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Fong, Peter C.C.; Retz, Margitta; Drakaki, Alexandra; Massard, Christophe; Berry, William R.; Romano, Emanuela; De Bono, Johann S.; Feyerabend, Susan; Appleman, Leonard Joseph; Conter, Henry Jacob; Sridhar, Srikala S.; Shore, Neal D.; Linch, Mark David; Joshua, Anthony M.; Gurney, Howard; Wu, Helen; Schloss, Charles; Poehlein, Christian Heinrich; Yu, Evan Y.

Pembrolizumab (pembro) plus enzalutamide (enza) in abiraterone (abi)-pretreated patients (pts) with metastatic castrate resistant prostate cancer (mCRPC): Cohort C of the phase 1b/2 KEYNOTE-365 study

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  • Medientyp: E-Artikel
  • Titel: Pembrolizumab (pembro) plus enzalutamide (enza) in abiraterone (abi)-pretreated patients (pts) with metastatic castrate resistant prostate cancer (mCRPC): Cohort C of the phase 1b/2 KEYNOTE-365 study
  • Beteiligte: Fong, Peter C.C.; Retz, Margitta; Drakaki, Alexandra; Massard, Christophe; Berry, William R.; Romano, Emanuela; De Bono, Johann S.; Feyerabend, Susan; Appleman, Leonard Joseph; Conter, Henry Jacob; Sridhar, Srikala S.; Shore, Neal D.; Linch, Mark David; Joshua, Anthony M.; Gurney, Howard; Wu, Helen; Schloss, Charles; Poehlein, Christian Heinrich; Yu, Evan Y.
  • Erschienen: American Society of Clinical Oncology (ASCO), 2019
  • Erschienen in: Journal of Clinical Oncology
  • Sprache: Englisch
  • DOI: 10.1200/jco.2019.37.15_suppl.5010
  • ISSN: 0732-183X; 1527-7755
  • Schlagwörter: Cancer Research ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:p> 5010 </jats:p><jats:p> Background: Pembro has activity as monotherapy in pts with pretreated advanced mCRPC. A phase 2 study suggested that pembro + enza after progression on enza may have clinical activity. Data from cohort C (pembro + enza) of KEYNOTE-365 (NCT02861573), a phase 1b/2 umbrella study to test combinations in mCRPC, are presented. Methods: Pts who were unsuccessful with or became intolerant to ≥4 weeks of abi in the prechemotherapy mCRPC state, with either PSA or radiologic progression within 6 mo before screening were included. Pts received pembro 200 mg IV Q3W with enza 160 mg/day orally. Primary end points were safety and PSA response rate (confirmed PSA decrease ≥50%). Key secondary end points were investigator-assessed ORR (RECIST v1.1), disease control rate (DCR: CR+PR+SD ≥6 mo), time to PSA progression, rPFS, and OS. Results: 69 pts began treatment (median age, 69 y; visceral disease, 26%; measurable disease, 36%). Median (95% CI) follow-up was 9 (7-13) mo. Efficacy is outlined in the table. Treatment-related AEs occurred in 63 (91%) pts; most frequent (≥20%) were fatigue (30%), rash (23%), and nausea (22%). Grade 3/4 treatment-related AEs occurred in 28 (41%) pts; most common was rash (10%); no deaths were from treatment-related AEs. Conclusions: The pembro + enza combination showed sustained activity in abi-pretreated chemotherapy-naive mCRPC. AEs were considered tolerable for the treatment combination; incidence of rash resolved with standard-of-care treatment. Clinical trial information: NCT02861573. [Table: see text] </jats:p>
  • Zugangsstatus: Freier Zugang