PROSELICA Trial–Efficacy & Safety Overview
Study Design
A large, noninferiority, multicenter, randomized, open-label trial in patients (N=1200) with mCRPC who previously received docetaxel. These patients were randomized 1:1 to JEVTANA 20 mg/m2 (n=598) or JEVTANA 25 mg/m2 (n=602). The trial included patients with high disease burden and rapid progression after docetaxel.1,2
mCRPC=metastatic castration-resistant prostate cancer.
JEVTANA 20 mg/m2 Dose Was Validated in the PROSELICA Trial, Delivering a Median Overall Survival (OS) Comparable to 25 mg/m2 1,2
Per-Protocol Population: Median OS
- Per intent-to-treat population: 13.4 months (95% CI: 12.2-14.9) median OS for JEVTANA 20 mg/m2 and 14.5 months (95% CI: 13.5-15.3) for JEVTANA 25 mg/m2 (HR=1.024) (97.78% CI: 0.886-1.184)1
No notable difference in OS was observed in subgroups based on the stratification factors of ECOG PS score, measurability of disease, or region1
ECOG PS=Eastern Cooperative Oncology Group performance status.
PROSELICA Safety
Difference in Incidence of ARs With JEVTANA 20 mg/m2 vs 25 mg/m2
ARs* and Hematologic Abnormalities in ≥5% of Patients in the PROSELICA Trial1
|
JEVTANA 20 mg/m2 + prednisone (n=580) |
JEVTANA 25 mg/m2 + prednisone (n=595) |
JEVTANA 20 mg/m2 + prednisone (n=580) |
JEVTANA 25 mg/m2 + prednisone (n=595) |
||
| Adverse reactions | Grade 1–4 | Grade 3–4 | |||
| Anemia† | 99.8% | 99.7% | 10% | 14% | |
| Leukopenia† | 80% | 95% | 29% | 60% | |
| Neutropenia† | 67% | 89% | 42% | 73% | |
| Thrombocytopenia† | 35% | 43% | 3% | 4% | |
| Febrile neutropenia | 2% | 9% | 2% | 9% | |
| Diarrhea | 31% | 40% | 1% | 4% | |
| Nausea | 25% | 32% | 0.7% | 1% | |
| Constipation | 18% | 18% | 0.3% | 0.7% | |
| Vomiting | 15% | 18% | 1.2% | 1% | |
| Abdominal pain | 6% | 9% | 0.5% | 1% | |
| Stomatitis | 5% | 5% | 0 | 0.3% | |
| Fatigue | 25% | 27% | 3% | 4% | |
| Asthenia | 15% | 20% | 2% | 2% | |
| Edema peripheral | 7% | 9% | 0.2% | 0.2% | |
| Pyrexia | 5% | 6% | 0.2% | 0.2% | |
| Hematuria | 14% | 21% | 2% | 4% | |
| Dysuria | 5% | 4% | 0.3% | 0 | |
| Decreased appetite | 13% | 19% | 0.7% | 1% | |
| Back pain | 11% | 14% | 0.9% | 1% | |
| Bone pain | 8% | 8% | 2% | 2% | |
| Arthralgia | 8% | 7% | 0.5% | 0.8% | |
| Pain in extremity | 5% | 7% | 0.2% | 0.5% | |
| Dysgeusia | 7% | 11% | 0 | 0 | |
| Peripheral sensory neuropathy | 7% | 11% | 0 | 0.7% | |
| Dizziness | 4% | 5% | 0 | 0 | |
| Headache | 5% | 4% | 0.2% | 0.2% | |
| Urinary tract infection‡ | 7% | 11% | 2% | 2% | |
| Neutropenic infection§ | 3% | 7% | 2% | 6% | |
| Dyspnea | 5% | 8% | 0.9% | 0.7% | |
| Cough | 6% | 6% | 0 | 0 | |
| Weight decreased | 4% | 7% | 0.2% | 0 | |
| Alopecia | 3% | 6.1% | 0 | 0 | |
| Wrong technique in drug usage process | 0.3% | 5% | 0 | 0 | |
|
JEVTANA 20 mg/m2 + prednisone (n=580) |
JEVTANA 25 mg/m2 + prednisone (n=595) |
|
| Adverse reactions | Grade 1–4 | |
| Anemia† | 99.8% | 99.7% |
| Leukopenia† | 80% | 95% |
| Neutropenia† | 67% | 89% |
| Thrombocytopenia† | 35% | 43% |
| Febrile neutropenia | 2% | 9% |
| Diarrhea | 31% | 40% |
| Nausea | 25% | 32% |
| Constipation | 18% | 18% |
| Vomiting | 15% | 18% |
| Abdominal pain | 6% | 9% |
| Stomatitis | 5% | 5% |
| Fatigue | 25% | 27% |
| Asthenia | 15% | 20% |
| Edema peripheral | 7% | 9% |
| Pyrexia | 5% | 6% |
| Hematuria | 14% | 21% |
| Dysuria | 5% | 4% |
| Decreased appetite | 13% | 19% |
| Back pain | 11% | 14% |
| Bone pain | 8% | 8% |
| Arthralgia | 8% | 7% |
| Pain in extremity | 5% | 7% |
| Dysgeusia | 7% | 11% |
| Peripheral sensory neuropathy | 7% | 11% |
| Dizziness | 4% | 5% |
| Headache | 5% | 4% |
| Urinary tract infection‡ | 7% | 11% |
| Neutropenic infection§ | 3% | 7% |
| Dyspnea | 5% | 8% |
| Cough | 6% | 6% |
| Weight decreased | 4% | 7% |
| Alopecia | 3% | 6.1% |
| Wrong technique in drug usage process | 0.3% | 5% |
| Adverse reactions | Grade 3–4 | |
| Anemia† | 10% | 14% |
| Leukopenia† | 29% | 60% |
| Neutropenia† | 42% | 73% |
| Thrombocytopenia† | 3% | 4% |
| Febrile neutropenia | 2% | 9% |
| Diarrhea | 1% | 4% |
| Nausea | 0.7% | 1% |
| Constipation | 0.3% | 0.7% |
| Vomiting | 1.2% | 1% |
| Abdominal pain | 0.5% | 1% |
| Stomatitis | 0 | 0.3% |
| Fatigue | 3% | 4% |
| Asthenia | 2% | 2% |
| Edema peripheral | 0.2% | 0.2% |
| Pyrexia | 0.2% | 0.2% |
| Hematuria | 2% | 4% |
| Dysuria | 0.3% | 0 |
| Decreased appetite | 0.7% | 1% |
| Back pain | 0.9% | 1% |
| Bone pain | 2% | 2% |
| Arthralgia | 0.5% | 0.8% |
| Pain in extremity | 0.2% | 0.5% |
| Dysgeusia | 0 | 0 |
| Peripheral sensory neuropathy | 0 | 0.7% |
| Dizziness | 0 | 0 |
| Headache | 0.2% | 0.2% |
| Urinary tract infection‡ | 2% | 2% |
| Neutropenic infection§ | 2% | 6% |
| Dyspnea | 0.9% | 0.7% |
| Cough | 0 | 0 |
| Weight decreased | 0.2% | 0 |
| Alopecia | 0 | 0 |
| Wrong technique in drug usage process | 0 | 0 |
ARs=adverse reactions.
*Grade from NCI CTCAE version 4.03.
†Based on laboratory values, JEVTANA 20 mg/m2: n=577, JEVTANA 25 mg/m2: n=590.
‡Includes urinary tract infection staphylococcal, urinary tract infection bacterial, urinary tract infection fungal, and urosepsis.
§Includes neutropenic sepsis.
Difference in Incidence of ARs¶ With JEVTANA 20 mg/m2 vs 25 mg/m2 1
- Deaths within 30 days of last study drug dose were reported in 22 (3.8%) patients in the 20 mg/m2 arm and 32 (5.4%) patients in the 25 mg/m2 arm
- Grade 1-4 ARs occurring ≥5% more commonly in patients on 25 mg/m2 vs 20 mg/m2 were leukopenia, neutropenia, thrombocytopenia, febrile neutropenia, decreased appetite, nausea, diarrhea, hematuria, and asthenia
- Grade 3-4 ARs occurring ≥5% more commonly in patients on 25 mg/m2 vs 20 mg/m2 were leukopenia, neutropenia, and febrile neutropenia
17% of patients on 20 mg/m2 and 20% of patients on 25 mg/m2 discontinued treatment due to ARs.
The most common ARs leading to treatment discontinuation were fatigue and hematuria.1
Fewer Patients Receiving 20 mg/m2 Were Reported to Have Infectious ARs1
- Grade 1-4 infections were experienced by 28% (160) of patients receiving 20 mg/m2 vs 38% (227) of patients receiving 25 mg/m2
- Grade 3-4 infections were experienced by 10% (57) of patients receiving 20 mg/m2 vs 20% (120) of patients receiving 25 mg/m2
¶Grade from NCI CTCAE version 4.03.
Get more information on the
PROSELICA trial
Find out the median number of
treatment cycles for each study