Ivonescimab Plus Chemotherapy Shows Significant Efficacy in First-Line sq-NSCLC Treatment Compared to Tislelizumab

In a significant development in the field of oncology, Akeso, Inc., a prominent biopharmaceutical company based in Hong Kong, has announced encouraging results from a Phase III clinical trial involving its innovative drug, ivonescimab. This drug, a PD-1/VEGF bispecific antibody, was tested in combination with chemotherapy for the treatment of advanced squamous non-small cell lung cancer (sq-NSCLC). The trial, referred to as AK112-306/HARMONi-6, met its primary endpoint of progression-free survival (PFS) during its first interim analysis, as reported by the Independent Data Monitoring Committee (IDMC). These results are both statistically significant and clinically valuable.

The HARMONi-6 study evaluated the effectiveness of ivonescimab in comparison to tislelizumab, another treatment option for lung cancer, when used alongside chemotherapy. The data revealed that ivonescimab significantly improved PFS across the entire patient population, including those who were either PD-L1-positive or PD-L1-negative. The trial included 532 participants, with approximately 63% diagnosed with centrally located squamous cell carcinoma, reflecting real-world conditions.

The safety profile of ivonescimab was favorable, with no new safety concerns identified. The rates of serious adverse events and high-grade bleeding incidents were comparable to those observed in the control group. These positive results underscore ivonescimab's potential to address the limitations associated with bevacizumab, another treatment currently used for sq-NSCLC.

This trial marks the third successful Phase III clinical study for ivonescimab in lung cancer, reinforcing its potential as a comprehensive treatment option for both initial and subsequent lines of therapy. Conducted at 66 research centers across China, the study's findings suggest ivonescimab could become a new standard of care, offering an improvement over existing treatments.

Professor Lu Shun, a leading figure in lung cancer research and a principal investigator in the study, highlighted that ivonescimab's success signals a breakthrough in global oncology immunotherapy. He noted that the drug's combination of immune and antiangiogenic mechanisms provides a promising new avenue for patients with advanced squamous carcinoma, overcoming current treatment limitations and enhancing the benefits of immunotherapy for NSCLC.

Ivonescimab's approval in China for treating EGFR-TKI-resistant advanced nsq-NSCLC has already earned it considerable recognition. Earlier studies, such as the HARMONi-2 study, showed ivonescimab's effectiveness in treating PD-L1-positive NSCLC, further confirmed by the positive outcomes of the HARMONi-6 study.

Dr. Xia Yu, the Founder, Chairwoman, President, and CEO of Akeso, expressed excitement over the promising results of ivonescimab's Phase III study, describing the drug as a breakthrough in cancer therapy with significant clinical value and market potential. Akeso remains committed to advancing ivonescimab's role as a next-generation immunotherapy, with ongoing Phase II and III trials exploring its efficacy in various cancer types.

The HARMONi-6 study's success not only validates Akeso's confidence in ivonescimab but also strengthens its position in the global oncology landscape. Through collaborations with partners, Akeso aims to expand the availability of ivonescimab worldwide, improving treatment standards and offering safer, more effective solutions for cancer patients globally.

As Akeso continues its journey, the company remains focused on developing innovative solutions that address unmet medical needs across multiple disease areas, ensuring that patients worldwide have access to cutting-edge therapies.