Safety
TEAE.Dose, TEAEs, high‐dose corticosteroids, adrenal insufficiency, hypothyroidism
ADRENAL INSUFFICIENCY, HYPOTHYROIDISM, ADVERSE EVENT, CARDIOPULMONARY ARREST
An overview of TEAEs is shown in Table Overview of TEAEs and drug modificationsAbbreviation: TEAE, treatment‐emergent adverse event.One patient developed both a nonfatal (pneumocystis pneumonia) and a fatal (cardiopulmonary arrest) TEAE.Dose reductions of pembrolizumab were not permitted according to the study protocol.TEAEs ≥30% in any treatment group by preferred termAbbreviation: TEAE, treatment‐emergent adverse event.Alanine aminotransferase/aspartate aminotransferase increased in 4.8%/7.1% (grade 3: 0%/0%) of patients in the lenvatinib plus pembrolizumab arm, and 16.1%/12.9% (grade 3: 9.7%/3.2%) in the sunitinib arm.A summary of frequently occurring TEAEs (ie, those occurring in ≥30% of patients in any treatment group) in Japanese patients who received lenvatinib plus pembrolizumab or sunitinib is shown in Table Immune‐mediated AEs occurred in 31 (73.8%) patients in the lenvatinib plus pembrolizumab arm. Seven (16.7%) patients were treated with high‐dose corticosteroids to manage immune‐mediated AEs. Of these patients, two (4.8%) received high‐dose corticosteroids for 14 or more consecutive days, and none of the patients received high‐dose corticosteroids for 30 or more consecutive days. The most common immune‐mediated AEs treated with high‐dose corticosteroids were adrenal insufficiency and hypothyroidism (4.8% each).