BeiGene has announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with chemotherapy as a first-line treatment for two aggressive cancer types: esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. This decision is based on promising clinical trial data, offering new hope for patients with limited treatment options.
Addressing an Urgent Need
“Patients diagnosed with advanced gastric and esophageal cancers face median survival times measured in months rather than years,” stated Professor Florian Lordick, Director of the University Cancer Center Leipzig in Germany. “The compelling data from the RATIONALE-305 and 306 trials underscore tislelizumab’s potential to significantly improve outcomes for eligible patients, providing much-needed hope where it’s most critical.”
TEVIMBRA’s approval targets two groups of patients:
- For ESCC, the combination therapy is indicated for adults with unresectable, locally advanced, or metastatic cancer expressing PD-L1 with a tumor area positivity (TAP) score of ≥ 5%.
- For G/GEJ adenocarcinoma, it is approved for HER2-negative, locally advanced, or metastatic cases expressing PD-L1 with a TAP score of ≥ 5%.
Clinical Trial Results: RATIONALE-306
The approval for ESCC is based on data from the RATIONALE-306 trial, a Phase 3, global, placebo-controlled study involving 649 patients across Europe, North America, and the Asia-Pacific region. The trial evaluated the efficacy and safety of TEVIMBRA combined with chemotherapy versus placebo plus chemotherapy.
Key findings include:
- Median overall survival (OS): 17.2 months for TEVIMBRA with chemotherapy compared to 10.6 months for the placebo group, a significant improvement (HR: 0.66, p < 0.0001).
- PD-L1 ≥ 5% population: Median OS extended to 19.1 months with TEVIMBRA versus 10.0 months with placebo, representing a 38% reduction in the risk of death (HR: 0.62).
These results establish TEVIMBRA as a superior first-line treatment option for eligible patients with advanced ESCC.
Clinical Trial Results: RATIONALE-305
The approval for G/GEJ adenocarcinoma stems from findings in the RATIONALE-305 trial, a Phase 3, global, placebo-controlled study involving 997 patients. It evaluated TEVIMBRA with chemotherapy against placebo with chemotherapy as first-line treatments for advanced unresectable or metastatic G/GEJ cancer.
Key results include:
- Median OS: 15.0 months for TEVIMBRA with chemotherapy versus 12.9 months for the placebo group, representing a 20% reduction in the risk of death (HR: 0.80, p = 0.0011).
- PD-L1 ≥ 5% population: Median OS improved to 16.4 months with TEVIMBRA compared to 12.8 months for placebo, demonstrating a 29% reduction in the risk of death (HR: 0.71).
These results highlight the combination therapy’s ability to extend survival for patients with advanced G/GEJ adenocarcinoma, addressing a critical unmet need.
Safety Profile
The safety data for TEVIMBRA includes findings from over 2,800 patients treated in clinical trials, either as monotherapy (1,534 patients) or in combination with chemotherapy (1,319 patients). The most common severe adverse reactions (Grade 3 or 4) included neutropenia, anemia, thrombocytopenia, fatigue, and hypokalemia.
Expanding TEVIMBRA’s Reach
TEVIMBRA is already approved in the European Union for advanced ESCC after prior platinum-based chemotherapy and for three indications in non-small cell lung cancer (NSCLC) across both first- and second-line settings.
“As the cornerstone of our solid tumor portfolio, TEVIMBRA reflects BeiGene’s mission to deliver innovative cancer treatments globally,” said Dr. Mark Lanasa, Chief Medical Officer for Solid Tumors at BeiGene. “With over 1.3 million patients treated worldwide, TEVIMBRA’s approvals in the EU for six indications in just over a year mark significant progress in ensuring access to life-saving therapies.”
Looking Ahead: BeOne Medicines
BeiGene recently announced its intention to rebrand as BeOne Medicines, emphasizing its global commitment to developing innovative cancer treatments. The company aims to eliminate cancer by collaborating with the international healthcare community and expanding access to medicines for as many patients as possible.
This latest approval reinforces BeiGene’s growing impact in oncology and its dedication to transforming cancer care for patients worldwide.
