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Celldex Jumps on Phase II Overall Survival Data on Rintega

Celldex Therapeutics, Inc.CLDX presented mature survival data from a phase II study (ReACT) on its lead pipeline candidate, Rintega, at the annual meeting of the Society for Neuro-Oncology. Rintega, an EGFRvIII specific therapeutic vaccine, is being evaluated for the treatment of patients suffering from EGFRvIII-positive, recurrent glioblastoma (GBM). Celldex's shares were up 11.6% on the news.

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 Holding AG's RHHBY Avastin (bevacizumab) improves outcomes in patients with EGFRvIII-positive, recurrent GBM across multiple measures. Data for the long-term update included study results through Sep 1, 2015.

Results showed that Rintega plus Avastin demonstrated a statistically significant, clinically meaningful long-term overall survival benefit compared to Avastin alone. At two years, the survival rate for patients on Rintega was found to be 25% versus 0% for control patients in the intent to treat population, with five patients extending beyond two years. Moreover, Rintega met the six-month primary endpoint of progression free survival (PFS6). At six months, 28% of patients receiving Rintega did not progress on the disease as compared to 16% in the control arm.

In addition, Rintega showed superiority across multiple other important endpoints including long-term PFS, objective response rate and need for steroids. On the safety front, Rintega was found to be very well tolerated without additional toxicity to Avastin.

We are pleased with the encouraging data from the phase II ReACT study. Rintega was granted Breakthrough Therapy status for the GBM indication in Feb 2015.

Meanwhile, Celldex is also conducting a phase III study (ACT IV) on Rintega in newly diagnosed GBM patients. The company expects the study to achieve the required number of events to perform the second interim analysis in late 2015 with the analysis to occur in early 2016. We note that the study was recommended to continue following the first interim analysis by an independent Data Safety and Monitoring Board that was conducted in Jun 2015.

Celldex is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN and Anika Therapeutics Inc. ANIK . Both carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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