Andy Hahn: Tweetorial for our phase II trial of pre-operative apalutamide monotherapy for localized IRPCa led by John W. Davis

Andy Hahn, Genitourinary Medical Oncologist at MD Anderson Cancer Centre, shared on X:

“Tweetorial for our phase II, investigator-initiated trial of 6 months, pre-operative apalutamide monotherapy for men with localized IRPCa led by John W. Davis and the MD Anderson Cancer Center Uro Onc team in BJU International.

Hypothesis: pre-op apalutamide would decrease risk of path features associated with recurrence (pT3a-b, pN1, or PSM) from 35% to 15%. The study did not meet the 1° endpoint with adverse path features in 40%. Apa monotx was generally well tolerated with 4 pts d/c tx for TEAE

In RP tissue after apa monotx, bulk RNASeq showed adverse path features were associated with upregulation of cell cycle and plasticity pathways previously implicated in mCRPC and NE transformation

We performed GSEA supervised by BCR status and found similar trends. Since our endpoint relied on pT stage, we validated findings in UNTREATED Gleason 7 tumors from TCGA (n=246) and found upregulation of similar cell cycle and plasticity pathways in treatment-naïve tumors

Check out paper for additional somatic DNA NGS, germline DNA, and IHC studies. Thank you to the patients and families who participated and J&J Innovative Medicine for supporting.”

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Source: Andy Hahn/X