Abstract 2203
Background
Tivozanib is a VEGFR-TKI with high specificity and lower incidence of class effect adverse events. We have previously reported encouraging preliminary results for objective response rates and tolerability for tivozanib and nivolumab at full dose of each drug. We report herein results for progression-free survival for this phase Ib/II combination study.
Methods
In the phase II portion of the study, tivozanib was administered orally at 1.5 mg, once daily for 21 days every 28-day cycle in combination with nivolumab 240 mg every 14 days intravenously to 22 patients. Included here are the 3 patients who received 1.5 mg of tivozanib in phase I for a total of 25 patients.
Results
25 patients were treated with full dose tivozanib, 1.5 mg daily for 21 days. The median age was 62; 8 patients were IMDC favorable; 19 IMDC intermediate; 1 IMDC poor. 15 patients were ECOG 0 and 10 ECOG 1; and there were 19 males. 22 had clear cell histology. Median PFS is 18.9 months (95% CI 16.4; NR). PFS for previously untreated patients is 18.5 months and for previously treated patients the median has not been reached. ORR is 56% including 1 unconfirmed PR. There was 1 CR. DCR is 96%. All patients experienced at least one AE. 56% experienced a grade 3/4 AE related to treatment. The most common grade 3/4 adverse events related to treatment was hypertension seen in 44% of patients. Fatigue and palmar plantar dysesthesia were seen in 2 patients each.
Conclusions
The combination of tivozanib with nivolumab at full dose of both agents and leads to a high rate of prolonged disease control in both treatment naïve and previously treated metastatic RCC with an overall median PFS of 18.9 mos. This promising combination compares well with other TKI-IO combinations and deserves further evaluation.
Clinical trial identification
NCT03136627.
Editorial acknowledgement
Legal entity responsible for the study
AVEO Oncology.
Funding
AVEO Oncology.
Disclosure
P. Barthelemy: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Novartix; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Honoraria (self): Janssen; Advisory / Consultancy: Sanofi; Honoraria (self): Astellas; Advisory / Consultancy: BMS. B. Escudier: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Roche; Advisory / Consultancy: Ipsen; Advisory / Consultancy: EUSA; Research grant / Funding (institution): Aveo. S. Negrier: Honoraria (self), Research grant / Funding (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self): EUSA; Honoraria (self): Novartis. A. Ravaud: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen. M.N. Needle: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment, Officer / Board of Directors: Aveo Oncology. L. Albiges: Advisory / Consultancy, Institutional: Novartis; Advisory / Consultancy, Institutional: Pfizer; Advisory / Consultancy, Institutional: MSD; Advisory / Consultancy, Institutional: BMS; Advisory / Consultancy, Institutional: Ipsen; Advisory / Consultancy, Institutional: Roche; Advisory / Consultancy, Institutional: AstraZeneca.
Resources from the same session
5544 - Evaluation of a radiomic signature of CD8 cells in patients treated with immunotherapy-radiotherapy in three clinical trials.
Presenter: Roger Sun
Session: Poster Display session 3
Resources:
Abstract
1117 - Biomarkers predictive of overall survival in advanced cancer patients treated with a peptide-based cancer vaccine.
Presenter: Shigetaka Suekane
Session: Poster Display session 3
Resources:
Abstract
1922 - Expression of PD-L1 in plasma exosomes of NSCLC patients and its associations with PD-L1 expression of corresponding tumor tissues
Presenter: Shaorong Yu
Session: Poster Display session 3
Resources:
Abstract
5495 - Patient’s perspective on digital biomarkers in advanced urologic malignancies
Presenter: Severin Rodler
Session: Poster Display session 3
Resources:
Abstract
3166 - A comprehensive Pan-cancer study of FGFR Aberrations in Chinese cancer patients
Presenter: Yang Gao
Session: Poster Display session 3
Resources:
Abstract
3277 - A Systemic Inflammation Response Index (SIRI) correlates with survival and could be a Predictive Factor for mFOLFIRINOX in Metastatic Pancreatic Cancer (PC)
Presenter: Vilma Pacheco-Barcia
Session: Poster Display session 3
Resources:
Abstract
2680 - Circulating biomarkers and risk of immune-related adverse events (irAEs) in patients (pts) with advanced Non-small cell lung cancer (aNSCLC) and metastatic melanoma (mMel)
Presenter: Alberto Pavan
Session: Poster Display session 3
Resources:
Abstract
4066 - Breast cancer in young women of Kazakh population depending on germline mutations: results of next-generation sequencing
Presenter: Dilyara Kaidarova
Session: Poster Display session 3
Resources:
Abstract
5514 - Discovery of an ImmunoTranscriptomics signature in blood for early colorectal cancer detection
Presenter: Paolo Angelino
Session: Poster Display session 3
Resources:
Abstract
1595 - Serum Netrin-1 as a Biomarker for Colorectal Cancer Detection
Presenter: Jinzhou Zhu
Session: Poster Display session 3
Resources:
Abstract