FDA Approves Tislelizumab-jsgr for Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy


Results from the phase 3 RATIONALE 302 trial showed tislelizumab-jsgr prolonged survival compared to chemotherapy in patients who received prior systemic treatment.

The FDA approved tislelizumab-jsgr (Tevimbra; BeiGene) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy (not including a PD-[L]1 inhibitor). The approval is based on the results of the RATIONALE 302 study (NCT03430843), which met its primary end point in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit shown for treatment with tislelizumab-jsgr vs chemotherapy.

About the Study

Trial Name: A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

ClinicalTrials.gov ID: NCT03430843

Sponsor: BeiGene

Completion Date (Actual): December 28, 2022

Tislelizumab-jsgr, a uniquely designed, humanized immunoglobulin PD-1 monoclonal antibody, has a high affinity and binding specificity against PD-1. By minimizing binding to Fcγ receptors on macrophages, tislelizumab-jsgr is designed to aid the body’s immune cells to detect and fight tumors.

In the phase 3, global, randomized, open-label, RATIONALE 302 trial, investigators assessed the efficacy and safety of tislelizumab-jsgr when compared with investigator’s choice of chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic ESCC. The study included 512 patients from 132 research sites in 11 countries in Europe, Asia, and North America who were randomized to either the chemotherapy or tislelizumab-jsgr arm.

The median overall survival (OS) in the ITT population in the tislelizumab-jsgr arm was 8.6 months (95% CI: 7.5, 10.4) compared to 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy arm (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of tislelizumab-jsgr was also favorable when compared to chemotherapy, as the most common (≥20%) adverse events were laboratory abnormalities, such as increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased aspartate aminotransferase, musculoskeletal pain, decreased weight, increased alanine aminotransferase, and cough.

“Patients diagnosed with advanced or metastasized ESCC, the most common histologic subtype of esophageal cancer, often progress following initial therapy and are in need of new options,” Syma Iqbal, MD, associate professor of clinical medicine and section chief gastrointestinal oncology in the Division of Medical Oncology, and cancer physician in chief, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, said in the press release. “The RATIONALE 302 trial showed that patients with previously treated ESCC who received [tislelizumab-jsgr] saw a clinically meaningful survival benefit, highlighting its potential as an important treatment option for these patients.”

The FDA is also reviewing biologics license applications for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The target action dates are July and December 2024, respectively.

Tislelizumab-jsgr will be available in the United States for patients with unresectable or metastatic ESCC after prior systemic chemotherapy in the second half of 2024, according to the press release.

“Today’s FDA approval of [tislelizumab-jsgr] for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our BLA for first-line ESCC patients, represents a significant step in our commitment to bringing this therapy to more patients around the world,” said Mark Lanasa, MD, PhD, chief medical officer, solid tumors at BeiGene, in a press release.


BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy. News Release. March 14, 2024. Accessed March 14, 2024. https://ir.beigene.com/news/beigene-receives-fda-approval-for-tevimbra-for-the-treatment-of-advanced-or-metastatic-esophageal-squamous/20eb032c-15ce-456a-a852-39c88a28d811/

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