FDA Approves KEYTRUDA? (pembrolizumab) Plus LENVIMA? (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC)
- LENVIMA (20 mg orally once daily) in combination with KEYTRUDA (200 mg intravenously [IV] every three weeks for up to 24 months); or
- LENVIMA (18 mg orally once daily) in combination with everolimus (5 mg orally once daily); or
- Sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment).
Endpoint |
KEYTRUDA 200 mg every 3 weeks and LENVIMA 20 mg n=355 |
Sunitinib n=357 |
Progression-Free Survival (PFS) |
||
Number of events, n (%) |
160 (45%) |
205 (57%) |
Progressive disease |
145 (41%) |
196 (55%) |
Death |
15 (4%) |
9 (3%) |
Median PFS in months (95% CI) |
23.9 (20.8, 27.7) |
9.2 (6.0, 11.0) |
Hazard ratio* (95% CI) |
0.39 (0.32, 0.49) |
|
p-Value? |
<0.0001 |
|
Overall Survival (OS) |
||
Number of deaths, n (%) |
80 (23%) |
101 (28%) |
Median OS in months (95% CI) |
NR (33.6, NR) |
NR (NR, NR) |
Hazard ratio* (95% CI) |
0.66 (0.49, 0.88) |
|
p-Value? |
0.0049 |
|
Objective Response Rate (Confirmed) |
||
ORR, n (%) |
252 (71%) |
129 (36%) |
(95% CI) |
(66, 76) |
(31, 41) |
Complete response rate |
16% |
4% |
Partial response rate |
55% |
32% |
p-Value? |
<0.0001 |
|
Tumor assessments were based on RECIST 1.1; only confirmed responses are included for ORR. Data cutoff date = 28 Aug 2020 CI = Confidence interval; NE= Not estimable; NR= Not reached * Hazard ratio is based on a Cox Proportional Hazards Model. Stratified by geographic region and MSKCC prognostic groups. ??Two-sided p-value based on stratified log-rank test. ??Two-sided p-value based upon CMH test. |
- stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
- in combination with platinum- and fluoropyrimidine-based chemotherapy, or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS =10) as determined by an FDA-approved test.