Results from the phase 3 CLEAR study were presented in 2021 and showed the clinically significant benefit of lenvatinib plus pembrolizumab for the treatment of advanced renal cell carcinoma (aRCC) compared with lenvatinib plus pembrolizumab or everolimus versus sunitinib. The combination demonstrated benefits in progression-free survival (PFS), overall survival (OS), and objective response (OR) rate.
New research presented at the 2023 Kidney Cancer Research Summit has characterized patients with an OR in the lenvatinib plus pembrolizumab arm of the study at final analysis, with a median follow-up of 4 years.
A total of 355 treatment-naïve patients with aRCC were placed in the lenvatinib plus pembrolizumab arm and were administered lenvatinib 30 mg orally per day plus pembrolizumab 200 mg intravenously every 3 weeks. In the final OS dataset, 253 (71.3%) of these patients had an OR, 65 (18.3%) had a best response of complete response (CR), 188 (53.0%) had a best response of partial response (PR), and 59 (16.6%) had near-CR.
The median duration of OR (95% CI) for patients with a CR, near-CR, or PR was 43.7 months (39.2-not estimable [NE]), 30.5 months (22.4-NE), and 20.4 months (17.0-25.7), respectively. In patients with a CR, near-CR, or PR, 55 (84.6%), 35 (59.3%), and 80 (42.6%), respectively, had a duration of response ≥18 months.
Patients with a CR, near-CR, or PR were distributed across baseline International mRCC Database Consortium (IMDC) risk groups (CR/near-CR/PR in favorable: 38.5%/33.9%/27.1%; intermediate: 56.9%/57.6%/61.7%; poor: 4.6%/6.8%/10.6%). Tumor responses (CR/near-CR/PR) were observed across patients, irrespective of baseline programmed cell death 1 ligand 1 (PD-L1) status (PD-L1 positive: 40.0%/30.5%/28.2%; PD-L1 negative: 29.2%/30.5%/36.7%; PD-L1 not available: 30.8%/39.0%/35.1%). Prior nephrectomies had occurred in 93.8% of CR patients, 86.4% of near-CR patients, and 70.7% of PR patients.
The median duration of treatment in patients with a CR was 36.5 months (range, 4.4-59.1 month). The duration was similar in patients with a near-CR (26.6 months [range, 2.8-56.7 months]) and PR (23.8 months [range, 2.8-56.7 months]). ORs were found to be durable across CR, PR, and near-CR patients. Tumor response was observed regardless of PD-L1 status and IMDC risk group.
These follow-up results corroborate data from the study’s primary analysis, showing durable responses in patients with aRCC treated with lenvatinib plus pembrolizumab.