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The only microtubule inhibitor approved in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.

JEVTANA Trials Included mCRPC Patients with High-Disease Burden and Rapid Progression after Docetaxel1-4

JEVTANA Was Validated as a Second-line Treatment After Docetaxel in the TROPIC Trial

Large, international, randomized, open-label registration study.4

755 patients with mCRPC who previously received docetaxel

Primary Endpoint: Median Overall Survival
Secondary Endpoint: Investigator-assessed Tumor Response, Safety, Pharmacokinetics

Stratification:

ECOG PS: 0, 1 vs 2
Measurable vs nonmeasurable disease

JEVTANA
25 mg/m2

q3wks + prednisone (n=378)

mitoxantrone
12 mg/m2

q3wks + prednisone (n=377)

Conducted in 146 sites in 26 countries ECOG: Eastern Cooperative Oncology Group.

TROPIC Included Patients With High-Disease Burden (n=755)2,4

Disease Burden Presentation in TROPIC trial: 25% visceral, >80% bone, and 35% lymph nodes

TROPIC Patients Presented With Rapid Progression After Docetaxel (n=755)2

72% of patients progressed during or within
3 months of last docetaxel dose. 30% of patients progressed during their last docetaxel infusion and 42% of patients progressed within 3 months since their last dose

View Summary of Demographics and Patient Characteristics2,4

JEVTANA +
prednisone n=378
mitoxantrone +
prednisone n=377
Age
Median (range)
≥75(%)
68 (46 - 92)
18
67 (47 - 89)
19
ECOG PS (%)
0,1
2
93
7.4
91
8.8
PSA, ng/mL
Median 143.9 127.5
Measurability of disease (%)
Measurable disease
Pain at baseline
Nonmeasurable disease
53.2
174 (46%)
56.8
54.1
168 (45%)
45.9
Disease site (%)
Bone
Distant lymph nodes
Visceral
80.2
35.2
24.9
87.0
34.5
24.9
Disease progression relative to docetaxel administration
During treatment
< 3 months from last dose
≥3 months from last dose
Unknown
115 (30%)
158 (42%)
102 (27%)
3 (1%)
104 (28%)
181 (48%)
90 (24%)
2 (1%)
Last docetaxel dose to disease progression (months)
Median (time) 0.8 (0.0 - 3.1) 0.7 (0.0 - 2.9)

Pain was assessed with the McGill-Melzack present pain intensity scale and analgesic score was derived from analgesic consumption (morphine equivalents).

JEVTANA is a NCCN designated Category 1 second-line therapy for mCRPC5 and has been prescribed to more than 30,000* patients.

*Estimate based on sales & use data in the U.S., 6/2010-8/2017. sanofi-aventis U.S. LLC, A SANOFI COMPANY.

Identify Appropriate Patient Types for JEVTANA

Hear Dr. Pachynski apply trial information to clinical practice and talk about appropriate patient types for JEVTANA.

Russell K. Pachynski, MD
Assistant Professor, Oncology Division
Washington University School of Medicine, in St. Louis, MO.

Video of Dr. Pachynski talking about identifying the appropriate patient types for JEVTANA

IMPORTANT SAFETY INFORMATION

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

  • Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.
  • Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

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