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Girardi, Daniel M.; Niglio, Scot A.; Mortazavi, Amir; Nadal, Rosa; Lara, Primo; Pal, Sumanta K.; Saraiya, Biren; Cordes, Lisa; Ley, Lisa; Ortiz, Olena Sierra; Cadena, Jacqueline; Diaz, Carlos; Bagheri, Hadi; Redd, Bernadette; Steinberg, Seth M.; Costello, Rene; Chan, Keith S.; Lee, Min-Jung; Lee, Sunmin; Yu, Yunkai; Gurram, Sandeep; Chalfin, Heather J.; Valera, Vladimir; Figg, William D.; [...]

Cabozantinib plus Nivolumab Phase I Expansion Study in Patients with Metastatic Urothelial Carcinoma Refractory to Immune Checkpoint Inhibitor Therapy

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  • Medientyp: E-Artikel
  • Titel: Cabozantinib plus Nivolumab Phase I Expansion Study in Patients with Metastatic Urothelial Carcinoma Refractory to Immune Checkpoint Inhibitor Therapy
  • Beteiligte: Girardi, Daniel M.; Niglio, Scot A.; Mortazavi, Amir; Nadal, Rosa; Lara, Primo; Pal, Sumanta K.; Saraiya, Biren; Cordes, Lisa; Ley, Lisa; Ortiz, Olena Sierra; Cadena, Jacqueline; Diaz, Carlos; Bagheri, Hadi; Redd, Bernadette; Steinberg, Seth M.; Costello, Rene; Chan, Keith S.; Lee, Min-Jung; Lee, Sunmin; Yu, Yunkai; Gurram, Sandeep; Chalfin, Heather J.; Valera, Vladimir; Figg, William D.; [...]
  • Erschienen: American Association for Cancer Research (AACR), 2022
  • Erschienen in: Clinical Cancer Research, 28 (2022) 7, Seite 1353-1362
  • Sprache: Englisch
  • DOI: 10.1158/1078-0432.ccr-21-3726
  • ISSN: 1078-0432; 1557-3265
  • Schlagwörter: Cancer Research ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Purpose:</jats:title> <jats:p>This study investigated the efficacy and tolerability of cabozantinib plus nivolumab (CaboNivo) in patients with metastatic urothelial carcinoma (mUC) that progressed on checkpoint inhibition (CPI).</jats:p> </jats:sec> <jats:sec> <jats:title>Patients and Methods:</jats:title> <jats:p>A phase I expansion cohort of patients with mUC who received prior CPI was treated with cabozantinib 40 mg/day and nivolumab 3 mg/kg every 2 weeks until disease progression/unacceptable toxicity. The primary goal was objective response rate (ORR) per RECIST v.1.1. Secondary objectives included progression-free survival (PFS), duration of response (DoR), overall survival (OS), safety, and tolerability.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>Twenty-nine out of 30 patients enrolled were evaluable for efficacy. Median follow-up was 22.2 months. Most patients (86.7%) received prior chemotherapy and all patients received prior CPI (median seven cycles). ORR was 16.0%, with one complete response and three partial responses (PR). Among 4 responders, 2 were primary refractory, 1 had a PR, and 1 had stable disease on prior CPI. Median DoR was 33.5 months [95% confidence interval (CI), 3.7–33.5], median PFS was 3.6 months (95% CI, 2.1–5.5), and median OS was 10.4 months (95% CI, 5.8–19.5). CaboNivo decreased immunosuppressive subsets such as regulatory T cells (Tregs) and increased potential antitumor immune subsets such as nonclassical monocytes and effector T cells. A lower percentage of monocytic myeloid-derived suppressor cells (M-MDSC) and polymorphonuclear MDSCs, lower CTLA-4 and TIM-3 expression on Tregs, and higher effector CD4+ T cells at baseline were associated with better PFS and/or OS.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>CaboNivo was clinically active, well tolerated, and favorably modulated peripheral blood immune subsets in patients with mUC refractory to CPI.</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang