MEET MARY KISQALI PATIENT PROFILES

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1 KISQALI PATIENT PROFILES MEET MARY Mary was recently diagnosed with HR+/HER2- metastatic breast cancer Review the data from the MONALEESA-2 trial to see how patients like Mary responded The patient profile herein is hypothetical and based on characteristics of real patients from the MONALEESA-2 trial. MONALEESA-2 study description KISQALI (ribociclib) was studied in MONALEESA-2, a robust, randomized, double-blind, placebo-controlled, multicenter, phase III trial in postmenopausal women with HR+/HER2- ABC who received no prior therapy for advanced disease. Patients were stratified by presence of liver and/or lung metastases and randomized 1:1 to receive either KISQALI 600 mg (3 weeks on, 1 week off) and letrozole 2.5 mg (continuously) or placebo (3 weeks on, 1 week off) and letrozole (continuously). The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QOL, and safety; TTR was an exploratory end point.1-3 Indication KISQALI (ribociclib) is indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Important Safety Information QT interval prolongation. KISQALI has been shown to prolong the QT interval in a concentration-dependent manner, with estimated mean increase in QTc interval exceeding 20 ms (22.9 ms [90% CI: ]) at the mean steady-state Cmax following administration at the 600-mg once-daily dose. In MONALEESA-2, one patient (0.3%) had >500 msec postbaseline QTcF value (average of triplicate), and 9 of 329 patients (3.0%) had a >60 msec increase from baseline in QTcF intervals (average of triplicate). These electrocardiogram (ECG) changes occurred within the first 4 weeks of treatment and were reversible with dose interruption. There were no reported cases of torsades de pointes. Syncope occurred in 9 patients (2.7%) in the KISQALI + letrozole arm vs 3 patients (0.9%) in the placebo + letrozole arm. In the KISQALI + letrozole treatment arm, there was 1 (0.3%) sudden death in a patient with grade 3 hypokalemia and grade 2 QT prolongation. ABC=advanced breast cancer; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; QOL=quality of life; RECIST=Response Evaluation Criteria In Solid Tumors; TTR=time to response. 1

2 Mary De novo disease Mary has had many experiences throughout her life. At 62 years old, she s a mother of 2, grandmother of 2, and financial advisor at a community bank, where she s worked for more than 30 years. Her youngest son is due to be married in less than 3 months, and she is excited to celebrate with her family. Now, Mary faces a new experience, as she s been newly diagnosed with metastatic breast cancer. History No prior history of breast cancer Initial presentation Mammogram revealed suspicious mass in right breast Persistent pain in upper back and frequent fatigue ECOG PS 0 Workup Biopsy confirmed HR+/HER2- breast cancer with distant metastases in the cervical lymph nodes Metastases in T5 vertebra confirmed via bone scan CT scan revealed no evidence of visceral metastases Diagnosis De novo HR+/HER2- metastatic breast cancer with bone metastases Important Safety Information (continued) QT interval prolongation (continued). Assess ECG prior to initiation of treatment. Initiate treatment with KISQALI only in patients with QTcF values <450 msec. Repeat ECG at approximately Day 14 of the first cycle, at the beginning of the second cycle, and as clinically indicated. Monitor serum electrolytes (including potassium, calcium, phosphorus, and magnesium) prior to the initiation of treatment, at the beginning of each of the first 6 cycles, and as clinically indicated. Correct any abnormality before starting therapy with KISQALI. CT=computed tomography; ECOG PS=Eastern Cooperative Oncology Group performance status; T5=5th thoracic vertebra. 2

3 Patients with characteristics similar to Mary s were enrolled in MONALEESA-2 1,2 SELECT BASELINE CHARACTERISTICS 1,2 In each arm ~34 % Newly diagnosed disease ~74 % Bone metastases ~61 % ECOG PS 0 N=668 Characteristic KISQALI + letrozole (n=334) Placebo + letrozole (n=334) Age Median (range) 62 (23 91) 63 (29 88) Metastatic sites <3 220 (65.9%) 221 (66.2%) (34.1%) 113 (33.8%) Visceral disease a No 137 (41.0%) 138 (41.3%) Yes 197 (59.0%) 196 (58.7%) Grade 1/2 elevated ALT b No c 289 (86.5%) 282 (85.5%) Yes 45 (13.5%) 48 (14.5%) Grade 1/2 elevated AST b No d 282 (84.4%) 282 (85.5%) Yes 52 (15.6%) 48 (14.5%) ALT=alanine aminotransferase; AST=aspartate aminotransferase. a Visceral involvement included liver, lung, and other visceral metastases. 1 b Placebo arm n= c Includes patients with missing elevations; n=2 (0.6%) in the KISQALI + letrozole arm and n=0 (0.0%) in the placebo + letrozole arm. 2 d Includes patients with missing elevations; n=3 (0.9%) in the KISQALI + letrozole arm and n=1 (0.3%) in the placebo + letrozole arm. 2 Have you considered KISQALI + the AI of your choice to deliver first-line efficacy for patients like Mary? 1,3 AI=aromatase inhibitor. 3

4 RAPID and SUSTAINED efficacy... 44% reduction in risk of progression or death with KISQALI (ribociclib) + letrozole vs placebo + letrozole (HR=0.556 [95% CI: ]; P<0.0001) (primary end point, interim analysis). 3 PFS PER INVESTIGATOR ASSESSMENT (SUBSEQUENT PREPLANNED OS ANALYSIS) 4 PROBABILITY OF PFS (%) HR=0.568 (95% CI: ) KISQALI + letrozole mpfs: 25.3 months (95% CI: ) n=334 Placebo + letrozole mpfs: 16.0 months (95% CI: ) n=334 mpfs beyond 25 months Number of patients still at risk TIME (MONTHS) KISQALI + letrozole Placebo + letrozole mpfs=median progression-free survival. Rapid separation of the PFS curves evident at 8 weeks 4 Results reported at 8 weeks were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error QOL preserved throughout treatment 5 EORTC QLQ-C30 was one of the questionnaires used to assess HRQOL* During treatment, overall HRQOL was maintained from baseline and was similar in both arms. There was no significant difference in the time to deterioration of global health status/qol by 10% (HR=0.944 [95% CI: ]) At disease progression or EOT, overall HRQOL worsened in both arms Clinically meaningful reduction in pain for more than 1 year 5 Reduction in pain was one component of the composite* Compliance rate was >90% through 76 weeks (Cycle 19), and the sample size decreased over time as patients progressed or stopped treatment 60 weeks of clinically meaningful improvement in pain (>5 points) observed starting at 8 weeks with KISQALI + letrozole vs non-meaningful improvement in pain ( 5 points) in the placebo + letrozole arm over the same time period, except for Cycles 7 and 15 Beyond 60 weeks, the pain reduction compared to baseline was not clinically meaningful in either arm. Pain scores increased slightly above baseline at time of disease progression/ end of treatment in both treatment arms KISQALI is not approved for pain reduction 3 EORTC QLQ-C30=European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EOT=end of treatment; HRQOL=health-related quality of life. * EORTC QLQ-C30 is a standard QOL, patient-reported outcome tool that includes 5 functional scales: physical, role, emotional, cognitive, and social; 3 symptom scales: fatigue, nausea and vomiting, and pain; 6 single items: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. 4 4

5 ... for patients like Mary3,4 FOREST PLOT ANALYSIS ACROSS SELECT SUBGROUPS1,2 Subgroup No. of Patients Hazard Ratio (95% CI) All patients ( ) Age <65 y 65 y ( ) 0.61 ( ) ( ) 0.46 ( ) ( ) 0.69 ( ) ( ) 0.45 ( ) Number of metastatic sites <3 3 Bone-only disease No Yes Newly diagnosed disease No Yes KISQALI + LETROZOLE BETTER PLACEBO + LETROZOLE BETTER The size of the data points is proportional to the number of patients included in the subgroup analysis. From N Engl J Med, Hortobagyi GN et al, Ribociclib as first-line therapy for HR-positive, advanced breast cancer, 375: Copyright 2016 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. For patients like Mary, start with KISQALI + the AI of your choice for sustained first-line results3,4 Important Safety Information (continued) QT interval prolongation (continued). Avoid the use of KISQALI in patients who already have or who are at significant risk of developing QTc prolongation, including patients with: long QT syndrome uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina, and bradyarrhythmias electrolyte abnormalities Avoid using KISQALI with drugs known to prolong the QTc interval and/or strong CYP3A inhibitors, as this may lead to prolongation of the QTcF interval. Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction, or discontinuation. 5

6 Important Safety Information (continued) Hepatobiliary toxicity. In MONALEESA-2, increases in transaminases were observed. Grade 3 or 4 increases in alanine aminotransferase (ALT) (10% vs 1%) and aspartate aminotransferase (AST) (7% vs 2%) were reported in the KISQALI and placebo arms, respectively. Among the patients who had grade 3 ALT/AST elevation, the median time to onset was 57 days for the KISQALI + letrozole treatment group. The median time to resolution to grade 2 was 24 days in the KISQALI + letrozole treatment group. Concurrent elevations in ALT or AST >3 times the upper limit of normal (ULN) and total bilirubin >2 times the ULN, with normal alkaline phosphatase, in the absence of cholestasis occurred in 4 patients (1%) in MONALEESA-2, and all patients recovered after discontinuation of KISQALI. Perform liver function tests (LFTs) before initiating therapy with KISQALI. Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated. Based on the severity of the transaminase elevations, KISQALI may require dose interruption, reduction, or discontinuation. Recommendations for patients who have elevated AST/ALT grade 3 at baseline have not been established. Neutropenia. In MONALEESA-2, neutropenia was the most frequently reported adverse reaction (AR) (75%), and a grade 3/4 decrease in neutrophil count (based on laboratory findings) was reported in 60% of patients receiving KISQALI + letrozole. Among the patients who had grade 2, 3, or 4 neutropenia, the median time to grade 2 was 16 days. The median time to resolution of grade 3 (to normalization or grade <3) was 15 days in the KISQALI + letrozole treatment group. Febrile neutropenia was reported in 1.5% of patients receiving KISQALI and letrozole. Treatment discontinuation due to neutropenia was 0.9%. Perform complete blood count (CBC) before initiating therapy with KISQALI. Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated. Based on the severity of the neutropenia, KISQALI may require dose interruption, reduction, or discontinuation. Embryofetal toxicity. Based on findings from animal studies and the mechanism of action, KISQALI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of KISQALI to pregnant rats and rabbits during organogenesis caused embryofetal toxicities at maternal exposures that were 0.6 and 1.5 times the human clinical exposure, respectively, based on area under the curve. Advise pregnant women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during therapy with KISQALI and for at least 3 weeks after the last dose. Adverse reactions. The most common ARs reported in the KISQALI + letrozole arm vs letrozole arm (incidence 20%) were neutropenia (75% vs 5%), nausea (52% vs 29%), fatigue (37% vs 30%), diarrhea (35% vs 22%), leukopenia (33% vs 1%), alopecia (33% vs 16%), vomiting (29% vs 16%), constipation (25% vs 19%), headache (22% vs 19%), and back pain (20% vs 18%). The most common grade 3/4 ARs (reported at a frequency >2%) were neutropenia (60% vs 1%), leukopenia (21% vs <1%), abnormal LFTs (10% vs 2%), lymphopenia (7% vs 1%), and vomiting (4% vs 1%), respectively. Laboratory abnormalities. The most common laboratory abnormalities occurring in patients receiving KISQALI + letrozole vs letrozole arm (all grades, incidence 20%) were leukocyte count decrease (93% vs 29%), neutrophil count decrease (93% vs 24%), hemoglobin decrease (57% vs 26%), lymphocyte count decrease (51% vs 22%), ALT increase (46% vs 36%), AST increase (44% vs 32%), platelet count decrease (29% vs 6%), and creatinine increase (20% vs 6%). The most common grade 3/4 laboratory abnormalities (incidence >2%) were neutrophil count decrease (60% vs <2%), leukocyte count decrease (34% vs <2%), lymphocyte count decrease (14% vs 4%), ALT increase (10% vs 1%), AST increase (7% vs 2%), and phosphorus decrease (6% vs 1%), respectively. References: 1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18): ;(suppl). 2. Data on file. Study CLEE011A2301. Novartis Pharmaceuticals Corp; Kisqali [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol doi: /annonc/mdy155 [Epub ahead of print]. 5. Verma S, O Shaughnessy J, Burris HA, et al. Health-related quality of life of postmenopausal women with hormone receptorpositive human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2. Breast Cancer Res Treat doi: /s z [Epub ahead of print]. Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis 6/18 KIS

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