Patients in Cohort A were all previously treated with docetaxel (treatment with 1 other chemotherapy and <=2 second-generation hormonal treatments allowed). Once treatment with pembro commenced, it was continued until progression or a maximum of 35 treatment cycles (up to 2 years); treatment with olaparib is continued until progression. If patients discontinue treatment in one cohort due to adverse events (AE), they may continue the study with the other combination drugs. Some notable inclusion criteria include adenocarcinoma of the prostate without small cell histology, available biopsy tissue from a metastatic lesion within 1 year of screening and after developing mCRPC, cancer progression within 6 months prior to screening, castrate testosterone level and ECOG 0 or 1. The primary outcome measures include the percentage of patients with a decrease of >=50% in prostate-specific antigen (PSA), number of patients with AE, number of patients discontinuing the study due to AEs and objective response rate (ORR) based on RECIST 1.1.
With a median follow-up of 11 months, 41 patients started treatment. The median age was 69 years, 27% were PD-L1 +, 42% had visceral disease, 68% had RECIST-measurable disease, 0% had a homologous recombination repair mutation (HRR). Treatment-related AEs occurred in 39 (95%) with the most frequent being anemia (37%), fatigue (34%), and nausea (34%). Grade 3-5 treatment AEs occurred in 21 (51%). There were two deaths, one of which was treatment-related (cause unknown).
KEYNOTE-365: Yu, E.Y. et al. European Urology Supplements, Volume 16, Issue 3, e360
In conclusion, a combination of pembro + olaparib in HRR wild-type patients previously treated with docetaxel for mCRPC is under present investigation, with early results as summarized above.
Presented by: Evan Y. Yu, MD, Professor, Department of Medical Oncology, University of Washington School of Medicine, Member, Clinical Research Division, Fred Hutchinson Cancer Research Center, Assistant Fellowship Director, Hematology and Oncology Fellowship Training Program, University of Washington and Fred Hutchinson Cancer Research Center, Clinical Trials Core Director, Genitourinary Medical Oncology, Seattle Cancer Care Alliance
Written by: Selma Masic, MD, Urologic Oncology Fellow (SUO), Fox Chase Cancer Center, @selmasic at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA
Written by: Selma Masic, MD, Urologic Oncology Fellow (SUO), Fox Chase Cancer Center, @selmasic at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA