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
2600 - Atezolizumab (atezo) vs chemotherapy (chemo) in patients (pts) with platinum-treated locally advanced or metastatic urothelial carcinoma (mUC): a long-term overall survival (OS) and safety update from the Phase III IMvigor211 study
Presenter: Michiel Van der Heijden
Session: Poster Display session 3
Resources:
Abstract
3598 - Three-Year Follow-Up From the Phase 3 KEYNOTE-045 Trial: Pembrolizumab (Pembro) Versus Investigator’s Choice (Paclitaxel, Docetaxel, or Vinflunine) in Recurrent, Advanced Urothelial Cancer (UC)
Presenter: Andrea Necchi
Session: Poster Display session 3
Resources:
Abstract
2382 - First Report of Efficacy and Safety From a Phase 2 Trial of Tislelizumab, an Anti-PD-1 Antibody, for the Treatment of PD-L1+ Locally Advanced or Metastatic Urothelial Carcinoma (UC) in Asian Patients
Presenter: Dingwei Ye
Session: Poster Display session 3
Resources:
Abstract
2388 - Quality of Life of Metastatic Urothelial Cancer (mUC) Patients Treated with Enfortumab Vedotin (EV) Following Platinum-Containing Chemotherapy and a Checkpoint Inhibitor (CPI): Data from EV-201 Cohort 1
Presenter: Bradley McGregor
Session: Poster Display session 3
Resources:
Abstract
3748 - Safety and efficacy of atezolizumab (atezo) in patients (pts) with autoimmune disease (AID): subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma
Presenter: Yohann Loriot
Session: Poster Display session 3
Resources:
Abstract
1126 - Validation of the VIO prognostic index in patients with metastatic urothelial carcinoma treated with immune-checkpoint inhibitors
Presenter: Rafael Morales Barrera
Session: Poster Display session 3
Resources:
Abstract
3693 - Pathologic outcomes after neoadjuvant chemotherapy for high-risk muscle invasive bladder cancer
Presenter: Justin Matulay
Session: Poster Display session 3
Resources:
Abstract
4840 - Analysis of response to prior therapies and therapies after treatment with erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients (pts) with metastatic urothelial carcinoma (mUC)
Presenter: Arlene Siefker-Radtke
Session: Poster Display session 3
Resources:
Abstract
1221 - Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC)
Presenter: Jean Hoffman-censits
Session: Poster Display session 3
Resources:
Abstract
1715 - National Small Cell Bladder Cancer Audit: Results from 26 UK institutions
Presenter: Caroline Chau
Session: Poster Display session 3
Resources:
Abstract