(Corrects executive designation in paragraph 6 to “chief medical officer” from “chief scientific officer”)
By Mariam Sunny and Kamal Choudhury
May 31 (Reuters) – An experimental drug developed by China-based Akeso helped patients with advanced squamous non-small cell lung cancer live 15% longer than BeOne Medicines’ immunotherapy Tevimbra, and cut the risk of death by more than one-third in a study presented at a medical meeting on Sunday.
Patients who received ivonescimab and chemotherapy lived an average of 27.9 months, compared with 23.7 months for those who received Tevimbra and chemotherapy, according to a brief summary of the study results.
The company had reported in October that ivonescimab met the main goal of the study, showing that it cut disease progression or death by 40% versus Tevimbra, before the overall survival data was available.
The head-to-head study conducted in China involved 532 patients with newly diagnosed advanced stage 3 or stage 4 squamous non-small cell lung cancer. It compared ivonescimab with Tevimbra as an initial, or first-line, treatment. All patients also received chemotherapy.
The results are being presented at the American Society of Clinical Oncology meeting in Chicago on Sunday.
Dr. David Spigel, chief medical officer of the Sarah Cannon Research Institute in Nashville, Tennessee, said during a press briefing on Saturday it is not clear if the trial in China will translate to a wider population because differences in ethnicity sometimes affect how drugs work. But, he said, the results are “very encouraging.”
Ivonescimab belongs to a newer class of medicines known as bispecific antibodies, which have dual targets. It blocks the protein PD-1 that helps cancer avoid immune system attack and a second protein called VEGF that can promote tumor growth.
Tevimbra, like other widely used immunotherapies such as Merck’s Keytruda, is a monoclonal antibody that targets PD-1.
The company said with the improved survival data from the dual-target approach and the drug’s favorable risk-benefit profile, it should become the new standard of care in the management of advanced squamous NSCLC.
About 69% of people given the drug experienced serious side effects versus 59% given the standard treatment arm. About 5% of people stopped treatment due to side effects in both groups, according to the publication in the medical journal The Lancet.
Summit Therapeutics has rights for the drug in the U.S., Canada, Europe and Japan through a deal worth up to $5 billion, while Akeso retains rights for China and the rest of the world.
The new data will not be used to seek U.S. approval because the trial was conducted only in China, said Dr. Julie Gralow, ASCO’s chief medical officer.
A separate, ongoing global late-stage trial comparing ivonescimab with Keytruda is expected to produce interim data this year, she said.
“We’ve kind of moved from monoclonal antibodies to antibody drug conjugates. Now I think bispecific antibodies are the hot new area,” Gralow said. “If we see the same kind of benefits in this global trial, it will undoubtedly lead to an approval in the U.S.”
(Reporting by Kamal Choudhury and Mariam Sunny in Bengaluru and Julie Steenhuysen in Chicago; Editing by Sahal Muhammed and Bill Bekrot)
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