Bristol-Myers Squibb announced the UK launch of Opdivo® (nivolumab), as monotherapy, for the treatment of adult patients with advanced (unresectable or metastatic) melanoma, regardless of BRAF status. It is the first in a new class of medicines – PD-1 immune checkpoint inhibitors – to be licenced in the EU and works by harnessing the body’s own immune system to fight cancer. (1)
Bristol-Myers Squibb announced the UK launch of Opdivo® (nivolumab), as monotherapy, for the treatment of adult patients with advanced (unresectable or metastatic) melanoma, regardless of BRAF status. It is the first in a new class of medicines – PD-1 immune checkpoint inhibitors – to be licenced in the EU and works by harnessing the body’s own immune system to fight cancer. (1)
In clinical trials, nivolumab has been shown to significantly improve survival outcomes in this cancer, and in some patients, providing durable response. (2,3) It will now become an important new treatment option for UK patients who have either received prior therapy for their melanoma, or are previously untreated. (1)
Commenting on the decision, Professor John Wagstaff, Consultant Oncologist at South West Wales Cancer Institute & Swansea College of Medicine, said “The UK launch of nivolumab is a major milestone for the treatment of advanced melanoma and provides us with a new, effective option to help fight this cancer. Immunotherapies such as nivolumab are becoming a core part of our treatment armoury and we are seeing more and more patients with significant survival improvement using these medicines. What is particularly encouraging is that, in some patients, this survival can extend to months or even years. Our hope for the future is to make this the case for more people as this field progresses.”
Data from the CheckMate -066 Phase III study, which involved treatment-naïve patients with BRAF wild-type advanced melanoma (n=418), have shown that nivolumab can contribute to superior overall survival compared to chemotherapy in this group; data showed a one-year survival rate of 72.9% (n=210 95% CI, 65.5–78.9) in the nivolumab arm, compared with 42.1% (n=208 95% CI: 33.0–50.9) in the arm on the chemotherapy, dacarbazine. (2)
Nivolumab has also shown superiority when compared with chemotherapy (investigator’s choice) in previously treated advanced melanoma patients. Based on data from Phase III CheckMate -037 study, nivolumab has shown significantly higher overall response rates (ORR) in advanced melanoma patients previously treated with Yervoy® (ipilimumab) or ipilimumab and a BRAF inhibitor, if BRAF mutation positive. In patients with at least 24 weeks of follow-up, the ORR was 31.7% (n=38/120 95% CI, 23.5–40.8) in the nivolumab arm and 10.6% (n=5/47 95% CI, 3.5–23.1) in the chemotherapy arm.3 The safety profile of nivolumab compared to chemotherapy was reported in both the -066 and -037 studies and included a smaller percentage of treatment discontinuations and treatment-related serious (Grade 3/4) adverse events in favour of nivolumab. (2,3)
Commenting on the UK launch, Gill Nuttall, Melanoma UK said: “There has been an alarming rise in the number of cases of melanoma in the UK over recent years. Sadly, this too often translates into people being diagnosed with an advanced form of the disease, which is a very difficult situation to manage. Today’s news is therefore very welcome as it provides more options for patients and the potential of better, longer survival.”
In May 2015, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) adopted a positive scientific opinion, under the Early Access to Medicines Scheme (EAMS), for nivolumab, as a treatment option for advanced (unresectable or metastatic) melanoma. Granted to therapies that are deemed to offer significant advantages over other medicines, the scheme is designed to enable access to medicines ahead of marketing authorisation from the European Commission. Now that nivolumab has been licenced by the European Commission, the scheme will be required to stop.
Melanoma is the most dangerous form of skin cancer. While survival rates are very good in the early stages when surgical removal is an option, the disease can be fatal if it cannot be surgically removed and has spread beyond this (known as unresectable or metastatic melanoma). (4) In 2012, around 14,450 people in the UK were diagnosed with melanoma, (5) and although the majority of skin cancers are treatable, in 2012 this disease killed around 2100 people. (6) Each day more than two young adults aged 15–34 in the UK are diagnosed with malignant melanoma. Over the last 30 years, the incidence of melanoma across the UK has risen faster than any of the current top 10 most common cancers. (6)
Commenting on the announcement, Johanna Mercier, General Manager, Bristol Myers Squibb UK & Ireland said: “Bristol-Myers Squibb is committed to pioneering the field of immuno-oncology, and to translating this into better survival. We are therefore delighted that nivolumab is now available for UK patients as a licenced treatment and hope to be able to bring further advances in the treatment of this disease in the future.”
References:
- Opdivo Summary of Product Characteristics. Updated June 2015. Available at: https://www.medicines.org.uk/emc/. Last accessed June 2015.
- Robert C et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015;372:320–30.
- Weber JS et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol 2015;16:375–84.
- Skin Cancer Foundation: Melanoma. Available at: http://www.skincancer.org/skin-cancer-information/melanoma. Last accessed: June 2015.
- Ferlay, J et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. European Journal of Cancer 2013 49:1374–1403
- Cancer Research UK. Skin cancer statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/skin-cancer/. Last accessed: June 2015.
