Merck's Chief Medical Officer's Perspective on AK112

05 Jun 2024
www.echemi.com
Clinical ResultPhase 3
The rapid advancement of domestic innovative drugs has attracted widespread global attention. On May 31st, Akeso Biopharma announced that the results of the HARMONi-2 study for AK112 (ivosidenib) exceeded expectations - the AK112 treatment group showed a significant improvement in progression-free survival (PFS) compared to the control group. Akeso Biopharma called this result "unprecedented."
Eliav Barr, Merck's Chief Medical Officer, shared his perspective on the AK112 data at the 2024 ASCO conference. While he sees AK112 as a potential new treatment option for patients, Barr noted that the drug will need to demonstrate an overall survival (OS) benefit, which could be challenging based on prior experiences with PD-1/VEGF combinations.
Barr pointed out that Merck's own studies have shown positive PFS results with VEGF inhibitors in lung cancer, including their drug K. However, demonstrating an OS benefit has been more difficult. In Merck's Phase 3 LEAP-007 trial in first-line PD-L1 positive NSCLCPD-L1 positive NSCLC, the K-containing regimen reduced the risk of disease progression or death by 22%, but there was a 10% negative trend in OS compared to K alone.
Additionally, Barr stated that AK112 will need to show superiority over the K + chemotherapy combination, as this is the current standard of care, especially for patients with PD-L1 expression
While Barr sees AK112 as a potential new option, he highlighted the need for the drug to demonstrate OS benefit and superiority over the K + chemotherapy regimen to gain broader acceptance and adoption.
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