US-based biopharmaceutical company NovaRx will present the results from the Phase III trial of Lucanix (belagenpumatucel-L) post-frontline maintenance therapy in non-small cell lung cancer at the European Society for Medical Oncology (ESMO) 2013 annual meeting on 28 September 2013 in Amsterdam.
The Phase III study, an international, multicenter, randomized, double-blind, placebo-controlled trial, enrolled 532 patients with advanced non-small cell lung cancer who did not progress following frontline chemotherapy.
According to the company, the Phase III study failed to achieve the primary endpoint of improving overall survival in 532 patients.
The company cited the inclusion of patients more than 12 weeks following the completion of frontline chemotherapy for the failure of the trial.
A median survival of 20.7 months was observed for Lucanix compared to 13.4 months for the control (HR 0.75) in this predefined subgroup of 305 stage IIIB/IV patients.
A median survival of 20.7 months was observed for Lucanix compared to 12.3 months for the control (HR 0.58) in a predefined subgroup of these patients with a histology of squamous cell carcinoma.
Also, a median survival of 40.1 months was observed for Lucanix compared to 10.3 months for the control (HR 0.45) in the predefined subgroup of these patients who received radiation therapy prior to enrolment.
Lucanix, an investigational whole tumor cell vaccine, is being developed by NovaRx for the treatment of non-small cell lung cancer.