#Hong Kong #Cancer Treatment #Ivonescimab #HARMONi-6

Major Breakthrough in Cancer Treatment

At the 2025 ESMO Asia Congress, Akeso, Inc. unveiled groundbreaking data from the pivotal Phase III HARMONi-6 study, focusing on ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, used in combination with chemotherapy for advanced squamous non-small cell lung cancer (sq-NSCLC). This presentation, delivered by Professor Shun Lu from Shanghai Chest Hospital, showcased not only the robust efficacy previously reported but also pivotal improvements in patient-reported quality of life outcomes.

Key Findings

The study highlighted both the survival benefits and quality of life enhancements associated with ivonescimab. Compared to tislelizumab, a different PD-1 inhibitor, the ivonescimab regimen significantly prolonged progression-free survival (PFS) while offering better tolerability and adherence to treatment. Patients receiving ivonescimab reported an overall improvement in health status over extended periods, illustrating the dual benefits of this novel treatment approach.

The EORTC QLQ-C30 questionnaire revealed that patients treated with ivonescimab plus chemotherapy experienced significantly delayed deterioration in their global health status. The study reported a hazard ratio of 0.94 for the time to quality of life deterioration, receiving a lot of attention for signaling a reduced risk of quality of life decline compared to the control group.

Survival Rates and Clinical Impact

In terms of the PFS endpoint, the study provides compelling evidence supporting ivonescimab's role in treatment. The data showcased a hazard ratio of 0.60, which corresponds to an absolute improvement in PFS of approximately 4.24 months (11.14 months for ivonescimab versus 6.90 months for tislelizumab). This robust efficacy was consistent across different PD-L1 expression subgroups, reinforcing its potential as a first-line treatment.

Study Design and Population

The HARMONi-6 study enrolled 532 participants, predominantly stage IV patients, reflecting real-world scenarios where approximately 63% demonstrated the central squamous subtype of cancer. PD-L1 expression levels among patients aligned with expected clinical outcomes.

The findings reiterate the clinical value of the ivonescimab regimen in addressing gaps left by traditional treatments. Previous anti-angiogenic agents, like bevacizumab, have raised safety concerns that ivonescimab seeks to resolve, marking a critical shift in the treatment paradigm for sq-NSCLC.

Future Developments

Since ivonescimab's initial approval in 2024, it has been pivotal in transforming cancer treatment. Its integration into various clinical studies has involved over 40,000 patients, establishing a solid foundation of its clinical benefits. Part of this advancement includes the supplemental New Drug Application accepted for review by China's National Medical Products Administration, which could see ivonescimab being favored in therapy for sq-NSCLC.

Akeso continues to expand its roster of research, with their partner, Summit Therapeutics, conducting the global multicenter Phase III HARMONi-3 study. This trial evaluates ivonescimab combined with chemotherapy against pembrolizumab as a first-line therapy.

Conclusion

The data presented at ESMO Asia emphasizes ivonescimab's strong potential not just in extending patient survival but also significantly improving the quality of life for those battling advanced squamous non-small cell lung cancer. As Akeso moves forward with further studies and developments, ivonescimab may redefine current treatment standards in oncology and reinforce its mission to enhance patient outcomes globally.