On September 27, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) treported early results from a pivotal phase II study, IMvigor 210, of the investigational cancer immunotherapy atezolizumab (anti-PDL1; MPDL3280A) in people with locally advanced or metastatic urothelial carcinoma (mUC) (Press release, Hoffmann-La Roche , SEP 27, 2015, View Source [SID:1234507567]). The study showed that atezolizumab shrank tumours (objective response rate, ORR) in 27 percent of people with mUC whose disease had medium and high levels of PD-L1 expression and worsened after initial treatment. Ninety-two percent of people who responded to atezolizumab continued to respond when the results were assessed. Median duration of response was not yet reached. Adverse events were consistent with those observed in previous studies.
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"These results may represent the first major treatment advancement in advanced bladder cancer in nearly 30 years," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "We are encouraged that responses to atezolizumab were ongoing in the large majority of people when the study results were assessed."
Roche is planning to submit these data to global health authorities and to the FDA under a Breakthrough Therapy Designation for the treatment of people whose metastatic bladder cancer expresses PD-L1. This designation is designed to expedite the development and review of medicines intended to treat serious diseases that may demonstrate substantial improvement over existing therapies.
About the IMvigor 210 study
These final results from cohort 2 of this study (minimum of 24 weeks’ follow-up) will be presented in an oral session presentation by Jonathan E. Rosenberg, MD, Memorial Sloan Kettering Cancer Center, USA (Abstract #21LBA) on Sunday, 27 September, 10:40 Central European Time (CET).
Atezolizumab in patients (pts) with locally-advanced or metastatic urothelial carcinoma (mUC): Results from a pivotal multicenter phase II study (IMvigor 210).
IMvigor 210 is an open-label, multicentre, single-arm phase II study that evaluated the safety and efficacy of atezolizumab in people with locally advanced or mUC, regardless of PD-L1 expression. People in the study were enrolled into one of two cohorts. Cohort 1 consisted of people who had received no prior therapies for locally advanced or mUC, but who were ineligible for first-line cisplatin-based therapy; results for this cohort are not yet mature. Cohort 2, for which results were announced today, included people whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen. People received a 1200-mg intravenous dose of atezolizumab on day one of 21-day cycles until progressive disease (Cohort 1) or loss of clinical benefit (Cohort 2).
The primary endpoint of the study was ORR. Secondary endpoints included duration of response (DoR), overall survival (OS), progression-free survival (PFS) and safety. People were selected by histology, prior lines of therapy and PD-L1 expression on tumour-infiltrating immune cells (IC), using an investigational immunohistochemistry (IHC) test that is being developed by Roche Diagnostics.