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1 Please See Additional Important Safety Information Throughout and Full Prescribing Information After Page 3 INDICATION INLYTA® (axitinib) is a kinase inhibitor and in the United States is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. MECHANISM OF ACTION Vascular endothelial growth factor (VEGF) plays an important role in RCC, in which it is constitutively upregulated.1,2 VEGF acts on 3 receptors: VEGFR-1, -2, and -3, which are implicated in pathologic angiogenesis, lymphangiogenesis, tumor growth, and metastasis.3 Preclinical evidence demonstrates that the VEGFR pathway plays a key role in continued RCC tumor growth and spread.3,4 INLYTA has been shown to inhibit receptor tyrosine kinases, including VEGFR-1, -2, and -3, in vitro and in preclinical models. However, preclinical activity does not necessarily correlate with clinical outcomes. METASTATIC RCC STUDY (AXIS TRIAL) The approval of INLYTA was based on data from the AXIS trial—a multicenter, open-label, head-to-head, phase 3 trial in 2nd-line metastatic RCC (mRCC) that compared INLYTA with sorafenib. Trial Design • Patients (N=723) with mRCC whose disease had progressed (per RECIST criteria) on or after treatment with one prior systemic therapy were randomized (1:1) to receive INLYTA 5 mg twice daily (n=361) or sorafenib 400 mg twice daily (n=362), with dose adjustments allowed in both groups5 Patients were stratified by prior therapy and ECOG performance status (0 or 1) before randomization • Primary endpoint was PFS. Secondary endpoints included ORR, OS, and safety and tolerability • Of the patients enrolled in this study, 389 patients (54%) had received 1 prior sunitinib-based therapy, 251 patients (35%) had received 1 prior cytokine-based therapy (interleukin-2 [IL-2] or interferon-alfa [IFN-α]), 59 patients (8%) had received 1 prior bevacizumab-based therapy, and 24 patients (3%) had received 1 prior temsirolimus-based therapy • Patients included in this study were evenly distributed across 3 risk groups: favorable (28%), intermediate (37%), and poor (33%)5 RESULTS FROM THE AXIS TRIAL Primary Endpoint • Progression-free survival (PFS) was the primary endpoint INLYTA significantly extended PFS [HR=0.67, 0.54-0.81; P<.0001] with a median PFS (mPFS) of 6.7 months (95% CI: 6.3, 8.6) vs 4.7 months (95% CI: 4.6, 5.6) with sorafenib There was a 33% reduction in risk of progression or death vs sorafenib Secondary Endpoints • Objective response rate (ORR) was a secondary endpoint The ORR with INLYTA was 19.4% (95% CI 15.4, 23.9) vs 9.4% (95% CI 6.6, 12.9) with sorafenib; risk ratio (RR)=2.06 (95% CI: 1.4, 3.0); P value for the RR is not included because it was not adjusted for multiple testing All responses were partial responses per RECIST criteria5 • Overall survival (OS) was a secondary endpoint Median OS for INLYTA was 20.1 months (95% CI: 16.7, 23.4) vs 19.2 months (95% CI: 17.5, 22.3) with sorafenib (HR=0.97 [95% CI: 0.80, 1.17); the difference between the treatment arms was not statistically significant ECOG=Eastern Cooperative Oncology Group; RECIST=Response Evaluation Criteria in Solid Tumors. SELECTED SAFETY INFORMATION Hypertension including hypertensive crisis has been observed. Blood pressure should be well controlled prior to initiating INLYTA. Monitor for hypertension and treat as needed. For persistent hypertension, despite use of antihypertensive medications, reduce the dose. Discontinue INLYTA if hypertension is severe and persistent despite use of antihypertensive therapy and dose reduction of INLYTA, and discontinuation should be considered if there is evidence of hypertensive crisis. Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk or who have a history of these events. Hemorrhagic events, including fatal events, have been reported. INLYTA has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. If any bleeding requires medical intervention, temporarily interrupt the INLYTA dose. Cardiac failure has been observed and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with INLYTA. Management of cardiac failure may require permanent discontinuation of INLYTA. 1 Please see additional Important Safety Information throughout and full Prescribing Information after page 3. RESULTS FROM THE AXIS TRIAL (cont’d) Most Common Adverse Events (AEs) From the AXIS Trial • The most common (≥20%) 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%), hand-foot 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%) 91% of patients did not discontinue INLYTA due to AEs in the phase 3 AXIS trial. • 9% of patients discontinued INLYTA (n=34/359) due to AEs vs 13% of patients with sorafenib (n=46/355) Overall, 61% of patients receiving INLYTA discontinued treatment vs 71% receiving sorafenib5 In both study groups, the most common reasons for discontinuation included disease progression or relapse and AEs5 • Fewer patients receiving INLYTA had dose modifications or temporary delay of treatment due to AEs compared with patients receiving sorafenib (55% vs 62%, respectively) CURRENT INLYTA PHASE 3 TRIALS IN ADVANCED RCC6,7 Trial Interventions NCT identifier axitinib + avelumab JAVELIN Renal 101 (INLYTA/IO combination in 1st line) vs NCT02684006 sunitinib axitinib + pembrolizumab KEYNOTE-426 (INLYTA/IO combination in 1st line) vs NCT02853331 sunitinib IO=immuno-oncologic. SELECTED SAFETY INFORMATION (cont’d) Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment. Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment. No formal studies of the effect of INLYTA onwound healing have been conducted. Stop INLYTA at least 24 hours prior to scheduled surgery. Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed. If signs or symptoms occur, permanently discontinue treatment. 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 moderatehepatic impairment, the starting dose should be decreased. INLYTA has not been studied in patients with severe hepatic impairment. 2 Please see additional Important Safety Information throughout and full Prescribing Information after page 3. PATIENT ACCESS TO INLYTA Access to medicines is a cornerstone of Pfizer’s commitment to healthcare. For more than 25 years, Pfizer has offered an array of prescription assistance programs to help eligible patients get access to their Pfizer medicines. Today, this assistance is provided through Pfizer Oncology Together, which helps eligible patients get access to their Pfizer medicines by offering a range of support services, including insurance counseling, co-pay help, providing Pfizer medicines for free or at a savings, and more. • Commercially insured: Eligible, commercially insured patients may pay as little as $0* per month for INLYTA. Enrollment is simple, with no income requirements, forms, or faxing • Medicare/government insured: We will help identify resources for patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans, including support from independent charitable foundations† and free medication‡ • Uninsured: If patients do not have insurance, prescription coverage, or are unable to afford their medication, we may be able to help. We can provide INLYTA for free or at a savings, if patients are eligible, through the Pfizer Patient Assistance Program§ * Limits. terms, and conditions apply. Patients may receive up to $25,000 in savings annually.The offer will be accepted only at participating pharmacies. This offer is not health insurance. For full terms and conditions, please visit PfizerOncologyTogether.com/terms. No membership fees apply. For any questions, please call 1-877-744-5675, visit PfizerOncologyTogether.com/terms or write: Pfizer Oncology Together Co-Pay Savings Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. † These foundations exist independently of Pfizer and have their own eligibility criteria and application process. Availability of support from the foundations
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