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FDA lifts clinical hold on vantictumab for NSCLC, breast cancer, pancreatic cancer
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OncoMed Pharmaceuticals recently announced that the FDA has removed the partial clinical hold on enrollment in phase 1 clinical trials for the company’s monoclonal antibody candidate, OMP-18R5.
The partial clinical hold was placed on July 1, 2014, following the company decision to voluntarily halt enrollment and dosing in its OMP-18R5 (vantictumab) trials, due to observed on-target mild-to-moderate bone-related adverse events.
OMP-18R5 is currently being evaluated in combination with standard-of-care chemotherapy in three phase 1b clinical trials among patients with advanced non-small cell lung cancer, advanced HER-2-negative breast cancer and advanced pancreatic cancer.
“We are pleased by the FDA’s action to allow the resumption of enrollment in the vantictumab clinical trials,” Jakob Dupont, MD, chief medical officer for OncoMed, said in a press release. “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 removed the partial clinical hold to permit the enrollment of OMP-18R5 clinical trials following its review of a substantial clinical safety and efficacy data package and revised study protocols submitted by the company.
Enrollment and dosing for new patients is projected to resume within the next few weeks as individual study sites’ institutional review boards receive and approve the amended trial protocols, which include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.
“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,” Paul J. Hastings, chairman and CEO of OncoMed, said in the release. “We look forward to proceeding with the vantictumab phase 1b clinical studies, and to the potential opt in by our partner Bayer based on data from these trials, to realize the future potential of this novel first-in-class WNT pathway inhibitor.”