Roche said Monday that the combination of Tecentriq (atezolizumab) and platinum-based chemotherapy showed a significant reduction in the risk of disease worsening or death in patients with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone. The company noted that IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in this indication.
The trial randomised 1213 patients with mUC who have not received prior systemic therapy for metastatic disease to receive Tecentriq plus platinum-based chemotherapy, the PD-L1 inhibitor alone or platinum-based chemotherapy plus placebo. Roche said that in the Tecentriq combination arm, the co-primary endpoints are overall survival (OS) and progression-free survival (PFS).
As well as hitting the co-primary endpoint of PFS, Roche indicated that the combination of Tecentriq and platinum-based chemotherapy showed "encouraging" OS results at the interim analysis. The company noted that the OS data are not yet mature and follow-up will continue until the next planned analysis. The drugmaker added that the results will be shared with global health authorities, including the FDA and European Medicines Agency.
Sandra Horning, head of global product development, remarked "these results support our broad clinical development programme 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 first authorised in 2016, when the FDA granted accelerated approval to the drug for the treatment of locally advanced or metastatic urothelial carcinoma based on tumour response rate and duration of response data from the IMvigor210 study. Specifically, the therapy was authorised for patients who have disease progression during or following platinum-based chemotherapy or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
However, Roche reported the following year that the confirmatory Phase III IMvigor211 study failed to meet its primary endpoint of OS compared to chemotherapy. The FDA and European Medicines Agency later restricted use of Tecentriq after an interim analysis of the IMvigor130 trial showed that patients with low PD-L1 expression who received the drug alone had decreased survival compared to those given cisplatin- or carboplatin-based chemotherapy. At the time, the drugmaker stopped enrolling patients whose tumours have PD-L1 low status to monotherapy arm.
Tecentriq was cleared by the FDA in 2017 for the treatment of people with locally advanced or mUC who are not eligible for cisplatin chemotherapy. The drug, which is also approved in the US, Europe and other countries, either alone or in combination with targeted therapies or chemotherapies, for various forms of non-small-cell and small-cell lung cancer, as well as PD-L1-positive triple-negative breast cancer, generated sales of CHF 782 million ($802 million) in the first half of 2019, up 141% year-on-year.
For related analysis, see ViewPoints: Roche hoping IMvigor130 gets Tecentriq back in the urothelial cancer game.
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