Akeso’s bispecific antibody has demonstrated a significant improvement in overall survival for first-line patients with severe gastric cancer or gastroesophageal junction adenocarcinoma in a phase 3 trial, successfully achieving its primary endpoint.
This positive outcome was announced during an interim analysis of the study, which evaluated the combination of cadonilimab and Xelox chemotherapy compared to a placebo plus Xelox. The biotech revealed that the combination therapy delivered a statistically significant enhancement in overall survival compared to the control group. Consequently, the trial’s independent monitoring committee has recommended that the company submit a supplemental new drug application for this patient population, which includes individuals with unresectable locally advanced or metastatic forms of these cancers.
Akeso further reported that the cadonilimab and chemotherapy combination reduced the risk of death for all patients, irrespective of their PD-L1 levels. Notably, the combination displayed superior overall survival results in patients with lower PD-L1 scores or those who tested PD-L1 negative.
This early clinical success paves the way for a potential second approval in China for the bispecific antibody, which targets PD-1 and CTLA-4. The drug had already gained approval as a monotherapy in June 2022 for patients with cervical cancer in the second or third line of treatment. Akeso’s strategy has been focused on expanding its applications rapidly, testing the drug as a monotherapy or in combination with other treatments in at least four other cancer types.
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“We extend our sincere gratitude to all the investigators, participants, and patients who actively took part in the clinical trial. Thanks to your dedication and efforts, an estimated 500,000 gastric cancer patients in China may have access to a new bispecific IO drug combination therapy offering improved treatment efficiency and survival prospects. We will continue to adhere to the recommendations of IDMC, efficiently promote the study, and engage in proactive communication with China’s National Medical Products Administration (NMPA) regarding the marketing application of cadonilimab for this new indication. We eagerly anticipate the early approval of this innovative therapy for the benefit of patients.”
– Dr. Yu Xia, Founder, Chairman, President, and CEO of Akeso
Despite the current emphasis on antibody-drug conjugates in the market, Akeso has continued to diligently advance the development of its bispecific antibodies. The biotech’s second-tier asset, ivonescimab, attracted a substantial deal with Summit Therapeutics, involving $500 million in upfront cash and a total deal value of $5 billion. In this agreement, Summit acquired commercialization and development rights for the US, Canada, Europe, and Japan.
