Why Is Summit Therapeutics Stock Trading Higher On Monday?

Summit Therapeutics Inc. SMMT on Friday noted that Akeso, Inc. announced the Chinese Health Authorities, the National Medical Products Administration (NMPA) approved ivonescimab for a second indication based on the results of the Phase 3 trial, HARMONi-2 or AK112-303.

On Friday, Summit Therapeutics stock closed almost 30% lower at around $23.47.

HARMONi-2 evaluated monotherapy ivonescimab, PD-1/VEGF bispecific antibody, against monotherapy Merck & Co Inc’s MRK Keytruda (pembrolizumab) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. HARMONi-2 was conducted in China, sponsored by Akeso, with all relevant data exclusively generated, managed and analyzed by Akeso.

As part of the review of Akeso’s supplemental marketing application seeking a label expansion of ivonescimab in China, the NMPA requested that Akeso perform an interim analysis of overall survival (OS).

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Akeso announced the results of this interim overall survival analysis included a clinically meaningful hazard ratio of 0.777.

The analysis was conducted at 39% data maturity, with a nominal alpha level of 0.0001.

In September 2024, for the primary analysis for HARMONi-2, ivonescimab monotherapy demonstrated a statistically significant improvement in the trial’s primary endpoint, progression-free survival (PFS) by Independent Radiologic Review Committee, when compared to monotherapy pembrolizumab, achieving a hazard ratio (HR) of 0.51 (p<0.0001).

A clinically meaningful benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression, PD-L1 high expression, and squamous and non-squamous histologies.

Summit is currently enrolling patients in the HARMONi-7 Phase 3 clinical trial sponsored by Summit, which is evaluating monotherapy ivonescimab against monotherapy (pembrolizumab) in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-7 is currently enrolling patients globally and is conducted with registrational intent for the U.S. and other regions within Summit’s license territories.

On Wednesday, Akeso released topline data from the Phase 3 HARMONi-6/K112-306 trial.

The trial evaluated Summit Therapeutic's ivonescimab in combination with platinum-based chemotherapy, compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression.

The trial met its primary endpoint of progression-free survival (PFS).

In reaction to ivonescimab, BioNTech SE – ADR BNTX is also trading higher on Monday. BioNTech is developing BNT327, a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization.

SMMT, BNTX Price Actions: Summit stock is up 6.73% at $25.05, and BioNTech stock is up 1.94% at $104 at publication Monday.

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