FDA Approves First PD-L1 Inhibitor for Urothelial Carcinoma

The approval is based on a Phase 2 open-label study
The approval is based on a Phase 2 open-label study

Genentech announced that the Food and Drug Administration (FDA) has granted accelerated approval of Tecentriq (atezolizumab) for the treatment patients with locally advanced or metastatic urothelilal carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. 

Tecentriq is the first programmed death-ligand 1 (PD-L1) blocking antibody to be approved. The monoclonal antibody binds with the protein PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity. 

The accelerated approval was based on data regarding tumor response rate and duration of response from the Phase 2 open-label, multi-center, 2-cohort IMvigor 210 study. A total of 310 patients received intravenous Tecentriq 1200mg on Day 1 of 21-day cycles until unacceptable toxicity or either radiographic or clinical progression. The primary endpoint was objective response rate (ORR) using the RECIST v1.1 criteria. The median follow-up time was 14.4 months.

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The data showed an ORR of 14.8% (95% CI: 11.1, 19.3) with complete response seen in 5.5% and partial response seen in 9.4%. The median duration of response (DOR), a secondary endpoint, has not been reached in the overall cohort. In a subset of 59 patients with disease progression following neoadjuvant or adjuvant platinum-containing therapy, treatment with Tecentriq shrank tumors (ORR) in 22% (95% CI: 12.3, 34.7) of patients.

Roche also announced that the FDA has approved the VENTANA PD-L1 (SP142) Assay as a complementary in vitro diagnostic to provide PD-L1 status on patients considering treatment with Tecentriq. This marks the first test to assess the patient's PD-L1 status using immune cell staining and scoring, offering clinicians information that may aid immunotherapy decisions. VENTANA PD-L1 utilizes the OptiView DAB IHC Detection Kit with OptiView Amplification. The Company plans to continue pursuing regulatory approval for the PD-L1 assay in combination with Tecentriq for other cancer indications.   

Continued approval for Tecentriq may be contingent upon clinical benefit in confirmatory trials. Tecentriq is currently under investigation in IMvigor 211, a Phase 3 confirmatory study that compares Tecentriq to chemotherapy in patients whose bladder cancer has progressed on at least 1 prior platinum-containing regimen.

Tecentriq will be available as a 1200mg/20mL (60mg/mL) strength solution for intravenous infusion in single-dose vials. It is anticipated to launch within 1 to 2 weeks. 

For more information call (888) 835-2555 or visit Tecentriq.com.

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