The US Food and Drug Administration (FDA) has lifted a partial hold on patient enrolments for three Phase Ib clinical trials evaluating OncoMed Pharmaceuticals’ experimental cancer drug, vantictumab.
In these trials, vantictumab is being evaluated in combination with standard-of-care chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer.
Vantictumab is being developed as part of OncoMed’s collaboration with Germany’s Bayer Pharma.
The company intends to resume patient enrolment and dosing within the next few weeks pending revised trial protocol approvals.
OncoMed chief medical officer Dr Jakob Dupont said: "We are pleased by the FDA’s action to allow the resumption of enrolment in the vantictumab clinical trials.
"Patient safety is our top priority. The revised protocols were developed with input from the vantictumab clinical investigators and academic bone experts and are intended to mitigate the risks of future adverse events as we seek an optimal efficacious dose to take forward in the development of this first-in-class WNT pathway inhibitor."
The FDA laid the partial clinical hold on 1 July following the company’s voluntary halt to its Wnt pathway programmes due to observed on-target mild-to-moderate bone-related adverse events.
After reviewing substantial clinical safety and efficacy data package and revised study protocols submitted by the company, the FDA had lifted the partial clinical hold to permit the enrolment of vantictumab clinical trials.
Modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrolment criteria are the amendments for the Phase Ib combination trials.
OncoMed chairman and chief executive officer Paul Hastings said: "The diligence and dedication of OncoMed’s clinical development team to temporarily halt the vantictumab studies and submit a comprehensive response to the FDA has led to a prompt action by the agency.
"We look forward to proceeding with the vantictumab Phase Ib clinical studies, and to the potential opt in by our partner Bayer based on data from these trials, to realise the future potential of this novel first-in-class WNT pathway inhibitor."