Clinical Outcomes
PD, tumor, non-clear, non-clear cell renal cell carcinoma
TUMOR, DISEASE, INV, TUMOR GROWTH, DISEASE
At 16 weeks, the ORR (prior to randomization) in all treated patients with nccRCC was 15.2% based on ­investigator-assessed tumor measurements. A total of 7 patients with non-clear cell (15%) achieved tumor shrinkage ≥25% compared with baseline, 22 patients (48%) had tumor measurements within 25% of baseline levels, and 12 patients (26%) demonstrated tumor growth ≥25% at or before Week 16 (Patient disposition. Abbreviations: NA, not applicable; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.Among the 22 patients with <25% tumor growth or shrinkage, 14 patients were randomly assigned to receive tivozanib and 8 patients to placebo. These randomized patients received an average of 9.4 cycles (median 7, range 1-25) of tivozanib or placebo, which corresponds to a mean of 8.4 months (median 6.27) inclusive of the 16 weeks prior to randomization. In total, 38 patients were continuously treated with tivozanib; of the 8 patients randomized to placebo, 6 successfully restarted tivozanib after the 12-week double-blind period.The best unconfirmed ORR (at any time point) in patients with nccRCC continuously treated with tivozanib was 31.6%, and the best confirmed ORR was 21.1%. When analyzed by nccRCC histologic subset, the best unconfirmed ORR ranged from 22.6% to 100.0% with lower responses among mixed/unclassified histological subtypes (ORR (mRECIST) at Week 16 in all patients and best response (RECIST 1.0) by INV in patients continuously treated with tivozanib.
Abbreviations: INV, investigator; nccRCC, non-clear cell renal cell carcinoma; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.The disease control rate (DCR) was 74% in all patients with nccRCC continuously treated with tivozanib. Disease control rate (CR + PR + SD as best responseProgression-free survival.