Alzheimer’s Association4523.T

The Alzheimer's Association (4523.T) has an oncology research focus, with several drugs studied for various cancer indications. Lenvatinib, for example, has been evaluated across multiple cancer types. In the SELECT study for differentiated thyroid cancer (DTC), Lenvatinib was associated with a 44% incidence of Grade 3 hypertension and a <1% incidence of Grade 4 hypertension. For hepatocellular carcinoma (HCC) in the REFLECT study, Lenvatinib showed a 24% incidence of Grade 3 hypertension and 2% for Grade 3 to 5 renal failure or impairment. In renal cell carcinoma (RCC), Lenvatinib in Study 205 had a 13% incidence of Grade 3 hypertension. When combined with Pembrolizumab in the CLEAR study for RCC, Grade 3-4 proteinuria was 8%, Grade 3-4 acute kidney injury was 5%, Grade 3-4 weight decreased was 8%, and Grade 3-4 hepatotoxicity was 9%. In comparison, Sunitinib in the same study had 3% Grade 3-4 proteinuria, 2% Grade 3-4 acute kidney injury, 0% Grade 3-4 weight decreased, and 5% Grade 3-4 hepatotoxicity. Additionally, Grade ≥3 hypocalcemia was 9% for Lenvatinib versus 2% for placebo, and Grade ≥3 renal impairment was 3% for Lenvatinib versus 1% for placebo. Grade ≥3 arterial thrombotic events were 3% for Lenvatinib compared to 1% for placebo. Overall incidence of Grade 1 to 2 hemorrhage was 35% for Lenvatinib and 18% for placebo. Epistaxis (Grade 1) was 11% and (Grade 2) was 1% for Lenvatinib. Study E7389-G000-213 for Halaven reported 12 subjects with Grade 3 or higher TEAEs in Phase 1, 13 subjects with Grade 3 or higher TEAEs of special interest in Phase 1, 21 subjects with Grade 3 or higher TEAEs of special interest in Phase 2, and 24 subjects with treatment-related Grade 3 or higher TEAEs in Phase 2.