Akeso’s bispecific antibody improved overall survival in first-line patients with severe gastric cancer or gastroesophageal junction adenocarcinoma in a phase 3 trial, acing the primary endpoint.
The victory reported Tuesday came from an interim analysis of the study, testing cadonilimab in combination with chemotherapy Xelox compared to placebo plus Xelox. The biotech said the novel one-two punch demonstrated a statistically significant improvement in overall survival compared to the control. The trial’s independent monitoring committee recommended that the company submit a supplemental new drug application for the patient population, which includes unresectable locally advanced or metastatic forms of the cancers.
Akeso reported that cadonilimab and chemo reduced the risk of death in “all-comer patients,” irrespective of PD-L1 levels. With that said, the combo showed “superior OS” in patients with lower PD-L1 scores or who were PD-L1 negative.
The early peek at clinical success tees up what could be a second approval in China for the bispecific antibody targeting PD-1 and CTLA-4. The drug was approved as a monotherapy in June 2022 for patients with second or third-line cervical cancer. Akeso’s plan has clearly been to swiftly expand its use, with the biotech testing the drug either solo or in combination with other therapies in at least four other cancer types.
Though the market has recently placed a premium on antibody-drug conjugates, Akeso has dutifully kept up its development of bispecific antibodies. Lucrative rights to the biotech’s second-in-command asset, ivonescimab, cost Summit Therapeutics $500 million in upfront cash just more than a year ago. The total deal value was $5 billion, in which Summit was granted commercialization and development rights for the U.S., Canada, Europe and Japan.