BMS/AbbVie's combo falls short in untreated multiple myeloma trial

Adding Bristol-Myers Squibb/AbbVie's Empliciti to Revlimid, developed by BMS' recently acquired Celgene unit, does not improve survival in untreated multiple myeloma, a study has shown.

BMS announced topline results from the phase 3 ELOQUENT-1 trial, testing the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide and dexamethasone), compared with Revlimid and dexamethasone alone, in patients with newly diagnosed previously untreated multiple myeloma who are transplant ineligible.

Both treatments were administered continuously until disease progression – but at the final analysis adding Empliciti did not show a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint.

There were no surprises on the safety front, but the failure is a disappointment for BMS, which hoped to gain further traction in multiple myeloma.

BMS was hoping that the combination would be effective enough to provide an alternative to Johnson & Johnson’s Darzalex (daratumumab) in this early use.

But the trial failure confirms what many in the industry thought: which was that Darzalex and its anti-CD38 mechanism of action is more effective than Empliciti’s anti-CS1 action.

It also denies the newly merged BMS and Celgene an opportunity to combine two well-established drugs ahead of Revlimid’s likely patent expiry in the coming years.

With this trial failure, the focus shifts to whether a CAR-T therapy, bb2121, will get approval by the FDA in more advanced cases of multiple myeloma.

Developed in partnership with bluebird bio, BMS added bb2121 to its pipeline with its $74 billion acquisition of Celgene late last year.

The CAR-T therapy is part of a three-drug ‘bet’ to sweeten the deal with Celgene shareholders – if bb2121 and two other cancer drugs are approved before certain deadlines then holders of the so-called “contingent value right” will get payouts of $9 per share.

BMS and AbbVie are co-developing Empliciti, with Bristol Myers Squibb solely responsible for marketing.