FDA approves Tevimbra for certain adults with advanced esophageal cancer
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The FDA approved tislelizumab-jsgr as a monotherapy for the treatment of certain adults with unresectable or metastatic esophageal squamous cell carcinoma, according to a press release.
The indication applies to adults who experienced disease progression following prior systemic chemotherapy that did not include a PD-1 or PD-L1 inhibitor.
Tislelizumab-jsgr (Tevimbra, BeiGene) is a humanized immunoglobin G4 anti-programmed cell death protein 1 (PD-1) monoclonal antibody.
The FDA based the decision on results from the RATIONALE 302 trial, which assessed the efficacy and safety of the agent among adults with unresectable or metastatic esophageal cancer.
Study results showed the agent provided a statistically significant survival benefit compared with chemotherapy. Study investigators reported median OS of 8.6 months (95% CI, 7.5-10.4) in the Tevimbra arm compared with 6.3 months (95% CI, 5.3-7) for the chemotherapy arm (HR = 0.7; 95% CI, 0.57-0.85).
“Patients diagnosed with advanced or metastasized [esophageal squamous cell carcinoma], the most common histologic subtype of esophageal cancer, often progress following initial therapy and are in need of new options,” Syma Iqbal, MD, cancer physician in chief and associate professor of clinical medicine in the division of medical oncology at USC Norris Comprehensive Cancer Center, said in a press release. “The RATIONALE 302 trial showed that patients with previously treated [esophageal squamous cell carcinoma] who received Tevimbra saw a clinically meaningful survival benefit, highlighting its potential as an important treatment option for these patients.”
The FDA is also reviewing a separate biologics license application for tislelizumab as a potential first-line treatment for patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
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