Serplulimab Approved by EC for Treating ES-SCLC

Hetronifly, the pioneering anti-PD-1 monoclonal antibody (mAb), has been granted approval by the European Commission (EC) for use alongside carboplatin and etoposide as an initial treatment for extensive stage small cell lung cancer (ES-SCLC). This landmark decision marks the first time an anti-PD-1 mAb has been approved for ES-SCLC treatment in Europe. Hetronifly, known scientifically as serplulimab, was developed by Henlius Biotech and will be marketed in Europe by Accord Healthcare Limited, following a partnership with Intas Pharmaceuticals in 2023, which provided Intas exclusive rights to commercialize the drug across over 50 countries, including Europe and India.

Serplulimab's approval extends across all 27 EU member states and the European Economic Area, including Norway, Iceland, and Liechtenstein. This is a significant milestone given that serplulimab had already earned orphan drug designation from the EC in December 2022 for treating SCLC, a status reviewed and renewed in subsequent years. The European Society for Medical Oncology (ESMO) has rated serplulimab with a notable 4 out of 5 on its magnitude of clinical benefit scale (MCBS) for ES-SCLC, underscoring its potential impact.

Paul Tredwell, Executive Vice-President of EMENA at Accord Healthcare, expressed enthusiasm over this development, emphasizing the company's commitment to enhancing patient outcomes by introducing essential treatment options for those suffering from extensive stage small cell lung cancer. Tredwell noted that this approval not only reinforces Accord's dedication to oncology innovation but also provides hope for patients and their families, offering them additional quality time together.

Serplulimab, a recombinant humanized anti-PD-1 monoclonal antibody, is notable for being the first of its kind approved for first-line SCLC treatment. Its impact is already being felt, having received approval in China and several Southeast Asian countries for diverse cancers, including squamous and non-squamous non-small cell lung cancer, esophageal squamous cell carcinoma, and ES-SCLC. The FDA and EC have both recognized serplulimab as an orphan drug for treating SCLC, further validating its significance in the oncology field. Current trials, particularly a bridging head-to-head study in the United States, aim to compare serplulimab with the standard care atezolizumab for ES-SCLC treatment.

The promising results of four pivotal trials on serplulimab have been published in renowned journals such as the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell, and the British Journal of Cancer. Moreover, serplulimab has been extensively recommended by various clinical guidelines in China, including those for small cell lung cancer, non-small cell lung cancer, esophageal cancer, and immune checkpoint inhibitor guidelines. These endorsements provide a solid foundation for its clinical application in tumor diagnosis and treatment.

Lung cancer remains the most prevalent cancer worldwide regarding both incidence and mortality. Data from GLOBOCAN 2022 reveal over 2.48 million new lung cancer cases globally, accounting for 12.4% of all new cancer cases. Small cell lung cancer (SCLC), making up 15% to 20% of lung cancers, is distinguished by its high malignancy, early metastasis, rapid progression, and poor prognosis. Within Europe, the prevalence of SCLC varies between 1 to 5 per 10,000 people, highlighting the urgent need for effective treatments like Hetronifly to address this challenging disease.