Ivonescimab monotherapy decisively beats pembrolizumab monotherapy head-to head, achieves statistically significant superiority in PFS in first-line treatment of patients with PD-L1 positive NSCLC in China . Summit Therapeutics + Akeso.
Summit Therapeutics Inc. announced that the Phase III clinical trial, HARMONi-2 or AK112-303, met its primary endpoint of progression-free survival (PFS). HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS greater than 1%).
HARMONi-2 is a single region, multi-center, double-blinded Phase III study conducted in China sponsored by Akeso, Inc. with data generated and analyzed by Akeso. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent central radiology review committee (BICR) compared to pembrolizumab. The PFS benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression (PD-L1 TPS 1-49%), PD-L1 high expression (PD-L1 TPS greater than 50%), squamous and non-squamous histologies, as well as other high-risk patients. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting. The Phase III HARMONi-2 study, along with the approval of ivonescimab in China in combination with chemotherapy based on the results of the HARMONi-A trial, provides clear evidence supporting the purposefully engineered, differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics, and its opportunity to improve upon the existing standards of care for solid tumors.
“HARMONi-2 clearly demonstrates that ivonescimab is the next generation in PD-1 directed immunotherapy, and its potential to make a significant difference in the lives of patients with lung cancer and prospectively other solid tumors,” stated Dr. Maky Zanganeh, Chief Executive Officer and President of Summit. “We want to congratulate our partners at Akeso for this incredible result and their work to advance the patient-friendly standards of care today and well into the future. This result validates Team Summit’s present-time intention to execute a development.
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