what's possible.
*Estimate based on US sales & use data. 01/2010-10/2019
Most recently, results from the CARD study were published in the New England Journal of Medicine and presented at 2019 ESMO and 2020 ASCO GU.1,2
TROPIC Results
Validated JEVTANA as a treatment
in mCRPC after docetaxel1,3
PROSELICA Results
Established JEVTANA
20mg/m2 as the recommended dose
25mg/m2 can be used in select patients at HCP discretion.1
CARD Results
The first comparative,
prospective, phase 4 trial
evaluating JEVTANA versus
abiraterone or enzalutamide2-4
Validated JEVTANA as a treatment in mCRPC after docetaxel.1,3
TROPIC trial (n=755): a randomized, open-label, international, multicenter study of JEVTANA (cabazitaxel) 25 mg/m2 (n=378) vs mitoxantrone 12 mg/m2 (n=377) in patients with mCRPC previously treated with a docetaxel-containing regimen. The primary endpoint was overall survival (OS).1
- JEVTANA significantly reduced risk of death by 30% vs mitoxantrone, an active comparator (95% CI: 0.59-0.83).
- JEVTANA delivered a >30% reduction in tumors (RECIST criteria) in 3x more mCRPC patients vs mitoxantrone, an active comparator: 14.4% (29/201) (95% CI: 9.6-19.3) vs 4.4% (9/204) (95% CI: 1.6-7.2) (P=0.0005).
- The most common (≥10%) grade 1-4 adverse reactions in patients who received JEVTANA vs mitoxantrone were anemia (98% vs 82%, respectively), leukopenia (96% vs 93%), neutropenia (94% vs 87%), thrombocytopenia (48% vs 43%), diarrhea (47% vs 11%), fatigue (37% vs 27%), nausea (34% vs 23%), vomiting (22% vs 10%), constipation (20% vs 15%), asthenia (20% vs 12%), abdominal pain (17% vs 6%), hematuria (17% vs 4%), back pain (16% vs 12%), anorexia (16% vs 11%), peripheral neuropathy (13% vs 3%), pyrexia (12% vs 6%), dyspnea (12% vs 4%), dysgeusia (11% vs 4%), cough (11% vs 6%), arthralgia (11% vs 8%), and alopecia (10% vs 5%)
- The most common (≥5%) grade 3-4 adverse reactions in patients who received JEVTANA vs mitoxantrone were neutropenia (82% vs 58%), leukopenia (69% vs 42%), anemia (11% vs 5%), febrile neutropenia (7% vs 1%), diarrhea (6% vs <1%), fatigue (5% vs 3%), and asthenia (5% vs 2%)
Established JEVTANA 20mg/m2 as the recommended dose
25mg/m2 can be used in select patients at HCP discretion.1
PROSELICA trial (n=1,200): a non-inferiority, multicenter, randomized, open-label study of JEVTANA 20 mg/m2 (n=598) vs JEVTANA 25 mg/m2 (n=602) in patients with mCRPC previously treated with a docetaxel-containing regimen. The primary endpoint was overall survival (OS).1
- 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).
- No notable difference in OS was observed in subgroups based on the stratification factors, ECOG performance status score, measurability of disease, or region.
Hematologic Lab Abnormalities in the PROSELICA Trial1
|
JEVTANA 20 mg/m2 + prednisone n=577 |
JEVTANA 25 mg/m2 + prednisone n=590 |
Absolute Difference |
JEVTANA 20 mg/m2 + prednisone n=577 |
JEVTANA 25 mg/m2 + prednisone n=590 |
Absolute Difference | ||
|---|---|---|---|---|---|---|---|
| Laboratory Abnormality | Grade 1–4 | Grade 3–4 | |||||
| Neutropenia | 67% | 89% | -22% | 42% | 73% | -31% | |
| Anemia | 99.8% | 99.7% | +0.1% | 10% | 14% | -4% | |
| Leukopenia | 80% | 95% | -15% | 29% | 60% | -31% | |
| Thrombocytopenia | 35% | 43% | -8% | 3% | 4% | -1% | |
ARs* >5% in the PROSELICA Trial
|
JEVTANA 20 mg/m2 + prednisone n=580 |
JEVTANA 25 mg/m2 + prenisone n=595 |
Absolute Difference |
JEVTANA 20 mg/m2 + prednisone n=580 |
JEVTANA 25 mg/m2 + prenisone n=595 |
Absolute Difference |
||
|---|---|---|---|---|---|---|---|
| Adverse Reaction | Grade 1–4 | Grade 3–4 | |||||
| Diarrhea | 31% | 40% | -9% | 1% | 4% | -3% | |
| Nausea | 25% | 32% | -7% | 0.7% | 1% | -0.3% | |
| Fatigue | 25% | 27% | -2% | 3% | 4% | -1% | |
| Constipation | 18% | 18% | 0 | 0.3% | 0.7% | -0.4% | |
| Vomiting | 15% | 18% | -3% | 1.2% | 1% | +0.2% | |
| Asthenia | 15% | 20% | -5% | 2% | 2% | 0% | |
| Hematuria | 14% | 21% | -7% | 2% | 4% | -2% | |
| Decreased appetite | 13% | 19% | -6% | 0.7% | 1% | -0.3% | |
| Back pain | 11% | 14% | -3% | 0.9% | 1% | -0.1% | |
| Bone pain | 8% | 8% | 0 | 2% | 2% | 0 | |
| Arthralgia | 8% | 7% | +1% | 0.5% | 0.8% | -0.3% | |
| Urinary tract infection† | 7% | 11% | -4% | 2% | 2% | 0 | |
| Dysgeusia | 7% | 11% | -4% | 0 | 0 | 0 | |
| Peripheral sensory neuropathy | 7% | 11% | -4% | 0 | 0.7% | -0.7% | |
| Peripheral edema | 7% | 9% | -2% | 0.2% | 0.2% | 0 | |
| Cough | 6% | 6% | 0 | 0 | 0 | 0 | |
| Abdominal pain | 6% | 9% | -3% | 0.5% | 1% | -0.5% | |
| Headache | 5% | 4% | +1% | 0.2% | 0.2% | 0 | |
| Dyspnea | 5% | 8% | -3% | 0.9% | 0.7% | +0.2% | |
| Stomatitis | 5% | 5% | 0 | 0 | 0.3% | -0.3% | |
| Pain in extremity | 5% | 7% | -2% | 0.2% | 0.5% | -0.3% | |
| Dysuria | 5% | 4% | +1% | 0.3% | 0 | +0.3% | |
| Pyrexia | 5% | 6% | -1% | 0.2% | 0.2% | 0 | |
| Dizziness | 4% | 5% | -1% | 0 | 0 | 0 | |
| Weight decreased | 4% | 7% | -3% | 0.2% | 0 | +0.2% | |
| Neutropenia‡ | 3% | 11% | -8% | 2% | 10% | -8% | |
| Neutropenic infection§ | 3% | 7% | -4% | 2% | 6% | -4% | |
| Alopecia | 3% | 6.1% | -3.1% | 0 | 0 | 0 | |
| Febrile neutropenia | 2% | 9% | -7% | 2% | 9% | -7% | |
| Wrong technique in drug usage process |
0.3% | 5% | -4.7% | 0 | 0 | 0 | |
*Grade from NCI CTCAE version 4.03. † Includes urinary tract infection staphylococcal, urinary tract infection bacterial, urinary tract infection fungal, and urosepsis. ‡ Based on adverse event reporting.§ Includes neutropenic sepsis.
- 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.
The first comparative, prospective, phase 4 trial
evaluating JEVTANA versus abiraterone or enzalutamide2-4
CARD trial (n=255): a randomized, open-label, multicenter study in patients (n=255) with mCRPC who had previously received docetaxel and had disease progression within 12 months on an alternative androgen receptor-targeted agent (abiraterone or enzalutamide). The primary endpoint was imaging-based progression-free survival (rPFS†) and secondary endpoints included overall survival (OS), tumor response, and safety.2
The CARD trial was an open label trial with no blinded central review of the standard imaging and was sponsored by Sanofi.3
*enzalutamide or abiraterone
ARTA=androgen receptor–targeted agent; BID=twice a day; DOCE=docetaxel; G-CSF=granulocyte-colony stimulating factor; Q3W=every 3 weeks; QD=once daily.
Median follow-up was 9.2 months from randomization until the end of the study.1
†rPFS (radiographic progression-free survival) was defined as the time from randomization to the occurrence of one of the following events: radiological tumor progression using RECIST 1.1 (except for lymph nodes: if lymph node metastasis is the only evidence of metastasis at baseline, it must be ≥20 mm in diameter when measured by spiral CT or MRI (as defined by PCWG2)), progression of bone lesions according to PCWG2 criteria, or death.
KEY PATIENT ELIGIBILITY CRITERIA2
- Histologically confirmed prostate cancer and castrate levels of testosterone (<0.5 ng/ml)
- Prior treatment with docetaxel (at least 3 cycles; before or after AR-targeted agent)
- Progression within 12 months with abiraterone or enzalutamide (before or after docetaxel)
Scroll down to see full patient baseline characteristics.
- All efficacy analyses were performed on the intention-to-treat population, at the cut-off date for 196 rPFS events.
- After progression, the choice of subsequent anticancer treatment was at the discretion of the investigator. Of 126 patients randomized to an AR-targeted agent, 42 (33.3%) received JEVTANA after progression. Of 129 patients randomized to JEVTANA, 30 (23.3%) received abiraterone or enzalutamide after progression.
- At the cutoff date, 153 deaths were noted, with 70 deaths (54.3%) occurring in the JEVTANA 25 mg/m2 group and 83 (65.9%) in the abiraterone or enzalutamide group.
The 25mg/m2 dose of JEVTANA was used in the CARD trial, which was conducted in Europe. The recommended starting dose of JEVTANA is 25mg/m2 in the European label.2
Cabazitaxel at 25 mg/m2 with concurrent steroid improved radiographic PFS and reduced the risk of death compared with abiraterone or enzalutamide in patients with prior docetaxel treatment for mCRPC in the CARD study.
- Partial response was measured by RECIST criteria, which is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
*Musculoskeletal pain or discomfort included back pain, flank pain, musculoskeletal discomfort and pain, neck pain, or pain in extremities.
†Renal disorder included acute kidney injury, renal failure and impairment, hydronephrosis, or pyelocaliectasis.
‡Spinal cord or nerve root disorder included sciatalgia, radiculopathy, or spinal cord compression.
§Psychiatric disorder included anxiety, depression, confusion, disorientation, or sleep disorder.
*Adverse events leading to death were assessed during the period from randomization to 30 days after the last treatment administration.
**Adverse events leading to death were assessed during the period from randomization to 30 days after the last treatment administration.
G-CSF was mandated every cycle per trial protocol. Per the full Prescribing Information, primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.2,3
- The median number of treatment cycles received was 7 cycles for patients on JEVTANA 25 mg/m2 compared with 4 cycles for those on abiraterone or enzalutamide. A treatment cycle was 3 weeks in both trial groups.
- At least 1 dose reduction occurred in 27 patients (21.4%) receiving JEVTANA 25 mg/m2 and in 47 patients (37.9%) receiving abiraterone or enzalutamide.
- A dose reduction occurred in 17 of 58 patients (29%) receiving abiraterone and in 30 of 66 patients (45%) receiving enzalutamide.
§One patient (0.8%) had missing data in the JEVTANA group.
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