The phase II trial in patients with non-small cell lung cancer (NSCLC) evaluating BLP25 Liposome Vaccine (L-BLP25) showed that the new formulation of the vaccine is not different from the previous formulation from a safety perspective. The reformulated vaccine incorporated manufacturing changes intended to secure the future commercial supply of the vaccine.
Though not a head-to-head comparison, the phase II trial compared the new formulation of L-BLP25 to the formulation used in the phase IIb trial, which was completed in 2004.
For the majority of patients in both trials, the laboratory results were within the normal range for both time points. Also examined, for the same time frame, were adverse events, and injection site reactions. Although the two trials have slightly different patient populations and different sample sizes, based on the information reviewed, there is no clinical rationale to indicate that the two vaccine formulations are different from a safety perspective.
The new formulation and incorporated manufacturing changes are intended to secure the future commercial supply of the vaccine.