FDA Approves Second-Line Tislelizumab Monotherapy in Esophageal Cancer

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Data from the phase 3 RATIONALE 302 trial (NCT03430843) supported the FDA approval of tislelizumab-jsgr as a treatment for those with previously treated unresectable or metastatic esophageal squamous cell carcinoma.

The FDA has approved tislelizumab-jsgr (Tevimbra) monotherapy for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy not including a PD-L1 inhibitor, according to a press release from BeiGene, the developers of the agent.1

The developers noted that tislelizumab will be available in the second half of 2024 in the United States. The approval was based on results from the phase 3 RATIONALE 302 trial (NCT03430843) assessing tislelizumab as monotherapy vs chemotherapy in the second-line setting for this patient population.2

“Today’s FDA approval of [tislelizumab] for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our [biologic license application] for first-line ESCC, 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 of Solid Tumors at BeiGene, said in the press release.1

The RATIONALE 302 trial enrolled 512 patients from 132 research sites across 11 countries in Europe, Asia, and North America.

The overall survival in the tislelizumab arm was 8.6 months (95% CI, 7.5-10.4) vs 6.3 months (95% CI, 5.3-7.0) in the chemotherapy arm (HR, 0.70; 95% CI, 0.57-0.85; P = .0001). The most common adverse effects included increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, and decreased albumin.

In July 2022, the FDA delayed the decision to approve tislelizumab monotherapy based on COVID-19 travel restrictions in China, as on-site inspections of the developer’s facilities could not be completed.3

“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. The RATIONALE 302 trial showed that patients with previously treated ESCC who received [tislelizumab] saw a clinically meaningful survival benefit, highlighting its potential as an important treatment option for these patients,” concluded Syma Iqbal, MD, associate professor of clinical medicine, and section chief of Gastrointestinal Oncology in the Division of Medical Oncology, and cancer physician in chief at Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California.1


  1. BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy. News release. BeiGene. March 14, 2024. Accessed March 14, 2024. https://shorturl.at/bzZ37
  2. Shen L, Kato K, Kim SB, et al. RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma. J Clin Oncol. 2021;39(suppl 15):4012-4012. doi: 10.1200/JCO.2021.39.15_suppl.4012
  3. BeiGene provides regulatory update on the U.S. biologics license application (BLA) for PD-1 inhibitor tislelizumab in 2L ESCC. News Release. BeiGene. July 14, 2022. Accessed July 14, 2022. https://bit.ly/3P9gFhU

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