A potential new standard of care: Tecentriq looks promising as a front-line therapy of cisplatin-ineligible advanced and metastatic bladder cancer.
By Dominique Fontanilla, Senior Analyst
8 June 2016
I joined Datamonitor Healthcare’s disease team in 2014 having previously worked as a biochemistry postdoctoral fellow ...
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At ASCO 2016, the first results from the pivotal Phase II IMvigor210 Cohort 1 study assessing Tecentriq (atezolizumab; Roche) as a first-line therapy for cisplatin-ineligible locally advanced/metastatic bladder cancer were presented. Tecentriq demonstrated encouraging and meaningful clinical efficacy and tolerability in the front-line setting. These positive results reinforce Tecentriq’s strong position in this indication as compared to Keytruda (pembrolizumab; Merck & Co), Opdivo (nivolumab; Bristol-Myers Squibb), avelumab (Merck KGaA/ Pfizer), and durvalumab (AstraZeneca), which are currently in Phase III development for the treatment of advanced bladder cancer. Tecentriq gained accelerated FDA approval in May 2016 for second-line platinum-refractory advanced or metastatic bladder cancer.
In this traditionally hard-to-treat patient population where cisplatin- or carboplatin-based chemotherapy is the standard of care at first-line, the results from Cohort 1 demonstrate that Tecentriq has the potential to drastically change treatment paradigms, especially for treatment-naïve cisplatin-ineligible patients with metastatic bladder cancer. As shown in the table below, the primary endpoint of the IMvigor210 Cohort 1 study was overall response rate (ORR), and secondary endpoints included duration of response, overall survival (OS), progression-free survival (PFS), and safety outcomes. After a median follow-up duration of 14.4 months, the ORR was 24% with 7% of patients achieving a complete response. As with previous data from the IMvigor210 Cohort 2 study, Tecentriq was generally well tolerated with a favorable AE profile.
Patients were also segmented by PD-L1 expression status. Interestingly, while responses to Tecentriq treatment in platinum-refractory advanced bladder cancer (Cohort 2) improved significantly with increasing levels of PD-L1 expression, these topline data from Cohort 1 indicate that Tecentriq treatment produces similar overall response rates and complete response rates in patients across all PD-L1 expression levels (IC0, IC1, IC2/3, IC1/2/3). The meaningful clinical activity seen in patients underexpressing PD-L1 (IC0 and IC1) means that Tecentriq could be a potential first-line therapy for all cisplatin-ineligible patients regardless of PD-L1 status.
Tecentriq in treatment-naïve cisplatin-ineligible patients with metastatic bladder cancer – Top-line results of IMvigor210 Cohort 1
|Number of Patients||32||80||119|
|Overall Response Rate (ORR)
|Complete Response (CR)||N/A||N/A||7 %|
|Median Overall Survival (OS)
|Overall Survival at 12 Months||N/A||N/A||57 %|
|Disease Control Rate||44 %||40 %||38 %|
|Median Progression Free Survival (PFS)
|2.9 Months||2.3 Months||2.4 Months|
|Source: Datamonitor Healthcare, 2016; Biomedtracker, 2016|
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