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
2927 - Singapore Caregiver Quality Of Life Scale (SCQOLS): Turkish Validity and Reliability Study
Presenter: Nur Basak
Session: Poster Display session 3
Resources:
Abstract
5066 - Screening for Psicosocial Distress in recently diagnosed cancer patients
Presenter: Eva Baillès
Session: Poster Display session 3
Resources:
Abstract
6074 - Socio-demographic characteristics and quality of life analysis of cancer survivors followed at a Primary Care Center.
Presenter: Begona Grana Suarez
Session: Poster Display session 3
Resources:
Abstract
5129 - The adhesion in the screening measures in carrying patients of breast cancer and ovary hereditary and the relationship with the psychological aspects
Presenter: Melinda Concepcion
Session: Poster Display session 3
Resources:
Abstract
5635 - Assessment of emotional discomfort of oncological patients in the first nursing visit at Donostia University Hospital
Presenter: Elena Uranga
Session: Poster Display session 3
Resources:
Abstract
858 - A systematic review and meta-analysis of the distress thermometer for the screening of distress in Chinese patients with cancer
Presenter: Hui Hui Sun
Session: Poster Display session 3
Resources:
Abstract
4475 - Pharmacist and Nurse (PN) Led Melanoma Immunotherapy Clinic: Patient Experience Survey
Presenter: Dharmisha Chauhan
Session: Poster Display session 3
Resources:
Abstract
1871 - Phone Triage & Acute Review Clinics: The emerging role of the Oncology Specialist Nurse
Presenter: Fiona Barrett
Session: Poster Display session 3
Resources:
Abstract
5193 - Patient reported outcomes during immunotherapy: symptom burden in daily clinical practice
Presenter: José Koldenhof
Session: Poster Display session 3
Resources:
Abstract
2453 - Factors related to hospital length of stay, re-admissions and unplanned care for patients with cancer, an on-going study
Presenter: Helena Ullgren
Session: Poster Display session 3
Resources:
Abstract