HETRONIFLY®▼ (serplulimab) becomes first anti-PD-1 immunotherapy for extensive-stage small cell lung cancer recommended for NHS use in England and Wales

This is a promotional article funded and developed by Accord Healthcare and is intended for UK Healthcare professionals. Prescribing Information and Adverse Event reporting details can be found at the end of this article.

For people diagnosed with extensive-stage small cell lung cancer, time can quickly become the question that matters most.

It is a question measured not only in months, but in moments: time with family, time to adjust, and time to make decisions.

Extensive-stage small cell lung cancer, or ES-SCLC, is typically aggressive, often diagnosed at an advanced stage, and associated with rapid progression.^1,2  For patients and their families, the impact of diagnosis can be immediate and profound. Treatment decisions need to be made quickly, often in the backdrop of limited treatment options and a poor prognosis.

Now, eligible patients in England and Wales can access a first-line treatment option through the NHS, following a positive recommendation from the National Institute for Health and Care Excellence.

NICE has recommended HETRONIFLY® (serplulimab), in combination with platinum-based chemotherapy – carboplatin and etoposide – as a first-line treatment option for adults with previously untreated ES-SCLC in England and Wales.³

The recommendation means eligible patients can receive serplulimab through the NHS as part of their first-line treatment. It also makes HETRONIFLY the first anti-PD-1 monoclonal antibody recommended by NICE for use in ES-SCLC in England and Wales.⁴

Around 4,500 people in England and Wales are diagnosed with ES-SCLC each year.^5,6 Small cell lung cancer accounts for around 15% of all lung cancer cases, and most people are diagnosed only after the disease has already spread.^7,8 ES-SCLC is associated with particularly poor outcomes, with a five-year mortality rate above 90% and many patients living less than a year after diagnosis.^2,9

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

“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. By contrast, people diagnosed with small cell lung cancer have faced extremely limited options and devastating outcomes for far too long.

This aggressive disease progresses rapidly. That is why every additional month, every milestone and every precious moment gained through new treatment options matters so deeply. For families affected by this disease, that time is truly priceless.”

An immunotherapy option

Serplulimab is an anti-PD-1 monoclonal antibody. It works by blocking the PD-1 receptor on immune cells, helping the immune system recognise and attack cancer cells.¹⁰

The NICE recommendation is supported by data from the global Phase 3 ASTRUM-005 study, which evaluated serplulimab in combination with chemotherapy compared with chemotherapy alone in previously untreated ES-SCLC.¹

In the study, serplulimab plus chemotherapy demonstrated significantly longer overall survival than chemotherapy alone, with median overall survival of 15.8 months compared with 11.1 months in the placebo plus chemotherapy group.¹¹ Longer-term follow-up showed that more than one in five patients receiving serplulimab plus chemotherapy were alive at four years.¹²

For clinicians, these data provide evidence to support conversations that are often among the most difficult in oncology. They do not remove uncertainty, and they do not guarantee how any individual patient will respond. But they do offer an evidence-based option in a setting where progress has been limited for many years.

“Even with current standards of care, median survival for extensive-stage small cell lung cancer in England and Wales remains less than a year, with the majority of patients relapsing rapidly. Today’s decision… to recommend serplulimab is a step forward in expanding potential treatment options for patients facing this challenging cancer,” said Dr Giuseppe Banna, Consultant Medical Oncologist for Lung and Urology Tumours, Department of Oncology of Portsmouth Hospitals University NHS Trust.

“I am grateful to NICE for enabling eligible patients to have the option of accessing this treatment. Whilst extensive-stage small cell lung cancer will remain a difficult prospect for the clinical community to manage, this decision creates new possibilities and will allow us to provide patients with an innovative immunotherapy via the NHS.”

More time, considered carefully

As with all cancer treatments, the potential benefits of serplulimab must be considered alongside its safety profile and the individual needs of each patient.

In ASTRUM-005, the safety profile of serplulimab was consistent with previous studies. The most common grade 3 adverse events included neutropenia, leukopenia, thrombocytopenia, anaemia, hyponatraemia and lymphopenia.^1,11

“At Accord Healthcare, we’re absolutely committed to supporting people living with lung cancer,” said Paul Tredwell, CEO of Accord Healthcare.

“This recommendation means ES-SCLC patients who might previously have had limited options now have access to a treatment with a meaningfully different and improved survival profile. That represents two important things: more time and more hope.

“We will continue working with the NHS and oncology community to make sure those who could benefit from this treatment are able to access it as quickly as possible.”

For patients with ES-SCLC, the recommendation does not remove the seriousness of the diagnosis. It does not remove the uncertainty faced by each patient, their family, or the clinicians caring for them.

But it does mark a meaningful step forward: a first-line NHS treatment option in England and Wales, supported by Phase 3 clinical trial data showing improved overall survival compared with chemotherapy alone.^1,11,12

In a disease where progress has been limited for decades, that matters – because in ES-SCLC, time is never just a statistic. It is the chance for more conversations, more milestones, and more moments with the people who matter most.

Prescribing information and Adverse Event Reporting information for HETRONIFLY® (serplulimab) are available here; for carboplatin are available here; for etoposide are available here.

Date of preparation September 2026

UK-Onc-Het-01594

References:

1. Cheng Y et al. JAMA 2022; 328(12): 1223-32
2. Dingemans AMC et al. Ann Oncol 2021: 32(7): 839-53
3. Serplulimab NICE guidance, June 2026. Available at: https://www.nice.org.uk/guidance/TA1167 (accessed September 2026)
4. National Institute for Health and Care Excellence (NICE). Lung cancer: diagnosis and management (NG122) – Management. Available at: https://www.nice.org.uk/guidance/ng122/chapter/Management (accessed September 2026)
5. Cancer Research UK. CancerStats Data Hub: lung cancer incidence (UK). Available at: https://crukcancerintelligence.shinyapps.io/CancerStatsDataHub/ . (accessed September 2026)
6. Mao Y, et al. Lung Cancer Manag. 2024;13(1):LMT64
7. Zhang X, et al. Front. Immunol. 2022;13:1059331
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9. Khakwani A et al. PLoS One. 2014; 9(2): e89426
10. National Cancer Institute. Serplulimab. Available at: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/serplulimab (accessed September 2026)
11. HETRONIFLY SmPC, June 2026. Available at: https://accord-healthcare-products.co.uk/products/h/hetronifly-concentrate-for-solution-for-infusion/hetronifly-10-mgml-concentrate-for-solution-for-infusion (accessed September 2026)
12. Cheng Y, et al. Cancer Communications (London). 2025;45(8):990–.