On May 25, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the presentation of updated results from its ongoing Phase 2 trial of batiraxcept in clear cell renal cell carcinoma (ccRCC) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place June 2-6, 2023 in Chicago, IL and virtually (Press release, Aravive, MAY 25, 2023, View Source [SID1234632039]). The poster presentation will highlight updated results from the Phase 2 portion of the trial in patients with advanced or metastatic ccRCC with or without prior line(s) of therapy, including immuno-oncology (IO)- and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies. In addition, an abstract highlighting batiraxcept data in pancreatic adenocarcinoma (PDAC) will be published in the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

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"We are excited to present updated results from our Phase 2 trial in ccRCC, demonstrating the promise of batiraxcept plus cabozantinib combination therapy in this high unmet need population," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "These results continue to support our belief that the highest potential impact of batiraxcept in ccRCC is combined batiraxcept plus cabozantinib treatment in patients treated with prior IO and VEGF-TKI therapies. Importantly, this therapeutic combination and patient population will be the focus of our planned pivotal Phase 3 trial, which is anticipated to initiate the second half of 2023."

Poster Presentation Details:

Title: Phase 2 study of batiraxcept (AVB-S6-500, an AXL inhibitor) as monotherapy, in combination with cabozantinib (cabo), and in combination with cabo and nivolumab (nivo) in patients with advanced clear cell renal cell carcinoma (ccRCC)
Presenter: Kathryn Beckermann, MD, PhD
Abstract Number: 4534
Format/Session: Poster; Genitourinary Cancer—Kidney and Bladder
Session Date/Time: Saturday, June 3, 2023, 8:00 AM – 11:00 AM CDT

Safety and clinical activity of batiraxcept as monotherapy in heavily pretreated patients with no curative intent, in combination with cabozantinib (cabo) in patients who had failed first line and subsequent therapies, and in combination with cabo and nivolumab (nivo) as first line therapy were evaluated.

The abstract was released by ASCO (Free ASCO Whitepaper) today and contains data available as of January 17, 2023. The poster will be presented at ASCO (Free ASCO Whitepaper) on June 3, 2023 and will have more mature data as of April 21, 2023 and will include:

Batiraxcept monotherapy and batiraxcept plus cabo or cabo/nivo demonstrated a manageable safety profile, consistent with cabo and nivo prescribing information.
Batiraxcept plus cabo showed promising results in previously IO and VEGF-TKI-treated ccRCC patients, with an objective response rate (ORR) of 50% in this population (n=12), compared to 38% (n=13) in patients with no prior VEGF-TKI.
Batiraxcept plus cabo and nivo showed an ORR of 55% (n=11) in first-line treatment, consistent with combination first-line therapies.
In the batiraxcept monotherapy cohort (n=10), one patient attained stable disease, suggesting that batiraxcept achieves greatest activity in combination therapies, supporting the intended combination approach in the planned registrational Phase 3 trial.
The combination of batiraxcept and cabo appears to improve median progression-free survival (mPFS) in patients previously treated with IO and VEGF-TKI treatments compared to those without prior VEGF-TKI exposure, consistent with the P1b data and supporting the intended target population of the planned Phase 3 trial.
Batiraxcept was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced or metastatic ccRCC who have progressed after 1 or 2 prior lines of systemic therapy, including both IO-based and VEGF-TKI-based therapies (either in combination or sequentially). Fast Track Designation was based on data submitted to the agency from 26 patients treated with 15 mg/kg or 20 mg/kg batiraxcept plus 60 mg cabozantinib in the Phase 1b ccRCC study as of September 26, 2022. Results showed no dose limiting toxicities at either dose of batiraxcept and demonstrated clinical activity of batiraxcept plus cabozantinib in patients with metastatic ccRCC. Following an End-of-Phase 2 meeting with the FDA, the Company anticipates initiating a registrational Phase 3 trial of batiraxcept in combination with cabozantinib in patients previously treated with IO and VEGF-TKI therapies in the second half of 2023.

Publication-only Abstract Details:

Title: Phase 1b Batiraxcept (AVB-S6-500, BT) plus Gemcitabine (G) and Nab-paclitaxel (NP) as first-line treatment (1L) for pancreatic adenocarcinoma (PDAC)
Abstract Number: e16258

As of January 17, 2023, safety, pharmacokinetics and clinical activity of batiraxcept plus gemcitabine and nab-paclitaxel as first-line treatment were evaluated in 21 patients with PDAC. Combination treatment was well-tolerated, with batiraxcept safety profiles consistent with prior trials. Patients who achieved trough concentrations greater than the model-informed minimum effective concentration (MEC) demonstrated significantly longer mPFS. As of May 2023, median overall survival (OS) for patients with trough levels above the minimal batiraxcept efficacious concentration is greater than 15 months, which is longer than historical data of 8.5 monthsi. One patient who achieved >MEC by C2D1 has demonstrated a complete response from 10 months to 20 months and is still on study. Additional dose levels of batiraxcept in combination with gemcitabine and nab-paclitaxel are under study to see if higher doses will increase the proportion of patients with longer OS.