Opdivo® (nivolumab) with chemotherapy before surgery then alone after surgery recommended for use on the NHS when treating adult patients with resectable NSCLC

Nivolumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat adult patients with resectable non-small cell lung cancer (NSCLC).1

This provides an additional treatment option for patients with a high risk of occurrence whose tumours are resectable and have no epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.1

It is estimated that approximately 85% of people with lung cancer have a form of NSCLC.2

(Uxbridge, Middlesex, Tuesday 20 January 2026) – Bristol Myers Squibb (BMS) has announced that the National Institute for Health and Care Excellence (NICE) has published its Final Draft Guidance (FDG) recommending Opdivo® (nivolumab) as an option for neoadjuvant treatment with platinum-based chemotherapy, then alone as adjuvant treatment, for non-small cell lung cancer (NSCLC) with a high risk of occurrence in adults whose tumours are resectable (4cm or more or node positive) and have no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.1

Eligible resectable NSCLC cancer patients in England, Wales, and Northern Ireland will have access to nivolumab as a treatment option, via routine commissioning funded by NHS England.1 The NICE decision follows regulatory authorisation of nivolumab in this indication by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2025.3

Dr Adam Januszewski, Consultant Medical Oncologist at Barts Health NHS Trust said: “The NICE recommendation of nivolumab for patients with early-stage non-small cell lung cancer represents a significant and welcome step forward in the management of this disease. It is particularly important when considered alongside the national lung cancer screening programme, which is now identifying more people at an earlier, potentially curable stage. Despite major advances in recent years, lung cancer continues to have some of the poorest outcomes of any common cancer in the UK. The introduction of effective immunotherapy in the early-stage setting strengthens the treatment options we can offer, with the aim of reducing the risk of recurrence and ultimately improving long-term survival for patients.”

Guy Oliver, UK and Ireland General Manager at Bristol Myers Squibb said: “This announcement by NICE is fantastic news for eligible non-small cell lung cancer patients, their loved ones, and the wider health system. Lung cancer can affect anyone, with many patients diagnosed at later stages of the disease, which can lead to poorer outcomes. General awareness of the risk factors of lung cancer, understanding of the symptoms, as well as advances in screening and the availability of immunotherapies are so important in helping to offer patients opportunities in the fight against this disease.”

Lung cancer is the third most common type of cancer in the UK with more than 49,000 people diagnosed each year.4 NSCLC is the most common form of the disease, with approximately 85% of people with lung cancer having a form of NSCLC.2 There are three common types of NSCLC: Adenocarcinoma (non-squamous); Large Cell Carcinoma (non-squamous); and Squamous Carcinoma. Some of these cancers have genetic mutations.2 There are other types of cancers that can also affect the lungs, but most of them are rare.2

The NICE recommendation is supported by data from the CheckMate-77T trial.1,5 CheckMate-77T evaluated the perioperative regimen of nivolumab (neoadjuvant nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab) versus perioperative placebo (neoadjuvant placebo plus chemotherapy followed by surgery and adjuvant placebo) in patients with resectable stage IIA–IIIB NSCLC.6

The trial met its primary endpoint of event-free survival (EFS), showing that the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 97.36% Confidence Interval [CI]: 0.42 to 0.81; P<0.001) in patients treated in the nivolumab arm, compared to the chemotherapy and placebo arm, after a median follow-up of 25.4 months.6

A pathological complete response occurred in 25.3% of the patients in the nivolumab group and in 4.7% of those in the chemotherapy group (odds ratio, 6.64; 95% CI, 3.40 to 12.97); a major pathological response occurred in 35.4% and 12.1%, respectively (odds ratio, 4.01; 95% CI, 2.48 to 6.49).6 Additionally, the safety profile of the perioperative regimen was consistent with previously reported studies in NSCLC. No new safety signals were identified.6

References:

1NICE. Final draft guidance: Nivolumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) for treating resectable non-small-cell lung cancer. Available at: https://www.nice.org.uk/guidance/gid-ta11504/documents/674. Accessed January 2026.

2 Roy Castle Lung Cancer Foundation. Types of Lung Cancer. Available at: https://roycastle.org/learn-about-lung-cancer/getting-diagnosed/types-of-lung-cancer/. Accessed January 2026.

3 MHRA. Press Release. MHRA authorises cancer treatment variation with an administration time of 3–5 minutes. https://www.gov.uk/government/news/mhra-authorises-cancer-treatment-variation-with-an-administration-time-of-3-5-minutes. Accessed January 2026.

4 Roy Castle Lung Cancer Foundation. Learn About Lung Cancer. https://roycastle.org/learn-about-lung-cancer/. Accessed January 2026.

5 Clinicaltrials.gov. A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer. Available at: https://www.clinicaltrials.gov/study/NCT04025879. Accessed January 2026.

6 Cascone T, Awad M, Spicer J, et al. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med . 2024;390:1756-1769. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2311926. Accessed January 2026.

7 EMC. Opdivo (nivolumab). Patient Leaflet (PIL). https://www.medicines.org.uk/emc/files/pil.6888.pdf. Accessed January 2026.

8 EMC. Opdivo (nivolumab). Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/6888/smpc. Accessed January 2026.