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JEVTANA ® (cabazitaxel) injection: CARD Trial - Efficacy & Safety Overview


   

Study Design

A randomized, open-label, multicenter trial in patients (N=255) with mCRPC who previously received docetaxel and had progressed within 12 months on an androgen-signaling-targeted inhibitor—either abiraterone or enzalutamide. These patients were randomized 1:1 to JEVTANA ® (cabazitaxel) injection (n=129) or abiraterone or enzalutamide (n=126); patients received abiraterone if they were previously treated with enzalutamide, or enzalutamide if they were previously treated with abiraterone. 1,2

mCRPC=metastatic castration-resistant prostate cancer.

46% Relative Reduction in Risk of Radiographic Progression or Death With JEVTANA® (cabazitaxel) injection vs Abiraterone or Enzalutamide1,2

Primary Endpoint: rPFS (Intent-to-treat Population)

Kaplan-Meier curve: Median rPFS of 8.0 months with JEVTANA + prednisone n=129, (95% CI: 5.7-9.2). Median rPFS of 3.7 months with abiraterone or enzalutamide + prednisone n=126, (95% CI: 2.8-5.1); HR=0.54(95% CI: 0.40-0.73); P<0.0001.

 
All efficacy analyses were performed on the intent-to-treat population, at the cutoff date for 196 rPFS events 2

In terms of therapy sequence prior to randomization, rPFS was consistent across the subgroups of patients who received abiraterone/enzalutamide prior to docetaxel (HR=0.61, 95% CI: 0.39-0.96) and those who received abiraterone/enzalutamide after docetaxel (HR=0.48, 95% CI: 0.32-0.70). 1

rPFS=radiographic progression-free survival.

Overall Survival (OS) Was Significantly Improved With JEVTANA Compared With Abiraterone or Enzalutamide 1,2

Other Efficacy Outcome: OS (Intent-to-treat Population)

Kaplan-Meier curve: Median OS of 13.6 months with JEVTANA + prednisone, n=129 (95% CI: 11.5-17.5), Median OS of 11 months with abiraterone or enzalutamide + prednisone, n=126 (95% CI: 9.2-12.9); HR=0.64 (95% CI: 0.46-0.89); P=0.008. 36% relative reduction in risk of death.

 
At the cutoff date, 153 deaths were noted, with 70 deaths (54.3%) occurring in the JEVTANA 25 mg/m 2 group and 83 (65.9%) in the abiraterone or enzalutamide group 2

CARD Tumor Response Rate

JEVTANA Delivered a ≥30% Tumor Reduction in 3X More Patients vs Abiraterone or Enzalutamide 1,2

Tumor Response (Patients With Measurable Disease at Baseline) 1,2

Horizontal bar graph showing JEVTANA 25mg/m² + prednisone (23 of 63 patients) (95% CI: 26.6-48.4) with a 36.5% circled. Abiraterone or enzalutamide (6 of 52 patients) (95% CI: 2.9-20.2) with 11.5% circled; P=0.004.

Percent of Patients

  • 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 3

RECIST=Response Evaluation Criteria in Solid Tumors.

CARD Safety

Incidence of ARs With JEVTANA vs Abiraterone or Enzalutamide

ARs* and Hematologic Abnormalities in ≥5% of Patients in the CARD Trial 1

 JEVTANA 25 mg/m 2 +
prednisone/
prednisolone + G-CSF
(n=126)
abiraterone +
prednisone/
prednisolone or
enzalutamide (n=124)
JEVTANA 25 mg/m 2 +
prednisone/
prednisolone + G-CSF
(n=126)
abiraterone +
prednisone/
prednisolone or
enzalutamide (n=124)
Adverse reactionsGrade 1–4Grade 3–4
Anemia99%95%8%4.8%
Lymphopenia72%55%27%17%
Neutropenia66%7%45%3.2%
Thrombocytopenia41%16%3.2%1.6%
Fatigue53%36%4%2.4%
Edema peripheral§11%10%0.8%1.6%
Pyrexia6%7%00
Pain6%6%00.8%
Diarrhea40%6%4.8%0
Nausea23%23%00.8%
Constipation15%11%00
Abdominal pain#14%6%1.6%0.8%
Vomiting13%12%01.6%
Stomatitis8%1.6%00
Dyspepsia4.8%2.4%00
Musculoskeletal pain**27%40%1.6%6%
Pain in extremity4.8%11%02.4%
Bone fracture††3.2%8%1.6%2.4%
Infections‡‡19%14%4%6%
Peripheral neuropathy§§18%4.8%1.6%0
Dysgeusia11%4%00
Polyneuropathy6%01.6%0
Dizziness0.8%4.8%00
Hematuria¶¶16%6%0.8%1.6%
Lower urinary tract symptoms##10%9%00
Acute kidney injury***5%10%2.4%4%
Decreased appetite14%15%0.8%2.4%
Hypokalemia3.2%6%00
Cancer pain8%9%1.6%2.4%
Cardiac disorders†††6%6%0.8%3.2%
Pneumonia‡‡‡6%3.2%1.6%0.8%
Dyspnea6%2.4%00
Alopecia6%000
Fall4.8%000
Hypertension§§§4%8%2.4%2.4%
Weight decreased4%6%00
Insomnia3.2%4.8%00

ARs=adverse reactions.
*Grade from National Cancer Institute Common Terminology Criteria for Adverse Events
version 4.0.
Based on laboratory values -% calculated using the number of patients with at least one event(n) over the number of patients assessed for each parameter during the on-treatment period.
Includes asthenia, fatigue, lethargy, malaise.
§Includes lymphoedema, edema peripheral, peripheral swelling.
Includes colitis, diarrhea, diarrhea hemorrhagic, gastroenteritis.
#Includes abdominal pain, abdominal pain lower, abdominal pain upper, flank pain, gastrointestinal pain.
**Includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain.
††Includes femoral neck fracture, pathological fracture, rib fracture, spinal compression fracture, sternal fracture, thoracic vertebral fracture.
‡‡Includes bacteremia, bacteriuria, cellulitis, device related sepsis, Enterobacter sepsis, erysipelas, furuncle, influenza, influenza like illness, localized infection, oral fungal infection, perineal cellulitis,
pulmonary sepsis, pyelocaliectasis, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, sepsis, septic shock, subcutaneous abscess, upper respiratory
tract infection, ureteritis, urinary tract infection, urinary tract infection bacterial, urosepsis, viral infection.
§§Includes neuropathy peripheral, paresthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy.
¶¶Includes hematuria, cystitis hemorrhagic.
##Includes lower urinary tract symptoms, micturition urgency, nocturia, pollakiuria, urinary incontinence, urinary retention, dysuria.
***Includes acute kidney injury, blood creatinine increased, renal failure, renal impairment.
†††Includes aortic valve incompetence, aortic valve stenosis, atrial fibrillation, atrial flutter, atrioventricular block complete, atrioventricular block second degree, bradycardia, sinus bradycardia,
tachycardia, cardiac failure, acute coronary syndrome, angina pectoris.
‡‡‡Includes lower respiratory tract infection, lung infection, lung infiltration, pneumonia.
§§§Includes hypertension, hypertensive crisis.

No New Safety Signals Were Observed 2

ARs of Grade ≥3 Occurred at Similar Rates For Men Receiving JEVTANA as Those Receiving Abiraterone or Enzalutamide (56.3% vs 52.4%)

ARs (Safety Population), No. (%)

 JEVTANA 25 mg/m 2
+ prednisone (n=126)
abiraterone or enzalutamide
(n=124)
Any AR124 (98.4)117 (94.4)
Grade ≥3 AR71 (56.3)65 (52.4)
Serious AR49 (38.9)48 (38.7)
AR leading to permanent
treatment discontinuation
25 (19.8)11 (8.9)
AR leading to death
(fatal outcome)*
7 (5.6)14 (11.3)

*ARs leading to death were assessed during the period from randomization to 30 days after the last treatment administration. 2 

Cabazitaxel (JEVTANA) is a National Comprehensive Cancer Network ® (NCCN ® ) designated Category 1 preferred regimen following docetaxel and novel hormonal therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) 4

Get more information on the
CARD trial

See results that validated
JEVTANA as a 2nd-line treatment
in mCRPC after docetaxel

Important Safety Information

WARNING: NEUTROPENIA AND HYPERSENSITIVITY
Neutropenia: Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. 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. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m2.

Severe hypersensitivity: 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.

Contraindications

JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500/mm3, patients with a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80, and patients with severe hepatic impairment (total bilirubin >3x upper limit of normal (ULN)).

Warnings and Precautions

Bone Marrow Suppression (BMS): BMS manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur. Neutropenic deaths have been reported. Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed. Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed. Caution is recommended in patients with hemoglobin < 10 g/dl.

Increased Toxicities in Elderly Patients: Patients ≥65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely.

Hypersensitivity Reactions: Severe hypersensitivity reactions can occur. Premedicate all patients with antihistamines, corticosteroids and H2 antagonists prior to JEVTANA. Observe patients closely, especially during the first and second infusions. Discontinue JEVTANA immediately if severe hypersensitivity occurs and treat as indicated.

Gastrointestinal (GI) Adverse Reactions: Nausea, vomiting, and severe diarrhea may occur. Death related to diarrhea and electrolyte imbalance occurred in the randomized clinical trials and mortality related to diarrhea has been reported. Intensive measures may be required for severe diarrhea and electrolyte imbalance. Rehydrate and treat with antiemetics and antidiarrheals as needed. If experiencing grade ≥3 diarrhea, dosage should be modified.

GI hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reported. Risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, antiplatelet therapy or anticoagulants, and prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding. Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious GI toxicity and should be evaluated and treated promptly. JEVTANA treatment delay or discontinuation may be necessary.

Renal Failure: Cases, including those with fatal outcomes, have been reported. Identify cause and manage aggressively.

Urinary Disorders including Cystitis: Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, has been reported with JEVTANA in patients who previously received pelvic radiation. Cystitis from radiation recall may occur late in treatment with JEVTANA. Monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on JEVTANA. Interrupt or discontinue JEVTANA in patients experiencing severe hemorrhagic cystitis. Medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis.

Respiratory Disorders: Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome have been reported and may be associated with fatal outcome. Patients with underlying lung disease may be at higher risk for these events. Acute respiratory distress syndrome may occur in the setting of infection. Interrupt JEVTANA if new or worsening pulmonary symptoms develop. Closely monitor, promptly investigate, and appropriately treat patients receiving JEVTANA. Consider discontinuation. The benefit of resuming JEVTANA treatment must be carefully evaluated.

Use in Patients with Hepatic Impairment: JEVTANA dose should be reduced for patients with mild (total bilirubin > 1 to ≤ 1.5 x ULN or AST > 1.5 x ULN) and moderate (total bilirubin > 1.5 to ≤ 3.0 x ULN and any AST) hepatic impairment, based on tolerability data in these patients. Administer JEVTANA 20 mg/m2 for mild hepatic impairment. Administer JEVTANA 15 mg/m2 for moderate hepatic impairment. Monitor closely.

Embryo-Fetal Toxicity: JEVTANA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of JEVTANA.

Adverse Reactions (ARs)

The most common all grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m2 or 25 mg/m2 are neutropenia, anemia, diarrhea, nausea, fatigue, asthenia, vomiting, hematuria, constipation, decreased appetite, back pain, and abdominal pain.

Drug Interactions

Avoid coadministration of JEVTANA with strong CYP3A inhibitors. If patients require coadministration of a strong CYP3A inhibitor, consider a 25% JEVTANA dose reduction.

Use in Specific Populations

  • Pregnancy: The safety and efficacy of JEVTANA have not been established in females. There are no human data on the use of JEVTANA in pregnant women to inform the drug-associated risk.
  • Lactation: The safety and efficacy of JEVTANA have not been established in females. There is no information available on the presence of JEVTANA in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
  • Females and Males of Reproductive Potential: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of JEVTANA.

Indication

JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing treatment regimen.

Important Safety Information

Indication

References: 1. JEVTANA Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC. 2. de Wit R, de Bono J, Sternberg CN, et al; for the CARD Investigators. Cabazitaxel versus abiraterone or enzalutamide in metastatic prostate cancer. N Engl J Med. 2019;381(26):2506-2518. 3. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer, V.1.2025. ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed December 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

JEVTANA and Sanofi are registered trademarks of Sanofi or an affiliate. All other trademarks are the property of their respective owners. MAT-US-2103013-v4.0-02/2025