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    Two-drug therapy for advanced UC shows superior PFS


    The objective response rate (ORR) was approximately doubled by adding ramucirumab to docetaxel compared with docetaxel alone (24.5% vs. 14.0%), and the complete response rate tripled from 1.4% to 4.2%.

    “The ORR in my mind is clinically significant and practice changing,” Dr. Petrylak said.

    Treatment was discontinued, primarily due to progressive disease, in 209 patients in the ramucirumab/docetaxel arm and 229 patients on placebo/docetaxel. Forty-nine patients in the combination arm remain on treatment compared with 36 in the docetaxel monotherapy arm.

    Also see: Investigational BCG-refractory NMIBC Tx shows promise

    There was no degradation in quality of life scores measured using either the EORTC QLQ-C30 Global Quality of Life or the EQ-5D-5L Index in patients on combination therapy versus docetaxel alone. Toxicities were similar between groups, with slightly less anemia with ramucirumab/docetaxel (16%) compared with placebo/docetaxel (24%), including grade ≥3 anemia (3% vs. 11%).

    RANGE is designed to examine overall survival as a secondary endpoint, but those data are still maturing.

    The activity and tolerability of ramucirumab/docetaxel in unselected patients remains uncertain, as RANGE had strict inclusion criteria: Patients could not have had brain metastases or a recent cardiovascular or thromboembolic event prior to entry, said invited discussant Yohann Loriot, MD, from Gustave Roussy, University of Paris Saclay, Villejuif, France.

    Several of Dr. Petrylak’s co-authors have a financial or other relationship with Eli Lilly and Co. and/or other pharmaceutical companies. The study was funded by Eli Lilly and Co.

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