AstraZeneca Gives Detailed Data From Calquence Leukemia Study
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
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