Bayer's Aliqopa Meets Primary Endpoint in Lymphoma Study
Bayer AG BAYRY announced that the phase III study, CHRONOS-3, evaluating Aliqopa (copanlisib) in combination with Roche’s RHHBY Rituxan (rituximab) in patients with relapsed indolent non-Hodgkin's Lymphoma (iNHL), met its primary endpoint of significantly prolonging progression-free survival (PFS). Non-Hodgkin’s lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. Histological subtypes included in the study were follicular lymphoma (FL), small lymphocytic lymphoma (SLL), lymphoplasmacytoid lymphoma/Waldenstrom macroglobulinemia (LPL/WM) and marginal zone lymphoma (MZL).
Shares of Bayer have declined 36.1% year to date against the industry’s 0.8% decline.
Aliqopa is a pan class I- phosphatidylinositol-3-kinase (PI3K) inhibitor, with predominant activity against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B-cells.It is approved by the FDA under accelerated approval for the treatment of adult patients experiencing relapsed FLwho have received at least two prior systemic therapies. The approval was based on the phase II CHRONOS-1 study.
CHRONOS-3 is a phase III study with the objective to evaluate whether Aliqopa in combination with Rituxan is superior to placebo plus Rituxan in extending PFS in patients with relapsed iNHL. Patients were randomized at a 2:1 ratio. Safety and tolerability observed in the study were generally consistent with the previously published data on the individual components of the combination and no new safety signals were identified.
We remind investors that Bristol-Myers Squibb’s BMY Revlimid (lenalidomide) in combination with a rituximab product (R²) is approved in the United States for the treatment of adult patients with previously treated FL or MZL. This is the first combination regimen for patients with these indolent forms of NHL that do not include chemotherapy.
Zacks Rank and A Stock to Consider
Bayer currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the healthcare sector includes Emergent Biosolutions Inc. EBS, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $4.03 to $6.61 for 2020 and from $5.07 to $8.42 for 2021 over the past 90 days. Shares of the company have increased 81.2% year to date.
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