Bristol-Myers Squibb and AbbVie's immunotherapy Empliciti has been given a green light in Europe for the treatment of the generally incurable blood cancer multiple myeloma.
The drug has been approved in combination with lenalidomide (Celgene's Revlimid) and the anti-inflammatory medicine dexamethasone for patients who have received at least one prior therapy, making it the only immunostimulatory antibody cleared for this use.
Approval came after Phase III data showed that in patients taking Empliciti (elotuzumab) as well as lenalidomide/dexamethasone the disease progressed more slowly (difference in medians of 4.2 months) than in those taking the latter regimen alone.
Also, extended follow-up data showed a 53 percent relative improvement in the progression free survival (PFS) rate at three years (23 percent versus 15 percent), the firms noted, while, on the safety side, the most common side effects of the drug were found to be infusion-related reactions, diarrhoea, cough, herpes zoster, nasopharyngitis, pneumonia, upper respiratory tract infection, lymphopenia and weight loss.
Fifth indication for Opdivo
Meanwhile, the European Commission has also handed down a fifth approval for BMS' Opdivo (nivolumab), this time in combination with Yervoy (ipilimumab) for the treatment of advanced (unresectable or metastatic) melanoma in adults, representing the first and only approved combination of two immuno-oncology agents in the region.
The decision was based on findings from the Phase III Checkmate-067 study, which showed a median PFS of 11.5 months for the Opdivo/Yervoy arm and 6.9 months for Opdivo, versus 2.9 months for Yervoy. The combination also demonstrated a 58 percent reduction in the risk of disease progression compared to Yervoy, while Opdivo cut the risk by 43 percent.
Recently published data from the Phase II CheckMate-069 trial showed that the combination demonstrated a two-year overall survival rate of 69 percent compared to 53 percent for Yervoy alone in patients with BRAF wild-type advanced melanoma.
"Both nivolumab and ipilimumab have changed survival expectations in advanced melanoma over the last few years and these latest data show us that combining these two immunotherapies is an effective two-pronged attack against the cancer," said Dr James Larkin, consultant medical oncologist at The Royal Marsden.