Nivolumab Approved by EC for Melanoma, Rejected by NICE for Lung Cancer

The immunotherapy agent nivolumab was approved by the European Commission in combination with ipilimumab for the treatment of advanced melanoma, but rejected by the National Institute for Health and Care Excellence for use in patients with advanced lung cancer.

While there was good news for nivolumab (Opdivo) from the European Commission (EC), the update from the National Institute for Health and Care Excellence (NICE) was not the same. Bristol-Myers Squibb (BMS)’s very-promising immuno-oncology agent, nivolumab, was approved by the EC in combination with ipilimumab (Yervoy) for the treatment of unresectable or metastatic melanoma. At the same time, NICE has published guidelines that reject nivolumab for use in patients with advanced non-squamous non-small cell lung cancer (NSCLC).

The EC’s approval came following the submission of the phase 3, double-blind, randomized CheckMate-067 study, which found that the combination of nivolumab and ipilimumab resulted in a 58% reduction in disease progression compared with ipilimumab alone in treatment-naïve patients with advanced melanoma. Nivolumab alone resulted in a 45% risk reduction compared with ipilimumab monotherapy.

Additional data submitted for review phase 2 results of the CheckMate-069 trial, which found patients treated with the combination had an objective response rate (ORR) of 61%, while those treated with ipilimumab alone had an ORR of 11%. The trial included patients with BRAF wild type advanced melanoma.

Meanwhile, it seems improbable that nivolumab will be available for the treatment of patients with advanced lung cancer in England and Wales, who have progressed on prior chemotherapy. Nivolumab was approved more than a year back in the United States by the FDA based on the results of the CheckMate-017 trial, which showed improved overall survival in previously treated NSCLC patients who were given nivolumab.

According to BMS, NICE has made the decision despite cost negotiations and discounts that include funding treatment after the first year.

“Lung cancer is the UK’s biggest cause of cancer deaths and making new medicines available to NHS patients is a vital part of raising standards of cancer care and survival rates in Britain to the levels seen in other European countries,” said Professor Dean Fennell, chair of Thoracic Medical Oncology at the University of Leicester, in a statement. “Nivolumab has the potential to provide increased long-term survival, compared with chemotherapy and with far less side effects. I hope that NICE will reconsider the value of this treatment and reverse its decision so that patients can benefit from nivolumab as soon as possible.”