BMS’ potential standard of care skin cancer combo approved in EU

Bristol-Myers Squibb received a double dose of good news this week with two key approvals in Europe.

The first is an Opdivo and Yervoy combination for advanced melanoma, the first such immuno-oncology combination therapy approved. The second is for Emplicti, developed with AbbVie for multiple myeloma.

Following strong trial results announced at the American Association of Clinical Oncology annual conference last year, the Opdivo+Yervoy combination has been hailed as the potential new standard of care for melanoma.

However in England there are question marks about whether Opdivo will be routinely available after NICE this week said it was not cost-effective in lung cancer despite heavy discounting compared with US prices.

The Opdivo (nivolumab) and Yervoy (ipilimumab) combination has been approved for advanced (unresectable or metastatic) melanoma in adults, representing the first and only approved combination of two immune-oncology agents in the EU.

Approval was based on CheckMate -067, the first phase 3 double-blind, randomised study in which the combination regimen and Opdivo monotherapy demonstrated superior progression-free survival and objective response rates in patients with advanced melanoma regardless of BRAF mutation status, versus Yervoy alone.

Safety profile was consistent with previously reported studies evaluation Opdivo+Yervoy and most treatment-related adverse events were managed events were managed using established algorithms.

The Opdivo and Yervoy combination was approved in the US for metastatic melanoma in the US in January.

Merck’s rival cancer immunotherapy, Keytruda (pembrolizumab), is also being developed as a combination therapy with Yervoy in this indication, but is only in an early stage trial.

Empliciti (elotuzumab) was approved in the EU for multiple myeloma in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone in patients who have received at least one prior therapy, for patients who have received at least one prior therapy.

It is now the first and only immunostimulatory antibody approved for multiple myeloma in the EU.

The approval is based on data from the randomised, open-label, phase 3 ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone.

The co-primary endpoints of this study, progression-free survival as assessed by hazard ratio (HR) and overall response rate were achieved, with extended follow-up data showing a 53% relative improvement in PFS rate at three years.

A pre-specified interim analysis for overall survival (OS) found a positive trend favouring the Empliciti combination versus Rd alone, although at the time of the interim analysis, the OS endpoint had not reached the pre-determined threshold for statistical significance. Patients will continue to be followed for survival, and the final analysis is pending.

The US regulator approved Empliciti in this use in November.

Related stories:

NICE says lung cancer breakthrough Opdivo too expensive

NICE fast-tracks Novartis’ skin cancer combination

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