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
2344 - Lung Cancer in Europe: strengthening policy responses to address unmet needs
Presenter: Mary Bussell
Session: Poster Display session 3
Resources:
Abstract
1359 - Curative treatment timelines for breast, colorectal, lung and prostate cancer: Implications for medical leave coverage
Presenter: Selina Wong
Session: Poster Display session 3
Resources:
Abstract
4433 - Acute Diagnostic Oncology Clinic: A Unique Primary Care-Oncology Service
Presenter: Abhijit Gill
Session: Poster Display session 3
Resources:
Abstract
3506 - THE NEW MUTATIONAL MODEL IN ONCOLOGY. What changes in welfare, clinical practice, research, and regulatory procedures
Presenter: Nicola Normanno
Session: Poster Display session 3
Resources:
Abstract
3350 - Selection of a set of quality indicators (QI) for oncological clinical pathway
Presenter: Aude Fourcade
Session: Poster Display session 3
Resources:
Abstract
4400 - Sustainable drug prices at market launch: policy proposals and their empirical evidence
Presenter: Nora Fanzen
Session: Poster Display session 3
Resources:
Abstract
4118 - Impact of financial considerations on French physicians’ prescription choices for advanced non-small cell lung cancer (NSCLC)
Presenter: Nathalie Olympios
Session: Poster Display session 3
Resources:
Abstract
1340 - The direct medical cost of breast cancer in a Belgian hospital
Presenter: Hannan Lemhouer
Session: Poster Display session 3
Resources:
Abstract
1863 - Does the healthcare system approaches cancer patients for using private services during diagnostic process?
Presenter: Karolina Osowiecka
Session: Poster Display session 3
Resources:
Abstract
2637 - Measuring financial toxicity of cancer in the Italian health care system: initial results of the patient reported outcome for Fighting Financial Toxicity of cancer project (proFFiT).
Presenter: Silvia Riva
Session: Poster Display session 3
Resources:
Abstract