnosed with early-stage non-small cell lung cancer are still alive after five years, while less than 10 per cent of those whose cancer has spread live that long.
Analysts have highlighted Akeso’s presentation as a key barometer for the Chinese drugmaker’s ability to innovate.
Akeso and Summit rose to international fame in 2024 when they claimed that ivonescimab was more effective than Keytruda in staving off a type of lung cancer.
Investors have grown sceptical as more research emerged in other studies.
In a different trial that included US patients with another type of lung cancer, Summit said the drug did not significantly prolong overall survival.
“This feels like a true ‘now or never’ moment for China biotech,” Cui Cui, head of Asia healthcare research at Jefferies, said in an interview ahead of the conference.
Strong data could reinforce Chinese firms’ credibility globally, while negative results could sow doubts about the whole sector. BLOOMBERG
