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Vaccine yielded encouraging long-term survival rates in certain patients with NSCLC

April 04, 2012

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.

-end-

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Founded in 1907, the American Association for Cancer Research (AACR) is the world's first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR's membership includes 34,000 laboratory, translational and clinical researchers; population scientists; other health care professionals; and cancer advocates residing in more than 90 countries. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis and treatment of cancer by annually convening more than 20 conferences and educational workshops, the largest of which is the AACR Annual Meeting with more than 18,000 attendees. In addition, the AACR publishes seven peer-reviewed scientific journals and a magazine for cancer survivors, patients and their caregivers. The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration and scientific oversight of individual and team science grants in cancer research that have the potential for patient benefit. The AACR actively communicates with legislators and policy makers about the value of cancer research and related biomedical science in saving lives from cancer.

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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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