Bristol-Myers Squibb’s Opdivo has become the first PD-1/PD-L1 inhibitor to get approval in the EU for a haematological cancer, getting the nod for classical Hodgkin lymphoma (cHL).
The EMA cleared Opdivo (nivolumab) for adult patients with cHL who have previously received an autologous stem cell transplant and treatment with Seattle Genetics/Takeda’s Adcetris (brentuximab vedotin) – the current standard of care. The US FDA approved the drug for the same indication in May.
The approval is based on data from the phase II CheckMate-205 trial and the phase I CheckMate-039 study, which found that two-thirds of patients treated with Opdivo had an objective response. In 6% of cases the cancer was completely destroyed, with the remaining 60% experiencing a partial response.
Less common than non-Hodgkin’s lymphoma, cHL affects around 12,200 people in the EU every year, often being diagnosed in early adulthood. Around 2,600 people are killed by the disease every year.
“We now have an entirely new treatment approach that has shown impressive response rates and durability of response in this difficult-to-treat population,” commented Andreas Engert, the lead investigator in the trial who is professor of internal medicine, haematology and oncology at the University Hospital of Cologne in Germany.
The approval is good news for patients and for BMS, which is still coming to terms with the news of Opdivo’s failure to show efficacy as a first-line therapy for non-small cell lung cancer (NSCLC) after a string of approvals in other cancers.
The setback put Opdivo under pressure both in first- and second-line NSCLC where it competes with rival PD-1 inhibitor Keytruda (pembrolizumab) from Merck & Co and Roche’s recently approved PD-L1 inhibitor Tecentriq (atezolizumab).
BMS says the drug is still showing robust growth in other indications such as melanoma, renal cancer and cHL. It has also just picked up an FDA approval in head and neck cancer and could get a green light in bladder cancer in 2017.
BMS is also testing Opdivo in combination with Adcetris in patients with previously-untreated cHL, as well as a three-drug combination of Opdivo, its CTLA4 inhibitor Yervoy (ipilimumab) and Adcetris in relapsed patients.
Meanwhile, Keytruda is also being developed for cHL and is currently in a phase II trial in this indication, as well as being tested as a combination with Adcetris for patients with relapsed or refractory cHL in a phase III trial (KeyNote-204).