Continue the fi ght with INLYTA Proven effi cacy with a distinct safety profi le The ONLY approved treatment option to demonstrate Signifi cant and superior PFS vs a VEGFR-TKI in a phase 3 trial for 2nd-line mRCC* * Based on MEDLINE® literature review for phase 3 trials in mRCC as of November 2016. Primary endpoint: progression-free survival (PFS) 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 MONTHS with INLYTA (n=361) MONTHS with sorafenib (n=362) A distinct safety profi le All rights reserved. November 2016 Data are from a multicenter, open-label, phase 3 trial of 723 patients with mRCC after failure of 1st-line therapy (sunitinib-, temsirolimus-, bevacizumab-, or cytokine- containing regimen 54%, 3%, 8%, and 35% of patients in each of the treatment arms, respectively). Patients were randomized 1:1 to either INLYTA 5 mg twice daily (n=361) or sorafenib 400 mg twice daily (n=362), with dose adjustments allowed in both groups. Primary endpoint was PFS. Secondary endpoints included objective response rate, overall survival, and safety and tolerability.1 †IMS® MIDASTM, July 2016. Monitor for proteinuria before initiation of, and periodically throughout, treatment. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment. Liver enzyme elevation has been observed during treatment with INLYTA. Monitor ALT, AST, and bilirubin before initiation of, and periodically throughout, treatment. For patients with moderate hepatic impairment, the starting dose should be decreased. INLYTA has not been studied in patients with severe hepatic impairment. Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving INLYTA. Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose. Grapefruit or grapefruit juice may also increase INLYTA plasma concentrations and should be avoided. Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5 inducers. The most common (≥20%) adverse events (AEs) occurring in patients receiving INLYTA (all grades, vs sorafenib) were diarrhea (55% vs 53%), hypertension (40% vs 29%), fatigue (39% vs 32%), decreased appetite (34% vs 29%), nausea (32% vs 22%), dysphonia (31% vs 14%), handfoot syndrome (27% vs 51%), weight decreased (25% vs 21%), vomiting (24% vs 17%), asthenia (21% vs 14%), and constipation (20% vs 20%). The most common (≥10%) grade 3/4 AEs occurring in patients receiving INLYTA (vs sorafenib) were hypertension (16% vs 11%), diarrhea (11% vs 7%), and fatigue (11% vs 5%). The most common (≥20%) lab abnormalities occurring in patients receiving INLYTA (all grades, vs sorafenib) included increased creatinine (55% vs 41%), decreased bicarbonate (44% vs 43%), hypocalcemia (39% vs 59%), decreased hemoglobin (35% vs 52%), decreased lymphocytes (absolute) (33% vs 36%), increased ALP (30% vs 34%), hyperglycemia (28% vs 23%), increased lipase (27% vs 46%), increased amylase (25% vs 33%), increased ALT (22% vs 22%), and increased AST (20% vs 25%). Please see Brief Summary on the following pages. Proportion progression-free 0 2 4 6 8 10 12 14 16 18 20 0.0 HR=0.67 (95% CI: 0.54, 0.81); P<.0001 Time (months) 33% REDUCTION IN RISK OF PROGRESSION Over 4 years of clinical experience 49,000 patients treated worldwide† 7 clinical studies reported in a long-term safety analysis2
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