Abstract 730P
Background
Cabozantinib is approved in Europe for the treatment of aRCC in treatment-naive patients with intermediate or poor risk, or following VEGF-targeted therapy. We report interim data on real-world use of cabozantinib as second- (2L) or later-line (≥ 3L) aRCC therapy.
Methods
CASSIOPE is an ongoing, non-interventional study in patients with aRCC initiating cabozantinib after ≥ 1 VEGF-targeted therapy. The primary objective of this pre-planned interim analysis (conducted when 50% of the population had completed ≥ 3 months of follow-up) was to describe dose modifications due to adverse events (AEs) during the first 3 months of treatment; secondary objectives include AE characterisation and best overall response (BOR) by RECIST 1.1.
Results
A total of 337 patients (Full Safety Population) received cabozantinib (median age, 66 y; 73.0% male; 83.7% clear-cell histology; 96.4% metastatic disease, 85.7% ECOG 0–1); 265 (78.6%) remained on treatment at 3 months. In total, 217 (64.4%) patients initiated cabozantinib at the recommended dose of 60 mg (Primary Safety Population), while 109 (32.3%) and 6 (1.8%) initiated at 40 mg or 20 mg, respectively. AE-related dose modifications and AE intensities are shown in the Table. During the first 3 months, 30 (8.9%) patients in the Full Safety Population died (disease progression, 19; serious AE, 9; other, 2). Of the 131 patients in the Full Safety Population with an evaluable BOR during the first 3 months, 31.2% had a partial response, 53.4% had stable disease and 15.3% had progressive disease.
Conclusions
In this real-world study, 64.4% of patients initiated cabozantinib at the recommended dose; AE-related dose modifications for patients initiating therapy at the recommended dose were similar to those for the overall population. No new safety signals were seen in this 3-month interim analysis. Dose modifications may be required to optimize cabozantinib use in routine clinical practice. Table: 730P
| Primary Safety Population (initiated at 60 mg) | Full Safety Population (initiated at any dose) | |||||
| 2L (n = 106) | ≥ 3L (n = 111) | Total (n = 217) | 2L (n = 146) | ≥ 3L (n = 191) | Total (n = 337) | |
| Dose modification due to AEs, n (%) | ||||||
| Any | 68 (64.2) | 74 (66.7) | 142 (65.4) | 84 (57.5) | 122 (63.9) | 206 (61.1) |
| Reduction | 42 (39.6) | 57 (51.4) | 99 (45.6) | 51 (34.9) | 81 (42.4) | 132 (39.2) |
| Interruption | 46 (43.4) | 51 (45.9) | 97 (44.7) | 55 (37.7) | 88 (46.1) | 143 (42.4) |
| Discontinuation | 8 (7.5) | 15 (13.5) | 23 (10.6) | 11 (7.5) | 24 (12.6) | 35 (10.4) |
| AE intensity, n (%) | ||||||
| Grade 3 | 37 (34.9) | 42 (37.8) | 79 (36.4) | 54 (37.0) | 72 (37.7) | 126 (37.4) |
| Grade 4 | 7 (6.6) | 5 (4.5) | 12 (5.5) | 8 (5.5) | 10 (5.2) | 18 (5.3) |
Clinical trial identification
NCT03419572.
Editorial acknowledgement
Dr Tamzin Gristwood of Oxford PharmaGenesis, Oxford, UK, provided medical writing and editorial support, which was sponsored by Ipsen, in accordance with Good Publication Practice guidelines.
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
G. Procopio: Advisory/Consultancy: Bayer; Advisory/Consultancy: BMS; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Janssen; Advisory/Consultancy: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer. P. Hamberg: Advisory/Consultancy: Ipsen. P. Bigot: Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD. C. Suarez: Honoraria (self), Speaker Bureau/Expert testimony: Astellas; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Eusa; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Ipsen; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy: Sanofi-Aventis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme Corop; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol-Myers Squibb (inst). P. Barthélémy: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Janssen Cilag; Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: EusaPharma; Advisory/Consultancy: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas. J-C. Eymard: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi. C. Masini: Advisory/Consultancy: MSD ; Speaker Bureau/Expert testimony: Astellas; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Speaker Bureau/Expert testimony: Janssen; Speaker Bureau/Expert testimony: Novartis; Travel/Accommodation/Expenses: Ipsen. P. Gajate Borau: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen. P. Dutailly: Full/Part-time employment: Ipsen. V. Perrot: Full/Part-time employment: Ipsen. M. Staehler: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): GlaxoSmithKline; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Aveo; Honoraria (self), Advisory/Consultancy: EUSAPharm; Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Ipsen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Exelixis; Honoraria (self), Advisory/Consultancy: Pelloton; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): EISAI; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy: MSD; Research grant/Funding (institution): Immatics; Research grant/Funding (institution): Wilex.