Treat early to give your mHSPC patients the chance to live longer[1]
With ERLEADA® + ADT, the TITAN final analysis shows you can extend life and offer additional clinical benefits vs. placebo + ADT.[1]a
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aPatients with severe angina, myocardial infarction, congestive heart failure, arterial or venous thromboembolic events, a history of or predisposition to seizure, or recent ventricular arrhythmias were excluded.[2]
Reduction in risk of death at almost 4 years[1]
An IPCW crossover analysis of OS was performed to adjust for the 208 patients in the placebo + ADT group that crossed over to ERLEADA® + ADT treatment at unblinding.[1]
OS in the unadjusted patient population[1]b
Adapted from Chi KN, et al. 2021.
bOS and rPFS were dual primary endpoints of the TITAN study.[2]
OS adjusted for patient crossover[1]
Adapted from Chi KN, et al. 2021.
What is a crossover-adjusted analysis and what can it show?
The IPCW model is frequently used to correct for bias of crossover patients in oncology trials.[3]
After unblinding, 208 patients without disease progression in the placebo + ADT group crossed over to receive open-label ERLEADA® + ADT. The median treatment duration with ERLEADA® + ADT in the crossover group was 15.4 months[1]
The IPCW method adjusts for placebo patients who cross over to receive active treatment, to provide a more accurate indication of efficacy of the treatment received[1]
Treat early with ERLEADA® + ADT to delay progression vs. placebo + ADT[1][2]
Treating early with ERLEADA® + ADT gives your mHSPC patients the chance to live longer.[2]
Radiographic progression-free survival[2]c
Adapted from Chi KN, et al. 2019.
crPFS: time from randomisation to first imaging-based documentation of progressive disease or death, whichever occurred first.[2]
Maintain the benefits of ERLEADA® + ADT through
to the next line of therapy[1]
ERLEADA® + ADT maintains benefits through to the next line of therapy, significantly reducing the risk of PFS2 or death on the subsequent treatment compared with placebo + ADT.[1]
Time to second progression or death (PFS2) – exploratory endpoint[1]
Why is PFS2 relevant?
- PFS2 assesses the impact of a therapy on two subsequent lines of treatment[4]
- PFS2 is a validated surrogate endpoint for OS according to the EMA[4]
- PFS2 reflects the advantage of early treatment[1]
Measuring PFS2[1][2]
In the TITAN study, PFS2 was defined as time from randomisation to the first occurrence of investigator-determined disease progression (PSA progression, progression on imaging or clinical progression) on first subsequent therapy or death.[2]
Adapted from Chi KN, et al. 2021.
Click below to see how you can give your patients a better chance of delaying progression with ERLEADA® + ADT vs. placebo + ADT[1][2]
Treat early with ERLEADA® + ADT to delay time to initiation of cytotoxic chemotherapy.[1]
Time to initiation of cytotoxic chemotherapy – secondary endpoint[1]
ERLEADA® + ADT prolonged median time to PSA progression compared with placebo + ADT.[1]
Time to PSA progression – exploratory endpoint[1]d
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Adapted from Chi KN, et al. 2021.
dTime to PSA progression: time from randomisation to date of PSA progression based on Prostate Cancer Working Group 2 criteria.
Prolong median time to castration resistance with ERLEADA® + ADT vs. placebo + ADT[1]
Time to castration resistance[1]
Other secondary endpoints[1]
The secondary endpoints of time to pain progression, time to chronic opioid use, and time to skeletal-related event all favoured ERLEADA® + ADT over placebo + ADT.[1]
Treating early with ERLEADA® + ADT delays disease progression
in mHSPC patients and gives them the chance to live longer vs. placebo + ADT[1]
Click below to find out more about the clinical benefits with ERLEADA® + ADT:
Give patients with mHSPC the opportunity for an additional treatment option upon disease progression[1][2]
Extend life across a broad range of mHSPC patients with ERLEADA® + ADT[1]
Push back on progression and maintain QoL in mHSPC[1]
Abbreviations
ADT, androgen deprivation therapy. CI, confidence interval. EMA, European Medicines Agency. HR, hazard ratio. IPCW, inverse probability of censoring weighting. ITT, intention-to-treat. mCRPC, metastatic castration-resistant prostate cancer. mHSPC, metastatic hormone-sensitive prostate cancer. OS, overall survival. PFS2, second progression-free survival. PSA, prostate-specific antigen. QoL, quality of life. rPFS, radiographic progression-free survival.
Titular da Autorização de Introdução no Mercado: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Bélgica.
Para mais informações deverá contactar o Representante do Titular da Autorização de Introdução no Mercado: Janssen-Cilag Farmacêutica, Lda.
Medicamento de receita médica restrita, de utilização reservada a certos meios especializados.
Antes de prescrever consulte o RCM completo.
RCM de Erleada®, veja aqui
