PERJETA logo
PERJETA NOW APPROVED
IN THE ADJUVANT SETTING
in combination with Herceptin® (trastuzumab) and chemotherapy for patients with HER2+ early breast cancer (EBC) at high risk of recurrence1
Patient eligibility table
• Patients who begin PERJETA and Herceptin in the neoadjuvant setting should continue to receive PERJETA and Herceptin after surgery, every 3 weeks, for a total of 1 year (up to 18 cycles)1
• Patients who begin treatment in the adjuvant setting should receive a total of 1 year (up to 18 cycles) of PERJETA and Herceptin-based therapy, every 3 weeks, starting on Day 1 of the first taxane-containing cycle1
• Patients should discontinue treatment before 1 year if they experience disease recurrence or unmanageable toxicity1
PERJETA dosing: 840-mg loading dose, 420 mg for subsequent cycles; Herceptin dosing: 8-mg/kg loading dose, 6 mg/kg for subsequent cycles. Chemotherapy schedule and duration will vary by regimen. Visit Perjeta.com to learn about chemotherapy options for use in combination with PERJETA and Herceptin.
LEARN MORE ABOUT ELIGIBILITY
APHINITY was a phase III, randomized, double-blind, placebo-controlled study conducted in 4804 patients with HER2+ EBC who had their primary tumor excised. Patients were randomized to receive PERJETA or placebo, in combination with adjuvant Herceptin and chemotherapy. The trial excluded patients who had received neoadjuvant treatment. The primary endpoint of the study was invasive disease-free survival (iDFS).1,2
PERJETA and Herceptin-based therapy significantly improved iDFS vs Herceptin-based therapy in the adjuvant setting for HER2+ EBC1
iDFS was defined as time from randomization to first occurrence of ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.1
         
Indications
PERJETA® (pertuzumab) is indicated for use in combination with Herceptin® (trastuzumab) and chemotherapy for
• the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer (EBC)
• the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) at high risk of recurrence
BOXED WARNINGS: Left Ventricular Dysfunction and Embryo-Fetal Toxicity
• PERJETA can result in subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function
• Exposure to PERJETA can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception
Please see additional Important Safety Information below.
Results in the overall study population1
 
18% reduction in the risk of recurrence (HR=0.82, 95% CI: 0.67-1.00; P=0.047)1*
> After a median follow-up of 45.4 months, PERJETA and Herceptin-based therapy provided a statistically significant improvement in iDFS vs placebo and Herceptin-based therapy1
Kaplan-Meier curve of invasive disease-free survival (iDFS, primary endpoint)1
KM curve of iDFS with 3-year iDFS rates
* All analyses stratified by nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen.1
4-year iDFS Estimates
> 92.3% (95% CI: 91.1-93.4) iDFS for PERJETA and Herceptin-based therapy vs 90.6% (95% CI: 89.3-91.8) for placebo and Herceptin-based therapy3
> Limitations of data: These data are considered descriptive. Only 1745 patients (36% of the overall trial population) were evaluable for an iDFS event at the 4-year time point; other patients were censored (had yet to reach the 4-year mark or had dropped out of the trial) or had experienced an event prior to the 4-year time point3
Efficacy results by baseline disease characteristics1†
iDFS subgroup data table
† Exploratory analyses without adjusting multiple comparisons; therefore, results are considered descriptive.1
  CI=confidence interval; HR=hazard ratio.
CONTACT A REPRESENTATIVE TO LEARN MORE
Most common >2% severe (Grades 3-4) adverse reactions (ARs) in patients receiving PERJETA1
Most common severe ARs chart
‡ Denotes an AR that has been reported in association with a fatal outcome.1
Important Safety Information
BOXED WARNINGS: Left Ventricular Dysfunction and Embryo-Fetal Toxicity
> PERJETA can result in subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function
> Exposure to PERJETA can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception
— Verify the pregnancy status of females of reproductive potential prior to the initiation of PERJETA. Advise pregnant women and females of reproductive potential that exposure to PERJETA in combination with trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm, including embryo-fetal death or birth defects. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of PERJETA in combination with trastuzumab
— There is a pregnancy-exposure registry that monitors pregnancy outcomes in women exposed to PERJETA during pregnancy. Encourage women who receive PERJETA in combination with trastuzumab during pregnancy or within 7 months prior to conception to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/
— If PERJETA is administered during pregnancy, or if a patient becomes pregnant while receiving PERJETA or within 7 months following the last dose of PERJETA in combination with trastuzumab, healthcare providers and patients should immediately report PERJETA exposure to Genentech at 1-888-835-2555
Additional Important Safety Information
PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients
Left Ventricular Dysfunction (LVD)
> Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits. If LVEF declines and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and trastuzumab should be strongly considered
> In the NeoSphere study, for patients receiving neoadjuvant treatment, a LVEF decline >10% and a drop to <50% occurred in 2% of patients treated with neoadjuvant trastuzumab and docetaxel as compared to 8% of patients in the PERJETA-treated group. LVD occurred in 0.9% of patients treated with neoadjuvant trastuzumab and docetaxel as compared to 3% of patients in the PERJETA-treated group. Symptomatic left ventricular systolic dysfunction (LVSD) occurred in 0.9% of patients treated with neoadjuvant PERJETA in combination with trastuzumab and in no patients in the other 3 arms
> In the TRYPHAENA study, for patients receiving neoadjuvant treatment, in the overall treatment period, LVEF decline >10% and a drop to <50% occurred in 7% of patients treated with PERJETA plus trastuzumab and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by PERJETA plus trastuzumab and docetaxel; in 16% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC; and in 11% of patients treated with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH). LVD occurred in 6% of patients treated with PERJETA plus trastuzumab and FEC, followed by PERJETA plus trastuzumab and docetaxel; in 4% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC; and in 3% of patients treated with PERJETA in combination with TCH. Symptomatic LVSD occurred in 4% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC, in 1% of patients treated with PERJETA in combination with TCH, and in none of the patients treated with PERJETA plus trastuzumab and FEC, followed by PERJETA plus trastuzumab and docetaxel
> In the BERENICE study, for patients receiving neoadjuvant PERJETA, LVEF decline ≥10% and a drop to <50% occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following dose-dense doxorubicin and cyclophosphamide (ddAC) and in 2% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC. Ejection fraction decrease (asymptomatic LVD) occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and in 4% of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC. Symptomatic LVSD occurred in 2% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and in none of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC
> In the APHINITY study, for patients treated in the adjuvant setting, the incidence of symptomatic heart failure with a LVEF decline ≥10% and a drop to <50% was <1% (0.6% of PERJETA-treated patients vs 0.2% of placebo-treated patients). Of the patients who experienced symptomatic heart failure, 47% of PERJETA-treated patients and 67% of placebo-treated patients had recovered (defined as 2 consecutive LVEF measurements above 50%) at the data cutoff. The majority of the events (86%) were reported in anthracycline-treated patients. Asymptomatic or mildly symptomatic declines in LVEF ≥10% and a drop to <50% were reported in 3% of PERJETA-treated patients and in 3% of placebo-treated patients, of whom 80% of PERJETA-treated patients and 81% of placebo-treated patients recovered at the data cutoff
Infusion-Associated Reactions
> PERJETA has been associated with infusion reactions
> In the NeoSphere, TRYPHAENA, and APHINITY studies, PERJETA was administered on the same day as the other study treatment drugs. For APHINITY, infusion-related reactions occurred in 21% of patients in the PERJETA-treated group and in 18% of patients in the placebo arm. The incidence of Grades 3-4 National Cancer Institute–Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0) reactions was 1% for the PERJETA arm and 0.7% for the placebo arm
> If a significant infusion reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies. Monitor patients carefully until complete resolution of signs and symptoms. Consider permanent discontinuation in patients with severe infusion reactions
Hypersensitivity Reactions/Anaphylaxis
> In the CLEOPATRA study, the overall frequency of hypersensitivity reaction/anaphylaxis was 11% in the PERJETA-treated group and 9% in the placebo-treated group. The incidence of Grades 3-4 hypersensitivity reaction/anaphylaxis was 2% in the PERJETA-treated group and 3% in the placebo-treated group according to NCI-CTCAE v3.0
> In the NeoSphere, TRYPHAENA, BERENICE, and APHINITY studies, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA
> Patients should be observed closely for hypersensitivity reactions. Severe hypersensitivity, including anaphylaxis, has been observed in clinical trials of PERJETA. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
Most Common Adverse Reactions
Neoadjuvant Treatment of Breast Cancer
> The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 4 cycles were alopecia, neutropenia, diarrhea, and nausea. The most common NCI-CTCAE v3.0 Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, leukopenia, and diarrhea
> The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 3 cycles following 3 cycles of FEC were diarrhea, nausea, alopecia, neutropenia, vomiting, and fatigue. The most common NCI-CTCAE v3.0 Grades 3-4 adverse reactions (>2%) were neutropenia, leukopenia, febrile neutropenia, diarrhea, left ventricular dysfunction, anemia, dyspnea, nausea, and vomiting
> The most common adverse reactions (>30%) with PERJETA in combination with TCH administered for 6 cycles were diarrhea, alopecia, neutropenia, nausea, fatigue, vomiting, anemia, and thrombocytopenia. The most common NCI-CTCAE v3.0 Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, anemia, leukopenia, diarrhea, thrombocytopenia, vomiting, fatigue, alanine aminotransferase (ALT) increased, hypokalemia, and hypersensitivity
> The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and paclitaxel administered for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache. The most common Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, neutrophil count decreased, white blood cell count decreased, anemia, diarrhea, peripheral neuropathy, ALT increased, and nausea
> The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia. The most common Grades 3-4 adverse reactions (>2%) were febrile neutropenia, diarrhea, neutropenia, neutrophil count decreased, stomatitis, fatigue, vomiting, mucosal inflammation, neutropenic sepsis, and anemia
Adjuvant Treatment of Breast Cancer
> The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting. The most common Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, diarrhea, neutrophil count decreased, anemia, white blood cell count decreased, leukopenia, fatigue, nausea, and stomatitis
> The incidence of diarrhea, all Grades, was higher when chemotherapy was administered with targeted therapy (61% in the PERJETA-treated group vs 34% in the placebo-treated group) and was higher when administered with non–anthracycline-based therapy (85% in the PERJETA-treated group vs 62% in the placebo-treated group) than with anthracycline-based therapy (67% in the PERJETA-treated group vs 41% in the placebo-treated group). The incidence of diarrhea during the period that targeted therapy was administered without chemotherapy was 18% in the PERJETA-treated group vs 9% in the placebo-treated group
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at 1-888-835-2555.
Please see full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.
References: 1. PERJETA Prescribing Information. Genentech, Inc. 2017. 2. von Minckwitz G, Procter M, de Azambuja E, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. 2017;377(2):122-131. 3. Data on file, Genentech, Inc.
 
Genentech logo
Genentech USA, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
©2018 Genentech USA, Inc. All rights reserved.
This email is intended for US healthcare professionals only.
PER/111717/0041a   |   1/18
Unsubscribe
This promotional email is brought to you by Genentech.
Contact Genentech
Privacy Policy
Terms and Conditions
                                                           
Advertisement