A randomized phase 2 trial of pembrolizumab versus pembrolizumab and acalabrutinib in patients with platinum-resistant metastatic urothelial cancer.
Tian ZhangMichael R HarrisonPeter H O'DonnellAjjai S AlvaNoah M HahnLeonard J ApplemanJeremy CetnarJohn M BurkeMark T FlemingMatthew I MilowskyAmir MortazaviNeal ShoreGuru P SonpavdeEmmett V SchmidtBojena BitmanVeerendra MunugalavadlaRaquel IzumiPriti PatelJanet StaatsCliburn ChanKent J WeinholdDaniel J GeorgePublished in: Cancer (2020)
Both treatments were generally well tolerated, although serious AE rates were higher with the combination. Acalabrutinib plus pembrolizumab did not improve the ORR, PFS, or OS in comparison with pembrolizumab alone in mUC. Baseline and on-treatment peripheral monocytic MDSCs were not different in the treatment cohorts. Proliferating CD8+ T-cell subsets increased during treatment, particularly in the combination cohort. Ongoing studies are correlating these peripheral immunome findings with tissue-based immune cell infiltration.