Perioperative Cabozantinib Demonstrates Promise in Metastatic Renal Cell Carcinoma

Article

Patients with intermediate- and poor-risk metastatic renal cell carcinoma experienced promising responses after being treated with perioperative cabozantinib.

Patients with intermediate- and poor-risk metastatic renal cell carcinoma experienced promising responses after being treated with perioperative cabozantinib, according to data presented at the 2021 European Society for Medical Oncology Congress.1

Perioperative cabozantinib demonstrated feasibility and promising responses in patients with intermediate- and poor-risk metastatic renal cell carcinoma (mRCC), according to findings from the phase 2 CABOPRE trial which were presented at the 2021 European Society of Medical Oncology Congress.

Patients with favorable responses to systemic therapy have been suggested as the ideal candidates for cytoreductive nephrectomy (CN). In both the first and second lines of therapy cabozantinib may be beneficial treatment for those with intermediate or poor risk mRCC.

The study accrued patients with mRCC and an ECOG performance status of 0 or 1. The primary end point was overall response rate (ORR) prior to CN at week 12. Secondary end points include progression-free survival (PFS), overall survival (OS), safety and tolerability. The exploratory end point was molecular and pathological changes in biomarkers.

In total, 18 patients were enrolled across 4 University Hospitals in Spain between December 2018 and December 2020. Patients included were 18 years of age or older, suitable for CN surgery, have measurable disease, adequate organ function, and no prior therapy for mRCC.

During the study, all patients received cabozantinib at 60mg daily for 12 weeks. Cabozantinib was halted at least 28 days prior to CN and was restarted upon adequate wound healing.

The median age of patients included was 56.5 years (range, 49.0-63.0), with 66.6% being male and 66.6% have a performance status of 1. Most, 77.7%, were of intermediate risk. The mean primary tumor size was 96 mm and 100% had clear cell histology. Of the 16 patients evaluable, CN was performed on 11 of them.

The median PFS was 12.7 months, with the 12-month PFS rate being 56%. The 12-month OS rate was 70%, according to the Kaplan-Meier curve. In total 15 patients were included in the end point analysis and the ORR at 12 weeks was 26.7% at a 95% confidence interval. Three patients were not evaluable for response. Partial responses were seen in 26.7% of patients, stable disease was seen in 66.7% of patients, and progressive disease was seen in 6.7% of patients.

Sixty-one differently expressed miRNAs were correctly classified post treatment with cabozantinib. miRNA testing was done using the Nanostring miRNA expression panel V3. According to investigators, dynamic biomarkers may be key for treatment assessment.

All 18 patients were evaluated for safety. Common all-grade adverse events (AEs) included asthenia (67%), hypertension (55%), diarrhea (55%), mucositis (39%), hyperoxia (33%), hand-foot syndrome (22%), dysphonia (16%), hypothyroidism (16%). Only 1 incidence of grade 3/4 asthenia was reported.

Reference

Velasco G, Alonso T, Francisco J, et al. CABOPRE: A phase II study of cabozantinib (cabo) prior cytoreductive nephrectomy (CN) in metastatic renal cell carcinoma (mRCC). Presented at the 2021 ESMO Virtual Congress. September 16-20.

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
“If you have a [patient in the] fourth or fifth line, [JNJ-5322] could be a valid drug of choice,” said Rakesh Popat, BSc, MBBS, MRCP, FRCPath, PhD.
Earlier treatment with daratumumab may be better tolerated for patients with pretreated MRD-negative multiple myeloma.
The trispecific antibody JNJ-5322 demonstrated superior efficacy vs approved agents in multiple myeloma in results shared at the 2025 EHA Congress.
Despite CD19 CAR T-cell therapy exhibiting efficacy in patients with relapsed/refractory large B-cell lymphoma, less than half achieve long-term remission.
Current findings from the phase 1/2 CaDAnCe-101 trial show no predictive factors of improved responses with BGB-16673 in patients with CLL or SLL.
The phase 3 NIVOSTOP trial evaluated an anti–PD-1 immunotherapy, nivolumab, in a patient population similar in the KEYNOTE-689 trial.
Related Content