Item 8.01. Other Events.
OnApril 11, 2021 ,BeiGene, Ltd. (the "Company") announced that clinical data on its anti-PD-1 antibody tislelizumab, in combination with the investigational spectrum-selective kinase inhibitor sitravatinib being jointly developed with Mirati Therapeutics, Inc. (Mirati), were presented in two oral presentations at theAmerican Association for Cancer Research (AACR) Annual Meeting 2021. Data presented at the meeting were from two cohorts of a Phase 1b trial (NCT03666143), in patients with unresectable or metastatic melanoma who were refractory or resistant to PD-1/L1 inhibitors and in patients with advanced platinum-resistant ovarian cancer (PROC). 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. OnApril 12, 2021 , the Company announced results from a planned interim analysis of the Phase 3 RATIONALE 303 trial of its anti-PD-1 antibody tislelizumab compared to docetaxel as second- or third-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in an oral presentation at the AACR Annual Meeting 2021. A supplemental biologics application (sBLA) based on these results from the RATIONALE 303 trial was accepted inMarch 2021 and is currently under regulatory review inChina . The full text of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press Release titled "BeiGene Presents Clinical Data on Sitravatinib in Combination with Tislelizumab at the AACR Annual Meeting 2021" issued onApril 11, 2021 . 99.2 Press Release titled "BeiGene Presents Interim Analysis Results of RATIONALE 303 Trial of Tislelizumab in Second- or
Third-
Lung Cancer at the AACR Annual Meeting 2021"
issued on
104 The cover page from this Current Report on Form
8-K, formatted in Inline
XBRL.
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Exhibit Index Exhibit No. Description 99.1 Press Release title d " B
eiGene Presents Clinical Data on
Sitravatinib in Combination with Tislelizumab at
the AACR Annual Meeting
2021 " issued on April 11 ,
2021.
99.2 Press Release titled " BeiGene Presents
Interim Analysis Results of
RATIONALE 303 Trial of Tislelizumab in Second- or
Third-
Lung Cancer at the AACR Annual Meeting 2021 "
issued on
104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL.
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