Why Is Summit Therapeutics Stock Trading Higher On Monday?

Summit Therapeutics Inc. (NASDAQ: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 (NYSE: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 (NASDAQ: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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