Akeso's Ivonescimab Demonstrates Continued Success in Lung Cancer Trials

Akeso and Summit Therapeutics' PD-1/VEGF bispecific antibody, ivonescimab, has achieved another significant milestone in its development, further solidifying its potential as a groundbreaking treatment for non-small cell lung cancer (NSCLC). The latest phase 3 trial results showcase the drug's efficacy as part of a chemotherapy combination, building upon its previous success against established treatments like Merck's Keytruda.

HARMONi-6 Trial Success

The HARMONi-6 trial, focusing on first-line treatment of advanced squamous NSCLC, has met its primary endpoint of progression-free survival (PFS). An independent data monitoring committee confirmed that ivonescimab plus chemotherapy significantly outperformed BeiGene's PD-1 inhibitor Tevimbra combined with chemotherapy in the 532-patient Chinese study.

Key findings from the trial include:

• Statistically significant and clinically meaningful results
• Efficacy demonstrated in both PD-L1-positive and PD-L1-negative patients
• Favorable safety profile with no new signals identified
• Comparable incidence of treatment-related serious adverse events and high-grade bleeding events between study arms

Dr. Lu Shun, the principal investigator of HARMONi-6, hailed the results as a "breakthrough" that "not only advances the treatment of non-small cell lung cancer but also marks a significant milestone in global oncology immunotherapy."

Implications for Global Market and Future Trials

This latest success marks ivonescimab's third triumphant trial in lung cancer and its second victory against a PD-1 treatment in NSCLC. The drug's consistent performance across multiple studies has caught the attention of investors and analysts alike.

Citi analyst Yigal Nochomovitz, Ph.D., noted that the HARMONi-6 results "put to rest the concern that HARMONi-2 was somehow a 'fluke,'" and demonstrates that ivonescimab's clinical effect over competing PD-1 inhibitors is not diminished when combined with chemotherapy.

The positive outcome of HARMONi-6 also bodes well for Summit's ongoing HARMONi-3 study outside of China, which pits ivonescimab plus chemotherapy against Keytruda plus chemotherapy. A successful result in this global trial could position ivonescimab as a strong contender in the U.S. market.

Market Response and Future Outlook

Following the announcement of the HARMONi-6 results, shares of Summit Therapeutics rose by 18%. The Florida-based company holds the rights to ivonescimab in the U.S., Europe, and Japan, while Akeso retains control in Australia and China, where the drug received approval 10 months ago.

As ivonescimab continues to demonstrate its efficacy across multiple trials, it is poised to potentially reshape the landscape of NSCLC treatment. The pharmaceutical industry eagerly awaits further data and the drug's performance in global populations, which could ultimately determine its impact on established treatments like Keytruda in the U.S. market.