Summit Therapeutics Inc.'s (NASDAQ:SMMT) partner, Akeso, Inc., released topline data from the Phase 3 HARMONi-6/K112-306 trial on Wednesday.
The trial is evaluating 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.
HARMONi-6 is a study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso.
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The trial met its primary endpoint of progression-free survival (PFS).
At a prespecified interim analysis conducted by an Independent Data Monitoring Committee, ivonescimab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to BeiGene, Ltd's (NASDAQ:ONC) Tevimbra (tislelizumab) plus chemotherapy.
The PFS benefit was demonstrated in patients with either PD-L1-positive or PD-L1-negative tumors.
Akeso noted that this Phase 3 study identified no new safety signals.
The full data set for HARMONi-6 will be presented at an upcoming major medical conference later this year.
The companies add that before HARMONi-6, there were no known Phase 3 trials in NSCLC that showed a statistically significant improvement compared to PD-(L)1 inhibitor therapy in combination with chemotherapy in a head-to-head setting.
Summit is currently enrolling patients in the HARMONi-3 Phase 3 study sponsored by Summit to evaluate ivonescimab combined with chemotherapy compared to Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab) combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC.
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 pembrolizumab, achieving a hazard ratio (HR) of 0.51.
In February, Summit Therapeutics announced a clinical trial collaboration with Pfizer Inc. (NYSE:PFE) to evaluate ivonescimab with several of Pfizer's antibody-drug conjugates (ADCs) across multiple solid tumor settings.
Under the terms of the agreement, Summit will provide ivonescimab for use in the proposed studies, and Pfizer will be responsible for conducting the studies' operations. Summit and Pfizer will oversee the studies. Both parties retain their respective rights to their products. The studies combining ivonescimab with Pfizer's vedotin ADCs are planned to begin in the middle of this year.
Price Action: SMMT stock is up 21.11% at $33.11 at the last check Wednesday.
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