Celldex's Rintega Phase III Study Recommended to Continue - Analyst Blog
Celldex Therapeutics, Inc. CLDX announced that an independent Data Safety and Monitoring Board (DSMB) completed its first pre-specified review of a phase III study (ACT IV) on Rintega (rindopepimut) and recommended the continuation of the study in patients with newly diagnosed glioblastoma.
The randomized, double-blind, placebo controlled study on Rintega plus granulocyte-macrophage colony-stimulating factor (GM-CSF) added to standard-of-care treatment like Merck’s MRK Temodar (temozolomide) is being conducted in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma.
In the study, 745 patients were enrolled in order to reach the required 374 patients with minimal residual disease needed for analysis of the primary overall survival endpoint. Patients including those with disease that exceed this threshold will be included in a secondary analysis of overall survival as well as analyses of progression-free survival, safety and tolerability and quality of life. Moreover, the timing of the overall survival primary endpoint data is event driven.
The interim analysis, assessing the safety, futility and efficacy of the candidate and being conducted by an independent DSMB, is pre-specified at 50% and 75% of events. With the first interim analysis having been completed, the second is expected to take place in late 2015/early 2016. Final data from the study is expected by the end of 2016.
We remind investors that in late May, Celldex had reported positive results from a phase II exploratory study (ReACT) on Rintega in patients suffering from EGFRvIII-positive, recurrent glioblastoma. We note that Rintega was granted Breakthrough Therapy status for the glioblastoma indication in Feb 2015.
Being the lead candidate in the company’s pipeline, we expect investor focus to remain on updates pertaining to its development.
Celldex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Hospira Inc. HSP. Both hold a Zacks Rank #1 (Strong Buy).
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 >>
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
HOSPIRA INC (HSP): Free Stock Analysis Report
GILEAD SCIENCES (GILD): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis Report
CELLDEX THERAPT (CLDX): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
