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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Esophageal Squamous Cell Carcinoma |
| Drug: | Tevimbra (tislelizumab-jsgr) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy
Published date:
03/14/2024
Excerpt:
...today announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
Source:
Title:
BeiGene’s tislelizumab wins nod in Korea to treat esophageal cancer
Published date:
11/21/2023
Excerpt:
BeiGene Korea...obtained the Ministry of Food and Drug Safety’s approval for Tevimbra Inj. 100mg (ingredient: tislelizumab) to treat esophageal squamous cell carcinoma (ESCC)...Specifically, anti-PD-1 immunotherapy Tevimbra has been authorized as monotherapy in adults with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who are unable to continue prior platinum-based chemotherapy or who have relapsed or progressed since its administration.
Source:
Title:
China NMPA Approves Tislelizumab for Patients with Second-Line Esophageal Squamous Cell Carcinoma
Published date:
04/15/2022
Excerpt:
BeiGene...announced that the China National Medical Products Administration (NMPA) has granted approval to BeiGene’s anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy.
Source:
Title:
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
Published date:
04/26/2024
Excerpt:
Systemic Therapy for Unresectable Locally Advanced, Recurrent, or Metastatic Disease (where local therapy is not indicated)...Preferred Regimens...Tislelizumab-jsgr (category 1)
Source:
Title:
BeiGene Announces Positive CHMP Opinion for Tislelizumab as a Treatment for Advanced or Metastatic ESCC
Published date:
07/21/2023
Excerpt:
BeiGene...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy...The Marketing Authorization Application (MAA) for ESCC is based on results from BeiGene’s RATIONALE 302, a global, randomized, open-label, Phase 3 study (NCT03430843) to investigate the efficacy and safety of tislelizumab when compared with investigator’s choice chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic ESCC.
Trial ID:
Source:
Title:
Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study
Published date:
04/17/2023
Excerpt:
Tislelizumab plus chemotherapy as a first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma provided superior overall survival with a manageable safety profile versus placebo plus chemotherapy.
Secondary therapy:
Chemotherapy
DOI:
10.1016/S1470-2045(23)00108-0
Trial ID:
Source:
Title:
Global Phase 3 Trial of BeiGene’s PD-1 Inhibitor, Tislelizumab, in Combination with Chemotherapy Meets Primary Endpoint in First-Line Advanced Esophageal Squamous Cell Carcinoma
Published date:
04/27/2022
Excerpt:
BeiGene...announced the Independent Data Monitoring Committee (IDMC) determined at a pre-planned interim analysis that RATIONALE 306, a global Phase 3 trial of tislelizumab in combination with chemotherapy, had met the study’s primary endpoint of overall survival (OS) in patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma (ESCC). The safety and tolerability profile for tislelizumab in combination with chemotherapy at this interim analysis was consistent with previous trials and no new safety signals were identified.
Trial ID:
Source:
Title:
BeiGene Announces Positive Topline Results for Global Phase 3 Trial of Tislelizumab in Esophageal Squamous Cell Carcinoma
Published date:
01/27/2021
Excerpt:
...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...
Trial ID:
