Celldex Glioblastoma Vaccine Hits Phase II Primary Endpoint - Analyst Blog
Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Late last week, Celldex Therapeutics, Inc. CLDX presented positive results from a phase II study (ReACT) on Rintega (rindopepimut) at the annual meeting of the American Society of Clinical Oncology. Rintega, a therapeutic vaccine, is being developed for the treatment of patients suffering from EGFRvIII-positive, recurrent glioblastoma (GBM).
The randomized, controlled, double-blind phase II exploratory study was conducted with the goal of determining whether Rintega when added to standard-of-care treatment like Roche’s RHHBY Avastin (bevacizumab) improves outcomes in patients with EGFRvIII-positive, recurrent GBM across multiple measures.
In the study, patients were randomized into two treatment arms: Rintega plus Avastin or a control agent plus Avastin. Moreover, patients were Avastin-naïve at the beginning of the study. Results demonstrated that Rintega met the six-month primary endpoint of progression free survival (PFS6). At six months, 28% of these patients receiving Rintega did not progress on the disease as compared to 16% in the controlled arm. Additionally, a statistically significant overall survival benefit was also observed in the Rintega arm. The Rintega group registered a median overall survival rate of 11.6 months compared with 9.3 months in the control arm.
In addition to this, Rintega showed superiority across multiple other important endpoints including long-term progression-free survival, objective response rate and need for steroids. On the safety front, Rintega was found to be very well tolerated without additional toxicity to Avastin.
On the back of encouraging results from the ReACT study, Celldex is looking to seek approval for Rintega both in the U.S. and EU.
We are pleased with the encouraging data from the phase II ReACT study. There is significant unmet need for effective therapies in this indication. We note that Rintega was granted Breakthrough Therapy status for the GBM indication in Feb 2015.
Meanwhile, Celldex is also conducting a large randomized, blinded phase III study (ACT IV) on Rintega in patients with newly diagnosed GBM. The company intends to report first interim data from the study in the next three months.
Celldex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Gilead Sciences Inc. GILD and Actelion Ltd. ALIOF. Both hold a Zacks Rank #1 (Strong Buy).
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