CHICAGO — Long-term follow-up of a phase II clinical trial showed encouraging survival in some patients with stage 3B/4 non-small cell lung cancer treated with belagenpumatucel-L, a therapeutic vaccine. The findings were presented here at the AACR Annual Meeting 2012, held March 31 - April 4.
"This is a novel immunotherapy that appears to show unusually long survival in some patients," said Lyudmila Bazhenova, M.D., associate clinical professor at the University of California-San Diego Moores Cancer Center in La Jolla, Calif.
These findings represent an updated long-term survival analysis on patients treated with belagenpumatucel-L, a cell-based allogeneic vaccine derived from four lung cancer cell lines. The open-label study included 75 patients with non-small cell lung cancer (NSCLC) — two patients with stage 2 disease, 12 with stage 3A, 15 with stage 3B and 46 with stage 4. The researchers randomly assigned patients to three dose cohorts: 1.25, 2.5 or 5 × 107 cells/injection.
For all patients, median survival was 14.5 months, and the five-year survival rate was 20 percent. The 40 patients with stage 3B/4 cancer enrolled in the second and third dose cohorts had a median survival of 15.9 months and a one-year survival rate of 61 percent, a two-year survival rate of 41 percent and a five-year survival rate of 18 percent.
Patients with stage 3B/4 nonprogressive disease after chemotherapy had a median survival of 44.4 months; five-year survival was 50 percent, which is "unheard of for patients with NSCLC," Bazhenova said.
In contrast, patients who progressed after front-line chemotherapy had a median survival rate of 14.1 months and a 9.1 percent five-year survival rate.
Bazhenova said that although these results are intriguing, they must be confirmed in a phase III clinical trial, which is currently under way in eight countries.
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Presenter: Lyudmila Bazhenova, M.D.
Abstract Number: 5367
Title: Long-term survival in a phase II atudy of belagenpumatucel-L (TGF-β antisense modified tumor cell vaccine) in non-small cell lung cancer (NSCLC).
Author Block: Lyudmila Bazhenova1, Ewa Carrier2, Daniel Shawler2, Habib Fakhrai2. 1UC San Diego Moores Cancer Center, La Jolla, CA; 2NovaRx, San Diego, CA
Background: Cancer therapeutics vaccines continue to be investigated in a variety of solid malignancies. Belagenpumatucel-L (Lucanix®), a therapeutic vaccine comprised of 4 TGF-β2 antisense gene-modified allogeneic NSCLC cell lines. Phase II trial finished its enrollment in March of 2004 and was published in 2006. We now report an updated survival analysis with over 5 years of follow up.
Methods: Three arms, open label clinical trial enrolled seventy-five subjects. 2 stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients were randomized into three dose cohorts of 1.25, 2.5, or 5 107 cells/injection. Several cellular (ELISPOT and cytoplasmic cytokine expression) and humoral (antibody ELISA) immunity assays were also performed and correlated with survival.
Results: Median follow up for all patients was 14.5 months and for patients with stable disease 44 months. Median survival for all subjects was 14.5 months and one-year, two-years and five-year survival were respectively 55%, 35% and 20%. Stages IIIB/IV subjects enrolled into cohorts 2 and 3 (N=40) had a median survival of 15.9 months and one-year, two-year and five-year survivals were respectively 61%, 41% and 18%. For stage IIIB/IV patients with non progressive disease following frontline chemotherapy, median survival was 44.4 months and five-year survival was 50%. For subjects who progressed following frontline chemotherapy, median survival was 14.1 months and five-year survival was 9.1%. Subjects who demonstrated an increase in both cellular and humoral immune reactivity following treatment had a significant survival advantage over subjects who showed an increase in only one measure of immunity with a median survival of 32.5 months vs. 11.6 months (p = 0.015).
Conclusion: Long term follow up of a phase II clinical trial confirmed encouraging survival for patients with stage IIIB/IV disease. Based on these data, we have instituted an international, randomized, pivotal Phase III trial to evaluate the efficacy of belagenpumatucel-L in a maintenance setting in stage III/IV NSCLC patients who have stable disease or better following frontline chemotherapy. The trial is designed to enroll 506 patients and is powered to measure a 3.5 month survival difference. There are two planned interim analyses. To date, 285 patients have been enrolled in 8 countries. Confirmation of the phase II data in a randomized, phase III setting would provide an important improvement for the treatment of non-small cell lung cancer.
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