Tislelizumab Shows Improvements in Efficacy Vs Chemo in Esophageal Cancer

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The toxicity profile of tislelizumab also appears to look better compared with chemotherapy in metastatic esophageal squamous cell carcinoma.

Treatment with tislelizumab-jsgr (Tevimbra) has led to improvements in efficacy outcomes compared with standard chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC), according to Syma Iqbal, MD.

Iqbal spoke with CancerNetwork® about efficacy and safety findings from the phase 3 RATIONALE 302 trial (NCT03430843) that supported the FDA approval of tislelizumab in unresectable or metastatic ESCC following prior systemic chemotherapy. In addition to demonstrating superior efficacy compared with chemotherapy, Iqbal highlighted the agent’s safety profile and said that there were no unexpected toxicities observed during the trial.

Data from the RATIONALE 302 trial indicated a median overall survival of 8.6 months (95% CI, 7.5-10.4) in the tislelizumab arm 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). Common adverse effects associated with tislelizumab included anemia, fatigue, musculoskeletal pain, and laboratory abnormalities.

Iqbal is an associate professor of clinical medicine and the section chief of Gastrointestinal Oncology in the Division of Medical Oncology and a cancer physician in chief at Norris Comprehensive Cancer/Keck School of Medicine at the University of Southern California.

Transcript:

RATIONALE 302 is a randomized study for patients who had progressed on chemotherapy who had advanced or metastatic squamous cell carcinoma of the esophagus. These patients were entered into study and subsequently randomly assigned to tislelizumab vs standard-of-care chemotherapy. There was superiority in terms of efficacy end points in the patients who received tislelizumab. In fact, the toxicity profile looks better for those patients, as well.

The toxicity profile looked better than chemotherapy; it didn’t necessarily improve the outcomes. But when you compare the toxicity of the 2 arms, overall, it looked better for the patients who received the tislelizumab. There weren’t any adverse events that were unexpected from these checkpoint inhibitors. The toxicities that we’re seeing are similar to what we see with other checkpoint inhibitors, so it’s just those class effects. There weren’t other untoward or unexpected toxicities.

Reference

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 April 4, 2024. https://shorturl.at/bzZ37

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