Abstract 295P
Background
The combination of lenvatinib and pembrolizumab (len+pembro) demonstrated significant benefit over sunitinib in the Phase 3 CLEAR study for patients with untreated metastatic renal cell carcinoma (RCC). However, only 9.3% of patients had poor risk according to the IMDC criteria in this trial. Our real-world study aimed to evaluate the preliminary efficacy and safety of len+pembro in metastatic RCC patients with poor and intermediate risk treated in routine practice.
Methods
This multicenter retrospective cohort study included patients with metastatic clear-cell RCC and poor/intermediate IMDC risk who received standard doses of len (20 mg daily) and pembro (200/400 mg every 3/6 weeks) as first-line therapy. The primary endpoint was ORR. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
Results
A total of 60 patients were enrolled, with a median age of 56 years (range, 36–73). Most patients (90%) had ≥2 metastatic organs, including the liver (33%) and bones (15%). Sarcomatoid features were present in 18.3% of cases. Thirty-two patients (53%) had poor risk, while 28 (47%) had intermediate risk. Patients received len+pembro for a median of 15.7 months, achieving a best ORR of 48.3% and a disease control rate of 86.7%. The median PFS was 19.0 months (95% CI, 9.38–28.62), and the median OS was not reached. Grade ≥3 treatment-related adverse events occurred in 15 (25%) patients. Overall, 33.3% of patients required a len dose reduction, and 5% discontinued len.
Conclusions
The ORR and PFS results of len+pembro were slightly lower than those observed in the prospective study, which may be explained by the more complex real-world patient population, with a higher number of poor risk patients, advanced disease, liver metastases, and sarcomatoid features. The treatment was well tolerated.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
BUCARE.
Disclosure
I. Tsimafeyeu: Financial Interests, Personal, Speaker, Consultant, Advisor: Eisai, Merck; Financial Interests, Personal, Funding: Ruspharmtech. All other authors have declared no conflicts of interest.