#China #Hong Kong #Akeso #Cadonilimab #G/GEJ Adenocarcinoma

Akeso's Cadonilimab: A Breakthrough in Gastric Cancer Treatment

Akeso, Inc., a leading biopharmaceutical company, has recently announced that the first patient has been enrolled in a pivotal Phase III clinical trial evaluating cadonilimab, a novel PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy. This trial, supported by the designation of AK104-310/COMPASSION-33, is focused on the perioperative treatment of resectable gastric and gastroesophageal junction (G/GEJ) adenocarcinoma. This move represents the third Phase III trial for cadonilimab targeting gastric cancer and signifies a substantial advancement in cancer treatment strategies.

Expanding Treatment Horizons

Previously, cadonilimab has primarily been evaluated in the context of unresectable advanced gastric cancer. The new trial aims to broaden its application to include patients eligible for surgery, thereby increasing the potential benefits to a wider patient population. The key objectives are to enhance the radical resection rates, lower the instances of recurrence and metastasis, and ultimately improve the overall survival rates for those diagnosed with advanced gastric cancers.

Proven Efficacy in China

Cadonilimab has already gained approval in China as a first-line treatment for advanced gastric cancer, demonstrating significant efficacy across all levels of PD-L1 expression, including both high and low tumoral expression. A critical upcoming assessment of cadonilimab will include its use alongside pulocimab, intending to provide an innovative second-line treatment option for patients exhibiting resistance to current immunologic therapies, thereby potentially addressing a significant gap in treatment.

The Need for Perioperative Solutions

Globally, there is currently a lack of approved perioperative immunotherapy options, underscoring an urgent need within the medical community. As the world’s first approved bispecific antibody that simultaneously targets PD-1 and CTLA-4 pathways, cadonilimab has shown preliminary data suggesting superior efficacy and safety compared to existing PD-1 therapies for the perioperative management of G/GEJ adenocarcinoma. This dual-target mechanism holds promise, particularly for patients with challenging tumor profiles that may not respond well to conventional therapies.

Not Just Numbers: Real Patient Impact

Cadonilimab has made headlines by demonstrating its effectiveness across varying expressions of PD-L1 in patients, a notable contrast to existing treatment options that often yield minimal or no survival benefits for those with lower expressions. Results from prior Phase III trials indicate a meaningful survival advantage, particularly evident in patients with low or negative PD-L1 expressions. Such outcomes can prove transformative for patient groups traditionally marginalized in terms of treatment eligibility.

The Journey Ahead

Looking forward, Akeso emphasizes the intrinsic uncertainties and challenges that accompany drug development, including regulatory hurdles and market dynamics. Although the pathway for cadonilimab may face numerous obstacles, the potential for it to reshape treatment avenues for gastric cancer cannot be overlooked. With ongoing research and robust clinical trials, cadonilimab stands at the forefront of a new era in effective cancer treatment, showcasing a dedication to addressing critical unmet needs in patient care.

About Akeso

Founded in 2012, Akeso, Inc. is committed to the research, development, and commercialization of break-through biological medicines. With a focus on innovative solutions across various therapeutic areas, including cancer and autoimmune diseases, Akeso’s approach is characterized by cutting-edge technology and a robust pipeline of over 50 drug candidates, demonstrating their position as a growing leader in the biopharmaceutical landscape.

For further details regarding Akeso and its initiatives, visit Akeso's corporate profile.