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June 13, 2014
17:53 EDTOMEDOncoMed says Phase 1 clinical trials of vantictumab put on partial hold by FDA
OncoMed Pharmaceuticals discussed the vantictumab and Fzd8-Fc Phase 1 Wnt pathway programs with the U.S. FDA. The FDA informed the company that a partial clinical hold has been placed on Phase 1 clinical trials of vantictumab until revised protocols have been submitted and concurred with. The company reported that, according to the FDA, this action is being taken in view of OncoMed's decision to voluntarily halt enrollment and dosing in the ongoing vantictumab Phase 1 trials. The FDA concurred with OncoMed's plan to continue dosing of a patient in the single-agent Phase 1a vantictumab clinical trial who has remained on treatment for greater than 700 days progression free without significant drug-related adverse effects. The FDA also concurred with OncoMed's plan to continue dosing a patient in the single-agent Phase 1a Fzd8-Fc clinical trial who has remained on treatment for greater than 390 days progression free without significant drug-related adverse effects. "As we announced this morning, we are analyzing the data in hand with the investigators and academic bone expert advisors to assess the adverse events observed in these trials and develop revised clinical trial protocols. Today's discussion with the FDA advanced the process to determine the best path forward. We remain committed to evaluating vantictumab and Fzd8-Fc as possible therapies for cancer patients," stated Paul J. Hastings, Chairman and CEO of OncoMed.
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February 8, 2016
08:10 EDTOMEDOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
08:09 EDTOMEDOncoMed discontinues dosing in ALPINE trial, unblinds study
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