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
5389 - Two-weekly accelerated BEP (aBEP) regimen as induction chemotherapy (CT) in intermediate and poor prognosis patients (pts) with nonseminomatous germ cell tumors (NSGCT): final results of phase II trial.
Presenter: Alexey Tryakin
Session: Poster Display session 3
Resources:
Abstract
2934 - Differential expression of circulating miR375 and miR371 to detect teratoma and viable germ cell malignancy
Presenter: Lucia Nappi
Session: Poster Display session 3
Resources:
Abstract
3585 - Prognosis of anaemia in disseminated testicular germ cell tumours. On behalf of the Spanish Germ Cell Cancer Group (SGCCG)
Presenter: Esmeralda Garcia Torralba
Session: Poster Display session 3
Resources:
Abstract
2254 - The Effects Of Primary Testicular Tumor Localization On Prognosis In Patients With Nonseminomatous Testis Cancer
Presenter: Birol Yildiz
Session: Poster Display session 3
Resources:
Abstract
4505 - Initial Results of a Phase II study of Nivolumab and Ipilimumab in Metastatic Adrenal Tumors.
Presenter: Matthew Campbell
Session: Poster Display session 3
Resources:
Abstract
3369 - NEMIO: a randomized phase II trial evaluating efficacy and safety of dose dense MVAC (ddMVAC) + durvalumab +/- tremelimumab as neoadjuvant treatment in patients with bladder muscle-invasive urothelial carcinoma
Presenter: Constance Thibault
Session: Poster Display session 3
Resources:
Abstract
2075 - KEYNOTE-866: Phase 3 Study of Perioperative Pembrolizumab (pembro) or Placebo (pbo) in Combination With Neoadjuvant Chemotherapy in Cisplatin (cis)-Eligible Patients (pts) With Muscle-Invasive Bladder Cancer (MIBC)
Presenter: Arlene Siefker-Radtke
Session: Poster Display session 3
Resources:
Abstract
4824 - KEYNOTE-905: A Phase 3 Study of Cystectomy Plus Perioperative Pembrolizumab Versus Cystectomy Alone in Cisplatin (cis)-Ineligible Patients (pts) With Muscle-Invasive Bladder Cancer (MIBC)
Presenter: Matthew Galsky
Session: Poster Display session 3
Resources:
Abstract
2253 - Phase 3 LEAP-011 trial: First-Line Pembrolizumab With Lenvatinib in Patients With Advanced Urothelial Carcinoma Ineligible to Receive Platinum-Based Chemotherapy
Presenter: Yohann Loriot
Session: Poster Display session 3
Resources:
Abstract
4310 - PULSE : A Single Arm Trial Assessing The Activity and Safety of Avelumab Immunotherapy Maintenance among Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma (mSCPC).
Presenter: Noemie Gassian
Session: Poster Display session 3
Resources:
Abstract