On Monday, BioNTech SE (NASDAQ:BNTX) and OncoC4 Inc. released the first median overall survival results from stage 1 of their global PRESERVE-003 Phase 3 trial.
The data indicate their investigational therapy nearly doubled survival times compared to standard chemotherapy for a specific patient population.
Following the announcement, the stock jumped nearly 2%.
Evaluating Gotistobart for Lung Cancer
The study investigates gotistobart (BNT316 or ONC-392) for metastatic squamous non-small cell lung cancer (NSCLC). It focuses on patients whose cancer advanced despite prior immunotherapy and chemotherapy.
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Trial Results And Safety Profile
Researchers presented the findings at the International Association for the Study of Lung Cancer 2026 World Conference on Lung Cancer.
At the July 17 cut-off, the study tracked 87 randomized patients over a median follow-up of 25.4 months.
The gotistobart cohort achieved a median overall survival of 18.5 months, significantly outperforming the 10 months observed in the docetaxel group.
The safety profile for gotistobart remains manageable and consistent with previous reports.
Severe treatment-related adverse events affected 44.4% of patients receiving gotistobart, compared to 48.8% of patients receiving docetaxel.
Ongoing Research And Prior Validation
The pivotal stage 2 segment of the PRESERVE-003 trial continues to enroll patients at more than 160 locations worldwide.
Gotistobart previously showed a meaningful survival advantage and durable anti-tumor activity over docetaxel for NSCLC patients progressing on PD-(L)1 inhibitors.
BNTX Price Action: BioNTech shares were up 1.70% at $98.37 at the time of publication on Monday, according to Benzinga Pro data.
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