A comprehensive development program of three Phase 3 clinical trials demonstrates the benefit of tislelizumab in patients with treatment-naïve and relapsed NSCLC
This decision is the second approval for tislelizumab in the region
Beijing, China, Cambridge, Massachusetts, and Basel, Switzerland, April 23, 2024 /PRNewswire/ -- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology innovator, today announced that the European Commission (EC) has approved tislelizumab for the first- and second-line treatment of three non-small cell lung cancer (NSCLC) indications.
Mark Lanasa, M.D., Chief Medical Officer of Solid Oncology at BeiGene, said, "Tislelizumab is the foundation of BeiGene's solid oncology portfolio and has demonstrated potential in multiple tumor types including NSCLC. There are many unmet needs in all disease stages of NSCLC. The EC decision marks the second approval of tislelizumab in the European Union, where tislelizumab can be used for the treatment of NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). A few weeks ago, the U.S. Food and Drug Administration (FDA) approved tislelizumab as a second-line treatment for ESCC, which better positions us to deliver on our commitment to bring this innovative treatment to more patients around the world." "
Tislelizumab is approved for the following indications:
- the combination of paclitaxel and carboplatin or injectable paclitaxel (albumin-bound) and carboplatin for the first-line treatment of adult patients with locally advanced or metastatic squamous non-small cell lung cancer who are not candidates for surgical resection or undergoing platinum-containing chemoradiotherapy;
- The combination of pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer with PD-L1 expression of ≥50% without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-positive mutations, who are not suitable for surgical resection or receiving platinum-containing chemoradiotherapy;
- Monotherapy is used to treat adult patients with locally advanced or metastatic NSCLC after prior treatment with platinum-containing agents. Patients with NSCLC who are positive for EGFR mutations or ALK mutations should have received targeted therapy prior to tislelizumab.
Luis Paz-Ares, MD, MD, Head of Medical Oncology at Hospital Universitario 12 de Octubre in Madrid, Spain, said: "Non-small cell lung cancer remains one of the most common and deadly cancers in Europe, with half of patients progressing to an advanced stage at the time of diagnosis, making it difficult to treat. In these three Phase 3 studies, tislelizumab has been shown to improve outcomes in patients with specific types of NSCLC, providing patients with new options. "
The trade name of tislelizumab approved for the above NSCLC indications is TIZVENI®. BeiGene plans to merge the NSCLC indication with the second-line ESCC indication under the brand name TEVIMBRA®, which® will be available in the first EU countries later in 2024. TEVIMBRA has been approved in the U.S. and the European Union for the treatment of patients with advanced or metastatic ESCC who have received prior chemotherapy,® and is also being reviewed by the European Medicines Agency (EMA) and FDA for the first-line treatment of patients with unresectable, recurrent, locally advanced or metastatic ESCC, as well as for patients with gastric or gastroesophageal junction adenocarcinoma.
The EC approval was based on the results of three Phase 3 RATIONALE clinical studies that enrolled 1,499 patients:
- RATIONALE 307 (NCT03594747) is an open-label, randomized, phase 3 trial enrolling a total of 360 patients with advanced squamous NSCLC. The study met the primary endpoint of statistically significant improvement in progression-free survival (PFS), higher objective response rate, and manageable safety/tolerability profile with tislelizumab in combination with chemotherapy as first-line therapy, regardless of PD-L1 expression level. The most common treatment-emergent adverse events (TEAEs) of grade 3 and above were decreased neutrophil count, neutropenia, and leukopenia. The full results of the study were published in JAMA Oncology.
- RATIONALE 304 (NCT03663205) is an open-label, randomized, phase 3 trial enrolling a total of 334 patients with locally advanced or metastatic non-squamous NSCLC. The study met the primary endpoint of a statistically significant improvement in PFS with tislelizumab plus chemotherapy as first-line therapy compared with chemotherapy (HR 0.65 [95% CI: 0.47-0.91]; P=0.0054), and the response rate was higher and the duration of response was longer. The most common grade 3 and above TEAEs are associated with chemotherapy and include neutropenia and leukopenia. The full results of the study were published in the Journal of Thoracic Oncology.
- RATIONALE 303 (NCT03358875) is an open-label, randomized, phase 3 trial comparing tislelizumab with docetaxel in a total of 805 patients with advanced NSCLC who have progressed on prior platinum-based chemotherapy. The primary endpoint was met for a statistically and clinically meaningful improvement in overall survival (OS) of tislelizumab as second- or third-line therapy compared with docetaxel in the intention-to-treat population, regardless of PD-L1 expression levels (HR: 0.66 [95% CI: 0.56-0.79]; PJournal of Thoracic Oncology。
To date, BeiGene has initiated more than 17 potential registrational studies of tislelizumab, of which 11 Phase 3 randomized controlled trials and 4 Phase 2 studies have positive data. Through these studies, tislelizumab has demonstrated its potential: in many cases, it can deliver clinically meaningful survival benefits and quality of life improvements in hundreds of thousands of patients in monotherapy or in combination with a wide range of tumor types, regardless of PD-L1 expression levels. To date, tislelizumab has benefited more than 900,000 patients worldwide.
concerning NSCLCLung cancer is the second most common type of cancer and the leading cause of cancer-related deaths worldwide [1]. Lung cancer is the third most common cancer in Europe, with NSCLC accounting for 85-90% of all lung cancers [2]. In 2020, the number of newly diagnosed lung cancer cases in Europe was estimated at 477,534 [3].
About tislelizumab:Tislelizumab (Chinese trade name: tislelizumab ®, English trade name: TEVIMBRA®) is a specially designed humanized IgG4 anti-PD-1 monoclonal antibody with high affinity and binding specificity for PD-1, designed to minimize binding to Fcγ receptors in macrophages and help human immune cells recognize and kill tumor cells.
About BeiGene:BeiGene is a global oncology innovation company focused on developing innovative oncology drugs for cancer patients around the world. Through strong independent R&D capabilities and external strategic partnerships, we continue to accelerate the development of diversified and innovative drug pipelines and product portfolios, and are committed to comprehensively improving drug accessibility and affordability for more patients around the world. We have a team of more than 10,000 people on five continents and have major offices in Beijing, Cambridge, Massachusetts, and Basel, Switzerland.
Forward-Looking StatementsThis press release contains information contained in the context of the provisions of the Private Securities Litigation Reform Act of 1995 1995) and other forward-looking statements within the meaning of other federal securities laws, including BeiGene's ability to meet its commitment to bring tislelizumab to more patients worldwide, the potential for tislelizumab to deliver clinically meaningful survival benefit improvements and quality of life improvements for hundreds of thousands of patients in monotherapy or combination therapy across a broad range of tumors, and BeiGene's plans, commitments, aspirations and goals referenced under the heading "About BeiGene." Actual results may differ materially from those in the forward-looking statements as a result of a variety of important factors. These factors include: BeiGene's ability to demonstrate the efficacy and safety of its drug candidates, the clinical results of the drug candidates may not support further development or marketing approval, the actions of the regulatory authorities that may affect the initiation, timeline and progress of clinical trials and drug marketing approvals, BeiGene's ability to commercially succeed its marketed drugs and, if approved, BeiGene's ability to obtain and maintain intellectual property protection for its drugs and technologies, and BeiGene's reliance on third parties for drug development, manufacturing, commercialization and other services, BeiGene's limited experience in obtaining regulatory approvals and commercializing medicinal products and its ability to obtain further working capital to complete the development of drug candidates and to achieve and maintain profitability, as well as the risks discussed more fully in the "Risk Factors" section of BeiGene's most recent Annual Report on Form 10-K, and BeiGene's discussion of potential risks, uncertainties and other important factors in BeiGene's subsequent filings with the Securities and Exchange Commission. All information in this press release is current only as of the date of this press release, and BeiGene undertakes no obligation to update such information except as required by law.
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[2] European Society of Medical Oncology. What is Non-Small-Cell Lung Cancer? .
[3] Sung H, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021; 71(3):209-49.