1. Adjuvant autologous renal tumour cell vaccine and risk of tumour progression in patients with renal- cell carcinoma after radical nephrectomy: phase III, randomized controlled trial. Jocham D, Richter A, Hoffmann L, et al. Lancet. 2004;363:594-599.

2. Background and Rationale Patients with T2 and T3 renal cell cancer are at significant risk for relapse after radical nephrectomy Current adjuvant therapies confer no survival advantage A pilot study demonstrated that patients treated with adjuvant autologous vaccine therapy had significantly longer progression-free and overall survival relative to control patients Jocham, et al. Lancet. 2004;363:594-599.

3. Summary of Study Design Experimental arm n = 276 Control arm n = 277 Observation only n = 202 Autologous vaccine therapy, 6 intradermal applications every 4 weeks n = 177 Excluded from trial based on inappropriate staging, inability to make vaccine, or no histologically proven renal cell carcinoma n = 174 Surgery Patients with renal cell carcinoma scheduled for radical nephrectomy N = 558 Randomized 1:1 prior to surgery Evaluation of postoperative inclusion criteria 5-year follow-up Phase 3 randomized, multicenter German trial Jocham, et al. Lancet. 2004;363:594-599.

4. Eligibility Postoperative inclusion criteria –Histologically proven primary stage pT2-3b, pN0-N3, M0 renal cell carcinoma –ECOG performance status 0-2 –Ability to cooperate and give informed consent Postoperative exclusion criteria –Surgery other than radical nephrectomy –Relapse of renal cell carcinoma –Prior adjuvant treatment for renal cell carcinoma –Serious pulmonary or cardiac disease –Previous cancer, except basal cell carcinoma –Active or chronic infection, including hepatitis or HIV –Pregnancy –Simultaneous participation in another clinical trial Jocham, et al. Lancet. 2004;363:594-599.

5. Baseline Characteristics Treatment Group (n = 177) Control Group (n = 202) Men, n (%)113 (64)133 (66) Median age, n (range)58 (53-64)59 (53-64) ECOG performance status, n (%) 0151 (85)170 (84) 123 (13)26 (13) Tumor stage, n (%) pT1a18 (10)31 (15) pT1b84 (47)85 (42) T217 (10)29 (14) T358 (30)57 (28) N0 lymph node status, n (%)169 (95)194 (96) Clear cell carcinoma, n (%)134 (76)138 (68) Störkel score, n (%) Good prognosis72 (41)104 (51) Intermediate prognosis102 (58)92 (45) Jocham, et al. Lancet. 2004;363:594-599.

6. Main findings Progression-free survival for all patients –60 months: 77.4% vaccine vs 67.8% control (P =.0204) –70 months: 72.0% vaccine vs 59.3% control At 72-month follow-up, median progression-free survival was not reached in either group 5-year progression-free survivalMedian time to tumor progression* Tumor stageVaccine armControl armP valueVaccine armControl arm T281.3%74.6%0.216Not reached58.9 months T367.5%49.7%0.03947.8 months13.5 months *25% progression rate within a given tumor stage Jocham, et al. Lancet. 2004;363:594-599.

7. Key Conclusions Progression-free survival significantly prolonged in patients with renal cell cancer treated with adjuvant autologous vaccine therapy Pronounced response in patients with pathologic stage T3 tumors Neoadjuvant autologous vaccine therapy useful in organ-confined renal cell tumors > 2.5 cm diameter prior to radical nephrectomy Jocham, et al. Lancet. 2004;363:594-599.