The ACCEPT and ProCAID trials

09 Dec 2020
Announcement
ACCEPT Trial 
The initial analysis has been completed for the Southampton-based phase Ib/II ACCEPT study. From May 2017 to Jan 2020, 38 patients, with newly diagnosed diffuse large B-cell lymphoma, were enrolled with all patients receiving 6 cycles of R‐CHOP therapy on a standard 21‐day schedule, with the addition of acalabrutinib in cycles 2‐6. A continuation phase of acalabrutinib only, for 2 cycles of 28 days administered after R-CHOP. The primary objective of the phase Ib was to establish a recommended phase II dose (RP2D) of acalabrutinib in combination with R‐CHOP. Phase II assessed the overall response rate (ORR) of the combination and ascertained additional safety information.
Results were presented in a poster presentation at ASH this December (2020).  
 
ProCAID Trial presents results
The main analysis has been completed for the Southampton-based ProCAID study. ProCAID is a placebo controlled randomised phase II trial in patients suitable for chemotherapy with mCRPC. Patients received up to ten 21 day cycles of docetaxel (75 mg/m2 IV, day 1) and prednisolone (5 mg bd oral, day 1 to 21) and were randomly assigned to oral capivasertib (320 mg twice daily, 4 days on/3 days off, from cycle 1, day 2), or matched placebo, until disease progression. The primary objective, by intention to treat, was to determine if addition of capivasertib prolonged progression-free survival. Progression free and overall survival were also assessed by composite biomarker subgroup for PI3K/AKT/PTEN pathway activation status. 
 
150 patients were enrolled between October 2015 and January 2019. Median follow up was 16.77 months (IQR 12.0-26.5). Median progression free survival was 7.03 (95% confidence interval (CI) 6.28-8.25) and 6.7 months (95% CI 5.52-7.36) in the capivasertib and placebo arms respectively (hazard ratio (HR) 0.92, 80% CI 0.73-1.16; 1-sided p=0.32). Median overall survival was 31.15 (95% CI 20.07-not reached) and 20.27 months (95% CI 17.51-24.18) respectively (HR 0.54, 95% CI 0.34-0.88; 2-sided p=0.01). Progression free and overall survival results were consistent irrespective of PI3K/AKT/PTEN pathway activation status.
 
Results were presented in a poster discussion session at ASCO earlier this year  and have been accepted for publication in the Journal of Clinical Oncology (currently in press).