– IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer –
– Data will be shared with health authorities globally, including the U.S. Food and Drug Administration (FDA) –
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival (PFS). The combination of Tecentriq® (atezolizumab) plus platinum-based chemotherapy showed a statistically significant reduction in the risk of disease worsening or death in people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone. Encouraging overall survival (OS) results were observed at this interim analysis, however these data are not yet mature and follow-up will continue until the next planned analysis.
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. Results will be presented at an upcoming medical meeting and shared with health authorities globally, including the U.S. Food and Drug Administration (FDA).
“IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer, an aggressive disease with high unmet need,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These results support our broad clinical development program for Tecentriq in bladder cancer, as well as our approach of combining immunotherapy with chemotherapy or other medicines to improve patient outcomes, and we look forward to discussing them with health authorities.”
Tecentriq was the first cancer immunotherapy approved in bladder cancer. Tecentriq has accelerated approval from the FDA for the 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 percent 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.
Currently, 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.
About the IMvigor130 study
IMvigor130 is a multicenter, partially blinded, randomized Phase III study, evaluating the efficacy and safety of Tecentriq in combination with chemotherapy or alone versus chemotherapy alone for people with mUC who have not received prior systemic therapy for metastatic disease. It enrolled 1,213 people that were randomized to receive:
- Tecentriq plus platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin), or
- Tecentriq, or
- Platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin) plus placebo (control arm).
In the Tecentriq combination arm, the co-primary endpoints are OS and PFS as assessed by investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).