Aravive, Inc. announced the presentation of updated Phase 1b/2 ccRCC data at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, taking place June 3-7, 2022 in Chicago. The abstract presents the updated response rate, landmark progression-free-survival data, and biomarker data. A summary of the interim Phase 1b results include (as of April 30, 2022, the cut-off date): Batiraxcept 15 mg/kg in combination with cabozantinib 60 mg has a manageable safety profile in previously treated ccRCC; no dose-limiting toxicities have been observed; a similar safety profile was observed across the 15 mg/kg and 20 mg/kg dose cohorts; Batiraxcept given every 2 weeks suppressed serum GAS6 to below the level of quantitation in 25/26 patients (1 patient did not have an assessment), showing a clear pharmacokinetic (PK)/pharmacodynamic (PD) relationship; 23/26 patients had batiraxcept trough levels above the minimally efficacious concentration of 13.8 mg/L by Cycle 2; The confirmed + unconfirmed response rate in the total population was 46% with a 50% confirmed response rate in the 15mg/kg (RP2D) batiraxcept group; The proportion of patients in the total population who were progression free at 7 months was 71%; The proportion of patients in the total population who had a duration of response of at least 7 months was 75%; A baseline biomarker enriched the confirmed response rate in the RP2D (15mg/kg) biomarker high population to 67%, increased the proportion of patients progression free at 7 months to 91% and increased the proportion of patients who had a duration of response of at least 7 months to 80%; 58% (15/26) of total population achieved a better response on the batiraxcept trial than they did with their therapy prior to study entry, which was only 23%; The safety and clinical activity of this combination together with PK/PD data support a RP2D of 15 mg/kg.
1st Jan change | Capi. | |
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+7.52% | 111B | |
+11.38% | 106B | |
-12.64% | 22.24B | |
+0.44% | 21.25B | |
-4.18% | 18.97B | |
-37.85% | 18.52B | |
-8.58% | 16.81B | |
+37.41% | 12.54B | |
-23.95% | 8.09B |