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    Association details:
    Biomarker:FGFR mutation
    Cancer:Urothelial Cancer
    Drug:Balversa (erdafitinib) (FGFR inhibitor, FGFR1 inhibitor, FGFR4 inhibitor, FGFR2 inhibitor, FGFR3 inhibitor) +
    cetrelimab (JNJ-63723283) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    ESMO 2021
    Title:

    LBA27 - Erdafitinib (ERDA) or ERDA plus cetrelimab (CET) for patients with metastatic or locally advanced urothelial carcinoma (mUC) and Fibroblast Growth Factor Receptor alterations (FGFRa): First phase (Ph) II results from the NORSE study

    Published date:
    09/13/2021
    Excerpt:
    NORSE Ph 2 is enrolling pts ≥ 18 y with mUC, select FGFRa (mutation/fusion)...Efficacy data in response-evaluable pts are shown in the table....RDA + CET showed clinically meaningful responses in cis-ineligible patients with 1L mUC and FGFRa.
    Trial ID:
    NORSE
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2020
    Title:

    752P - Updated data from the NORSE trial of erdafitinib (ERDA) plus cetrelimab (CET) in patients (pts) with metastatic or locally advanced urothelial carcinoma (mUC) and specific fibroblast growth factor receptor (FGFR) alterations

    Published date:
    09/14/2020
    Excerpt:
    Adult pts with mUC and specific FGFR alterations who progressed after ≥ 1 prior systemic therapy...received 240 mg CET intravenously + 1 of 3 ERDA doses….Confirmed ORR in 11 evaluable pts treated at the RP2D was 55%...and disease control rate...was 100%....The combination of ERDA and CET is tolerable and associated with promising antitumor activity. ERDA 8 mg Upt + CET 240 mg was established as RP2D.
    Trial ID:
    NORSE
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2020
    Title:

    Evolving development of PD-1 therapy: Cetrelimab (JNJ-63723283) from monotherapy to combination with erdafitinib.

    Published date:
    05/13/2020
    Excerpt:
    In the phase 1 combination study (NORSE), pts with mUC + FGFR alt (n=17) received fixed-dose CET IV 240 q2w + ERD 6mg, 8 mg or 8mg + up titration (UpT) to 9 mg to establish the RP2D for the combination as CET + ERD 8mg + UpT. In the RP2D group (n=10), 60% had treatment-related grade ≥3 AEs. ORR (all confirmed PR) was 50% in the all treated response-evaluable group (n=16)....In NORSE phase 1, CET+ ERD demonstrated antitumor activity in mUC with an acceptable safety profile.
    DOI:
    10.1200/JCO.2020.38.15_suppl.3055