Europe approves Opdivo for lung cancer

Bristol-Myers Squibb's (BMS) immunotherapy treatment Opdivo has gained marketing approval in Europe for patients with squamous non-small cell lung cancer (NSCLC).

The approval makes Opdivo (nivolumab) the first in the PD-1 immune checkpoint inhibitor class to reach the European market for NSCLC, keeping it ahead of its close rival, Merck's Keytruda (pembrolizumab).

Clinical trials show Opdivo can almost double the number of patients still alive after 12 months compared to chemotherapy, making it a major breakthrough against the disease.

The announcement follows Opdivo's approval in the US for the same indication in March, where the FDA granted its authorisation in record time, a recognition of its importance for lung cancer patients.

The approvals are based on the Checkmate -017 and -063 phase III trials, which looked at the drug in treating patients with previously treated locally advanced or metastatic squamous (SQ) NSCLC.

Results from CheckMate -017 showed a 41 per cent reduction in the risk of death with a one-year survival rate of 42 per cent for nivolumab versus 24 per cent for docetaxel. Median overall survival was 9.2 months versus six months for nivolumab and docetaxel.

"With the EU approval of nivolumab, patients in Europe have, for the first time in more than ten years, access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care," said Emmanuel Blin, senior vice president, Head of Commercialisation, Policy and Operations, BMS.

The news will also be welcomed by Europe's oncologists. Rolf Stahel, MD, president of the European Society of Medical Oncology and Professor at University Hospital Zurich, called the approval "truly a major advance for patients fighting this devastating disease, and the providers that treat them."

While the gain of three months is relatively modest, these significant gains in some of the sickest lung cancer patients suggest the drug could provide much bigger benefits for patients with less advanced tumours.

Opdivo has been approved for these NSCLC patients regardless of their PD-L1 expression status. BMS has not taken the marker into account in its trials and marketing applications, but trials are increasingly confirming that patients with high levels of PD-L1 benefit more from the PD-1/PD-L1 inhibitors than those with low levels.

This may help Merck, Roche and AstraZeneca position their rival drugs, as most of these trials are targeting their treatments at patients with high PD-L1 expression. Nevertheless, BMS has established a substantial lead.

The approval in squamous NSCLC in Europe follows hot on the heels of Opdivo's first European licence, for advanced melanoma, just last month.

In Europe, incidence and mortality rates for lung cancer are on the rise, currently the cause of 20 per cent of all cancer deaths. NSCLC is one of the most common types of the disease and accounts for approximately 85 per cent of lung cancer cases. SQ NSCLC accounts for approximately 25-30 per cent of all lung cancers.

Negotiations on pricing and reimbursement with individual European markets will now get under way in earnest. Opdivo carries a very high cost in the US – $12,500 a month or $150,000 for patients who stay on the drug for a year, but BMS is likely to offer the drug at a discount on this level in Europe.