EC Approves BeiGene's Tevimbra Combo for Small Cell Lung Cancer

BeiGene's Tevimbra (tislelizumab) has received approval from the European Commission (EC) as part of a primary treatment regimen for an aggressive variant of lung cancer. The medication is specifically sanctioned for use with etoposide and platinum-based chemotherapy to treat adult patients dealing with extensive-stage small cell lung cancer (SCLC).

SCLC is known for its rapid growth and dissemination compared to other lung cancer types and constitutes approximately 15% of all lung cancer cases. A significant majority, around 70%, of SCLC patients are diagnosed at an extensive stage, which typically correlates with a particularly unfavorable prognosis.

The EC's approval came in the wake of a recent endorsement by the human medicines committee of the European Medicines Agency. This decision was underpinned by findings from the late-stage RATIONALE-312 trial. This trial showed that the combination of Tevimbra with chemotherapy resulted in a statistically substantial and clinically meaningful enhancement in overall survival (OS) compared to a placebo combined with chemotherapy in participants who intended to receive treatment. Specifically, the median OS was 15.5 months for the combination of Tevimbra and chemotherapy, compared to 13.5 months for the placebo with chemotherapy, indicating a 25% decrease in the risk of death.

Additional support for the approval was derived from cumulative safety data involving more than 3,900 patients who were treated with Tevimbra, either as a standalone therapy or in conjunction with chemotherapy, at the sanctioned dosing regimen.

Silvia Novello, who presides over Women Against Lung Cancer in Europe and heads the medical oncology unit at San Luigi Hospital, remarked, “The RATIONALE-312 study outcomes demonstrated that [Tevimbra] combined with chemotherapy enhanced survival compared to treatment with placebo plus chemotherapy. This highlights its potential to yield better results for qualifying patients.”

Tevimbra is administered via intravenous infusion and functions as a humanized immunoglobulin G4 anti-PD-1 monoclonal antibody, engineered to aid the body’s immune cells in recognizing and combating tumors. The drug has already been approved within the European Union for treating specific instances of non-small cell lung cancer, as well as esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma.

Mark Lanasa, BeiGene’s chief medical officer for solid tumors, commented on the drug’s progress: “Tevimbra has now secured approval in four distinct disease areas within the EU in less than two years, demonstrating its capability to achieve clinically significant improvements in survival while maintaining a well-characterized safety profile across a variety of tumor types.”