#China #Hong Kong #Akeso #Ivonescimab #NSCLC

Breakthrough Approval for Ivonescimab in NSCLC Treatment

Akeso, Inc. has recently made waves in the oncology field with the announcement that their innovative PD-1/VEGF bispecific antibody, Ivonescimab, has received the green light from China’s National Medical Products Administration (NMPA). This marks a significant milestone as Ivonescimab is now approved as a first-line treatment for patients with PD-L1-positive non-small cell lung cancer (NSCLC) who are negative for any mutations in the epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) genes.

The approval of Ivonescimab is grounded in the promising results of the Phase III clinical trial known as AK112-303/HARMONi-2. This study was designed as a double-blind, controlled trial, comparing the efficacy of Ivonescimab directly against Pembrolizumab, a well-established treatment. In a remarkable outcome, Ivonescimab showcased a statistically significant increase in median progression-free survival (PFS)—about 11.14 months compared to Pembrolizumab, achieving a hazard ratio (HR) of 0.51. This suggests a 49% reduced risk of disease progression or death when using Ivonescimab.

Further supporting the benefits of Ivonescimab, an interim analysis indicated a clinically meaningful improvement in overall survival (OS), with a hazard ratio of 0.777—indicating a 22.3% reduction in mortality risk compared with the established drug. Notably, this is the first time a bispecific therapy like Ivonescimab has provided statistically significant results in a head-to-head comparison with Pembrolizumab at this level of evidence.

Professor Zhou Caicun, the principal investigator of the HARMONi-2 study and the director of the Department of Oncology at Shanghai East Hospital, praised these results, stating that Ivonescimab offers not only significant improvements in treatment efficacy but also a safer option compared to traditional chemotherapy. He emphasized its potential to help patients who need better efficacy or prefer to avoid chemotherapy due to its associated side effects.

The Significance of Ivonescimab in Lung Cancer Treatment

The dual-action mechanism of Ivonescimab targets both immune pathways and angiogenesis, positioning it as a groundbreaking therapy in the treatment landscape of NSCLC. It has demonstrated successful results in other Phase III trials, addressing various types of lung cancer, including cases that are resistant to EGFR tyrosine kinase inhibitors (TKIs) and testing in combination with chemotherapy.

Dr. Xia Yu, the Founder and CEO of Akeso, expressed her enthusiasm about this approval, highlighting it as a critical advancement in cancer immunotherapy. She thanked all participants involved in the trial and noted the importance of regulatory oversight that allowed the swift transition of Ivonescimab from research to clinical application. The success seen with Ivonescimab thus far raises hopes of its broader application across several types of cancers beyond lung, demonstrating effectiveness in additional sites such as breast and colorectal cancer, substantiated by ongoing trials worldwide.

With over 50 innovative assets in various stages of development, Akeso's commitment to revolutionizing cancer treatment is evident. This approval and the accompanying positive results from multiple pivotal trials position Ivonescimab as a promising contender in the evolving landscape of cancer therapies, paving the way for safer and more effective treatment options globally.

In conclusion, Ivonescimab's NMPA approval exemplifies a significant triumph for Akeso in its quest to reshape cancer care. With ongoing studies and its dual-action approach, Ivonescimab might redefine treatment standards not only in NSCLC but across other cancers as part of a new generation of immunotherapies.