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Data shows around a third of advanced kidney cancer patients still alive at five years with Opdivo (nivolumab)

Bristol-Myers Squibb has announced the latest long-term overall survival (OS) results from two dose-ranging Phase I and Phase II studies, CA209-003 and CA209-010, which evaluated nivolumab in patients with previously treated advanced renal cell carcinoma (RCC).1 These findings include the first report of four and five-year survival data from the advanced RCC cohort (n=34) of study -003, in which 38% and 34% of patients were still alive at four and five years respectively.1 In the second study, -010 (n=167), 29% of patients were still alive at four years.1 These data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting during an oral presentation (Abstract #4507).

“Renal cell carcinoma is the most common form of kidney cancer and less than 10% of people with advanced disease are likely to survive five years or more, until now,” said Professor John Wagstaff, Professor of Medical Oncology, The College of Medicine, Swansea University. “In recent months it has been shown that immunotherapies are changing the survival outlook for patients with advanced kidney cancer. Today, we have seen for the first time, landmark long-term survival results for nivolumab, with a significant proportion of patients continuing to live with their disease for up to five years.”

Nivolumab is currently licensed in the UK to treat adult patients with advanced renal cell carcinoma who have received prior therapy.2 In the studies presented today, patients had received prior therapies and were randomised to receive investigational doses of nivolumab which are not licensed for use in patients.

Commenting on the potential impact of these results for advanced kidney cancer patients, Nick Turkentine, Chief Operating Officer, Kidney Cancer UK, said “We are delighted to read these results and any increase in survival rates are cherished by patients and families alike. Every year, thousands of people in the UK will be diagnosed with kidney cancer and for those with advanced stages of disease, the impact on their lives will be significant and their outlook potentially poor. Therefore, effective treatment options which provide some hope of longer-term survival for patients and their families are sorely needed and we remain hopeful that eligible patients will soon be able to access nivolumab for kidney cancer on the NHS nationwide.”

In today’s data presentation, the -003 study (n=34) showed that at four years, treatment with nivolumab demonstrated a median OS of 22.4 months (95% CI:12.5-NE).1 Patients treated with nivolumab in the -010 study (n=167) demonstrated a median OS of 23.4 months (95% CI: 17.7-26.9), at a minimum follow-up of 49.2 months.1 In this study, the objective response rate (ORR) was 21.6% (95% CI: 15.6-28.6) with a median duration of response lasting 23 months (15.7-35.1).1

The long-term safety profile of nivolumab in -003 and -010 was consistent with previously reported studies, with no new safety signals identified after more than four years of follow-up. In the -003 and -010 studies, grade 3-4 treatment-related adverse events (AEs) occurred in 17.6% and 14.4% of patients respectively.1 Any grade treatment related AEs led to a discontinuation of treatment in 8.8% and 9.6% of patients respectively.1

“Bristol-Myers Squibb is pleased to be sharing these important new data for advanced kidney cancer patients, adding to the growing wealth of clinical data supporting the use of nivolumab across a number of tumour types,” said Dr Sue Bailey, Disease Area Head, Oncology, Bristol-Myers Squibb UK and Ireland,. “We are fully committed to ensuring survival for British cancer patients is maximised and will share these data with relevant reimbursement authorities as we collaborate to secure prompt NHS access to nivolumab.”

In 2013, almost 12,000 people in the UK were diagnosed with kidney cancer,3 and in 2012, around 4,250 people died from the disease – an average of more than 11 people per day.3 In cases of late-stage kidney cancer, it is estimated that less than 10% of patients will survive for five years or more in the UK.3