Ivonescimab Approved by NMPA for PD-L1-Positive NSCLC, Outperforming Pembrolizumab in Phase III Trial

HONG KONG, April 25, 2025 - Akeso, Inc. has announced that its pioneering PD-1/VEGF bispecific antibody, ivonescimab, has been approved by the National Medical Products Administration (NMPA) for use as a monotherapy. This approval is specifically for the first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) in patients without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene mutations. This marks the second significant approval for ivonescimab.

The approval follows the promising results from the Phase III AK112-303/HARMONi-2 study, which compared ivonescimab directly with pembrolizumab in treating PD-L1-positive NSCLC. The study showed that ivonescimab significantly improved the primary endpoint of median progression-free survival (PFS), achieving a median PFS of 11.14 months and reducing the risk of disease progression or death by 49% compared to pembrolizumab. Additionally, an interim analysis of overall survival (OS) at 39% data maturity indicated a meaningful improvement, with ivonescimab reducing the risk of death by 22.3%.

Ivonescimab distinguishes itself as the first therapy to deliver statistically significant positive results in a Phase III trial when compared head-to-head with pembrolizumab. It represents a new, more effective, and safer "chemotherapy-free" option for first-line treatment in NSCLC. Globally, ivonescimab is the first bispecific antibody approved with a dual "cancer immunotherapy + anti-angiogenesis" mechanism. It has shown positive outcomes across three Phase III trials for lung cancer, including treatment for EGFR-TKI-resistant NSCLC and as a combination therapy with chemotherapy for squamous NSCLC.

Professor Zhou Caicun, the principal investigator of the HARMONi-2 trial and director of the Department of Oncology at Shanghai East Hospital, Tongji University, remarked on the significant improvements in both progression-free and overall survival that ivonescimab offers over pembrolizumab. This advancement provides a more effective and safer first-line treatment option for NSCLC, beneficial for patients needing better efficacy or those unsuitable for chemotherapy due to its adverse side effects.

Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso, expressed enthusiasm about the approval as a landmark in cancer immunotherapy. The milestone is attributed to the dedication of researchers, participants, and patients, as well as the diligent review by regulatory authorities. Ivonescimab has demonstrated superior efficacy in the Phase III HARMONi-2 trial, establishing itself as the first therapy to surpass pembrolizumab in this context.

The clinical data underscore ivonescimab's exceptional efficacy and safety benefits, not only for lung cancer but potentially for other cancer types, such as breast, head and neck, biliary tract, and colorectal cancer. Akeso is committed to furthering ivonescimab's role in global cancer immunotherapy and providing safer, more effective treatment options for patients worldwide.

About Akeso: Akeso is a leading biopharmaceutical company dedicated to developing innovative biological medicines. Since its founding in 2012, the company has developed a robust platform for drug development and has focused on creating first or best-in-class biopharmaceuticals globally. Akeso is advancing its pipeline of over 50 innovative assets across various fields and continues to strive towards affordable therapeutic solutions for patients globally.