Results presented Monday at the European Society for Medical Oncology (ESMO) congress showed that the combination of Roche's Tecentriq (atezolizumab) and platinum-based chemotherapy reduced the likelihood of disease progression by 18% compared with chemotherapy alone in patients with previously untreated locally advanced or metastatic urothelial carcinoma. In the Phase III IMvigor130 study, after a median follow-up of 11.8 months, Tecentriq plus chemotherapy showed a statistically significant improvement in progression-free survival (PFS) compared to chemotherapy alone with median PFS of 8.2 months and 6.3 months, respectively, in the two treatment groups.
In the study, 1213 patients with metastatic urothelial cancer were randomly assigned to treatment with Tecentriq plus platinum-based chemotherapy, Tecentriq alone or platinum-based chemotherapy alone.
In August, Roche announced that the trial hit its co-primary endpoint of PFS, adding at the time that at the interim analysis for the other dual main goal, the combination of Tecentriq and platinum-based chemotherapy showed "encouraging" overall survival (OS) results, adding however that the OS data were not yet mature and follow-up will continue until the next planned analysis. Interim analysis data presented at ESMO, indicated that the median OS was 16 months in the Tecentriq plus chemotherapy arm, which did not reach statistical significance compared to 13.4 months for chemotherapy alone.
Study author Enrique Grande remarked "this is a new option for the upfront treatment of patients with metastatic urothelial cancer, adding "longer follow-up is needed on [OS] and we will continue to search for biomarkers to identify which patients respond best to this therapy."
Roche noted that in addition to the primary endpoints, the study secondary endpoints included objective response rate (ORR) and duration of response, with ORR of 47% for the combination arm versus 44% for chemotherapy alone. Meanwhile, the ORR for Tecentriq monotherapy was 23%.
In addition, the complete response rates in the Tecentriq and chemotherapy combination, Tecentriq alone and chemotherapy alone arms were 13%, 6% and 7%, respectively. Meanwhile, according to the drugmaker, the rates of treatment discontinuation due to adverse events were 34% in both the combination and chemotherapy alone groups, compared with 6% for the Tecentriq alone arm.
Commenting on the results, Ignacio Durán of the Hospital Universitario Marques de Valdecilla-IDIVAL noted that the "complete responses.... were around twice as likely with the combination compared to chemotherapy or immunotherapy alone", adding "we are now eager to see if patients receiving the two therapies together live longer, and with a similar quality of life, than those receiving chemotherapy and immunotherapy alone or sequentially." Duran continued "the interim analysis of overall survival seems to be promising, but data are immature: overall survival data are needed to consider the combination of chemotherapy and immunotherapy as a new standard of care.”
Roche noted that follow-up for endpoints including OS will continue until the next analysis. The drugmaker said that four Phase III studies evaluating Tecentriq alone and in combination with other medicines in early and advanced bladder cancer are currently ongoing.
Tecentriq was awarded accelerated approval by the FDA in 2016 for the treatment of locally advanced or metastatic urothelial carcinoma based on tumour response rate and duration of response results from the IMvigor210 study. The following year, Roche unveiled data from the confirmatory Phase III IMvigor211 study illustrating that the drug failed to increase survival versus chemotherapy in advanced bladder cancer study.
Sales of Tecentriq for the first six months of 2019 increased by 141% year-over-year to CHF 782 million ($784 million).
Meanwhile, Roche announced other data at the ESMO congress last week, which showed that Tecentriq extended OS by 7.1 months compared with chemotherapy in the first-line treatment of certain patients with advanced non-squamous and squamous non-small-cell lung cancer.
For related analysis, see ViewPoints: Roche hoping IMvigor130 gets Tecentriq back in the urothelial cancer game.
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