Tevimbra Approved for Lung Cancer

“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,” said  Prof. Silvia Novello, President Women Against Lung Cancer in Europe (WALCE) and Head of Medical Oncology Unit of San Luigi Hospital in Orbassano, Italy. “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.”

The extension of indication for ES-SCLC is based on results from BeiGene’s RATIONALE-312 (NCT04005716), a randomized, double-blind, placebo-controlled, multicenter, Phase III  study to evaluate the efficacy and safety of Tevimbra  in combination with platinum (investigator’s choice of cisplatin or carboplatin) plus etoposide, as first-line treatment in adult patients with ES-SCLC. The study, which randomized 457 patients, met its primary endpoint, exhibiting a statistically significant and clinically meaningful improvement in overall survival (OS) with Tevimbra in combination with chemotherapy, compared with placebo plus chemotherapy in the intent-to-treat (ITT) population. As reported in the Journal of Thoracic Oncology, at the protocol-defined final analysis, the median OS was 15.5 months for Tevimbra  with chemotherapy versus 13.5 months for placebo plus chemotherapy (HR 0.75 [95% CI: 0.61–0.93]; one-sided p = 0.0040), resulting in a 25% reduction in the risk of death. Tevimbra plus chemotherapy was generally well tolerated, with no new safety signals identified.

“The 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,” said Dr. Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene. “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.”

The pooled safety data in this extension of indication included more than 3,900 patients who received Tevimbra as either monotherapy (n=1,952) or in combination with chemotherapy (n=1,950) at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥ 2%) for Tevimbra  given in combination with chemotherapy were neutropenia, anemia, thrombocytopenia, hyponatremia, hypokalemia, fatigue, pneumonia, lymphopenia, rash, decreased appetite, increased aspartate aminotransferase and increased alanine aminotransferase.

Citation: Original Article | Small Cell Lung CancerVolume 19, Issue 7p1073-1085July 2024.Tislelizumab Plus Platinum and Etoposide Versus Placebo Plus Platinum and Etoposide as First-Line Treatment for Extensive-Stage SCLC (RATIONALE-312): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase III Clinical Trial Ying Cheng, MD^a jl.cheng@163.com ∙ Yun Fan, MD^b ∙ Yanqiu Zhao, MD^c∙ … ∙ Wenjuan Zheng, MDⁿ ∙ Yong Song, MD^p on behalf of the RATIONALE-312 Study Group…Journal of Thoracic Oncology.