MHRA approves first immunotherapy treatment for mesothelioma   

MHRA approves first immunotherapy treatment for mesothelioma

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the combination of nivolumab plus ipilimumab for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) in Great Britain.[1]

Bristol Myers Squibb’s immunotherapy combination is the first treatment option approved for patients in the UK for more than 15 years.[6]

Approximately 2,700 people are diagnosed with mesothelioma in the UK annually and due to a lack of symptoms in the early stages, the condition is frequently diagnosed at an advanced stage, with an expected lifespan of less than a year if untreated.[4,5]

The MHRA decision is supported by data from the ongoing Phase 3 Checkmate -743 study, in which the combination of nivolumab plus ipilimumab provided a significant improvement in overall survival versus standard of care pemetrexed and cisplatin or carboplatin chemotherapy (median overall survival 18·1 months; p=0·0020).

At two-years, 41% of patients treated with nivolumab plus ipilimumab were alive, compared to 27% of patients treated with chemotherapy. Grade 3–4 treatment-related adverse events were experienced by 30% of patients treated with nivolumab plus ipilimumab (n=300) versus 32% of patients treated with chemotherapy (n=284).[3]

The decision by the MHRA follows the European Medicines Agency’s (EMA) approval of the same treatment combination on 1st June 2021.[7] Nivolumab plus ipilimumab is now approved for use across England, Scotland, Wales, Ireland, and Northern Ireland for the first-line treatment of adult patients with unresectable MPM.[1,7]

Dr Sanjay Popat, Consultant Thoracic Medical Oncologist, Royal Marsden Hospital said: “Pleural mesothelioma is a devastating disease with a poor prognosis and treatment options are limited to chemotherapy and supportive care to help manage symptoms and improve quality of life. The approval of nivolumab plus ipilimumab is the first drug approval for mesothelioma since 2004 and will potentially improve survival expectations in these patients.”

Dr Hubert Bland, Executive Medical Director UK and Ireland, Bristol Myers Squibb said: “The MHRA approval of our immunotherapy combination for patients with pleural mesothelioma demonstrates our commitment to developing innovative treatments for patients with serious diseases. We will now work with the reimbursement authorities in the UK to help bring this combination treatment to patients as soon as possible.”

References

References

[1] Medicines and Healthcare products Regulatory Agency. Marketing Authorisation: nivolumab plus ipilimumab for the treatment of adult patients with unresectable malignant pleural mesothelioma. July 2021.
[2] Baas P, Fennell D, Kerr KM, et al. Malignant pleural mesothelioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(suppl5):v31–9.
[3] Baas P, Scherpereel A, Nowak AK, et al. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021; 397:375-386.
[4] Cancer Research UK. What is Mesothelioma? Available at: https://www.cancerresearchuk.org/about[1]cancer/mesothelioma/about?_ga=2.17890106.2079800900.1594113032-2109912623.1585666223 Last accessed: July 2021.
[5] Milano MT, Zhang H. Malignant pleural mesothelioma: a population-based study of survival. J Thorac Oncol. 2010;5:1841–48.
[6] European Medicines Agency, Alimta approval 2004. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/alimta. Last accessed July 2021
[7] Myers Squibb, press release 2021. Available at: https://news.bms.com/news/details/2021/Bristol-Myers-Squibb-Receives-European-Commission-Approval-for-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-as-First-Line-Treatment-for-Unresectable-Malignant-Pleural-Mesothelioma/default.aspx. Last accessed July 2021