NewLink Genetics' Indoximod + PROVENGE® Results in Statistically Significant Improvement in Radiographic Progression-Free Survival (rPFS) for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) in Phase 2 Trial
In the study, forty-six patients were randomized into two arms to receive either twice daily oral indoximod (n=22) or placebo (n=24) for 6 months beginning the day after the third and final PROVENGE infusion. The indoximod treatment arm for the study showed a statistically significant improvement in radiographic progression-free survival (rPFS) when compared to placebo and was well tolerated.
Key findings presented from the study include:
- Statistically significant improvement in median rPFS was 10.3 months in the treatment arm compared to 4.1 months in the placebo arm (p = 0.011)
- Median Overall Survival (OS) has not yet been reached
- Patients tolerated therapy with indoximod with no significant differences in adverse events between the two arms
- There was no statistical difference in the primary endpoint of ELISPOT assay immune response to PA2024, the PROVENGE-related fusion protein, in the 35 of 46 patients who had clinical samples available for testing
"Given that PROVENGE alone has not shown any PFS benefit in multiple prior studies, this randomized, placebo controlled data, although limited in
number of patients, is quite encouraging and has the potential to offer some measurable clinical benefits for patients," said
An infographic accompanying this release is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2b9ffc61-5de8-43b4-8a37-6f8cb3790234
Data reported at ASCO 2017 indicate that treatment with NewLink Genetics' proprietary IDO pathway inhibitor, indoximod, post PROVENGE therapy leads to significant improvement in rPFS when compared to placebo and is well tolerated.
"These results are additional evidence that indoximod has the potential to improve outcomes for patients in combination with therapies beyond the established checkpoint inhibitors," said
About
NewLink Genetics is a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' product candidates are designed to harness multiple components of the immune system to combat cancer. For more information, please visit http://www.newlinkgenetics.com.
PROVENGE® is a registered trademark of
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
Investor Contact:Source:Lisa Miller Director of Investor RelationsNewLink Genetics 515-598-2555 lmiller@linkp.com Media:Andrew Mastrangelo AVP, Public & Media Relations LaVoieHealthScience 617-374-8800, ext. 108 amastrangelo@lavoiehealthscience.com
News Provided by Acquire Media