(HealthDay News) – Use of belagenpumatucel-L, a therapeutic vaccine comprised of four tumor growth factor-β2 antisense gene-modified allogeneic non-small-cell lung cancer (NSCLC) cell lines, is associated with encouraging long-term survival for patients with Stage IIIB and IV NSCLC, according to a study presented at the annual meeting of the American Association for Cancer Research, held from March 31–April 4 in Chicago.
Lyudmila Bazhenova, MD, from the San Diego Moores Cancer Center in La Jolla, CA, and colleagues conducted a long-term follow-up of a Phase 2 trial of belagenpumatucel-L. The clinical trial enrolled 75 patients, two with Stage II, 12 Stage IIIA, 15 Stage IIIB, and 46 with Stage IV NSCLC, who were randomly allocated into three dose cohorts (1.25, 2.5, or 5 × 107 cells/injection). Patients were followed for a median of 14.5 months, and those with stable disease were followed for 44 months.
The researchers found that the one-, two-, and five-year survival rates were 55%, 35%, and 20%, respectively, with median survival of 14.5 months. Patients with stage IIIB and IV NSCLC enrolled into the second and third dose cohorts had one-, two-, and five-year survival rates of 61%, 41%, and 18%, respectively, with median survival of 15.9 months. Stage IIIB and IV patients with nonprogressive disease following frontline chemotherapy had a median survival of 44.4 months and five-year survival of 50%, whereas those who progressed had median survival of 14.1 months and five-year survival of 9.1%.
“Based on these data, we have instituted an international, randomized, pivotal Phase 3 trial to evaluate the efficacy of belagenpumatucel-L in a maintenance setting in stage III/IV NSCLC patients,” the authors write.
The study was sponsored by NovaRx Corporation, the manufacturer of belagenpumatucel-L (Lucanix); several authors are employees of NovaRx.