Bristol-Myers Squibb today announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the reimbursement within the Cancer Drugs Fund (CDF) of the immunotherapy, nivolumab, as adjuvant treatment after surgery, to potentially keep the cancer from returning, for melanoma patients in England.

This recommendation for nivolumab in the adjuvant setting signifies an important milestone for patients with resected stage III and IV disease in the UK who, before now, have predominantly been monitored through routine surveillance and may not have received an active treatment following surgery.

Nivolumab is the first of a modern type of immunotherapy, known as PD-1 checkpoint inhibitors, to be approved in the European Union.

It is immediately available on the CDF as adjuvant treatment of early stage melanoma, and could benefit around 1,480 melanoma patients each year in England.

"Until now, patients at high risk of melanoma returning after their initial surgery have had limited options to reduce their risk of recurrence, which, if it occurs, can prove fatal. Today's recommendation opens up a new opportunity for these patients to access effective immunotherapy," said Dr Pippa Corrie, Consultant and Associate Lecturer in Medical Oncology, Cambridge University Hospitals NHS Foundation Trust. "There have been huge advances in the treatment of advanced melanoma in recent years, but cure rates are low. So, being able to give nivolumab to high risk patients after their surgery is a significant step forward in improving outcomes for what can be a devastating disease."

The recommendation from NICE today will make nivolumab available immediately to NHS patients in England via the CDF.

Nivolumab will be reimbursed as adjuvant treatment after surgery, for melanoma patients with involvement of lymph nodes or metastatic (advanced) disease who have undergone complete resection.

As more long-term clinical data become available within the next two years, nivolumab may be made available routinely through the National Health Service (NHS) following review of the data.

Data from the Phase III CheckMate -238 study, the longest running clinical trial investigating immuno-oncology (I-O) agents in the adjuvant melanoma setting, supported the approval for nivolumab in the adjuvant setting.

Data demonstrated that nivolumab may significantly reduce the risk of a patient’s cancer returning (recurrence-free survival, RFS) compared to ipilimumab.

In this study, 906 stage IIIb/c and IV melanoma patients were treated with either nivolumab or ipilimumab as adjuvant therapy, following surgical resection.

Results showed that at 24 months, nearly two thirds (63%) of patients treated with nivolumab had significantly longer RFS, compared to those treated with ipilimumab (50% [HR 0.66; 95% CI: 0.54 to 0.81]), regardless of BRAF mutation status.

After a minimum of 18 months, nivolumab demonstrated a lower rate of treatment related adverse events (TRAEs) of grade 3/4 compared to ipilimumab (17.5% versus 40.4%, respectively).

Ipilimumab is an active treatment that has previously been shown to reduce the risk of recurrence in stage III melanoma patients, after complete resection, compared to placebo, but is not approved for this use in the UK.

Gill Nuttall, Chief Executive Officer and Founder of Melanoma UK, said: “Being diagnosed with stage III or IV melanoma is a daunting and frightening experience for patients, exacerbated by the fact that there are currently limited treatment options following surgery, regardless of BRAF mutations. Many patients are put under routine surveillance known as the “watch and wait” approach. This means that patients and their families often feel left in the dark, waiting for their disease to return or to worsen, before they receive treatment for the more advanced cancer. Increasing earlier stage access to effective treatments, such as nivolumab, will make a tremendous difference to many patients, and we welcome this new treatment in the adjuvant melanoma setting.”

Melanoma incidence rates in the UK have more than doubled in approximately the last 25 years and are among the ten highest in Europe.

Typically, 68% of patients with stage IIIb and 89% of those with stage IIIc melanoma may experience a recurrence of their cancer within five years of surgery.

In 2015, more than 15,900 people were diagnosed with melanoma in the UK and approximately 2,285 people died from the disease in 2016.

Veronique Walsh, General Manager, Bristol-Myers Squibb UK & Ireland, said: “Today’s recommendation represents an important step forward in improving outcomes for melanoma patients by treating them with immunotherapy earlier as the first IO treatment available in the UK. Since approval in the summer, we have provided nivolumab as adjuvant treatment to surgery for any patient whose physician requested it through a controlled program to ensure patients had access before reimbursement. So we are delighted that more people will have the opportunity to receive treatment on the NHS, via the CDF. This approval complements our dedication and commitment to patients with unresectable metastatic melanoma through our combination immunotherapy, which has been available for several years.”

Source: Reynolds Mackenzie