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
3073 - 1 patient 3 different advance Ca nurse’s roles: symptom management&continuum care through a joint approach in a clinical case
Presenter: Catarina Almeida
Session: Poster Display session 3
Resources:
Abstract
4527 - Identification of malnutrition risk factors in patients with cancer in the first nursing visit
Presenter: Amaia Valverde
Session: Poster Display session 3
Resources:
Abstract
2904 - Engaging Cancer Survivors, Healthcare Providers and Advocates in The Development of a Colorectal Cancer Survivorship Information Resource: A Participatory Action Research Study
Presenter: Amanda Drury
Session: Poster Display session 3
Resources:
Abstract
3435 - Medical nurses’ experiences of the care-needs of adult patients with a primary brain tumour
Presenter: Jamila Mohammed
Session: Poster Display session 3
Resources:
Abstract
857 - Feasibility and acceptability of a mHealth intervention to increase colonoscopy uptake among Chinese first-degree relatives: a pilot cluster randomized controlled trial
Presenter: Yang Bai
Session: Poster Display session 3
Resources:
Abstract
1087 - Cancer patient participation and compliance in microbiome sample collection: an oncology research nurse’s experience
Presenter: Julie Malo
Session: Poster Display session 3
Resources:
Abstract
2783 - Implementing Digital Individual Care plans for Patients with Head and Neck cancer- Challenges and opportunities
Presenter: Helena Ullgren
Session: Poster Display session 3
Resources:
Abstract
1152 - The Effect of the Short-term and Long-term Compassion Fatigue Resiliency Program on the Quality of Life, Perceived Stress and Psychological Resilience of Oncology-Hematology Nurses
Presenter: Tugba Pehlivan
Session: Poster Display session 3
Resources:
Abstract
1172 - Competing risk analyses of overall survival and cancer-specific survival in patients with orbital rhabdomyosarcoma after surgery: a large cohort study
Presenter: Yu Zhang
Session: Poster Display session 3
Resources:
Abstract
5949 - Communication of genetic information to family members in hereditary cancers and healthcare providers’ role
Presenter: Carla Pedrazzani
Session: Poster Display session 3
Resources:
Abstract