On March 13, 2024, the U.S. Food and Drug Administration (FDA) 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. TEVIMBRA, a humanized IgG4 antibody engineered with modifications that stabilize the hinge region and abrogate binding to Fc receptors, was approved as an orphan drug for this indication.
FDA’s approval is based on the Phase 3 RATIONALE 302 trial (NCT03430843), which met its primary endpoint in the intention-to-treat (ITT) population, with a median overall survival (OS) in the TEVIMBRA arm or 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 results showed a statistically significant and clinically meaningful survival benefit for TEVIMBRA compared with chemotherapy and the safety profile of TEVIMBRA was favorable over chemotherapy.
In 2019, China’s National Medical Products Administration granted the first global approval of tislelizumab. In 2023, the product received approval by the European Commission for advanced or metastatic ESCC after prior chemotherapy, and it received a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency in February 2024 as a treatment for non-small cell lung cancer across three indications.
Biologics license applications for tislelizumab as 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 are currently undergoing FDA review. The target action dates for these applications are in July and December 2024, respectively.
Details for all approved antibody therapeutics and those in regulatory review can be found in our searchable table.
