PROSELICA Results Established JEVTANA 20 mg/m2 as the Recommended Dose1,2

JEVTANA 25 mg/m2 Can Be Used in Select Patients at the Healthcare Provider’s Discretion

Large, Noninferiority, Multicenter, Randomized, Open-Label Trial (N=1200)

  • The trial enrolled patients with mCRPC who previously received docetaxel

Endpoints

  • The primary endpoint was OS

N=1200

Patients with mCRPC who previously received docetaxel

Stratification:

ECOG PS: 0,1 vs 2

Measurable vs nonmeasurable disease

RANDOMIZED 1:1

JEVTANA 20 mg/m2 + prednisone
(n=598)

JEVTANA 25 mg/m2 + prednisone
(n=602)

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




Identify Appropriate Patients for JEVTANA in Your Practice

JEVTANA Was Studied in mCRPC Patients With High Disease Burden and Rapid Progression
After Docetaxel2

PROSELICA Trial Included Patients With High
Disease Burden2

Patients Presented With Rapid Progression
After Docetaxel2




Summary of Demographics and Patient Characteristics2,3

  JEVTANA 20 mg/m2 +
prednisone (n=598)
JEVTANA 25 mg/m2 +
prednisone (n=602)
Age Median (range) 68 (45-89) 69 (45-88)
≥75, No. (%) 120 (20.1) 127 (21.1)
ECOG PS, No. (%) 0,1 539 (90.1) 540 (89.7)
2 59 (9.9) 62 (10.3)
PSA, ng/mL Median 159.49 170.90
Disease progression relative
to treatment, No. (%)
During last docetaxel
treatment
153 (25.6) 154 (25.6)
<3 months since
last docetaxel dose
251 (42.0) 270 (44.9)
3-6 months since
last docetaxel dose
110 (18.4) 96 (15.9)
>6 months since
last docetaxel dose
69 (11.5) 61 (10.1)
Missing 15 (2.5) 21 (3.5)
Time from last docetaxel dose
to progression, months
Median 1.0 1.0
Mean (SD) 2.7 (5.3) 2.3 (4.1)
Pain at baseline, No. (%) Pain at baseline* 248 (41.5) 284 (47.2)
Measurability of
disease (%)
Measurable disease 49.0 48.0
Nonmeasurable disease 51.0 52.0
  JEVTANA 20 mg/m2 +
prednisone (n=598)
JEVTANA 25 mg/m2 +
prednisone (n=602)
Age    
Median (range) 68 (45-89) 69 (45-88)
≥75, No. (%) 120 (20.1) 127 (21.1)
ECOG PS, No. (%)    
0,1 539 (90.1) 540 (89.7)
2 59 (9.9) 62 (10.3)
PSA, ng/mL    
Median 159.49 170.90
Disease progression relative
to treatment, No. (%)
   
During last docetaxel
treatment
153 (25.6) 154 (25.6)
<3 months since
last docetaxel dose
251 (42.0) 270 (44.9)
3-6 months since
last docetaxel dose
110 (18.4) 96 (15.9)
>6 months since
last docetaxel dose
69 (11.5) 61 (10.1)
Missing 15 (2.5) 21 (3.5)
Time from last docetaxel dose
to progression, months
   
Median 1.0 1.0
Mean (SD) 2.7 (5.3) 2.3 (4.1)
Pain at baseline, No. (%)    
Pain at baseline* 248 (41.5) 284 (47.2)
Measurability of
disease (%)
   
Measurable disease 49.0 48.0
Nonmeasurable disease 51.0 52.0

PROSELICA Included Patients With Multiple Metastases

Disease site (%) Bone 93.5 94.5
Lymph nodes 49.2 49.7
Lung 15.6 15.9
Liver 15.7 15.0
Disease site (%)    
Bone 93.5 94.5
Lymph nodes 49.2 49.7
Lung 15.6 15.9
Liver 15.7 15.0

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