European Commission Approves Tislelizumab for Lung Cancer

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a leading oncology firm, revealed today that the European Commission (EC) has granted approval for tislelizumab as a treatment for non-small cell lung cancer (NSCLC) in three indications, encompassing both first- and second-line utilization.

BeiGene’s Tislelizumab Approved by European Commission for Non-Small Cell Lung Cancer Treatment”

“Tislelizumab, a cornerstone of BeiGene’s solid tumor portfolio, has been granted European Commission approval for treating non-small cell lung cancer (NSCLC) across three indications, addressing critical unmet needs in the disease,” remarked Dr. Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene. “This marks the second approval for tislelizumab in the region, following its recent approval for locally advanced or metastatic esophageal squamous cell carcinoma by both the EU and the U.S. FDA. These milestones reinforce our commitment to delivering innovative therapies to patients globally.”

The approved indications for tislelizumab include:

In combination with carboplatin and either paclitaxel or nab-paclitaxel as a first-line treatment for adult patients with squamous NSCLC who are not candidates for surgery or platinum-based chemoradiation, or have metastatic NSCLC. In combination with pemetrexed and platinum-containing chemotherapy as a first-line treatment for adult patients with non-squamous NSCLC whose tumors express PD-L1 on ≥50% of tumor cells, with no EGFR or ALK positive mutations, and who are not candidates for surgery or platinum-based chemoradiation, or have metastatic NSCLC. As monotherapy for adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should have also received targeted therapies before receiving tislelizumab. Dr. Luis Paz-Ares, Head of the Medical Oncology Service at the Hospital Universitario 12 de Octubre, Madrid, highlighted the challenges in treating NSCLC, underscoring tislelizumab’s potential to improve outcomes for patients across multiple Phase 3 studies.

Tislelizumab, approved under the brand name TIZVENI®, will be combined with the second-line esophageal squamous cell carcinoma (ESCC) indication under the brand name TEVIMBRA®, set to launch in select EU countries later in 2024. TEVIMBRA is already approved in the U.S. and EU for advanced or metastatic ESCC after prior chemotherapy and is under review for additional indications by regulatory authorities.

The EC approval is based on results from three Phase 3 studies in the RATIONALE program, involving 1,499 patients:

RATIONALE 307 (NCT03594747), a Phase 3 trial in advanced squamous NSCLC, demonstrated significant improvements in progression-free survival (PFS) and objective response rates with tislelizumab in combination with chemotherapy compared to chemotherapy alone. RATIONALE 304 (NCT03663205), a Phase 3 trial in locally advanced or metastatic non-squamous NSCLC, showed a statistically significant improvement in PFS with tislelizumab in combination with chemotherapy versus chemotherapy alone. RATIONALE 303 (NCT03358875), a Phase 3 trial in advanced NSCLC after prior platinum-based therapy, demonstrated a significant improvement in overall survival with tislelizumab compared to docetaxel. With more than 17 potentially registration-enabling trials underway, tislelizumab has shown promising results in improving survival and quality of life for cancer patients across various tumor types, both as monotherapy and in combination with other regimens.

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