NewLink reports Phase II data for indoximod following Provenge in CRPC

In an abstract released ahead of the American Society of Clinical Oncology meeting in Chicago, NewLink Genetics Corp. (NASDAQ:NLNK) reported data from 35 evaluable patients with metastatic castration-resistant prostate cancer (CRPC) in a Phase II trial showing that indoximod (1-MT, NLG8189, 1-methyl-D-tryptophan) following completion of treatment with Provenge sipuleucel-T led to no significant difference in augmenting immune response to PA2024 at week 14, the primary endpoint, vs. placebo following Provenge. PA2024 is the fusion protein component of Provenge consisting of recombinant prostatic acid phosphatase and GM-CSF. Additionally, there was difference in prostate-specific antigen (PSA; KLK3) progression between treatment arms.

Indoximod following Provenge did significantly improve median radiographic progression-free survival (PFS) vs. placebo following Provenge (10.3 vs. 4.1 months, p=0.011). Median overall survival (OS), a secondary endpoint, has not yet been reached. The double-blind, U.S. trial enrolled 46 patients to receive twice-daily 600 mg oral indoximod or placebo for 6 months following Provenge. Other secondary endpoints in the trial include safety, PFS, objective response rate (ORR) and quality of life (QOL). The trial was sponsored by the Masonic Cancer Center...