256O - Prostate-specific antigen response to different real-world treatments in high-risk metastatic hormone-naïve prostate cancer in J-ROCK registry study

Background

J-ROCK study evaluates the real-world long-term clinical and patient-reported outcomes of Japanese patients (pts) with high-risk metastatic hormone-naïve prostate cancer (mHNPC) and is the largest prostate cancer-related registry in Japan.

Methods

Pts diagnosed with mHNPC from May 2019 and met the LATITUDE study high-risk definition were enrolled based on treatment (Rx) decisions in clinical practice before being divided into cohort (Co)1: androgen deprivation therapy alone (ADT), combined androgen blockade (CAB); Co2: ADT+docetaxel (DTX), ADT+abiraterone acetate plus prednisolone (AAP), ADT+enzalutamide (ENZ), ADT+apalutamide (APA). Clinical outcomes of each Co at interim analysis 2 were presented in the Japanese Urological Association annual meeting 2023. PSA response data from the same analysis were further divided into Co2A (DTX) and Co2B (AAP, ENZ, APA), and reported here.

Results

A total of 974 pts were enrolled, where Co1 had 371 pts (ADT: 121, CAB: 250), Co2A had 27 pts (DTX) and Co2B had 576 pts (AAP: 358, ENZ: 72, APA: 146). Median follow-up period was 22.7 months (m). There were no major differences in baseline patient demographics between Co1 and Co2, except for age and Gleason Score. Median Rx duration was longer for Co2B (AAP: 16.9 m, ENZ: 15.4 m, APA: 15.1 m) than Co1 (ADT: 8.5 m, CAB: 12.0 m) and Co2A (DTX: 8.6 m). Rate of ≥90% PSA decline within 3m were higher in Co2A and Co2B, than Co1 (Co1: 69%, Co2A: 93%, Co2B: 87%). Achievement rate of PSA ≤0.2 ng/ml and ≤0.02 ng/ml within 3m were higher in Co2B (30%, 5.2%) than Co1 (8.6%, 0.5%) and Co2A (3.7%, 0%). In Co2B, APA achieved the highest rate of PSA ≤0.2 ng/ml and ≤0.02 ng/ml within 3m (APA: 39%, 9.6%; AAP: 27%, 4.2%; ENZ: 22%, 1.4%). Rx-related AEs of special interest (AESI) were more frequent for Rx in Co2, and grade 3-4 only seen in Rx in Co2.

Conclusions

Median Rx duration was longer in Co2B (AAP, ENZ, APA) and these life prolonging therapies achieved rapid (3m) and deep PSA response, where APA showed the highest rates. Incidence of Rx-related AESI were higher in Co2, and the AE profiles observed were consistent with prior drug experiences reported in large clinical studies.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Janssen Pharmaceutical K.K.

Funding

Janssen Pharmaceutical K.K.

Disclosure

A. Mizokami: Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen Pharmaceutical K.K. K. Fujimoto: Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Financially compensated role: Janssen Pharmaceutical K.K. H. Miyake: Financial Interests, Personal, Financially compensated role: Janssen Pharmaceutical K.K. H. Uemura: Financial Interests, Institutional, Research Funding: Takeda Pharmaceutical; Financial Interests, Personal, Speaker, Consultant, Advisor: Takeda Pharmaceutical, Janssen Pharmaceutical K.K., Bayer Yakuhin, AstraZeneca, Pfizer; Financial Interests, Personal, Other, Travel fee: Takeda Pharmaceutical, Janssen Pharmaceutical K.K., Bayer yakuhin, Astellas Pharma, Sanofi, Daiichi Sankyo, Kyowa Kirin, Chugai Pharmaceutical; Financial Interests, Personal, Advisory Role: Ono Pharmaceutical. H. Uemura: Financial Interests, Institutional, Research Grant: Astellas Pharmaceutical, Takeda Pharmaceutical, MSD, Janssen Pharmaceutical K.K., Pfizer; Financial Interests, Institutional, Research Funding: AstraZeneca, Ono Pharmaceutical, Osaka Urology Research foundation; Financial Interests, Personal, Speaker, Consultant, Advisor: Takeda Pharmaceutical, Janssen Pharmaceutical K.K., Pfizer, Bristol Myers Squibb, Sanofi, Bayer Yakuhin; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Role: Ono Pharmaceutical; Financial Interests, Personal, Project Lead: Chugai Pharmaceutical. K. Nakamura: Financial Interests, Institutional, Research Grant: AstraZeneca, Eli Lilly & Company, Janssen Pharmaceutical K.K.; Financial Interests, Personal, Invited Speaker: AstraZeneca, Janssen Pharmaceutical K.K., Astellas Pharmaceutical, Bayer Yakuhin, Takeda Pharmaceutical; Financial Interests, Institutional, Research Funding: Tsumura. K. Shibayama: Financial Interests, Personal, Full or part-time Employment: Janssen Pharmaceutical K.K. Y. Tajima: Financial Interests, Personal, Full or part-time Employment: Janssen Pharmaceutical K.K., Ono Pharmaceutical. T. Kamoto: Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen Pharmaceutical K.K., Sanofi, Takeda Pharmaceutical, Astellas Pharmaceutical, AstraZeneca; Financial Interests, Personal, Research Grant: EP-CRSU. H. Matsuyama: Financial Interests, Personal, Advisory Board: Janssen Pharmaceutical K.K. All other authors have declared no conflicts of interest.