The decision makes serplulimab, marketed as Hetronifly, the first anti-PD-1 immunotherapy recommended by NICE for untreated extensive-stage small cell lung cancer (ES-SCLC) in England and Wales. The treatment is approved for use in combination with carboplatin and etoposide.

Small cell lung cancer accounts for around 15% of lung cancer diagnoses and is one of the most aggressive forms of the disease. Approximately two-thirds of patients are diagnosed after the cancer has already reached an extensive stage, limiting treatment options and contributing to poor survival outcomes.

Around 4,500 people are diagnosed with extensive-stage small cell lung cancer each year across England and Wales. Despite advances in other lung cancer subtypes, progress in small cell lung cancer has historically been limited.

NICE’s recommendation was supported by results from the Phase 3 Astrum-005 study, which demonstrated a median overall survival of 15.8 months for patients receiving serplulimab plus chemotherapy compared with 11.1 months for those receiving chemotherapy alone. Approximately 22% of patients receiving the immunotherapy remained alive four years after starting treatment.

Paula Chadwick, chief executive of Roy Castle Lung Cancer Foundation, said: “Today’s approval represents an important and long-overdue breakthrough for people living with extensive-stage small cell lung cancer and the families who support them.”

She added: “For decades, progress in treating small cell lung cancer has lagged far behind the advances seen in non-small cell lung cancer, where patients now benefit from a growing range of targeted and immunotherapy treatments.”

Serplulimab is a monoclonal antibody that targets the PD-1 pathway, helping the immune system recognise and attack cancer cells. The treatment previously received approval from the Medicines and Healthcare products Regulatory Agency for patients with extensive-stage small cell lung cancer.

Giuseppe Banna, consultant medical oncologist for lung and urology tumours at Portsmouth Hospitals University NHS Trust, said: “Even with current standards of care, median survival for extensive-stage small cell lung cancer in England and Wales is approximately 12 months, with the majority of patients relapsing rapidly.”

He added: “Today’s decision from NICE to recommend serplulimab is a step forward in expanding potential treatment options for patients facing this challenging cancer.”

The safety profile observed in Astrum-005 was consistent with previous studies. The most common grade 3 adverse events included neutropenia, leukopenia, thrombocytopenia and anaemia.

The recommendation provides NHS clinicians with a new immunotherapy option for a patient population that has historically had few advances in treatment and continues to face poor long-term outcomes.