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Bristol-Myers Reports Data on Immuno-Oncology Drug Empliciti

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Bristol-Myers Squibb Company (BMY - Free Report) announced four-year follow-up data from the phase III study, ELOQUENT-2 on immuno-oncology Empliciti during the 22nd Congress of the European Hematology Association in Madrid, Spain.

The results from the trial showed that Empliciti plus lenalidomide/dexamethasone (ELd) continued to demonstrate efficacy in patients with relapsed/refractory multiple myeloma (RRMM), compared with patients treated with lenalidomide/dexamethasone (Ld) alone.

The trial randomized 646 patients with RRMM who had one to three prior therapies to receive either ELd (321 patients) or Ld (325 patients) in 28-day cycles until their disease progressed or they withdrew consent.

ELd therapy maintained a reduction in the risk of disease progression or death of 29%. At four-years, ELd therapy continued to demonstrate a clinically meaningful and sustained relative improvement of 50% in progression-free survival (PFS) rate, 21% compared to Ld therapy, 14% (95% CI: 12.1,17.3). Patients receiving ELd therapy also demonstrated an overall response rate (ORR) of 79% among patients receiving Ld therapy alone.

We note that Empliciti is already approved in the U.S. in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. It gained EU approval in May 2016.

The long-term efficacy data for Empliciti in patients with advanced multiple myeloma shows the combination of Empliciti with standard lenalidomide/dexamethasone treatment can improve patient outcome.

The company’s key oncology products include Opdivo, Sprycel, Yervoy and Empliciti. Bristol-Myers Squibb and AbbVie (ABBV - Free Report) are co-developing Empliciti with the former being solely responsible for commercial activities.

Meanwhile, Bristol-Myers’ shares declined 21.0% in the last 12 months, the Zacks classified Large Cap Pharmaceuticals industry gained 7.7%. The company suffered a setback in Jan 2017 when it decided not to pursue accelerated regulatory pathway for Opdivo plus Yervoy in first-line lung cancer in the U.S. based on a review of available data. The share price of the company declined significantly on the news. Opdivo is facing stiff competition in the U.S. With the FDA approving Merck’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic nonsquamous NSCLC, the company is expected to suffer further loss of market share.

Zacks Rank & Key Pick

Bristol-Myers currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the health care sector is VIVUS, Inc.   which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates have narrowed from 50 cents to 39 cents for 2017 in the last 60 days. The company delivered positive earnings surprises in the four trailing quarters, with an average beat of 233.69%.

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