BeiGene’s TEVIMBRA® Gets CHMP Nod for First-Line Lung Cancer Treatment
BeiGene, Ltd., a global oncology company soon to be rebranded as BeOne Medicines Ltd., has announced a significant milestone in its efforts to expand cancer treatment options. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of TEVIMBRA® (tislelizumab) in combination with etoposide and platinum-based chemotherapy as a first-line treatment for adult patients diagnosed with extensive-stage small cell lung cancer (ES-SCLC).
Extensive-stage small cell lung cancer is an aggressive and challenging form of lung cancer, often characterized by rapid progression and limited treatment options. Prof. Silvia Novello, M.D., Ph.D., President of Women Against Lung Cancer in Europe (WALCE) and Head of the Medical Oncology Unit at San Luigi Hospital in Orbassano, Italy, emphasized the critical need for more effective treatments.
“The aggressive nature of extensive-stage small cell lung cancer makes it an extremely difficult type of lung cancer to treat, and currently available treatments may not adequately control disease progression. The compelling data from the RATIONALE-312 study demonstrates the potential of TEVIMBRA plus chemotherapy as a further first-line treatment option to extend overall survival for patients with ES-SCLC,” she stated.
The positive CHMP opinion is based on data from BeiGene’s RATIONALE-312 (NCT04005716), a large-scale, randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical trial. The study evaluated the efficacy and safety of TEVIMBRA in combination with platinum-based chemotherapy (cisplatin or carboplatin) and etoposide as a first-line treatment for ES-SCLC. A total of 457 patients were enrolled, and the trial successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival (OS).
At the protocol-defined final analysis, the median OS for patients receiving TEVIMBRA plus chemotherapy was 15.5 months compared to 13.5 months in the placebo plus chemotherapy group. The results, published in the Journal of Thoracic Oncology, indicate a hazard ratio (HR) of 0.75 (95% CI: 0.61–0.93) with a one-sided p-value of 0.0040, reflecting a 25% reduction in the risk of death. TEVIMBRA plus chemotherapy was generally well tolerated, with no new safety concerns identified.
Dr. Mark Lanasa, M.D., Ph.D., Chief Medical Officer of Solid Tumors at BeiGene, underscored the significance of this development. “Today’s positive CHMP opinion marks another important step for TEVIMBRA to potentially expand its indications in a fourth disease area in Europe to reach more patients affected by cancer. TEVIMBRA is the cornerstone of our solid tumor portfolio, with 58 regulatory approvals in 18 months, and is being studied in combination with multiple novel molecules with the potential to herald the next wave of cancer therapeutics,” he noted.
Beyond its application in ES-SCLC, TEVIMBRA has already been approved in the European Union for multiple indications. It is currently authorized as a first-line treatment for eligible patients with unresectable esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy. Additionally, it is approved as a second-line treatment for patients with unresectable, locally advanced, or metastatic ESCC after prior platinum-based chemotherapy. The drug also has approvals for three non-small cell lung cancer (NSCLC) indications covering both first-line and second-line settings.
The safety data supporting this indication extension is robust, comprising more than 3,900 patients who received TEVIMBRA either as monotherapy (n=1,952) or in combination with chemotherapy (n=1,950) at the approved dosing regimen. The most commonly reported Grade 3 or 4 adverse reactions (incidence ≥ 2%) for TEVIMBRA in combination with chemotherapy included neutropenia, anemia, thrombocytopenia, hyponatremia, hypokalemia, fatigue, pneumonia, lymphopenia, rash, decreased appetite, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase).
This potential approval in the EU aligns with BeiGene’s broader mission to advance innovative oncology treatments and bring new therapeutic options to cancer patients worldwide. TEVIMBRA, a humanized monoclonal antibody targeting PD-1, is a key asset in BeiGene’s oncology pipeline, with a strategic focus on broadening its applications across multiple tumor types.
The decision from the European Commission on the marketing authorization of TEVIMBRA for ES-SCLC is expected in the coming months. If approved, this will mark another significant step in the company’s expansion of its oncology portfolio and its commitment to improving patient outcomes in lung cancer treatment.
In addition to TEVIMBRA’s clinical progress, BeiGene recently announced its intention to rebrand as BeOne Medicines Ltd. This strategic move reflects the company’s ongoing commitment to pioneering innovative cancer therapies and fostering global collaborations to reach as many patients as possible. With a vision centered on eliminating cancer through scientific advancement and patient-centric approaches, BeOne Medicines aims to drive the next generation of breakthroughs in oncology care.
As BeiGene continues to expand its global footprint, the potential approval of TEVIMBRA in ES-SCLC further solidifies its position as a leader in oncology drug development. The company remains focused on leveraging cutting-edge research, strategic partnerships, and regulatory milestones to bring novel treatment options to patients facing life-threatening cancers.
About Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Lung cancer is the leading cause of cancer-related deaths worldwide.1 SCLC is an aggressive, high-grade cancer that accounts for 15% of all lung cancers,2 and is typically classified as limited-stage or extensive-stage disease.3 Approximately 70% of SCLC patients are diagnosed with extensive-stage disease,4 defined as cancer that has spread throughout or beyond the lungs, or exceeding an area that can be treated with radiation alone.5 In Europe, the estimated prevalence of SCLC is 1-5 per 10,000 people.6 ES-SCLC is associated with a very poor prognosis with a median OS of 8 to 13 months and an expected 2-year survival rate of only 5%.7
About TEVIMBRA (Tislelizumab)
TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1(PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
TEVIMBRA is the foundational asset of BeiGene’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 45 countries, and more than 1.3 million patients have been treated globally.
