Nubeqa Drug Information
Generic name: DAROLUTAMIDE
Uses of Nubeqa
NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). metastatic castration-sensitive prostate cancer (mCSPC). metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Dosage & Administration of Nubeqa
Recommended Dosage
The recommended dose of NUBEQA is 600 mg (two 300 mg tablets) taken orally, twice daily, with food. Continue treatment until disease progression or unacceptable toxicity occurs. Patients receiving NUBEQA should also receive a gonadotropin-releasing hormone (GnRH) agonist or antagonist concurrently or have had a bilateral orchiectomy.
When used in combination with docetaxel for mCSPC, administer the first of 6 cycles of docetaxel within 6 weeks after the start of NUBEQA treatment. Refer to docetaxel prescribing information for additional dosing information, including dosage modifications. Treatment with NUBEQA may be continued until disease progression or unacceptable toxicity, even if a cycle of docetaxel is delayed, interrupted, or discontinued.
Advise patients to swallow tablets whole with food, to take any missed dose as soon as they remember prior to the next scheduled dose, and not to take two doses together to make up for a missed dose.
Dosage Modification If a patient experiences a greater than or equal to Grade 3 or an intolerable adverse reaction, withhold NUBEQA or reduce dosage to 300 mg twice daily until symptoms improve. NUBEQA may be resumed at a dose of 600 mg twice daily, when adverse reaction returns to baseline. Dosage reduction below 300 mg twice daily is not recommended.
For patients who experience ischemic heart disease or seizure, additional dose modifications may be required.
Recommended Dosage in Patients with Severe Renal Impairment
For patients with severe renal impairment (eGFR 15–29 mL/min/1.73 m 2 ) not receiving hemodialysis, the recommended dose of NUBEQA is 300 mg twice daily.
Recommended Dosage in Patients with Moderate Hepatic Impairment For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dose of NUBEQA is 300 mg twice daily.
Side Effects of Nubeqa
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled data in WARNINGS and PRECAUTIONS reflect two randomized clinical trials in patients with nmCRPC (N = 954) and mCSPC (N = 445) treated with NUBEQA. In these trials, the median duration of treatment was 18.2 months (range 0.03 to 44.3) for patients who received NUBEQA.
In this pooled safety population, the most common adverse reactions (>10% with a ≥2% increase over placebo), including laboratory test abnormalities were increased AST, decreased neutrophil count, increased bilirubin, fatigue and increased ALT. The safety of NUBEQA in combination with docetaxel in mCSPC is based on data from 1302 patients of whom 652 received at least one dose of NUBEQA in the ARASENS study. Non-Metastatic Castration Resistant Prostate Cancer ARAMIS The safety of NUBEQA in nmCRPC patients was evaluated in ARAMIS, a randomized (2:1), double-blind, placebo-controlled, multi-center clinical study.
Patients received either NUBEQA at a dose of 600 mg, or a placebo, twice a day. All patients in the ARAMIS study received a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. Among patients who received NUBEQA, the median duration of exposure was 14.8 months (range: 0 to 44.3 months).
Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo.
Permanent discontinuation of NUBEQA due to adverse reactions occurred in 9% of patients receiving NUBEQA. The most common adverse reactions requiring permanent discontinuation in patients who received NUBEQA included cardiac failure (0.4%), and death (0.4%). Dosage interruptions due to adverse reactions occurred in 13% of patients treated with NUBEQA.
The most common adverse reactions requiring dosage interruption in patients who received NUBEQA included hypertension (0.6%), diarrhea (0.5%), and pneumonia (0.5%). Dosage reductions due to adverse reactions occurred in 6% of patients treated with NUBEQA. The most common adverse reactions requiring dosage reduction in patients treated with NUBEQA included fatigue (0.7%), hypertension (0.3%), and nausea (0.3%).
The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity, and rash. Table 1 summarizes the adverse reactions in ARAMIS. Table 2 summarizes the laboratory test abnormalities in ARAMIS.
Table 2: Laboratory Test Abnormalities in ARAMIS 7 0 Metastatic Castration-Sensitive Prostate Cancer ARANOTE The safety of NUBEQA in mCSPC patients was evaluated in ARANOTE, a randomized (2:1), double-blind, placebo-controlled, multi-center clinical study. All patients in the ARANOTE study received a concomitant gonadotropin-releasing hormone (GnRH) agonist or antagonist or had a bilateral orchiectomy. Among patients who received NUBEQA, the median duration of exposure was 24 months (range: 0.03 to 39 months).
Permanent discontinuation of NUBEQA due to adverse reactions occurred in 6% of patients treated in the NUBEQA arm. The most common adverse reactions which resulted in permanent discontinuation of NUBEQA were increased ALT, increased AST, craniocerebral injury, myocardial infarction, and rash (all with 0.4%). Dosage interruptions of NUBEQA due to adverse reactions occurred in 14% of patients treated in the NUBEQA arm.
The most common adverse reactions requiring dosage interruption of NUBEQA were increased AST (1.6%), increased ALT (1.3%), and rash (1.3%). Table 3 summarizes the adverse reactions in ARANOTE. Table 4 summarizes the laboratory test abnormalities in ARANOTE.
Table 4: Laboratory Test Abnormalities (≥15% with a ≥5% increase over placebo) in ARANOTE ARASENS The safety of NUBEQA, in combination with docetaxel, in mCSPC patients was evaluated in ARASENS, a randomized (1:1), double-blind, placebo-controlled, multi-center clinical study. Eighty-eight percent and 86% of patients received the 6 planned cycles of docetaxel, in the NUBEQA with docetaxel arm and placebo with docetaxel arm, respectively. Serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel.
Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. The most common adverse reactions which resulted in permanent discontinuation of NUBEQA were rash (1.1%), musculoskeletal pain (0.9%), and increased aspartate aminotransferase (AST) (0.9%). The most common (>2%) adverse reactions requiring dosage reduction of NUBEQA were increased ALT (2.8%) and increased AST (2.5%).
The most common ( > 10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) are anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Table 5 summarizes the adverse reactions in ARASENS.
Table 6 summarizes laboratory test abnormalities in the ARASENS study.
| Adverse Reaction | NUBEQA (N=954) | Placebo (N=554) | ||
|---|---|---|---|---|
| All Grades % | Grades 3 or 4 % | All Grades % | Grade 3 or 4 % | |
| Fatigue Includes fatigue and asthenia | 16 | 0.6 | 11 | 1.1 |
| Pain in extremity | 6 | 0 | 3 | 0.2 |
| Rash Includes rash, eczema, rash maculo-papular, dermatitis, erythema multiforme, rash macular, rash papular, rash pustular, skin exfoliation | 4 | 0.1 | 1.4 | 0 |
| Laboratory Abnormality | NUBEQA (N=954) The denominator used to calculate the rate varied based on the number of patients with a baseline value and at least one post-treatment value. | Placebo (N=554) | ||
|---|---|---|---|---|
| All Grades % | Grade 3 or 4 % | All Grades % | Grade 3 or 4 % | |
| AST increased | 23 | 0.5 | 14 | 0.2 |
| Neutrophil count decreased | 20 | 4 | 9 | 0.6 |
| Bilirubin increased | 16 | 0.1 | 7 | 0 |
| Adverse Reaction | NUBEQA (N=445) | Placebo (N=221) | ||
|---|---|---|---|---|
| All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) | |
| Urinary Tract Infection | 12 | 1.8 | 8 | 0.5 |
| Laboratory Abnormality | NUBEQA (N=445) The number of patients tested for a specific laboratory test parameter may be different. The incidence of each laboratory test abnormality was calculated accordingly. | Placebo (N=221) | ||
|---|---|---|---|---|
| All Grades Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 4 laboratory test values were limited to neutrophil count decreased. % | Grade 3 or 4 % | All Grades % | Grade 3 or 4 % | |
| AST increased | 32 | 2.8 | 25 | 0.5 |
| ALT increased | 28 | 2.1 | 23 | 0.5 |
| Bilirubin increased | 17 | 0.5 | 7 | 0 |
| Neutrophil count decreased | 16 | 1.2 | 9 | 0.5 |
| Adverse Reaction | NUBEQA with docetaxel (N=652) | Placebo with docetaxel (N=650) | ||
|---|---|---|---|---|
| All Grades % | Grades 3 or 4 % | All Grades % | Grades 3 or 4 % | |
| Constipation | 23 | 0.3 | 20 | 0.3 |
| Rash Rash includes rash, rash maculo-papular, palmar-plantar erythrodysesthesia syndrome, eczema, dermatitis, skin exfoliation, dermatitis acneiform, drug eruption, rash pruritic, rash erythematous, erythema multiforme, rash macular, dermatitis exfoliative generalized, penile rash, dyshidrotic eczema, rash papular, dermatitis bullous, rash follicular, rash pustular, rash vesicular, toxic skin eruption | 20 | 1.8 | 15 | 0.2 |
| Decreased Appetite | 19 | 0.2 | 13 | 0.6 |
| Hemorrhage Hemorrhage includes hematuria, epistaxis, anal hemorrhage, hemorrhoidal hemorrhage, rectal hemorrhage, upper gastrointestinal hemorrhage, hemoptysis, hemorrhage urinary tract, hemorrhagic stroke, subarachnoid hemorrhage, lower gastrointestinal hemorrhage, cystitis hemorrhagic, gastrointestinal hemorrhage, hemorrhage subcutaneous, intra-abdominal hemorrhage, nail bed bleeding, subdural hemorrhage | 18 | 1.4 | 13 | 1.4 |
| Weight Increased | 18 | 2.1 | 16 | 1.2 |
| Hypertension Hypertension includes hypertension, blood pressure increased, hypertensive emergency and hypertensive crisis. | 14 | 7 | 10 | 3.6 |
| Laboratory Abnormality | NUBEQA with docetaxel The denominator used to calculate the rate varied from 470 to 648 based on the number of patients with a baseline value and at least one post-treatment value. (N=652) | Placebo with docetaxel (N=650) | ||
|---|---|---|---|---|
| All Grades % | Grade 3-4 % | All Grades % | Grade 3-4 % | |
| Anemia | 72 | 6 | 71 | 7 |
| Hyperglycemia | 57 | 7 | 53 | 10 |
| Lymphocyte count decreased | 52 | 12 | 49 | 13 |
| Neutrophil count decreased | 49 | 33 | 44 | 31 |
| AST increased ALT or AST increases to ≥5 × upper limit of normal (ULN) occurred in 5.3% of patients who received NUBEQA with docetaxel. ALT or AST increases to ≥20 × ULN occurred in 0.3% of patients who received NUBEQA with docetaxel. The median time to onset of any grade ALT or AST increases was 2.8 months (range: 0.03 to 46.9). | 40 | 3.6 | 35 | 2.3 |
| ALT increased | 37 | 3.7 | 31 | 2.9 |
| Hypocalcemia | 31 | 2.8 | 28 | 1.9 |
Warnings & Cautions for Nubeqa
Ischemic Heart Disease
Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo. Monitor for signs and symptoms of ischemic heart disease.
Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.
Seizure
Seizure occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA.
In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA.
Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.
Embryo-Fetal Toxicity
The safety and efficacy of NUBEQA have not been established in females. Based on its mechanism of action, NUBEQA can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of NUBEQA.
Drug Interactions with Nubeqa
Effects of Other Drugs on NUBEQA Combined P-gp and Strong or Moderate CYP3A4 Inducer Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers. Combined P-gp and Strong CYP3A4 Inhibitors Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions.
Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.
Effects of NUBEQA on Other Drugs Breast Cancer Resistance Protein (BCRP) and Organic Anion Transporting Polypeptides (OATP) 1B1 and 1B3 Substrates NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and C max of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible.
If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates.
Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA, Review the prescribing information of the BCRP, OATP1B1 and OATP1B3 substrates when used concomitantly with NUBEQA.
Pregnancy Safety for Nubeqa
Pregnancy Risk Summary The safety and efficacy of NUBEQA have not been established in females. Based on its mechanism of action, NUBEQA can cause fetal harm and loss of pregnancy. Animal embryo-fetal developmental toxicology studies were not conducted with darolutamide.
There are no human data on the use of NUBEQA in pregnant females.
Pediatric Use of Nubeqa
Pediatric Use Safety and effectiveness of NUBEQA in pediatric patients have not been established.
Overdosage Information for Nubeqa
There is no known specific antidote for darolutamide overdose. The highest dose of NUBEQA studied clinically was 900 mg twice daily, equivalent to a total daily dose of 1800 mg. No dose limiting toxicities were observed with this dose.
Considering the saturable absorption and the absence of evidence for acute toxicity, an intake of a higher than recommended dose of darolutamide is not expected to lead to systemic toxicity in patients with intact hepatic and renal function. In the event of intake of a higher than recommended dose in patients with severe renal impairment or moderate hepatic impairment, if there is suspicion of toxicity, interrupt NUBEQA treatment and undertake general supportive measures until clinical toxicity has been diminished or resolved. If there is no suspicion of toxicity, NUBEQA treatment can be continued with the next dose as scheduled.
Clinical Studies of Nubeqa
Non-Metastatic Castration Resistant Prostate Cancer ARAMIS (NCT02200614) was a multicenter, double-blind, placebo-controlled clinical trial in 1509 patients with non-metastatic castration resistant prostate cancer with a prostate-specific antigen doubling time (PSADT) of ≤ 10 months. Randomization was stratified by PSADT and use of bone-targeted therapy at study entry. Patients with pelvic lymph nodes less than 2 cm in short axis below the aortic bifurcation were eligible to enter the study.
Absence or presence of metastasis was assessed by blinded independent central review (BICR). PSA results were not blinded and were not used for treatment discontinuation. Patients were randomized 2:1 to receive either 600 mg NUBEQA orally twice daily (n=955) or matching placebo (n=554).
Treatment continued until radiographic disease progression as assessed by CT, MRI, 99m Tc bone scan by BICR, unacceptable toxicity or withdrawal. All patients received a gonadotropin-releasing hormone (GnRH) analog concurrently or had a bilateral orchiectomy. A majority of patients (73%) had a Gleason score of 7 or higher at diagnosis.
The median PSADT was 4.5 months. Forty-two percent of patients in both treatment arms had prior surgery or radiotherapy to the prostate. Eleven percent of patients had enlarged pelvic lymph nodes less than 2 cm at study entry.
Six percent of patients were retrospectively identified by BICR as having metastases at baseline. Seventy-three percent of patients received prior treatment with an anti-androgen (bicalutamide or flutamide). All patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 at study entry.
At baseline, 47% of patients reported no pain on the Brief Pain Inventory-Short Form (a 7-day diary average of the daily worst pain item). There were 12 patients (1.3%) enrolled on the NUBEQA arm with a history of seizure. The major efficacy endpoint was metastasis free survival (MFS), defined as the time from randomization to the time of first evidence of BICR-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
Distant metastasis was defined as new bone or soft tissue lesions or enlarged lymph nodes above the aortic bifurcation. Overall survival (OS), time to pain progression, and time to initiation of cytotoxic chemotherapy, were additional efficacy endpoints. Treatment with NUBEQA resulted in a statistically significant improvement in MFS compared to placebo.
The final analysis of OS and time to initiation of cytotoxic chemotherapy was event-driven and conducted after 254 OS events had occurred. The efficacy results from ARAMIS are summarized in Table 7 and Figure 1. Table 7: Efficacy Results from the ARAMIS Study Figure 1: Kaplan-Meier Curve Metastasis Free Survival; Intent-To-Treat nmCRPC population (ARAMIS) Figure 2: Kaplan-Meier curves of Overall Survival; Intent-To-Treat nmCRPC population (ARAMIS) MFS results were consistent across patient subgroups for PSADT (≤ 6 months or > 6 months) or prior use of bone-targeting agents (yes or no).
Treatment with NUBEQA resulted in a statistically significant delay in time to pain progression (HR = p < 0.0001). Time to pain progression was defined as at least a 2-point worsening from baseline of the pain score on Brief Pain Inventory Short Form or initiation of opioids and reported in 28% of all patients on study. Figure 1 Figure 2 Metastatic Castration Sensitive Prostate Cancer (mCSPC) ARANOTE ARANOTE (NCT02799602) was a multicenter, double-blind, placebo-controlled study in 669 patients with mCSPC.
Patients were randomized 2:1 to receive 600 mg NUBEQA orally twice daily (n=446) or matching placebo (n=223). Patients with both high- and low-volume mCSPC were eligible for the study. High-volume disease was defined as presence of visceral metastases, or 4 or more bone lesions, with at least 1 metastasis beyond the vertebral column and pelvic bones.
Randomization was stratified by presence of visceral metastasis and use of prior local therapy at study entry. Treatment with NUBEQA or placebo continued until progressive disease, change of antineoplastic therapy, unacceptable toxicity, death, or withdrawal. Sixty-eight percent (68%) of patients had a Gleason score of 8 or higher at diagnosis.
At study entry, ECOG PS of respectively. Seventy-three percent (73%) of patients had de novo disease and 22% had recurrent disease. Seventy-one percent (71%) of patients had high-volume disease, including 12% with visceral metastases, and 29% had low-volume disease.
The median PSA level at baseline was 21 µg/L. One patient (0.2%) with a medical history of seizure was treated with NUBEQA in ARANOTE. The major efficacy outcome measure was radiographic progression-free survival (rPFS), defined as the time from randomization to radiological disease progression or death by central blinded review.
Radiographic disease progression was defined by identification of 2 or more new bone lesions on a bone scan with confirmation (Prostate Cancer Working Group 3 criteria) and/or progression in soft tissue disease. Additional efficacy outcome measure was overall survival (OS). There was no statistically significant improvement in OS.
Efficacy results for ARANOTE are shown in Table 8 and Figure 3. Table 8: Efficacy Results in Patients with mCSPC in ARANOTE; mCSPC population (ARANOTE) Figure 3 ARASENS ARASENS (NCT02799602) was a multicenter, double-blind, placebo-controlled clinical trial in 1306 patients with mCSPC. Patients with regional lymph node involvement only (M0) were excluded from the study.
Patients were stratified by extent of disease (non–regional lymph nodes metastases only (M1a), bone metastases with or without lymph node metastases (M1b) or visceral metastases with or without lymph node metastases or with or without bone metastases (M1c)) and by alkaline phosphatase level (< or ≥ upper limit of normal) at study entry. Seventy-eight percent (78%) of patients had a Gleason score of ≥8 at diagnosis. There were 86% of patients with de novo and 13% with recurrent disease.
Four patients (0.6%) with a medical history of seizure were treated with NUBEQA with docetaxel in ARASENS. The major efficacy outcome measure was overall survival (OS). Time to pain progression was an additional efficacy outcome measure.
OS results were consistent across stratified subgroups (extent of disease and alkaline phosphatase level). Efficacy results are shown in Table 9 and Figure 4. Pain progression is defined as: An increase of 2 or more points in the "worst pain in 24 hours" score (WPS) from nadir observed at 2 consecutive evaluations at least 4 weeks apart, or initiation of short- or long-acting opioid use for pain for at least 7 consecutive days, for asymptomatic patients (WPS=0) at baseline An increase of 2 or more points in the "worst pain in 24 hours" score (WPS) from nadir observed at 2 consecutive evaluations at least 4 weeks apart, and a WPS of 4 or greater, or initiation of short- or long-acting opioid use for pain for at least 7 consecutive days, for symptomatic patients (WPS ≥ 1) at baseline Patients with opioid use within 4 weeks before randomization were censored at randomization in this analysis (125 patients (19%) in the NUBEQA with docetaxel arm and 118 patients (18%) in the placebo with docetaxel arm).
Figure 4
| NUBEQA (N=955) | Placebo (N=554) | |
|---|---|---|
| NR: not reached | ||
| Metastasis-free survival Locoregional-only progression occurred in 6% of patients overall. | ||
| Distant Metastasis or Death (%) | 221 (23) | 216 (39) |
| Median, months (95% CI) Based on Kaplan-Meier estimates | 40.4 (34.3, NR) | 18.4 (15.5, 22.3) |
| Hazard Ratio (95% CI) Hazard ratio is based on a stratified Cox regression model. Hazard ratio < 1 favors NUBEQA. | 0.41 (0.34, 0.50) | |
| P-value The pre-specified final OS analysis was event-driven and occurred 14 months after the MFS analysis | <0.0001 | |
| Overall survival | ||
| Deaths (%) | 148 (15) | 106 (19) |
| Median, months (95% CI) | NR (56.1, NR) | NR (46.9, NR) |
| Hazard Ratio (95% CI) | 0.69 (0.53, 0.88) | |
| P-value P-value is based on a log-rank test stratified by PSADT (≤ 6 months vs. > 6 months) and use of osteoclast-targeted therapy (yes vs. no) | 0.003 | |
| Efficacy Endpoint | NUBEQA (N=446) | Placebo (N=223) |
|---|---|---|
| NR: not reached | ||
| NS: not statistically significant | ||
| Radiographic Progression-Free Survival | ||
| Patients with event, n (%) | 128 (29) | 94 (42) |
| Median, months (95% CI) | NR (NR, NR) | 25 (19, NR) |
| Hazard ratio (95% CI) Based on stratified Cox regression model | 0.54 (0.41, 0.71) | |
| p-value Based on stratified log-rank test | <0.0001 | |
| Overall Survival | ||
| Patients with event, n (%) | 115 (26) | 70 (31) |
| Median, months (95% CI) | NR (NR, NR) | NR (NR, NR) |
| Hazard Ratio (95% CI) | 0.78 (0.58, 1.05) | |
| p-value | NS | |
| NUBEQA with docetaxel (N=651) | Placebo with docetaxel (N=654) One patient in the placebo arm was excluded from all analyses due to the violation of Good Clinical Practices | |
|---|---|---|
| NR: not reached | ||
| Overall survival | ||
| Deaths (%) | 229 (35) | 304 (46) |
| Median in months (95% CI) | NR (NR, NR) | 48.9 (44.4, NR) |
| Hazard Ratio (95% CI) Hazard ratio < 1 favors NUBEQA | 0.68 (0.57, 0.80) | |
| P-value P-value is one-sided, and based on a log-rank test stratified by extent of disease (non-regional lymph nodes metastases only or bone metastases with or without lymph node metastases or visceral metastases with or without lymph node metastases or with or without bone metastases) and Alkaline Phosphatase (ALP < ULN or ALP ≥ ULN) | <0.0001 | |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
Ready to save on Nubeqa?
Compare prescription prices at over 70,000 pharmacies and start saving today—no enrollment required.
Compare Nubeqa Prices