AB-329 / Daiichi Sankyo, Nuvation Bio - LARVOL DELTA

Evaluation of combination treatment with DS-1205c, an AXL kinase inhibitor, and osimertinib in metastatic or unresectable EGFR-mutant non-small cell lung cancer: results from a multicenter, open-label phase 1 study. (PubMed, Invest New Drugs) - P1 | "DS-1205c was well-tolerated with no new safety signals in patients with advanced EGFR-mutant NSCLC when administered in combination with the EFGR TKI osimertinib. ClinicalTrials.gov ; NCT03255083."

Journal • Metastases • P1 data • Fatigue • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AXL • EGFR

Phase 1 Study of the AXL Inhibitor DS-1205c in Combination with Osimertinib in Subjects with Metastatic or Unresectable EGFR-Mutant NSCLC. (IASLC-WCLC 2018) - P1; "Method This is a multicenter, open-label, Phase 1, dose escalation and dose expansion study of DS-1205c in combination with osimertinib in metastatic or unresectable EGFR-mutant NSCLC subjects experiencing disease progression during treatment with erlotinib, gefitinib, or afatinib, and without T790M resistance mutation; or during treatment with osimertinib. Enrollment opened in December 2017. Clinicaltrials.gov identifier: NCT03255083 Result Section not applicable - Clinical trial in Progress Conclusion Section not applicable - clinical trial in progress "

Clinical • Combination therapy • P1 data • Non Small Cell Lung Cancer

Phase 1 study of DS-1205c combined with gefitinib for EGFR mutation-positive non-small cell lung cancer. (PubMed, Cancer Med) - P1 | "DS-1205c was generally safe and well tolerated at all dose levels, but the safety profile of ≤800 mg BID was more favorable than 1200 mg BID. The recommended dose for dose-expansion cohorts of DS-1205c in combination therapy with gefitinib was 800 mg BID."

Journal • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AXL • EGFR

AnHeart Therapeutics Launches Study to Evaluate AXL inhibitor AB-329 in Metastatic Breast Cancer (Businesswire) - "AnHeart Therapeutics...announced sponsored research to evaluate AB-329, an AXL inhibitor in metastatic breast cancer. The coprimary investigators of the study are Jangsoon Lee, Ph.D., and Naoto Ueno, M.D., both of The University of Texas MD Anderson Cancer Center...'We look forward to this study as it will enable us to identify molecules and chemotherapy agents to enhance the anti-tumor and anti-metastatic efficacy of our investigational candidate AB-329 in AXL-positive metastatic triple-negative breast cancer,' said Jerry Junyuan Wang, Ph.D., CEO and Co-Founder of AnHeart.'"

New trial • Breast Cancer • Oncology • Triple Negative Breast Cancer

[VIRTUAL] A first-in-human phase I study of the AXL inhibitor DS-1205c in combination with gefitinib in subjects with EGFR-mutant NSCLC (ESMO 2020) - P1 | "Funding: Daiichi Sankyo. Clinical trial identification: NCT03599518."

Clinical • Combination therapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

[VIRTUAL] Phase 1 Study of the AXL Inhibitor DS-1205 in Combination With Osimertinib in Subjects With Metastatic or Unresectable EGFR-Mutant NSCLC (IASLC-WCLC 2020) - "Eligible subjects must either have evidence of radiological disease progression during treatment with erlotinib, gefitinib, or afatinib without the T790M resistance mutation, or must experience disease progression during osimertinib treatment and no risk factors for QTc prolongation. Preliminary analysis of efficacy data reveals that three patients had stable disease beyond 100 days (RECIST v.1.1). Conclusion Dose escalation is ongoing and updated clinical and biomarker data will be presented."

Clinical • Combination therapy • P1 data • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • EGFR

Phase 1 study of the AXL inhibitor DS-1205c in combination with osimertinib in subjects with metastatic or unresectable EGFR-mutant NSCLC (ESMO 2018) - P1; "Trial design:This is a multicenter, open-label, Phase 1, dose escalation and dose expansion study of DS-1205c in combination with osimertinib in metastatic or unresectable EGFR-mutant NSCLC subjects experiencing disease progression during treatment with erlotinib, gefitinib, or afatinib, and without T790M resistance mutation; or during treatment with osimertinib. Retrospective analysis of AXL expression will be conducted using tumor tissue collected prior to study treatment. Enrollment opened in December 2017."

Clinical • Combination therapy • P1 data • Non Small Cell Lung Cancer

DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=13; Completed; Sponsor: Daiichi Sankyo, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Jun 2021 ➔ Sep 2020; Trial primary completion date: Apr 2021 ➔ Sep 2020

Clinical • Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=21; Completed; Sponsor: Daiichi Sankyo Co., Ltd.; Active, not recruiting ➔ Completed; N=63 ➔ 21; Trial completion date: Mar 2021 ➔ Jun 2020; Trial primary completion date: Mar 2021 ➔ Apr 2020

Clinical • Combination therapy • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • EGFR

DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=13; Active, not recruiting; Sponsor: Daiichi Sankyo, Inc.; Recruiting ➔ Active, not recruiting; N=21 ➔ 13

Clinical • Combination therapy • Enrollment change • Enrollment closed • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • EGFR

[VIRTUAL] Phase I study of the AXL inhibitor DS-1205c in combination with osimertinib in subjects with metastatic or unresectable EGFR-mutant non-small cell lung cancer (NSCLC). (ASCO 2020) - No abstract available

Clinical • Combination therapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • AXL • EGFR

[VIRTUAL] A first-in-human phase I study of the AXL inhibitor DS-1205c in combination with gefitinib in subjects with metastatic or unresectable EGFR-mutant NSCLC. (ASCO 2020) - No abstract available

Clinical • Combination therapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • AXL • EGFR

DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=63; Active, not recruiting; Sponsor: Daiichi Sankyo Co., Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • EGFR

DS1205 (AXL) (IASLC-LCTT 2020) - No abstract available

DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Daiichi Sankyo, Inc.; N=118 ➔ 18; Trial completion date: Oct 2020 ➔ Jun 2021; Trial primary completion date: Oct 2020 ➔ Jun 2021

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date

DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=63; Not yet recruiting; Sponsor: Daiichi Sankyo Co., Ltd.

Clinical • Combination therapy • New P1 trial

DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=63; Recruiting; Sponsor: Daiichi Sankyo Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open

DS-1205b, a novel selective inhibitor of AXL kinase, blocks resistance to EGFR-tyrosine kinase inhibitors in a non-small cell lung cancer xenograft model. (PubMed, Oncotarget) - "AXL was upregulated by long-term erlotinib or osimertinib treatment in HCC827 EGFR-mutant NSCLC cells, and DS-1205b treatment in combination with osimertinib or erlotinib effectively inhibited signaling downstream of EGFR in a cell-based assay. DS-1205b also delayed the onset of resistance when used in combination with osimertinib in the model. These findings strongly suggest that DS-1205b can prolong the therapeutic benefit of EGFR TKIs in nonclinical as well as clinical settings."

Journal • Preclinical