Summit Therapeutics Inc. (NASDAQ:SMMT) stock is down on Monday following the recent announcement regarding the clinical trial results of ivonescimab on Sunday.
SMMT Stock Catalyst: Ivonescimab Phase 3 Survival Data
The recent phase 3 HARMONi-6 trial results for ivonescimab showed a 34% reduction in the risk of death compared to BeOne Medicines Inc.’s (NASDAQ:ONC) Tevimbra (tislelizumab), marking a significant milestone in the treatment of non-small cell lung cancer.
In the HARMONi-6 planned interim analysis of overall survival (OS), ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement when compared to tislelizumab in combination with chemotherapy, with a hazard ratio (HR) of 0.66.
A clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1-negative or positive expression.
OS rates at 24 months were 64.7% for those patients receiving ivonescimab plus chemotherapy compared to 48.6% for those receiving tislelizumab plus chemotherapy.
Median follow-up time of the current data cut was 21.4 months.
The findings were published simultaneously in The Lancet, highlighting the drug’s promising efficacy and manageable safety profile.
New Colorectal Cancer Data Shows Encouraging Response Rates
On Saturday, Summit Therapeutics presented new results from the AK112-206 Phase 2 study of ivonescimab in first-line metastatic colorectal cancer (mCRC) co-sponsored by Summit and Akeso.
In this U.S.- and China-based Phase 2 cohort of treatment-naïve patients with mCRC, patients receiving ivonescimab in combination with standard-of-care doublet chemotherapy mFOLFOX6 demonstrated an objective response rate (ORR) of 70.8% across both arms in evaluable patients (n=48).
This result is encouraging compared to the historical performance of standard-of-care regimens combining bevacizumab with FOLFOX chemotherapy from prior studies.
Treatment responses in the ivonescimab 20 mg/kg arm were more durable than in the ivonescimab 10 mg/kg arm, with a duration of response landmark estimate at 9 months of 79.1% vs. 41.5%, respectively.
While progression-free survival (PFS) analysis is still immature in this study, the landmark 9-month PFS rate was 76.1% for those patients receiving 20 mg/kg of ivonescimab.
SMMT Price Action: Summit Therapeutics shares were down 10.72% at $15.66 at the time of publication on Monday, according to Benzinga Pro data.
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