Demcizumab: Additional Phase Ib data

Additional data from 22 evaluable patients in an open-label, dose-escalation, international Phase Ib trial showed that first-line treatment with IV demcizumab plus gemcitabine with Abraxane nab-paclitaxel led to a clinical benefit rate (CBR) of 86%, including 9 partial responses and 10 cases of stable disease. Data from 16 evaluable patients showed that first-line treatment with IV demcizumab plus gemcitabine alone led to a CBR of 69%, including 4 partial responses and 7 cases of stable disease. Median PFS was 1.7 months in patients who received 2.5 mg/kg demcizumab plus gemcitabine every 4 weeks; 3.4 months in patients who received 2.5 mg/kg demcizumab plus gemcitabine every 2 weeks; 7 months in patients who received 5 mg/kg demcizumab plus gemcitabine every 4 weeks; and 9.1 months in patients who received 2.5 mg/kg demcizumab plus gemcitabine plus Abraxane every 2 weeks. Median PFS was not reached in patients who received 3.5 and 5 mg/kg demcizumab plus gemcitabine plus Abraxane every 2 weeks.

The combinations were generally well tolerated with fatigue, nausea and vomiting reported as the most common treatment-related adverse events. Data were presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics meeting in Barcelona. OncoMed previously reported data from the trial (see BioCentury, Nov. 4, 2013 & Jan. 20, 2014). The trial includes a risk mitigation plan that includes cardiac monitoring using B-type natriuretic peptide (BNP; NPPB) testing and echocardiography as well as intervention with cardioprotective medication such as an angiotensin-converting enzyme (ACE) inhibitor in patients with rising BNP levels. In 2015, OncoMed plans to start a Phase II trial to evaluate 3.5 mg/kg demcizumab given once every 2 weeks in patients with first-line pancreatic cancer. ...