TROPIC Results Validated JEVTANA as a 2nd-Line Treatment After Docetaxel in a Pivotal Phase 3 Trial vs Mitoxantrone1,2

Large, International, Randomized, Open-Label Registration Trial (N=755)

  • The trial enrolled patients with mCRPC who previously received docetaxel
  • Conducted at 146 sites in 26 countries

Endpoints

  • Primary endpoint: OS
  • Secondary endpoints: Investigator-assessed tumor response, safety, and pharmacokinetics

N=755

Patients with mCRPC who progressed during or after treatment with a docetaxel-containing regimen

Stratification:

ECOG PS: 0,1 vs 2

Measurable vs nonmeasurable disease

RANDOMIZED 1:1

JEVTANA 25 mg/m2
q3w + oral prednisone 10 mg daily for 10 cycles
(n=378)

mitoxantrone 12 mg/m2
q3w + oral prednisone 10 mg daily for 10 cycles
(n=377)

ECOG PS=Eastern Cooperative Oncology Group performance status; mCRPC=metastatic castration-resistant prostate cancer; OS=overall survival; q3w=every 3 weeks.




Identify Appropriate Patients for JEVTANA in Your Practice

JEVTANA Was Studied in mCRPC Patients With High Disease Burden and Rapid Progression
After Docetaxel1-3

TROPIC Trial Included Patients With High Disease
Burden3

Patients Presented With Rapid Progression
After Docetaxel1-3




Summary of Demographics and Patient Characteristics2,3

  JEVTANA 25 mg/m2 +
prednisone (n=378)
mitoxantrone +
prednisone (n=377)
Age Median (range) 68 (46-92) 67 (47-89)
≥75, No. (%) 69 (18.3) 70 (18.6)
ECOG PS, No. (%) 0,1 350 (92.6) 344 (91.2)
2 28 (7.4) 33 (8.8)
PSA, ng/mL Median 143.9 127.5
Disease progression
relative to docetaxel
administration, No. (%)
During treatment 115 (30.4) 104 (27.6)
<3 months from last dose 158 (41.8) 181 (48.0)
≥3 months from last dose 102 (27.0) 90 (23.9)
Unknown 3 (0.8) 2 (0.5)
Last docetaxel dose to disease
progression (months)
Median (time) 0.8 (0.0-3.1) 0.7 (0.0-2.9)
Pain at baseline, No. (%) Pain at baseline* 174 (46.0) 168 (44.6)
Measurability of
disease (%)
Measurable disease 53.2 54.1
Nonmeasurable disease 46.8 45.9
  JEVTANA 25 mg/m2 +
prednisone (n=378)
mitoxantrone +
prednisone (n=377)
Age  
Median (range) 68 (46-92) 67 (47-89)
≥75, No. (%) 69 (18.3) 70 (18.6)
ECOG PS, No. (%)  
0,1 350 (92.6) 344 (91.2)
2 28 (7.4) 33 (8.8)
PSA, ng/mL  
Median 143.9 127.5
Disease progression
relative to docetaxel
administration, No. (%)
 
During treatment 115 (30.4) 104 (27.6)
<3 months from last dose 158 (41.8) 181 (48.0)
≥3 months from last dose 102 (27.0) 90 (23.9)
Unknown 3 (0.8) 2 (0.5)
Last docetaxel dose to disease
progression (months)
 
Median (time) 0.8 (0.0-3.1) 0.7 (0.0-2.9)
Pain at baseline, No. (%)  
Pain at baseline* 174 (46.0) 168 (44.6)
Measurability of
disease (%)
 
Measurable disease 53.2 54.1
Nonmeasurable disease 46.8 45.9

More Than 60% of Patients Had 2 or More Sites of Metastases

Disease site (%) Bone 80.2 87.0
Distant lymph nodes 35.2 34.5
Visceral 24.9 24.9
Disease site (%)    
Bone 80.2 87.0
Distant lymph nodes 35.2 34.5
Visceral 24.9 24.9

PSA=prostate-specific antigen.
*Pain was assessed with the McGill-Melzack present pain intensity scale, and analgesic score was derived from analgesic consumption (morphine equivalents).2
Measurable disease was measured by RECIST and nonmeasurable disease was measured by rising PSA levels or appearance of new lesions.1