MHRA Approves Serplulimab for Extensive-Stage SCLC

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved serplulimab  (Hetronifly, Henlius) to treat adults with extensive-stage small cell lung cancer (ES-SCLC). 

Serplulimab is the UK’s first licensed anti-PD-1 monoclonal antibody for this aggressive form of lung cancer. It is indicated for adults with untreated ES-SCLC, where the disease has spread within the lungs or to other parts of the body. 

SCLC is a fast-growing cancer that typically develops in the airways of the lungs. It accounts for 10%-15% of all lung cancer cases. Most patients are diagnosed at an advanced stage when treatment options are limited and the prognosis is poor.

How Serplulimab Works

Serplulimab binds to the PD-1 receptor on immune cells. By blocking PD-1, it prevents cancer cells from evading immune detection, enabling the immune system to better recognise and destroy malignant cells. This mechanism offers a significant advance over chemotherapy alone, enhancing the body’s natural defences against cancer.

The therapy is administered by intravenous infusion every 3 weeks. It is combined with standard chemotherapy agents, carboplatin and etoposide. Treatment continues for as long as clinical benefit is observed.

Julian Beach, interim executive director of healthcare quality and access at the MHRA, said in a press release, “As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis.”

Efficacy Data

Approval was based on results from the phase 3 ASTRUM-005 trial. The study enrolled 585 adults with ES-SCLC who had not received prior systemic therapy. 

This randomised, double-blind trial compared serplulimab plus chemotherapy with placebo plus chemotherapy as first-line treatment.

Results showed a significant improvement in overall survival (OS). Patients treated with serplulimab and chemotherapy had a median OS of 15.4 months — this compared with 10.9 months for those on chemotherapy and placebo. The hazard ratio for death was 0.63.

Safety Monitoring and Availability

The MHRA confirmed that serplulimab meets all regulatory standards for safety, quality, and efficacy. 

Ongoing safety monitoring will be maintained. Patients and healthcare professionals are encouraged to report any suspected adverse effects via the Yellow Card scheme. 

A full list of side effects will be included in the Patient Information Leaflet and the Summary of Product Characteristics. These documents will be available on the MHRA website within 7 days of approval.