Gustave Roussy Cancer Campus and University Paris-Sud, Villejuif, France
Christophe Massard , Margitta Retz , Peter Hammerer , Fernando Quevedo , Peter C.C. Fong , William R. Berry , Howard Gurney , Josep M. Piulats , Anthony Joshua , Mark David Linch , Michael Kolinsky , Emanuela Romano , Srikala S. Sridhar , Henry Jacob Conter , Marinela Augustin , Haiyan Wu , Charles Schloss , Christian Heinrich Poehlein , Evan Y. Yu
Background: Pembro had antitumor activity as monotherapy in pretreated advanced mCRPC (KEYNOTE-028; KEYNOTE-199). KEYNOTE-365 (NCT02861573) is a phase 1b/2 umbrella study testing combinations in mCRPC; we report early results from cohort B combining pembro + docetaxel in mCRPC. Methods: Pts who failed or became intolerant to ≥4 weeks of abi or enza in the pre-chemotherapy mCRPC state received pembro 200 mg IV with docetaxel 75 mg/m2 IV Q3W plus prednisone 5 mg orally twice daily. Pts also progressed within 6 months prior to screening as determined by either PSA progression or radiologic progression in bone or soft tissue. Response was evaluated by PSA levels Q3W and imaging Q9W for first year and Q12W thereafter. Primary end points: safety and PSA response rate (confirmed PSA decline ≥50%). Key secondary end points: investigator-determined ORR (RECIST v1.1), disease control rate (DCR: CR+PR+SD ≥6 mo), time to PSA progression, rPFS, and OS. Results: 72 pts (median age 68 years; PD-L1+ 29%; visceral disease 36%; measurable disease 50%) initiated pembro + docetaxel. Median (95% CI) follow-up was 10 (8-12) mo. Efficacy is outlined in table below. Treatment-related AEs occurred in 69 (96%) pts; most frequent (≥30%) were alopecia (43%), fatigue (40%), and diarrhea (39%). Grade 3-5 treatment-related AEs occurred in 27 (38%) pts, including 2 deaths due to treatment-related AEs (pneumonitis). Conclusions: Combination of pembro + docetaxel/prednisone has activity in pts with mCRPC previously failing anti-hormonal therapy. Observed safety profile for the combination was consistent with known safety profile of each component. Clinical trial information: NCT02861573
PSA response, pts w/elevated PSA at baseline, n/N (%) | 22/66 (33) |
ORR, pts w/measurable disease, n/N (%) | 5/36 (14); 5 PRs |
DCR, n/N (%) | |
Measurable disease | 18/36 (50) |
Nonmeasurable disease | 23/36 (64) |
Total | 41/72 (57) |
Median (range) duration of response, RECIST v1.1, mo | 4.9 (4.0-8.3+) |
Median (95% CI) time to PSA progression, wk | 24 (15,30) |
No confirmed PSA progression at 27 wk, % | 48 |
Median (95% CI) rPFS per PCWG-modified RECIST, mo | 8 (8, 10) |
Median (95% CI) OS, mo | Not reached (12.9, not reached) |
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Abstract Disclosures
2024 ASCO Genitourinary Cancers Symposium
First Author: Amit Bahl
2019 ASCO Annual Meeting
First Author: Christophe Massard
2019 Genitourinary Cancers Symposium
First Author: Peter C.C. Fong
2020 Genitourinary Cancers Symposium
First Author: William R. Berry