What's Going On With Summit Therapeutics Stock On Friday?

Summit Therapeutics Inc SMMT stock is trading lower on Friday.

On Thursday, Summit Therapeutics’ partner Akeso Inc. received the U.S. Food and Drug Administration (FDA) approval for its PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).

FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with at least one other prior line of therapy.

Also Read: Analyst Initiates Coverage On ‘Undervalued’ Summit Therapeutics

Penpulimab-kcqx was developed independently by Akeso, and further development and commercialization were managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group.

“This milestone marks penpulimab-kcqx as Akeso’s first internally developed innovative biologic to receive FDA approval…and marks Akeso’s successful entry into the United States regulatory system for the first time,” the company said in a press release on Thursday.

Penpulimab-kcqx has been approved in China for two indications:

First-line treatment of advanced NPC.
Second or later line treatment of advanced NPC.

The company added that the recent FDA approval of penpulimab-kcqx offers a new immunotherapy option for advanced NPC patients in the U.S.

The FDA approval is based on the international Phase 3 trial AK105-304 and the pivotal AK105-202 study, which supported the two Biologics License Application (BLA) for penpulimab-kcqx.

These studies demonstrated the drug’s clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC.

Akeso and Summit Therapeutic are collaborating to develop ivonescimab, a PD-1/VEGF bispecific antibody.

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 September 2024, Summit Therapeutics released data from the primary analysis of the Phase 3 HARMONi-2 trial of ivonescimab conducted in China.

Ivonescimab monotherapy demonstrated a statistically significant improvement in the trial’s primary endpoint, progression-free survival, compared to monotherapy Merck & Co Inc’s MRK Keytruda (pembrolizumab), achieving a hazard ratio (HR) of 0.51.

On Friday, China’s National Medical Products Administration approved supplemental application for ivonescimab for use as a monotherapy for the first-line treatment of PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) in patients who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) gene mutations.

This indication marks Ivonescimab’s second major approval.

Price Action: SMMT stock is down 36.8% at $23.21 at the last check Friday.

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