Bristol Myers Squibb (BMS) has announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the combination of nivolumab plus ipilimumab for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM), in England and Wales.
This treatment combination is the first immunotherapy in over ten years to be made available via the NHS for the treatment of untreated, unresectable MPM.
Within the FAD, the NICE committee also recommended extending the guidance of nivolumab plus ipilimumab to treat rarer forms of mesothelioma found in the pericardium and peritoneum (the lining of the heart and abdomen respectively).
“Mesothelioma is a devastating and hard to treat disease with people often diagnosed at a late stage and typically facing a poor prognosis. This decision from NICE has the potential to change the outlook for patients with MPM,” said Liz Darlison MBE, Chief Executive Officer, Mesothelioma UK.
“We know that asbestos exposure causes the majority of MPM cases, and it is important that we continue to raise awareness of the symptoms and risk factors.”
Approximately 2,700 people are diagnosed with mesothelioma in the UK annually, with MPM representing the majority of mesothelioma cases (90%).
The UK has the highest mesothelioma mortality rates globally, with the disease accounting for 1% of all cancer deaths across the nation.
MPM is a type of mesothelioma that affects the chest and lungs and is often diagnosed late, giving patients an average of less than a year’s survival without treatment, as there are few early symptoms.
Exposure to asbestos in the workplace is responsible for over 80% of MPM cases, and people who have a history of working in certain jobs, including construction and shipyard work, have an increased risk of MPM due to a higher risk of asbestos exposure.
Rates of MPM have increased by around three-fifths in the UK since the 1990s, due to the heavy industrial use of asbestos up until the mid-1970s.
In Great Britain, England has the highest MPM mortality rates, compared with Wales and Scotland.
Across England, there are regional disparities, with the North East, East and South East experiencing the highest mortality rates overall.
“Typically, treatment can be difficult for MPM, which is frequently diagnosed at an advanced stage,” said Professor Sanjay Popat, Consultant Thoracic Medical Oncologist, The Royal Marsden NHS Foundation Trust.
“The decision from NICE is a big step in the treatment landscape for MPM. Not only do MPM patients have an alternative treatment option, but one that has demonstrated positive overall survival in comparison to chemotherapy.”
The decision from NICE is supported by three-year follow up data from the ongoing Phase 3 Checkmate -743 study.
Results demonstrated improved overall survival (OS) among unresectable MPM patients who received first line treatment with nivolumab plus ipilimumab, in comparison to chemotherapy.
Patients treated with nivolumab plus ipilimumab lived a median of four months longer than those who received chemotherapy alone.
With a minimum follow-up of three years (35.5 months), median OS among patients receiving nivolumab plus ipilimumab (n=303) was 18.1 months, compared to 14.1 months among patients who received standard of care chemotherapy (n=302), [HR 0.73; 95% CI: 0.61 to 0.87].
After three years, over a quarter of patients (28%) were still responding to treatment after receiving nivolumab plus ipilimumab, compared to none of the patients who received chemotherapy.
Grade 3–4 treatment-related adverse events (TRAEs), such as hepatitis, diarrhoea and rash, in the were experienced by 31% of patients in the nivolumab plus ipilimumab arm (n=300) and by 32% of patients in the chemotherapy arm (n=284).
The NICE decision follows the reimbursement of the combination therapy in Scotland earlier this year.
“While MPM isn’t as well-known as some other cancers, there remains a huge unmet need for patients. This new treatment option is an important step forward,” said Scott Cooke, General Manager UK and Ireland, Bristol Myers Squibb.