CHICAGO — Akeso Therapeutics' experimental drug ivonescimab reduced the risk of death by 34% in Chinese patients with squamous non-small cell lung cancer compared to a standard treatment in the Harmoni-6 Phase 3 clinical trial. Patients who received ivonescimab combined with chemotherapy had a median overall survival of 27.9 months, compared to 23.7 months for those treated with a standalone PD-1 inhibitor plus chemotherapy.
The results, presented at the annual meeting of the American Society of Clinical Oncology and published simultaneously in The Lancet, come from a trial conducted entirely in China. A global Phase 3 study of ivonescimab, known as Harmoni-3, is ongoing.
Ivonescimab is a bispecific antibody that targets both PD-1 and VEGF. Summit Therapeutics holds the rights to develop and commercialize the drug outside of China, having licensed it from Akeso Therapeutics. Summit plans to report progression-free survival results from squamous patients in the Harmoni-3 trial in the second half of this year and data from non-squamous patients in the first half of next year.
Dr. Suresh Ramalingam, executive director of the Winship Cancer Institute of Emory University, called the findings “good news” for Chinese patients. “There is a new approach in squamous cell lung cancer that extends survival by about four months, which is a substantial improvement given that this is a patient population where progress has come in small steps.” Ramalingam added, “The fact that it shows an improvement in overall survival in a difficult-to-treat patient population is very encouraging.” He also noted, “I'm mindful of the fact that this trial was done exclusively in China, and that brings up the question of how do these data apply to patient populations outside of China, and that will require future investigations.”
Dr. Deborah Doroshow, associate professor of medicine, hematology and medical oncology at the Icahn School of Medicine at Mount Sinai, questioned the clinical significance of the survival benefit. “It's not clear how meaningful that is. It's certainly, it's not two months, but it's also not a huge difference, and I think in terms of whether or not living four months longer is meaningful absolutely depends on the person who is living it.” Doroshow serves on the steering committee for the ongoing Harmoni-3 global trial.
Bleeding of any severity occurred in nearly 25% of patients in the ivonescimab group—twice the rate observed in the control group. People in the control group, who received immunotherapy plus chemotherapy, lived an average of six months longer than historical expectations. Robert Duggan, Summit’s co-CEO and chairman, said the data mean the company has “a very valuable business with a very valuable product that is in its early stages.” Akeso Therapeutics had no comment for the story.