On June 5, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported the presentation of results from a randomized Phase 2 investigator initiated study with indoximod in combination with the therapeutic cancer vaccine, PROVENGE (sipuleucel-T), for patients with metastatic castration resistant prostate cancer (Press release, NewLink Genetics, JUN 5, 2017, View Source [SID1234519404]). The abstract, titled A phase 2 randomized, double-blind study of sipuleucel-T followed by IDO pathway inhibitor, indoximod, or placebo in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), is being presented in a poster session by Gautam G. Jha, M.D., Adjunct Assistant Professor, Division of Hematology and Oncology, University of Minnesota, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, IL this morning from 8:00-11:30 a.m. CT. Schedule your 30 min Free 1stOncology Demo! 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.
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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 Dr. Jha, principal investigator of this study.
An infographic accompanying this release is available at View Source
Data reported at ASCO (Free ASCO Whitepaper) 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 Charles J. Link, Jr. M.D., Chairman and CEO of NewLink Genetics.