Abstract 630P
Background
To compare time on apalutamide (APA), used as a proxy for time to progression, in high-risk nmCRPC patients (pts) (PSADT ≤10 months) administered with APA in an international NPP reflecting real life clinical practice and in the previously reported phase III SPARTAN study.
Methods
Since the NPP opened in March 2018, a total of 556 pts with nmCRPC have received APA pre-approval administration in 34 countries. In compliance with local rules, patient level data were available for analysis from 265 pts including Germany (41%), Italy (19%), Ireland (8%), UK (7%), and compared to data from pts in the phase III SPARTAN study (n=806). Based on a same initial follow-up of 10 mo for both cohorts, time on APA was compared using Kaplan Meier analyses and multivariable Cox proportional hazards regression, adjusting for the baseline characteristics age and PSADT. Pts still on APA at the time of data cut were censored.
Results
Median age (range) for NPP and SPARTAN was 74 (49-93) and 74 (48-94) yrs respectively, with % pts at age >80 being slightly higher in NPP (29.3% vs 25.8%). The % of pts with PSADT <6 mo in the two groups was 66% and 71.5%, respectively. The proportion still on APA at 10 mo was 83.0% (NPP) vs 78.8% (SPARTAN). Main reasons for discontinuation in the first 10 mo in NPP vs SPARTAN were investigator-assessed progressive disease (28.1% vs 28.2%), adverse events (31.4% vs 42.4%) or withdrawal by pt (21.9% vs 22.9%). Pts with older age (>75: HR=3.13 [p<0.0001], 65-74: HR=1.61 [p=0.122] vs age<65) were more at risk for earlier treatment discontinuation. The risk of APA discontinuation in the first 10 mo in NPP vs SPARTAN was HR= 0.72 [0.49; 1.06], adjusted for age and PSADT (vs HR=0.70 unadjusted). No new safety signals were identified in the NPP vs SPARTAN.
Conclusions
This is the first report on real world nmCRPC pts administered with APA. This report demonstrates a trend towards improved rates of APA continuation after first 10 mo follow up compared with those previously reported in a large phase III study. The reasons for APA discontinuation during first 10 mo of APA administration also appear to be comparable.
Clinical trial identification
Editorial acknowledgement
Editorial assistance was provided by Ramji Narayanan of SIRO Clinpharm Pvt Ltd, funded by Janssen Global Services, LLC.
Legal entity responsible for the study
Janssen Research & Development.
Funding
Janssen Research & Development.
Disclosure
H.A. Payne: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Astellas Pharma; Honoraria (self): Bayer; Honoraria (self): Ferring; Honoraria (self), Advisory/Consultancy: Aranda Pharma; Honoraria (self): Sanofi; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Janssen -Cilag; Advisory/Consultancy: Accord. G. Procopio: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Janssen; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer. L. Antoni: Full/Part-time employment: Janssen. J. Diels: Full/Part-time employment: Janssen. A. Lopez-Gitlitz: Full/Part-time employment: Janssen. S. McCarthy: Full/Part-time employment: Janssen. S.D. Mundle: Full/Part-time employment: Janssen. G. Pissart: Full/Part-time employment: Janssen. All other authors have declared no conflicts of interest.