About NUBEQA® (darolutamide) in mHSPC

NUBEQA + ADT in combination with docetaxel was investigated in ARASENS, a double-blind, placebo-controlled, multi-centre study. This study analysed 1,305 men with mHSPC (de novo + recurrent) who were randomised 1:1 to two arms: NUBEQA + ADT + docetaxel (n=651) and placebo + ADT + docetaxel (n=654). The primary endpoint of the study was overall survival (OS).

^* The secondary endpoints were tested with a hierarchical gatekeeping procedure. If the primary endpoint or a secondary endpoint did not reach significance, the hierarchical procedure was stopped, and subsequent analyses were considered to be exploratory.

NUBEQA's efficacy is backed by robust clinical data and supported by international guidelines. NUBEQA is the only NICE-recommended and SMC-accepted therapy in combination with ADT and docetaxel.

For your patients with mHSPC who need treatment intensification, NUBEQA added to ADT and docetaxel can extend their overall survival by >30% vs. ADT and docetaxel alone.

NUBEQA + ADT + docetaxel: 32.5% reduced risk of death vs. placebo + ADT + docetaxel (primary endpoint)

^†

Adapted from Smith M et al. 2022.

• At 4 years, the overall survival rate with NUBEQA + ADT + docetaxel was 62.7% (95% CI: 58.7–66.7%) vs. 50.4% (95% CI: 46.3–54.6%) with placebo + ADT + docetaxel.

^† ARASENS trial. Men with mHSPC. NUBEQA + ADT + docetaxel (n=651) vs. placebo + ADT + docetaxel (n=654). Primary endpoint was OS. 32.5% reduction in risk of death vs. placebo + ADT + docetaxel. Number of patients with events 229/651 (35.2%) vs. 304/654 (46.5%) with placebo + ADT + docetaxel. Median OS: NE months vs. 48.9 months with placebo + ADT + docetaxel (HR: 0.68; 95% CI: 0.57–0.80; p<0.001). Docetaxel 75 mg/m² q3w x 6 cycles.

After completing all docetaxel cycles, patients with mHSPC remained on treatment with NUBEQA and ADT longer than those on ADT + placebo (median 41.0 months vs 16.7 months).

Adapted from NUBEQASummary of Product Characteristics and data on file.

• Discontinuation rates due to AEs were 13.7% (NUBEQA with docetaxel and ADT) vs. 10.6% (Placebo with docetaxel and ADT).

^† Adverse reactions incidences may not be attributable to darolutamide alone but may contain contributions from other medicinal products used in combination.

^‡ Includes rash, rash maculopapular, drug eruption, rash pruritic, rash erythematous, rash follicular, rash pustular, rash vesicular, erythema, dermatitis. The incidence was highest during the first 6 months of treatment.

^# Includes hypertension, blood pressure increased, hypertensive emergency.

mHSPC patients should start NUBEQA in combination with docetaxel. The first of 6 cycles of docetaxel should be administered within 6 weeks after the start of NUBEQA treatment. The recommendation in the product information of docetaxel should be followed. Treatment with NUBEQA should be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued.

For more information about dosing modifications, missed doses, special warnings, precautions and interactions, please refer to the Summary of Product Characteristics.

NUBEQA is the only ARi in combination with docetaxel to be accepted for use by the SMC and recommended by NICE in mHSPC.

Approved by NICE

Recommended as a treatment with androgen deprivation therapy (ADT) and docetaxel for adult men with hormone-sensitive metastatic prostate cancer.

SMC accepted

For treatment of adults with hormone-sensitive prostate cancer in combination with docetaxel and ADT.

Combining three different modes of action offers you a different approach to potentially extending survival in mHSPC vs placebo + ADT + docetaxel.