AstraZeneca AZN announced detailed data from the phase III study – ASCEND – evaluating its BTK inhibitor, Calquence (acalabrutinib), in patients with relapsed or refractory chronic lymphocytic leukemia (“CLL”). Data were presented at the European Hematology Association (“EHA”) annual congress.
In May, the company announced that the study met its primary endpoint of statistically-significant and clinically-meaningful improvement in progression-free survival (“PFS”) in previously-treated CLL patients. The study compared Calquence monotherapy to a combination regimen of Roche RHHBY/Biogen’s BIIB CD-20 antibody, Rituxan (rituximab), plus Gilead’s GILD Zydelig (idelalisib) or Teva’s Treanda (bendamustine).
The latest detailed data from the ASCEND study showed that Calquence reduced the risk of disease progression by 69% compared to Rituxan combination therapy after median follow-up of 16.1 months. The median PFS for the Calquence is yet to be reached compared to 16.5 months for Rituxan combo. Meanwhile, 88% of patients treated with Calquence did not show any disease progression at 12 months compared to 68% for the control arm.
Earlier this month, AstraZeneca announced successful completion of the phase III study – ELEVATE-TN – evaluating Calquence in combination with Roche’s Gazyva in previously-untreated CLL patients. The combination therapy demonstrated statistically significant and clinically meaningful improvement in PFS compared to the chemotherapy-based combo of chlorambucil and Gazyva (standard-of-care medicines).
Calquence is presently marketed for the treatment of relapsed or refractory mantle cell lymphoma (“MCL”). It is being developed in phase III programs for larger CLL indication and AstraZeneca expects to file regulatory applications based on data from the ASCEND and ELEVATE-TN studies later this year to get an approval for CLL. If approved for CLL, this would definitely help AstraZeneca gain access to a broader patient population and boost sales of this promising drug.
Shares of AstraZeneca have gained 4.4% so far this year compared with the industry’s increase of 2.1%.
In a separate press release, the company announced data from the phase IIIb study, DIALIZE, evaluating Lokelma for the treatment of hyperkalemia in patients with end-stage renal disease (“ESRD”) on hemodialysis. Data from the study showed that 41.2% of patients maintained pre-dialysis normal potassium levels on at least three out of four dialysis treatments compared to 1% for placebo. Results demonstrate the potential of Lokelma in normalizing potassium levels in between dialysis sessions. This may lead to better prospects for the drug in hyperkalemia patients with ESRD, a patient population with high unmet treatment need.
The drug is already approved for hyperkalemia, a serious condition characterized by elevated potassium levels in the blood.
AstraZeneca PLC Price
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Radical New Technology Creates $12.3 Trillion Opportunity
Imagine buying Microsoft stock in the early days of personal computers… or Motorola after it released the world’s first cell phone. These technologies changed our lives and created massive profits for investors.
Today, we’re on the brink of the next quantum leap in technology. 7 innovative companies are leading this “4th Industrial Revolution” - and early investors stand to earn the biggest profits.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
AstraZeneca PLC (AZN): Free Stock Analysis Report
Roche Holding AG (RHHBY): Free Stock Analysis Report
Gilead Sciences, Inc. (GILD): Free Stock Analysis Report
Biogen Inc. (BIIB): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.