IMvigor210 Pivotal Study for TECENTRIQ

Phase II, multicenter, open-label, 2-cohort trial design in locally advanced or metastatic urothelial carcinoma (n=429) 1,8

Major efficacy endpoints 1

  • Overall response rate (ORR) assessed by IRF using RECIST v1.1
  • Duration of response (DoR)

The study excluded patients who had a history of autoimmune disease; active or corticosteroid-dependent brain metastases; administration of a live, attenuated vaccine within 28 days prior to enrollment; or administration of systemic immunostimulatory agents within 6 weeks or systemic immunosuppressive medications within 2 weeks prior to enrollment.
IRF=independent review facility; IV=intravenous; q3w=every 3 weeks; q9w=every 9 weeks; q12w=every 12 weeks; RECIST=Response Evaluation Criteria In Solid Tumors.
*Previously untreated or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy. Tumor specimens were evaluated prospectively using the VENTANA PD-L1 (SP142) Assay at a central laboratory, and the results were used to define subgroups for pre-specified analyses.
Disease progression during or following at least one platinum-containing chemotherapy regimen or disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.

Cisplatin-ineligible patients met ≥1 criteria at study entry 1

CrCI=creatinine clearance; dB=decibels; ECOG=Eastern Cooperative Oncology Group; PS=performance status.

  • Cisplatin-ineligible cohort included patients who were previously untreated or who progressed at least 12 months after neoadjuvant or adjuvant chemotherapy

Platinum-treated patients defined as having 1

First-Line, Cisplatin-Ineligible Patients

Platinum-Treated Patients