Mei Pharma ( MEIP Quick Quote MEIP - Free Report) along with partner Kyowa Kirin Co., Ltd. announced the initiation of a phase III COASTAL study to evaluate an investigational selective phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor, zandelisib, in patients with at least second-line relapsed or refractory follicular lymphoma (“FL”) or marginal zone lymphoma (“MZL”).
The phase III COASTAL study (n=534) will evaluate zandelisib plus rituximab in comparison with chemotherapy plus rituximab in patients with relapsed or refractory FL or MZL who received at least one prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide.
Shares of Mei have increased 0.4% so far this year against the
industry’s 13.5% decline. Image Source: Zacks Investment Research
The COASTAL study’s primary efficacy endpoint is progression-free survival. Secondary endpoints include overall response rate and survival, patient reported outcome assessments along with safety and tolerability.
The COASTAL study is also intended to act as the required confirmatory study for a potential accelerated approval in the United States for zandelisib based on the ongoing phase II TIDAL study evaluating patients with at least second-line relapsed or refractory FL and MZL.
Per the study, the drug will be administered once daily for two 28-day cycles followed by an intermittent schedule of once-daily dosing for seven days of each subsequent 28-day cycle for a total of 24 months, in combination with rituximab in the first six months only. The control arm of the study will consist of six cycles of the standard chemoimmunotherapy regimens for rituximab-CHOP or rituximab-bendamustine.
In April 2020, Mei Pharma and Kyowa Kirin entered into a global license, development, and commercialization agreement to further develop as well as commercialize zandelisib. Per the agreement terms, Mei Pharma will record all revenues from U.S. sales while Kyowa Kirin will hold exclusive commercialization rights of the drug outside the country.
We inform investors that the FDA granted Fast Track designation to zandelisib in March 2020 to treat adult patients with relapsed or refractory FL who have received at least two prior systemic therapies.
Zacks Rank & Stocks to Consider
Mei currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include
Moderna ( MRNA Quick Quote MRNA - Free Report) , Repligen Corporation ( RGEN Quick Quote RGEN - Free Report) and Vertex Pharmaceuticals ( VRTX Quick Quote VRTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Moderna’s earnings per share estimates for 2021 have increased from $25.19 to $29.04 in the past 30 days. The same for 2022 has risen from $17.71 to $22.26 over the same period. The stock has rallied 284.7% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.76 in the past 30 days. The same for 2022 has risen from $2.56 to $3.02 over the same period. The stock has rallied 34.1% in the year so far.
Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 30 days. The same for 2022 has risen from $12.24 to $13.13 over the same period.