Amgen Inc. (AMGN - Free Report) announced that results of a phase I/II study on its leukemia immunotherapy, Blincyto, were published in the Journal of Clinical Oncology (JCO).
The study evaluated Blincyto in pediatric patients with Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Data revealed that treatment with Blincyto induced complete remission in some patients across all pre-specified subgroups. In addition, over 50% of patients who achieved complete remission showed complete minimal residual disease response.
We remind investors that findings from the study had been the basis of a supplemental Biologics License Application (sBLA) for Blincyto in the U.S. to include additional data supporting the treatment of pediatric patients with Ph- relapsed or refractory B-cell precursor ALL. The sBLA gained FDA approval in Sep 2016.
Also, note that Blincyto had gained accelerated approval in the U.S. for the treatment of patients with Ph- relapsed or refractory B-cell precursor ALL in Dec 2014. Moreover, it was granted conditional approval in the EU in Nov 2015 for the same indication. However, Blincyto carries a boxed warning regarding cytokine release syndrome and neurological toxicities in the U.S.
As per the information provided by the company in its press release, each year in the U.S., approximately 15–20% of all children diagnosed with ALL experience relapses. Pediatric patients with relapsed or refractory ALL have poor long-term outcomes, and post-relapse survival is seen in only 40–50% of the patients.
In the first six months of 2016, Blincyto has raked in sales of $42 million in the U.S., up 40% from the year-ago period. In the rest of the world, the product generated sales of $15 million over the same time period.
Meanwhile, Blincyto is also in phase II development for the treatment of diffuse large b-cell lymphoma (DLBCL).
Amgen currently carries a Zacks Rank #3 (Hold).
Stocks to Consider
Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. (ACHN - Free Report) , Anika Therapeutics, Inc. (ANIK - Free Report) and VIVUS Inc. (VVUS - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Achillion has posted a positive earnings surprise in each of the last four quarters, with an average beat to 364.79%. The company’s share price has tanked 22.3% year to date.
Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 9.5% and 11.5%, over the last 60 days. The company’s earnings have beaten estimates in each of the last four quarters with an average surprise of 42.19%. Its share price has jumped 24.9% year to date.
VIVUS has posted a positive earnings surprise thrice in the last four quarters, with an average beat to 39.88%. The company’s share price have gained 7.5% year to date.
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