Bristol-Myers Squibb’s immunotherapy Opdivo has bagged a second European approval after regulators waved through its use in patients with non-small cell lung cancer.

The European Commission has cleared the PD-1 checkpoint inhibitor for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy, which the firm says gives patients in the region access to the first major treatment advance in more than a decade. 

Opdivo (nivolumab) is the first and only PD-1 immune checkpoint inhibitor to demonstrate overall survival in previously-treated metastatic SQ NSCLC, and has the potential to replace the current standard of care, BMS noted.

Approval came on the back of data from the Checkmate-017 trial, which showed that Opdivo cut the risk of death by 41% compared to docetaxel, and nearly doubled overall survival at one-year versus chemotherapy (42% vs. 24%). The file also included data from CheckMate-063, in which patients taking BMS’ drug showed an estimated 41% one-year survival rate and a median OS of 8.2 months. 

The drug fared well on the safety side too, with treatment-related side effects occurring less frequently with Opdivo (58%) than docetaxel (86%), leading to trial discontinuation in 3.1% of patients compared with 10.1% for the chemotherapy.

In Europe, incidence and mortality rates for lung cancer are on the rise and currently account for 20% of all cancer deaths. SQ NSCLC accounts for around 25%-30% of all lung cancers. Patients with NSCLC, whose disease reoccurs or progresses despite chemotherapy, face a five-year survival rate of just 2%, highlighting the urgent need for new treatment options.

Merck & Co is expected to file its rival immunotherapy Keytruda (pembrolizumab) in Europe for NSCLC sometime this year.