The 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 at the Annual Meeting of the American Association for Cancer Research (AACR), held in Chicago, March 31 – April 4, 2012.

?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, CA (USA).

Long-term survival analysis
These findings represent an updated long-term survival analysis on patients treated with belagenpumatucel-L (Lucanix?,NovaRx Corporation), a nonviral 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%. 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%, a two-year survival rate of 41% and a five-year survival rate of 18%. Patients with stage 3B/4 nonprogressive disease after chemotherapy had a median survival of 44.4 months; five-year survival was 50%, which is ?unheard of for patients with NSCLC,? Bazhenova said.

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In contrast, patients who progressed after front-line chemotherapy had a median survival rate of 14.1 months and a 9.1% 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.

For more information:
– Nemunaitis J, Dillman RO, Schwarzenberger PO, Senzer N, Cunningham C, Cutler J, et al. Phase II study of belagenpumatucel-L, a transforming growth factor beta-2 antisense gene-modified allogeneic tumor cell vaccine in non-small-cell lung cancer. J Clin Oncol. 2006 Oct 10;24(29):4721-30. Epub 2006 Sep 11.
– Fakhrai H, Mantil JC, Liu L, Nicholson GL, Murphy-Satter CS, Ruppert J, Shawler DL.Phase I clinical trial of a TGF-beta antisense-modified tumor cell vaccine in patients with advanced glioma.
Cancer Gene Ther. 2006 Dec;13(12):1052-60. Epub 2006 Jul 7.

Clinical trials:
NCT01058785 – Phase II Study of Lucanix? in Patients With Stages II-IV Non-Small Cell Lung Cancer (Completed)
NCT00676507 – Phase III Lucanix? Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy (STOP)

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