BeiGene's Tislelizumab Shows Non-Inferiority In Overall Survival, Safety Vs Standard Treatment In Solid Tumors

BeiGene Limited BGNE shared updates from its solid tumor development program for tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.
The Phase 3 RATIONALE 301 trial of tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma met its primary endpoint of overall survival (OS) non-inferiority.
The median OS was 15.9 months for tislelizumab compared to 14.1 months for Bayer AG BAYRY Nexavar (sorafenib).
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Superiority was subsequently tested, which was not met.
In the RATIONALE 301 trial, tislelizumab was associated with a higher objective response rate (ORR) (14.3% vs. 5.4%) and more durable responses (median duration of response (DoR) 36.1 months vs. 11.0 months) compared with sorafenib.
Median progression-free survival (PFS) for tislelizumab versus sorafenib was 2.1 months vs. 3.4 months respectively; HR: 1.11 [95% CI: 0.92, 1.33].
The safety profiles for tislelizumab and sorafenib treatments were consistent with previous studies, and tislelizumab demonstrated a comparatively favorable profile versus sorafenib with lower incidence rates of grade >3 adverse events.
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