Lenvatinib plus everolimus

The combination of lenvatinib plus everolimus was compared with each medication as a single agent in a randomized, controlled phase II study of 153 subjects with advanced-stage renal cell carcinoma who had received previous antiangiogenic therapy.[23] The primary end point was PFS.

The combination of lenvatinib plus everolimus was compared with each medication as a single agent in a randomized, controlled phase II study of 153 subjects with advanced-stage renal cell carcinoma who had received previous antiangiogenic therapy.[23] The primary end point was PFS.

Median PFS was significantly longer in the combination arm (14.6 months) than in the everolimus arm (5.5 months) (HR, 0.40; 95% CI, 0.24–0.68).[23][Level of evidence B1]

The combination of lenvatinib plus everolimus was compared with each medication as a single agent in a randomized, controlled phase II study of 153 subjects with advanced-stage renal cell carcinoma who had received previous antiangiogenic therapy.[23] The primary end point was PFS.

Median PFS was 7.4 months for lenvatinib, which was not significantly shorter than in the combination arm (HR, 0.66; 0.39–1.10), but was significantly longer than in the everolimus arm (HR, 0.61; 95% CI, 0.38–0.98; P = .048).

The combination of lenvatinib plus everolimus was compared with each medication as a single agent in a randomized, controlled phase II study of 153 subjects with advanced-stage renal cell carcinoma who had received previous antiangiogenic therapy.[23] The primary end point was PFS.

There was no significant difference in OS at the time of data cutoff. A later, post hoc analysis of OS with longer follow-up did show longer survival in the combination arm compared with the everolimus-alone arm (25.5 months [95% CI, 16.4 to not evaluable] vs. 15.4 months [95% CI, 11.8–19.6]; HR, 0.51; 95% CI, 0.30–0.88; P = .024).

The combination of lenvatinib plus everolimus was compared with each medication as a single agent in a randomized, controlled phase II study of 153 subjects with advanced-stage renal cell carcinoma who had received previous antiangiogenic therapy.[23] The primary end point was PFS.

Median OS in the lenvatinib-alone arm was 19.1 months and did not differ significantly from the other two arms.

The combination of lenvatinib plus everolimus was compared with each medication as a single agent in a randomized, controlled phase II study of 153 subjects with advanced-stage renal cell carcinoma who had received previous antiangiogenic therapy.[23] The primary end point was PFS.

All patients experienced adverse events and almost all of these were judged to be related to treatment. Seventy-one percent of patients had adverse events that were grade 3 or higher. The most common toxicities in the combination arm were diarrhea, hypertension, fatigue, loss of appetite, vomiting, and cough. One patient in the combination arm died of a cerebral hemorrhage that was thought to be related to treatment.