Akeso SA shares surged following the release of highly promising results for its innovative lung cancer treatment, Ivonescimab. The China-based randomized, double-blind phase III clinical trial compared Ivonescimab to Merck Sharp & Dohme's pembrolizumab (Keytruda), a market-leading treatment. The data, presented at this year’s World Conference on Lung Cancer, revealed a statistically significant increase in progression-free survival for patients treated with Ivonescimab.
Clinical Trial Results
The Phase III trial demonstrated that patients receiving Ivonescimab experienced a notable increase in their progression-free survival period compared to those treated with pembrolizumab. This benefit was observed across various subgroups, including differences in age, gender, and the presence of liver or brain metastasis. These findings suggest a potentially broader applicability of Ivonescimab in treating non-small cell lung cancer (NSCLC).
Ivonescimab's Potential
Pembrolizumab (Keytruda) generated USD 25 billion in sales last year, underscoring its dominance in the immunotherapy space for solid tumors. Ivonescimab's ability to outperform Keytruda in a head-to-head clinical trial highlights its substantial therapeutic and commercial potential. The drug has not yet received approval as a treatment for advanced programmed death ligand 1 (PD-L1)-positive non-small cell lung cancer. However, Akeso has submitted an application to China’s National Medical Products Administration (NMPA), with approval anticipated next year.
Regulatory and Financial Impact
In May, a therapy combining Ivonescimab with two other drugs received regulatory approval in China for treating non-squamous NSCLC. Akeso reported its first net profit of CNY 1.9 billion (USD 267 million) in the past year, a significant turnaround from a net loss of CNY 1.4 billion in 2022. This financial success was supported by a more than five-fold increase in revenue, reaching CNY 4.5 billion.
