![]() Medical writing support was provided by Valerie Hilliard, PhD, and funded by Pharmacyclics LLC, an AbbVie Company. Table: 754Pīest response by prior therapy and organ Response, n (%) No unexpected safety signals were observed. Ibr + pac showed activity in pts with aUC previously treated with platinum-based therapy. Analysis of baseline tumor biopsies (n=43) found that responders (n=18) had a nonsignificant trend toward higher gene expression of ibr targets (BTK, ErbB2, and ITK) vs pts with PD (n=10). Grade ≥3 adverse events occurred in 83% of pts major hemorrhage occurred in 4 pts (6%). One pt (2%) is still on treatment and 7 pts (11%) are still in follow-up. Median duration of response (DOR) was 4 mo (90% CI 3–5) maximum DOR was 24 mo. DCR was 65%, with an ORR of 27% and CR of 5% (Table). Median PFS was 4 mo (90% CI 3–4) median OS was 8 mo (90% CI 7–10). 68% of pts previously had a checkpoint inhibitor. Median age was 67 y 54% of pts had 2 prior therapies. ResultsĦ3 pts were treated with ibr (560 mg, n=4 840 mg, n=59) + pac with a median follow-up of 21 mo. Biomarker analysis of baseline tumor biopsies was done by NanoString gene expression assay. Additional endpoints included efficacy (overall response rate, disease control rate, and overall survival ), and safety. ![]() The primary endpoint was progression-free survival (PFS). Pts received once-daily ibr (at a starting dose of 560 mg or recommended phase 2 dose of 840 mg) in combination with weekly IV pac 80 mg/m 2 in 21-d cycles until unacceptable toxicity or progressive disease (PD). Pts treated with a prior BTK inhibitor were excluded. Ibr + pac was assessed in pts with aUC previously treated with platinum-based chemotherapy who had an ECOG performance status of 0–1. The combination of ibr + pac was evaluated in the aUC cohort of the phase 1b/2 study (NCT02599324). In vitro, ibr has been shown to mitigate resistance to pac (Zhang Mol Cancer Ther 2017). Ibr, a once-daily Bruton’s tyrosine kinase (BTK) inhibitor approved for various B-cell malignancies, also inhibits other kinases, such as ITK and ETK (Wang Clin Cancer Res 2018), that are upregulated in UC. 16 Medical Oncology, Hospital Clinic of Barcelona Hospital Clinic i Provincial de Barcelona, 08036 - Barcelona/ES.15 Surgical Oncology, Pharmacyclics LLC, an AbbVie Company, 94085 - Sunnyvale/US.14 Clinical Research, Pharmacyclics LLC, an AbbVie Company, 94085 - Sunnyvale/US.13 Biostatistics, Pharmacyclics LLC, an AbbVie Company, 94085 - Sunnyvale/US.12 Immunology, Pharmacyclics LLC, an AbbVie Company, 94085 - Sunnyvale/US.11 Medical Oncology/hematology, Clearview Cancer Institute, 35805 - Huntsville/US.10 Medical Oncology, Severance Hospital, Yonsei University Health System, 03722 - Seoul/KR.9 Medical Oncology, Hospital Universitario Ramon y Cajal, 28034 - Madrid/ES.8 Medical Oncology, Oxford University Hospitals NHS Trust - Churchill Hospital - Oxford Cancer and Haematology Centre, OX3 7LE - Oxford/GB.7 Division Of Hematology/ Oncology, Karmanos Cancer Institute, 48201 - Detroit/US.6 Drug Development, Sarah Cannon Research Institute - United Kingdom (SCRI-UK) - London Office, W1G 6AD - London/GB.5 Internal Medicine/hemato-oncology, Chonnam National University Hwasun Hospital, 58128 - Hwasun/KR.4 Internal Medicine, Seoul National University Hospital, 03080 - Seoul/KR.3 Medical Oncology, Hospital Universitario Marques de Valdecilla, 39008 - Santander/ES.2 Medical Oncology, Vall d’Hebron Institute of Oncology, Vall d’ Hebron University Hospital, Universitat Autònoma de Barcelona, 08035 - Barcelona/ES.1 Medical Oncology Department, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES.
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