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Martin H. Voss, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses early efficacy signals in the phase I/II DART study.
Martin H. Voss, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses early efficacy signals in the phase I/II DART study.
The study compared dalantercept plus axitinib with placebo plus axitinib for patients with advanced clear cell renal cell carcinoma. Median progression-free survival (PFS) was approximately 8 months across the entire population. Regarding the dosage level that will be used in the phase II setting, the median PFS has not yet been reached.
In comparing these results to phase III data involving axitinib alone in pretreated TKI patients, Voss says the DART study results are promising. Median PFS in the earlier study was less than 5 months.
Voss says the DART data should be taken cautiously, and not compared across other clinical trials. However, he adds the efficacy signals are helpful in determining if the trial is worth moving forward to phase II and III settings.