On May 26, 2022 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the presentation of updated Phase 1b/2 ccRCC data at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place June 3-7, 2022 in Chicago (Press release, Aravive, MAY 26, 2022, View Source [SID1234615069]). The abstract presents the updated response rate, landmark progression-free-survival data, and biomarker data.

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"We are jubilant about the selection of the poster on the use of batiraxcept in 2L+ ccRCC for oral discussion at this year’s ASCO (Free ASCO Whitepaper) annual meeting," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "This is a rare opportunity provided only to select abstracts at this meeting. Batiraxcept continues to show best-in-class potential in advanced or metastatic clear cell renal carcinoma, platinum resistant ovarian cancer, and pancreatic cancer. Enrollment in the registration directed Phase 3 program in PROC remains on pace to complete this year and we look forward to providing updates on the renal and pancreatic cancer programs throughout 2022."

Abstract Title: A Phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received front-line treatment (NCT04300140)
Abstract Number: 4511 (Poster Discussion Session – Data will be presented)
Poster Session: Genitourinary Cancer—Kidney and Bladder
Session Date: Poster Presentation: Saturday, June 4, 2022, 1:15 PM – 4:15 PM CDT
Discussion: Saturday, June 4, 2022, 4:30 PM CDT (5:30 PM EDT)

Abstract Title: A Phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib, cabozantinib and nivolumab, and as monotherapy in patients with advanced or metastatic clear cell renal cell carcinoma (NCT04300140)
Abstract Number: TPS4599 (Trials in Progress poster – No data presented)
Poster Session: Genitourinary Cancer—Kidney and Bladder
Session Date: Saturday, June 4, 2022, 1:15 PM – 4:15 PM CDT
Of note, 100% of patients had received a prior immunotherapy, 77% of the patients were in the IMDC (International Metastatic RCC Database Consortium) Risk Score of intermediate or poor, and 39% of the patients had received 2 or more prior lines of therapy prior to study entry.

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.