FDA Approves Tevimbra for Advanced Esophageal Squamous Cell Carcinoma Treatment

The FDA has approved Tevimbra® for the treatment of advanced esophageal cancer based on the positive outcomes of the RATIONALE 302 trial. Developed by BeiGene, Tevimbra is set to become a key therapy in the fight against this aggressive cancer.

BeiGene announced that the US Food and Drug Administration (FDA) has approved Tevimbra® (tislelizumab-jsgr) for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy. This approval marks a significant advancement in the treatment landscape for this aggressive form of cancer, demonstrating a meaningful survival benefit for patients.

A monotherapy treatment

The approval is based on the results of the global Phase 3 RATIONALE 302 trial, which demonstrated a statistically significant and clinically meaningful survival benefit of Tevimbra over chemotherapy. Patients treated with Tevimbra experienced a median overall survival of 8.6 months compared to 6.3 months in those who received chemotherapy, underscoring the therapy's potential to improve outcomes in this patient population.

Dr. Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene, emphasized the significance of this approval, noting it as a key milestone in the company's commitment to bringing innovative therapies to cancer patients worldwide. “As BeiGene’s first drug candidate produced through our immuno-oncology program and second approved medicine in the U.S., Tevimbra is poised to be a critical pillar of our solid tumor development program, which spans more than 17 registration-enabling clinical trials in more than 30 countries across regions globally.”

Esophageal cancer, particularly ESCC, presents a formidable challenge in oncology due to its aggressive nature and the limited efficacy of current treatments. As the sixth most common cause of cancer-related deaths globally, and with projections indicating a nearly 60% increase in new cases by 2040, the approval of Tevimbra® represents a critical step forward in addressing the urgent need for more effective treatment options.

The mechanism of action

Tevimbra's mechanism of action involves a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody, designed to minimize binding to Fc-gamma receptors on macrophages. This helps to enhance the body's immune response against tumors, offering a novel approach to cancer therapy that leverages the body's natural defenses.

Dr. Syma Iqbal, Associate Professor of Clinical Medicine and Section Chief of Gastrointestinal Oncology, states,  “The RATIONALE 302 trial showed that patients with previously treated ESCC 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 Biologics License Applications for Tevimbra® as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC, as well as for those with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, with decisions expected in the coming months.

This approval not only provides a new treatment option for patients with advanced ESCC but also highlights the importance of ongoing research and development in the field of immuno-oncology. With over 900,000 patients globally having been prescribed Tevimbra® to date, its potential to improve survival rates and quality of life for cancer patients continues to grow.

BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.