Item 8.01. Other Events.
On January 27, 2021, BeiGene, Ltd. ("BeiGene") announced that the global Phase 3
RATIONALE 302 trial of its anti-PD-1 antibody tislelizumab versus investigator's
choice chemotherapy in patients with advanced unresectable or metastatic
esophageal squamous cell carcinoma (ESCC) who have received prior systemic
treatment met its primary endpoint of overall survival (OS). In the trial
results, tislelizumab demonstrated a statistically significant and clinically
meaningful improvement in OS in the intention-to-treat (ITT) population, when
compared to chemotherapy. The safety profile of tislelizumab was consistent with
its known risks, with no new safety signals identified. The full text of this
press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is
incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Press Release titled "BeiGene Announces Positive Topline Results for Global
Phase 3 Trial of Tislelizumab in Esophageal Squamous Cell Carcinoma" issued
on January 27, 2021.
104 The cover page from this Current Report on Form 8-K, formatted in Inline
XBRL.
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