European Commission approves Bristol-Myers Squibb’s two new oncology treatments

The commission granted approval for Bristol-Myers Squibb’s (BMS) Opdivo in combination with Yervoy to treat advanced (unresectable or metastatic) melanoma in adults.

In the first Phase 3, double-blind, randomized CheckMate -067 study, the Opdivo + Yervoy regimen demonstrated a 58% reduction in the risk of disease progression versus Yervoy monotherapy in previously untreated patients with advanced melanoma.

BMS said Opdivo monotherapy demonstrated a 45% risk reduction versus Yervoy monotherapy.

The approval was also based on supportive data from the CheckMate -069 phase 2 study in which the Opdivo + Yervoy Regimen demonstrated an objective response rate (ORR), the primary endpoint, of 61% in patients with BRAF wild-type advanced melanoma, versus 11% ORR in the Yervoy monotherapy arm, with a minimum follow-up of 11 months.

In a separate decision, the EC approved Empliciti (elotuzumab) to treat multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone in patients who have received at least one prior therapy.

Empliciti, which is being co-developed by Bristol-Myers Squibb and AbbVie, is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7, a cell-surface glycoprotein.

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

The study’s co-primary endpoints, progression-free survival (PFS) as assessed by hazard ratio and ORR, were achieved, with extended follow-up data demonstrated a 53% relative improvement in PFS rate at three years.

Image: Bristol-Myers Squibb building in New Brunswick, New Jersey, US. Photo: courtesy of Bristol-Myers Squibb Company.