Abstract 5415
Background
Anti-angiogenic agents are approved for treatment of various cancers like Colon, Ovary, Breast, Glioma, Lung, Kidney and Liver. Axitinib, a selective inhibitor of Vascular Endothelial Growth Factor Receptors (VEGFR 1 / 2 / 3) was initially approved as a single agent for treatment of advanced Renal Cell Carcinomas (RCC), following failure of one prior line of systemic therapy, and recently as frontline treatment for RCC in combination with Pembrolizumab. Currently, Axitinib is not approved by US FDA or recommended by NCCN for use in combination with cytotoxic/targeted or endocrine therapies. We show that Axitinib can be combined for treatment of advanced solid organ tumors based upon Encyclopedic Tumor Analysis (ETA) with clinical benefit.
Methods
Between January 1, 2017 and November 30, 2018, 191 patients obtained ETA for considering precision treatment options to treat advanced broadly refractory solid organ tumors. Fresh tumor biopsies were submitted for evaluation. In a cohort of 30 patients who received combination treatment with Axitinib and cytotoxic and/or targeted and/or endocrine agents based on ETA, treatment response was evaluated as per RECIST 1.1 criteria. Objective Response Rate (ORR), Clinical Benefit Rate (CBR) and Progression Free Survival (PFS) were retrospectively determined. Therapy related adverse events were reviewed from clinical records.
Results
Out of 30 patients treated with combinations of Axitinib and either targeted, cytotoxic or endocrine drugs Partial Response (PR) was observed in 13 (43.3%) patients and Stable Disease (SD) was observed in 17 (56.7%) patients. ORR was 45.7% and CBR was 97.1%. Median PFS was 125 days (Range 35-368 days). There were no Grade IV treatment related Adverse Events (AEs) or any treatment related deaths. The most common Grade III treatment related AEs were anorexia, fatigue, and neutropenia.
Conclusions
Axitinib in combination with appropriate targeted and/or cytotoxic and/or endocrine drugs determined by ETA is well tolerated and is a potent precision therapeutic option for advanced broadly refractory solid organ cancers irrespective of the organ of origin.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Datar Cancer Genetics Limited.
Disclosure
T. Crook: Advisory / Consultancy: Datar Cancer Genetics Limited. D. Akolkar: Full / Part-time employment: Datar Cancer Genetics Limited. D. Patil: Full / Part-time employment: Datar Cancer Genetics Limited. A. Bhatt: Advisory / Consultancy: Datar Cancer Genetics Limited. A. Ranade: Advisory / Consultancy: Datar Cancer Genetics Limited. V. Datta: Full / Part-time employment: Datar Cancer Genetics Limited. S. Schuster: Full / Part-time employment: Datar Cancer Genetics Limited. A. Srinivasan: Full / Part-time employment: Datar Cancer Genetics Limited. R. Datar: Officer / Board of Directors: Datar Cancer Genetics Limited.
Resources from the same session
4614 - Predictors of Response to Checkpoint Inhibitors in Naïve and Ipilimumab-Refractory Melanoma
Presenter: Domenico Mallardo
Session: Poster Display session 3
Resources:
Abstract
2901 - IFN-γ/IL-10 ratio as predictive biomarker for response to anti-PD-1 therapy in metastatic melanoma patients
Presenter: Emilio Giunta
Session: Poster Display session 3
Resources:
Abstract
2306 - Multiplex Chromogenic Immunohistochemistry (IHC) for Spatial Analysis of Checkpoint-Positive Tumor Infiltrating Lymphocytes (TILs)
Presenter: Scott Ely
Session: Poster Display session 3
Resources:
Abstract
1678 - The role of PD-L1 expression as a predictive biomarker in advanced renal cell carcinoma: a meta-analysis of randomized clinical trials.
Presenter: Alberto Carretero-Gonzalez
Session: Poster Display session 3
Resources:
Abstract
5138 - Radiomic Features as a Non-invasive Biomarker to Predict Response to Immunotherapy in Recurrent or Metastatic Urothelial Carcinoma
Presenter: Kye Jin Park
Session: Poster Display session 3
Resources:
Abstract
5800 - Integrative combination of high-plex digital profiling techniques and cluster analysis to reveal complex immune biology in the tumor microenvironment of mesothelioma
Presenter: Carmen Ballesteros-Merino
Session: Poster Display session 3
Resources:
Abstract
5736 - Predictive factors of response to immunotherapy in 198 patients with metastatic non-microcytic lung cancer (mNSCLC): real world data from 2 university hospitals in Spain
Presenter: Juan Felipe Cordoba Ortega
Session: Poster Display session 3
Resources:
Abstract
5645 - Evaluating Lung CT Density Changes Among Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Treated with Thoracic Radiotherapy (TRT) alone or TRT Followed by Combined Ipilimumab (IPI) and Nivolumab (NIVO).
Presenter: Kujtim Latifi
Session: Poster Display session 3
Resources:
Abstract
1540 - Immuno-oncology therapy biomarkers differences between polyoma-virus positive and negative Merkel cell carcinomas
Presenter: Zoran Gatalica
Session: Poster Display session 3
Resources:
Abstract
4538 - Can we improve patient selection for phase 1 clinical trials (Ph1) based on Immuno-Oncology score prognostic index (VIO)?
Presenter: Ignacio Matos Garcia
Session: Poster Display session 3
Resources:
Abstract