Tecentriq plus chemotherapy showed a statistically significant improvement in progression-free survival compared with platinum-based chemotherapy alone for the first-line initial treatment of patients with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) eligible and ineligible for cisplatin chemotherapy.
Genentech, a member of the Roche Group, sponsored the phase III IMvigor130 study.
The median PFS of Tecentriq plus chemotherapy compared with platinum-based chemotherapy alone was 8.2 versus 6.3 months; [HR]=0.82, 95% CI: 0.70-0.96; p=0.007.
Encouraging overall survival results were observed for Tecentriq plus chemotherapy compared with chemotherapy alone in the intention-to-treat population, however these data did not reach statistical significance at this interim analysis (median OS=16.0 versus 13.4 months; HR=0.83, 95% CI: 0.69-1.00).
Safety in the Tecentriq plus chemotherapy arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
“There remains a high unmet need for people with advanced bladder cancer, where chemotherapy alone is the current standard of care. These results reinforce the role of immunotherapy in treating this aggressive disease,” Chief Medical Officer and head of Global Product Development at Roche/Genentech, Sandra Horning, said in a statement.
Additional data from the Tecentriq monotherapy arm were also presented in the ITT population and people with different levels of PD-L1 expression. Encouraging OS results were observed with Tecentriq monotherapy in people with high PD-L1 expression (IC2/3), however these data were not formally tested per the hierarchical design of the trial. Follow-up will continue until the next analysis.
These data were presented at ESMO Sept. 30.
Tecentriq was the first cancer immunotherapy approved in advanced bladder cancer. Tecentriq has accelerated approval from tFood and Drug Administration for treatment of adults with locally advanced or mUC, including those who are not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1 (PD-L1–stained tumor-infiltrating immune cells covering ≥5% of the tumor area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The accelerated approval also includes the treatment of adults with locally advanced or mUC whose disease had progressed during or following platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). These accelerated approvals are based on tumor response rate and durability of response. Continued approval in these types of bladder cancer may be contingent upon verification and description of clinical benefit in a confirmatory trial.
There are four ongoing phase III studies evaluating Tecentriq alone and in combination with other medicines in early and advanced bladder cancer. Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
