AstraZeneca PLC AZN announced that the phase III ELEVATE-TN study on its BTK inhibitor, Calquence (acalabrutinib), has met the primary endpoint. The late-stage study evaluated Calquence in combination with Roche’s RHHBY Gazyva (obinutuzumab) for the first-line treatment of chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adult patients.
In the study, the combination of Calquence plus Gazyva demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) among treatment naive patients as compared to the chemotherapy-based combo of chlorambucil and Gazyva (standard-of-care medicines).
Moreover, Calquence as a monotherapy showed better signs that are statistically significant and clinically meaningful pertaining to PFS as compared to the chemotherapy and Gazyva regimen, thereby achieving a key secondary endpoint of the study.
Overall it was observed that Calquence monotherapy or a combined regimen with Gazyva significantly increased the duration of time when patients lived without disease progression. The company plans to present detailed results from the ELEVATE-TN study at an upcoming medical conference.
Shares of AstraZeneca have inched up 2.2% so far this year versus the industry’s dip of 0.1%.
This is the second CLL study on Calquence to have tasted success. Last month, AstraZeneca announced that the phase III ASCEND analysis evaluating Calquence for relapsed/recurrent disease setting met the primary endpoint.
Calquence is presently marketed for the treatment of relapsed or refractory mantle cell lymphoma (MCL). It is being developed in phase III programs for the 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.
In the first quarter of 2019, Calquence generated sales of $29 million, reflecting sequential growth of 20.8%.
If approved for CLL, this would definitely help AstraZeneca gain an access to broader patient population and boost sales for this promising drug. Calquence is also being developed for other forms of blood cancers.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large cap pharmaceuticals sector include AbbVie Inc. ABBV and Merck & Co., Inc. MRK, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AbbVie’s earnings estimates have been revised 1.5% upward for 2019 and 1.3% for 2020 over the past 60 days.
Merck’s earnings estimates have moved 1.7% north for 2019 and 0.8% for 2020 over the past 60 days. The stock has rallied6.6% year to date.
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