FDA has partially lifted the clinical hold it placed on Merck Serono clinical program with BLP25 liposome vaccine, Stimuvax®. The firm says that it will resume development in patients with non-small-cell lung cancer (NSCLC), which includes Phase III studies STARTa and INSPIREb. Enrollment will start after approval by the local regulatory authorities and ethics committees.
In March the FDA placed a clinical hold after a suspected unexpected serious adverse reaction of encephalitis was observed in one patient enrolled in a Phase II trial in patients with multiple myeloma. Merck Serono thus temporarily suspended its global clinical program in all recruiting studies worldwide.
To ensure the safety of the study subjects, the protocols in the NSCLC trials are being amended to add specific safety measures. The Phase III STRIDEc trial in advanced breast cancer remains on clinical hold. Merck Serono says that it will continue to work closely with the health authorities including the FDA, to decide the next steps for the STRIDEc trial.
Merck KGaA, the parent company of Merck Serono, obtained Stimuvac through an exclusive, worldwide licensing agreement with Oncothyreon. The drug candidate received fast-track status for NSCLC in September 2004 by the FDA.
The START study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects suffering from unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy. The study will involve more than 1,300 patients in approximately 30 countries. The primary endpoint of the START study is overall survival (OS).
The design of the INSPIRE study is almost identical to the START study and will enroll approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore, and Taiwan. Study participation is expected to last for a minimum of 24 months.
STRIDE is a randomized, double-blind, controlled, multicenter study designed to determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have inoperable, locally advanced, recurrent, or metastatic breast cancer.