Pembrolizumab plus lenvatinib

An open-label, phase III, randomized controlled trial (NCT02811861) compared sunitinib with either lenvatinib plus pembrolizumab or lenvatinib plus everolimus. The study enrolled 1,609 patients who had received no previous systemic therapy for metastatic disease.[3]

An open-label, phase III, randomized controlled trial (NCT02811861) compared sunitinib with either lenvatinib plus pembrolizumab or lenvatinib plus everolimus. The study enrolled 1,609 patients who had received no previous systemic therapy for metastatic disease.[3]

With a median follow-up of 26.6 months, the 2-year OS rate was 79.2% in the pembrolizumab-plus-lenvatinib arm, compared with 70.4% in the sunitinib arm (HR, 0.66; 95% CI, 0.49–0.88; P = .005).[3][Level of evidence A1] There was no difference in OS between the sunitinib and lenvatinib-plus-everolimus arms.

An open-label, phase III, randomized controlled trial (NCT02811861) compared sunitinib with either lenvatinib plus pembrolizumab or lenvatinib plus everolimus. The study enrolled 1,609 patients who had received no previous systemic therapy for metastatic disease.[3]

The median PFS was also longer with pembrolizumab plus lenvatinib than with sunitinib (23.9 months vs. 9.2 months; HR, 0.39; 95% CI, 0.32–0.49; P < .001). The PFS was also longer in the lenvatinib-plus-everolimus arm (14.7 months), compared with the sunitinib arm (HR, 0.65; 95% CI, 0.53–0.80; P < .001).

An open-label, phase III, randomized controlled trial (NCT02811861) compared sunitinib with either lenvatinib plus pembrolizumab or lenvatinib plus everolimus. The study enrolled 1,609 patients who had received no previous systemic therapy for metastatic disease.[3]

The objective response rate was 71.0% with pembrolizumab-plus-lenvatinib therapy, compared with 36.1% with sunitinib (P < .001). Complete responses were reported in 16.1% of patients in the pembrolizumab-plus-lenvatinib arm, 4.2% of patients in the sunitinib arm, and 9.8% of patients in the lenvatinib-plus-everolimus arm.

An open-label, phase III, randomized controlled trial (NCT02811861) compared sunitinib with either lenvatinib plus pembrolizumab or lenvatinib plus everolimus. The study enrolled 1,609 patients who had received no previous systemic therapy for metastatic disease.[3]

Grade 3 or higher adverse event rates were more common in the lenvatinib arms: 82.4% of the patients in the pembrolizumab-plus-lenvatinib arm and 83.1% of patients in the lenvatinib-plus-everolimus arm, compared with 71.8% of patients in the sunitinib arm. Treatment was discontinued in 37.2% of patients in the pembrolizumab-plus-lenvatinib arm, compared with 14.4% of patients in the sunitinib arm. Hypertension (27.6%), diarrhea (9.7%), and weight loss (8.0%) were the most common high-grade toxicities in the pembrolizumab-plus-lenvatinib arm.

An open-label, phase III, randomized controlled trial (NCT02811861) compared sunitinib with either lenvatinib plus pembrolizumab or lenvatinib plus everolimus. The study enrolled 1,609 patients who had received no previous systemic therapy for metastatic disease.[3]

Health-related quality of life (HRQOL) was assessed using multiple measures. The results showed that patients who received pembrolizumab and lenvatinib had similar or less deterioration of their HRQOL and disease-related symptom scores over time when compared with patients who received sunitinib.[46][Level of evidence B2]