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EFFICACY STUDIED IN A PHASE III CLINICAL TRIAL

EFFICACY STUDIED IN A PHASE III CLINICAL TRIAL

CAMCEVI was evaluated in an open-label, single arm, multinational study involving 137 patients with advanced prostate cancer with a baseline morning serum testosterone level of >150 ng/dL and ECOG performance status of ≤2.1

CAMCEVI was dosed subcutaneously, 42 mg on Day 0 and again at Week 24.1

The primary endpoint was medical castration rate, defined as achieving and maintaining serum testosterone suppression to ≤50 ng/dL by Week 4 through Week 48 of treatment after the initial injection.1

≤50 ng/dL

Serum testosterone by Week 4 through Week 48 of treatment after the initial injection.1

KEY FINDING: EFFECTIVE SUPPRESSION OF TESTOSTERONE TO THE CASTRATION LEVEL


 
Inactive bar-graph

KEY FINDING: EFFECTIVE SUPPRESSION OF TESTOSTERONE TO THE CASTRATION LEVEL


Following the first injection of CAMCEVI, serum testosterone levels were suppressed to ≤50 ng/dL by Week 4 (+/-7 days) in 98.5% of the patients.1

From Week 4 through Week 48, serum testosterone levels were suppressed to ≤50 ng/dL in 97.0% of patients (95% CI: 92.2-98.9) estimated using the Kaplan-Meier method.1

CONSISTENT SUPPRESSION OF TESTOSTERONE
TO CASTRATE LEVELS, AFTER INITIAL DOSE, FROM WEEK 4 TO WEEK 481

Mean (95% CI) Percentage Change from Baseline in Serum
Testosterone Concentration Over Time (N=137)1

graph graph

ACHIEVING PROFOUND CASTRATION1

69.3%

of patients with testosterone suppression to ≤20 ng/dL on Day 28.1

SUPPRESSION OF PSA
OVER WEEKS 4-481

PSA levels were monitored and were lowered on average by 51% after 4 weeks after administration of CAMCEVI, 83% after 3 months, and remained suppressed throughout the 48 weeks of treatment.1

These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline correlates with clinical benefit.

REDUCTION IN PSA

PHARMACOKINETIC CHARACTERISTICS1

Leuprolide concentration is variable, exhibiting an initial rapid increase followed by a rapid decline over the first 3 days before reaching steady concentrations for the duration of the dosing interval.1

Following the first and second doses

Mean serum leuprolide Cmax was 94.5 and 99.0 ng/mL, respectively1

Mean serum concentration was maintained at 0.497-2.57 and 0.507-2.39 ng/mL after Day 31

Mean AUC0-6 mon was
224 and 268 day ng/mL1

SUB-Q ADMINISTRATION

CAMCEVI is delivered subcutaneously—offering patients leuprolide efficacy and an injection site reaction rate of just 11%* with no grade 3-4 injection site reactions.1

*Includes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth.1

SUB-Q ADMINISTRATION
SUB-Q ADMINISTRATION
DOSING
DOSING

SIMPLIFIED PREPARATION

CAMCEVI comes prefilled with no mixing required—simplifying syringe prep for you.1

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    IMPORTANT SAFETY INFORMATION

    Do not use CAMCEVI® in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI as anaphylactic reactions to these drugs have been reported in the medical literature.

    CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. As with other GnRH agonists, cases of ureteral obstruction, spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications.

    Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy.

    Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.

    Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. The risk appears low based on the reported odds ratios and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients should be monitored for cardiovascular disease and according to current clinical practice.

    Androgen deprivation therapy may prolong the QT interval. Consider periodic monitoring of electrocardiograms and electrolytes.

    Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Patients experiencing convulsions should be managed according to the current clinical practice.

    Monitor serum levels of testosterone following injection of CAMCEVI.

    Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women.

    The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

    INDICATION

    CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.

    Click here for full Prescribing Information.

    Reference:

    1. CAMCEVI. Prescribing information. Accord BioPharma; May 2021.