PATIENT CASE STUDY: FRANK†

Age: 83Frank has Rai stage III previously treated chronic lymphocytic leukemia (CLL)

† Fictitious patient. Individual results may vary.

PrCALQUENCE® (acalabrutinib) is indicated: • As monotherapy for the treatment of patients with CLL

who have received at least one prior therapy

AT A GLANCE: FRANK†

“I knew my CLL relapsing was a possibility, but I was still disappointed by the news. My doctor and I are hopeful about the next stage of my treatment.”

✦ Age: 83

✦ Retired veterinarian

✦ No other comorbidities noted

✦ Does not have del17p or any other genomic abnormalities such as 11q deletion or TP53 mutation, or high ECOG score

ECOG: Eastern Cooperative Oncology Group† Fictitious patient. Individual results may vary.

WOULD YOU CONSIDER FRANK A CANDIDATE FOR CALQUENCE TO TREAT HIS PREVIOUSLY TREATED CLL?

Initial Diagnosis:Rai stage III chronic lymphocytic leukemia (CLL)

CALQUENCE WAS EVALUATED IN RELAPSED OR REFRACTORY (R/R) CLL PATIENTS1

Selected baseline characteristics Patients in the ASCEND trial

≥65 years of age 63%

ECOG score of 0 or 1 87%

Rai stage III or IV disease 42%

Median number of prior therapies (range) 1 (1-8)

The safety and efficacy profiles of CALQUENCE in patients with relapsed or refractory CLL were evaluated in a randomized, multi-centre, open-label Phase 3 study (ASCEND) of 310 patients who received at least one prior therapy. Patients were randomized to receive CALQUENCE monotherapy or investigator’s choice of either idelalisib plus rituximab (IR) or bendamustine plus rituximab (BR). The primary endpoint was progression-free survival (PFS) as assessed by IRC. PFS was defined as the time from the date of randomization to the date of the first IRC-assessed disease progression or death due to any cause. The assessment of progressive disease was per the IWCLL 2008 criteria with incorporation of the clarification for treatment-related lymphocytosis.1

✦ Bendamustine + rituximab2 ✦ Stable disease for 1.5 years ✦ Has progressive disease

PRIOR TREATMENTS TREATMENT OUTCOME NOW

CONSIDER CALQUENCE FOR PREVIOUSLY TREATED CLL PATIENTS

CALQUENCE Demonstrated Safety Profile1

✦The overall safety profile of CALQUENCE is based on pooled data from 1,029 patients with hematologic malignancies receiving CALQUENCE monotherapy (n=820) or in combination with obinutuzumab (n=209).

✦The most common (≥20%) adverse drug reactions of any grade reported in patients receiving CALQUENCE were infection, headache, diarrhea, musculoskeletal pain, bruising, fatigue, nausea, and rash.

✦The most frequently reported (≥2%) serious adverse reaction was pneumonia (5%).

✦Dose reductions and interruptions due to adverse events (AEs) were reported in 5% and 39% of patients, respectively. Discontinuations due to AEs were reported in 10% of the patients.

CALQUENCE demonstrated a 69% statistically significant reduction in the risk of disease progression or death compared to investigator’s choice of IR or BR (17% vs. 44%; HR 0.31, 95% CI 0.20-0.49; p<0.0001)1

✦ At a median follow-up of 16.1 months, PFS as assessed by IRC indicated a 69% relative reduction in the risk of a PFS event for patients who received CALQUENCE compared to patients who received the investigator’s choice of therapy (17% vs. 44%; HR 0.31, 95% CI 0.20-0.49; p<0.0001).

✦ At the time of analysis, median overall survival had not been reached in any arm.

Median PFS for CALQUENCE was not reached compared to PFS of 16.5 months with IR or BR.1

Inactivation of Bruton’s tyrosine kinase (BTK) maintained with twice-daily dosing1

✦ CALQUENCE maintained median steady state BTK occupancy of ≥95% in peripheral blood over 12 hours, resulting in inactivation of BTK throughout the recommended dosing interval.

BR and IR: investigator’s choice of bendamustine + rituximab (BR) or idelalisib + rituximab (IR); HR: hazard ratio; CI: confidence interval

After progression following initial therapyCONSIDER CALQUENCE FOR PATIENTS WITH PREVIOUSLY TREATED CLL

CALQUENCE® and the AstraZeneca logo are trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.© AstraZeneca 2020. CAL2016E

References: 1. PrCALQUENCE® Product Monograph. AstraZeneca Canada Inc. November 28, 2019. 2. NCCN Clinical Practice Guidelines in Oncology. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Version 2.2020. October 8, 2019. Available at: https://www.nccn.org/professionals/physician_gls/default.aspx. Accessed November 19, 2019.

Important Safety Information

Indications and clinical use:

✦ CALQUENCE is indicated:

- in combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia

- for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy

✦ The safety and effectiveness of CALQUENCE in patients <18 years of age have not been established.

Contraindications:

✦ Hypersensitivity to CALQUENCE or any ingredient in the formulation or component of the container.

Most serious warnings and precautions:

Treatment with CALQUENCE: Should be initiated and supervised by a qualified physician experienced in the use of anticancer therapies.

Drug Interactions: Concomitant use of CALQUENCE with a strong CYP3A inhibitor or proton pump inhibitor should be avoided.

Serious Hemorrhage: Monitor for bleeding and manage appropriately.

Other relevant warnings and precautions:

✦ Atrial fibrillation; monitor all patients for symptoms of cardiac arrhythmia

✦ Second primary malignancies including skin and other solid tumours; advise protection from the sun

✦ Cytopenias; monitor complete blood counts regularly

✦ Hemorrhage; monitor all patients for signs of bleeding

✦ Infections including hepatitis B reactivation and progressive multifocal leukoencephalopathy; monitor patients for signs and symptoms of infection

✦ Driving and operating machinery

✦ CALQUENCE should not be used during pregnancy and women of childbearing potential should be advised to avoid becoming pregnant while receiving CALQUENCE

✦ Breast-feeding mothers are advised not to breast-feed during treatment with CALQUENCE and for 2 weeks after receiving the last dose

For more information:

Please consult the CALQUENCE Product Monograph at http://azinfo.ca/calquence/pm225 for important information relating to adverse reactions, drug interactions, and dosing information (including severe hepatic impairment) which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-668-6000.