Abstract 676P
Background
Favorable response to systemic therapy has been suggested as a suitable approach to select ideal candidates for CN in mRCC. Cabo demonstrated clinical benefit as first-line therapy in mRCC patients with intermediate- or poor-risk International Metastatic Renal Cell Carcinoma Database Consortium criteria (IMDC). CABOPRE trial is a single arm prospective multicentre phase II trial to assess the efficacy and safety of neoadjuvant cabo in patients with clear cell mRCC and potential candidates to CN (EudraCT Number: 2018-001201-93).
Methods
mRCC patients received three cycles of cabo 60mg/daily followed by CN. Patients continued cabo therapy after surgery. The primary endpoint was objective response rate (ORR) at 12 weeks (prior to CN). Progression-free survival (PFS), overall survival (OS), safety and exploratory biomarker analyses in paired tissue and blood samples were secondary endpoints.
Results
From Dec 2018 to Dec 2020, 18 patients were enrolled. The table summarizes baseline characteristics. At a median follow-up of 9.0 months, the 12 weeks ORR in the evaluable population (N=16) was 26.7% PR; 66.7% SD; 6.7% PD. Median PFS was 12.7 months. Median OS has not been reached. No new or unexpected safety findings were observed with cabo. No severe complications were reported postoperatively. Sequential microRNA profiling from plasma as well as tumor-derived exosomes is being analyzed. Table: 676P
Baseline characteristics
| Median age/range [years] | 56.5 (49.0, 63.0) |
| Male/Female | 66.6%/33.3% |
| ECOG 0/1: | 33.6%/66.6% |
| IMDC intermediate/poor risk | 77.7%/22.3% |
| ≥ 2 measurable metastatic sites | 77.7% |
| Mean primary tumor size (mm) | 96 |
| Progression at week 12* (*before CN) | N=1 (6,7%) |
| CN performed | N =11/16 (68.8%)*2 not evaluable |
Conclusions
Cabozantinib at 60 mg/day is feasible and active as a perioperative treatment in intermediate/poor-risk mRCC patients. Dynamic biomarkers might inform and help patient selection.
Clinical trial identification
EudraCT 2018-001201-93.
Editorial acknowledgement
Legal entity responsible for the study
ONCOSUR.
Funding
Ipsen.
Disclosure
G. De Velasco: Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Eusa P.; Financial Interests, Institutional, Research Grant: Roche. All other authors have declared no conflicts of interest.