REDWOOD CITY, Calif., May 14, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today highlighted data from several clinical studies that will be presented at the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting being held May 30 – June 3, 2014 in Chicago, IL. OncoMed will present new clinical data, as follows:
- Fzd8-Fc (OMP-54F28) Phase 1a trial in patients with advanced solid tumors (oral presentation);
- Anti-Notch 2/3 (OMP-59R5) Phase 1b/2 PINNACLE study in small cell lung cancer; and
- Demcizumab (anti-DLL4, OMP-21M18) Phase 1b study in non-small cell lung cancer.
"In this initial clinical study, we were impressed by the tolerability and the clear evidence of on-target activity as confirmed by bone turnover markers and hair follicle data showing Wnt pathway inhibition," said lead investigator Antonio Jimeno, M.D., Ph.D., of the University of Colorado Cancer Center. "Fzd8-Fc showed signs of anti-tumor activity with significantly longer than expected stable disease in several patients. Fzd8-Fc represents an entirely novel compound that targets the key Wnt cancer signaling pathway with promising anti-tumor potential."Anti-Notch 2/3 (OMP-59R5): Data in Combination with Standard-of Care in Small Cell Lung Cancer The ongoing Phase 1b PINNACLE study of anti-Notch 2/3 in small cell lung cancer (SCLC) is designed to determine a maximum-tolerated dose, PK, PD and preliminary efficacy of anti-Notch 2/3 in combinations with etoposide plus platinum chemotherapy. With 11 patients treated as of April 4, 2014, one dose-limiting toxicity of Grade 3 nausea and vomiting has been observed. The AEs related to anti-Notch2/3 treatment (in combination with etoposide and cisplatin chemotherapy) have been manageable and mostly Grade 1 and 2 and have included: fatigue, anemia, diarrhea, nausea, decreased appetite, alopecia, dehydration, thrombocytopenia (low platelets), vomiting and weight loss. Among 10 evaluable patients at doses of 5, 7.5 and 10 mg/kg, the best overall radiographic response have been nine patients with partial response and one patient with progressive disease. Six patients remain on treatment. "These early data show an acceptable safety profile of anti-Notch 2/3 used in combination with standard-of-care chemotherapy for small cell lung cancer, as well as early evidence of anti-tumor activity," said David R. Spigel, M.D., of the Sarah Cannon Research Institute in Nashville, Tennessee. "Identifying therapeutic options that provide better outcomes for this patient population is vitally needed, and I look forward to additional results from the PINNACLE trial of this novel anti-cancer stem cell agent in small cell lung cancer."
OncoMed expects to advance anti-Notch 2/3 into a randomized Phase 2 clinical trial in the SCLC indication later this year.Demcizumab (anti-DLL4, OMP-21M18): Interim Safety and Evidence of Activity Data in NSCLC OncoMed's ongoing Phase 1b clinical study of demcizumab in combination with pemetrexed and carboplatin in patients with first-line non-small cell lung cancer (NSCLC) is designed to determine a maximum-tolerated dose, safety, efficacy, immunogenicity, PK and biomarkers of Notch signaling. At ASCO, OncoMed will report interim safety and efficacy data from 39 patients enrolled in the study. The combination of demcizumab with carboplatin plus pemetrexed was generally well tolerated, with nausea, fatigue and hypertension being the most common drug-related toxicities. Two patients to date experienced reversible cardiotoxicity events, which has led to a limit of demcizumab dosing to 63 days. Of 32 evaluable patients, 14 (44%) achieved objective responses, including one complete response, 13 partial responses and an additional 14 patients achieved stable disease for an overall clinical benefit rate of 28/32 (88%) across the dose escalation cohorts. The estimated median progression free survival for patients at the 2.5, 5.0 and 7.5 (truncated) mg/kg dose were 4.3, 5.3 and 4.4 months, respectively. The estimated median progression free survival for the 5.0 mg/kg (truncated) patients has not yet been reached. "Through the current Phase 1b study in NSCLC and prior Phase 1 trials of demcizumab we have learned much about its safety and anti-tumor properties," said Mark McKeage, MBChB, MMedSc, Ph.D., FRACP, University of Auckland. "Demcizumab can be safely combined with carboplatin and pemetrexed which is a standard of care chemotherapy and the early efficacy data for this combination is encouraging. Particularly, six patients who have discontinued drug remained progression free for greater than 300 days and up to 850 days. We look forward to participating in the randomized Phase 2 trial of demcizumab in NSCLC that is planned to start later in 2014."
Based on this preliminary data, as well as results from prior clinical and preclinical studies, OncoMed expects to start a randomized Phase 2 trial of demcizumab in combination with carboplatin plus pemetrexed in NSCLC in the second half of 2014.The schedule for OncoMed's ASCO presentations is as follows:
- A first-in-human Phase 1 study of anti-cancer stem cell agent OMP-54F28 (Fzd8-Fc), decoy receptor for WNT ligands, in patients with advanced solid tumors. (Abstract# 2505) Presenting author: Antonio Jimeno M.D., Ph.D., University of Colorado Cancer Center Date and time: Saturday, May 31, 2014 at 1:15 PM – 4:15 PM CDT Session: Oral Abstract Session - Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics
- Phase 1b of anti-cancer stem cell antibody OMP-59R5 (anti-Notch2/3) in combination with etoposide and cisplatin (EP) in patients (pts) with untreated extensive-stage small-cell lung cancer (ED-SCLC). (Abstract# 7601) Presenting author: David R. Spigel, M.D., Sarah Cannon Research Institute Date and time: Saturday, May 31, 2014 at 1:15 PM – 5:00 PM CDT Session: General Poster Session - Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
- A Phase 1b study of the anti-cancer stem cell agent demcizumab (DEM), pemetrexed (PEM), and carboplatin (CARBO) in pts with first-line nonsquamous NSCLC. (Abstract# 2544) Presenting author: Mark McKeage, MBChB, MMedSc, Ph.D., FRACP, University of Auckland Date and time: Sunday, June 1, 2014 at 8:00 am – 11:45 am CDT Session: General Poster Session - Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics
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