BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced it will present new data on TEVIMBRA® (tislelizumab) at the European Society of Medical Oncology 2024 Congress (ESMO 2024) in Barcelona, Spain, from September 13-17, 2024. BeiGene has had seven abstracts accepted for ESMO 2024, including one featured in the special session revisiting the ESMO Virtual Plenary from February 2024.
New Data Reinforce TEVIMBRA’s Potential Across Multiple Cancers
At the ESMO 2024 Congress, BeiGene presented interim results from the RATIONALE-315 study, showing that neoadjuvant tislelizumab combined with chemotherapy, followed by adjuvant tislelizumab, significantly improved event-free survival (EFS) and showed a trend for overall survival (OS) benefits compared to placebo plus chemotherapy in patients with resectable non-small cell lung cancer (NSCLC). These findings align with previous data that showed significant improvements in major pathologic response (MPR) and pathologic complete response (pCR) rates: 56.2% vs. 15.0% and 40.7% vs. 5.7%, respectively. The safety profile of tislelizumab was consistent with that of the individual therapies, with 72.1% of patients in the tislelizumab group experiencing grade ≥3 treatment-related adverse events (TRAEs), compared to 66.4% in the placebo group. Common TRAEs included decreased neutrophil count, decreased white blood cell count, and alopecia. Patient-reported outcomes from RATIONALE-315 also showed symptomatic improvements.
Three-year OS data from RATIONALE-305 confirmed the long-term efficacy and safety of tislelizumab plus chemotherapy for first-line treatment of advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC). The study also highlighted improvements in patient-reported outcomes. Additionally, long-term outcomes from RATIONALE-307 showed sustained OS benefits for first-line squamous NSCLC patients treated with tislelizumab plus chemotherapy, with promising four-year OS rates.
A comparative analysis of tislelizumab against other anti-PD-1 treatments in the EU and UK for second-line esophageal squamous cell carcinoma (ESCC) using simulated treatment comparisons from RATIONALE-302 and other clinical studies will also be presented.
“TEVIMBRA has demonstrated potential across various cancer types, and the latest data from ESMO 2024 solidify its role as a cornerstone of our solid tumor portfolio,” said Dr. Jan-Henrik Terwey, Vice President, Medical Affairs Europe at BeiGene. “Following its recent launch in Germany, Austria, and Norway, we are committed to expanding access to TEVIMBRA across Europe.”
TEVIMBRA in Europe
BeiGene recently launched TEVIMBRA in Europe for eligible patients with ESCC and NSCLC following EU marketing authorizations. It is also approved in the UK and Switzerland for patients with advanced or metastatic ESCC.
“Advanced or metastatic ESCC and NSCLC are aggressive cancers with limited treatment options,” said Dr. Markus Moehler of the Johannes Gutenberg University Medical Center Mainz. “The availability of tislelizumab offers a significant advancement in treatment.”
TEVIMBRA’s EU approvals are based on results from four randomized Phase 3 studies: RATIONALE-302 for ESCC, and RATIONALE-307, RATIONALE-304, and RATIONALE-303 for NSCLC. The approved indications for TEVIMBRA in the EU include:
- Combination with carboplatin and paclitaxel or nab-paclitaxel for first-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
- Combination with pemetrexed and platinum-based chemotherapy for first-line treatment of adult patients with non-squamous NSCLC with PD-L1 expression on ≥50% of tumor cells, no EGFR or ALK positive mutations, and who have locally advanced or metastatic NSCLC.
- Monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy, with targeted therapy required for EGFR mutant or ALK positive NSCLC before tislelizumab.
- Monotherapy for adult patients with unresectable, locally advanced, or metastatic ESCC after prior platinum-based chemotherapy.
About TEVIMBRA® (tislelizumab)
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody with high specificity and affinity for PD-1. It is engineered to minimize Fc-gamma receptor binding on macrophages, enhancing the body’s immune response to tumors.
