The Germany-based pharma company said that the decision was taken in alignment with the FDA’s clinical hold placed on the investigational new drug (IND) application for Stimuvax.
In the trial, a patient participating in a Phase II exploratory clinical trial with the therapeutic cancer vaccine in patients with multiple myeloma developed encephalitis. The patient was randomised to an experimental arm of Stimuvax in combination with an intensified schedule of low-dose cyclophosphamide, which is not used in the other Stimuvax studies.
Reportedly, Merck has temporarily suspended recruitment into and treatment of patients already enrolled into the recruiting Stimuvax clinical trials.
The Phase III clinical program, consisting of the non-small cell lung cancer (NSCLC) studies Start and Inspire and the breast cancer study Stride, is impacted as well as the other recruiting studies.
Merck said that it is considering patient safety of paramount importance and will continue to work closely with the regulatory authorities, particularly with the FDA, to evaluate the implications of the adverse reaction on the clinical development program for Stimuvax and determine the most suitable course of action.