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 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 5×10⁷cells/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.

Source: AACR