Akeso's Ivonescimab Gains NMPA Approval for Lung Cancer
Akeso Celebrates Major Approval for Ivonescimab
Akeso, Inc. (9926.HK) has achieved a significant milestone with the approval of its innovative bispecific antibody, ivonescimab, by the National Medical Products Administration (NMPA). This approval enables ivonescimab to be used as a monotherapy for the first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) in patients lacking epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) gene mutations. This marks the second major endorsement for ivonescimab, emphasizing its potential in the oncology landscape.
Breakthrough Phase III Trial Results
The NMPA approval stems from the impressive outcomes of the Phase III AK112-303/HARMONi-2 study. This trial was rigorously designed as a randomized, double-blind, controlled study, placing ivonescimab directly against pembrolizumab for PD-L1 positive NSCLC. The findings were remarkable:
- Ivonescimab outperformed pembrolizumab, showcasing a statistically significant improvement in median progression-free survival (PFS) of 11.14 months. The hazard ratio (HR) was recorded at 0.51, reflecting a substantial 49% reduction in disease progression or mortality risk.
- An interim analysis revealed a meaningful increase in overall survival (OS), with an HR of 0.777, demonstrating a 22.3% lower risk of death compared to pembrolizumab.
- This trial marks ivonescimab as the first therapy to achieve significant positive results in comparison to pembrolizumab within a Phase III setting.
- Offering a novel, effective, and safer "chemotherapy-free" avenue for initial NSCLC treatment.
Innovative Mechanism of Action
Ivonescimab stands out as the first bispecific antibody globally recognized for its dual-action mechanism, combining cancer immunotherapy with anti-angiogenesis. It has demonstrated substantial efficacy through three Phase III clinical trials. These studies included treatments for EGFR-TKI-resistant NSCLC, a head-to-head comparison with pembrolizumab, and a combination therapy approach involving chemotherapy for squamous NSCLC.
Impactful Comments from Clinical Leaders
Professor Zhou Caicun, the principal investigator for the HARMONi-2 trial, noted, "The results from the Phase III HARMONi-2 study indicate that ivonescimab provides significant advancements in both progression-free survival and overall survival when compared to pembrolizumab. This breakthrough offers a safer and more effective option for NSCLC patients, particularly benefiting those who require improved efficacy or quality of life and those unable to undergo chemotherapy due to its adverse effects."
Future Outlook for Ivonescimab
The recognition of ivonescimab in treating EGFR-TKI-resistant NSCLC further highlights its clinical importance. The results from a recent combination trial show promise, positioning ivonescimab as a new standard of care for lung cancer, potentially transforming the treatment approach for both first- and second-line options. This development encourages optimism for the continuation of its success in global Phase III trials.
Akeso's Commitment to Oncology
Dr. Xia Yu, the Founder, Chairwoman, President, and CEO of Akeso, expressed her excitement regarding the approval, stating, "The approval of ivonescimab as a first-line treatment for PD-L1-positive NSCLC marks a significant milestone in cancer immunotherapy. We owe our gratitude to the investigators, participants, and patients, as well as the regulatory authorities for their diligent review, enabling us to make this new treatment available to patients across the board."
The clinical evidence supporting ivonescimab illustrates its outstanding efficacy and safety profile for patients across diverse cancer types. In addition to lung cancer, ivonescimab has shown favorable outcomes as a first-line treatment for other critical cancers such as breast, head, neck, biliary tract, and colorectal cancers. With over 12 ongoing Phase III trials, Akeso, alongside its partner, Summit, strives to position ivonescimab as a foundational element of global cancer immunotherapy.
About Akeso
Akeso (HKEX: 9926.HK) is a pioneering biopharmaceutical company dedicated to advancing the research, development, manufacturing, and commercialization of innovative biological medicines that lead the market. Established in 2012, Akeso leverages a unique integrated R&D innovation system, utilizing a comprehensive end-to-end drug development platform and advanced bispecific antibody drug development technology. With a robust pipeline featuring over 50 innovative assets targeting cancer, autoimmune diseases, inflammatory conditions, and metabolic disorders, Akeso is committed to delivering first-in-class and best-in-class therapeutics. As Akeso continues to cultivate its global presence, it aims to provide valuable and affordable treatments, ensuring improved health outcomes for patients worldwide.
Frequently Asked Questions
What is ivonescimab?
Ivonescimab is a bispecific antibody developed by Akeso for the treatment of PD-L1-positive non-small cell lung cancer.
What recent approval did Akeso receive for ivonescimab?
Akeso received approval from the NMPA for ivonescimab as a first-line treatment for PD-L1-positive NSCLC.
What were the findings of the HARMONi-2 trial?
The HARMONi-2 trial showed that ivonescimab significantly improved progression-free survival and overall survival compared to pembrolizumab.
How does ivonescimab work?
Ivonescimab works by combining cancer immunotherapy with anti-angiogenesis, targeting multiple pathways to enhance efficacy.
What is Akeso's mission?
Akeso aims to lead in the development of innovative treatments for serious illnesses while ensuring accessibility to high-quality biopharmaceuticals.
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