Vaccines

Stimuvax

Development Status Stimuvax® is currently being evaluated in three Phase 3 clinical trials: The global START (Stimulating Targeted Antigenic Responses To NSCLC) trial for patients with unresectable stage III non-small cell lung cancer (NSCLC). The INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response) trial in non small cell lung cancer The STRIDE trial in metastatic breast cancer The START trial is a randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum based chemo-radiotherapy. The study has been designed considering scientific advice from the European Medicines Agency (EMEA/CHMP) and has been agreed upon with the U.S. Food and Drug Administration (FDA) through a Special Protocol Assessment (SPA). The START trial is expected to include more than 1,300 patients in approximately 30 countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable stage III NSCLC. The INSPIRE trial is in Asian patients with advanced non-small cell lung cancer (NSCLC). INSPIRE is similar in design to START, the ongoing global Phase 3 trial of Stimuvax in NSCLC. Each trial is a multi-national, Phase 3, double-blind, placebo-controlled, randomized clinical trial to evaluate the efficacy, safety and tolerability of Stimuvax in patients with unresectable, stage III NSCLC who have demonstrated either stable disease or an objective response following primary chemo-radiotherapy. The primary endpoint of both trials is overall patient survival. The trial is anticipated to enroll approximately 420 patients in China, Hong Kong, South Korea, Singapore and Taiwan. The STRIDE trial is a global Phase 3 trial of Stimuvax in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Patients with estrogen receptor-positive and/or progesterone receptor-positive, non-resectable locally advanced, recurrent or metastatic breast cancer receiving hormonal therapy will be randomized to receive either Stimuvax or a placebo in a 2:1 ratio. The primary endpoint of STRIDE is progression-free survival. Overall survival, quality of life, tumor response and safety will also be assessed in this study. The STRIDE trial is anticipated to enroll more than 900 patients at approximately 180 sites in over 30 countries - including North America, Europe, Asia and Australia. Additional Information regarding Stimuvax trials can be found on our clinical trials page.