On January 8, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported updated results from the pivotal phase II study, IMvigor 210, of the investigational cancer immunotherapy atezolizumab (MPDL3280A) in people with locally advanced or metastatic urothelial carcinoma (mUC) (Press release, Hoffmann-La Roche , JAN 8, 2016, View Source [SID:1234508698]). Schedule your 30 min Free 1stOncology Demo! Median overall survival (mOS) in this heavily pre-treated population was 11.4 months [95% CI: 9.0, NE] in people with higher levels of PD-L1 expression, and 7.9 months [95% CI: 6.6, 9.3] in the overall study population. The study also showed that 84% (n=38/45) of people who responded to atezolizumab continued to respond regardless of their PD-L1 status, when the results were assessed with longer median follow-up of 11.7 months. Median duration of response has not yet been reached. Atezolizumab was well tolerated and adverse events were consistent with those observed in previous updates. These data were presented at the 2016 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO GU).1
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"It is encouraging to see that the majority of people with advanced bladder cancer who responded to atezolizumab maintained their response with longer follow up," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "We are looking forward to sharing these results with the US FDA and other health authorities in the hope that we may bring atezolizumab to treating physicians and their patients as soon as possible."
Roche is planning to submit these data imminently to Global health authorities and the U.S. Food and Drug Administration (FDA) under Breakthrough Therapy designation. This designation is designed to expedite the development and review of medicines that may demonstrate substantial improvement over existing therapies for serious diseases.
About the IMvigor 210 study
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 comprised those who had received no prior therapies for locally advanced or mUC, but who were ineligible for first-line cisplatin-based therapy. The results for this cohort are not yet mature. Cohort 2, for which updated results were announced today, included people whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen(heavily pretreated), 41 percent of people in the study had 2 or more treatments in the metastatic setting. People received a 1200-mg intravenous dose of atezolizumab on day 1 of 21-day cycles until progressive disease (Cohort 1) or loss of clinical benefit (Cohort 2).
Co-primary endpoints of the study included confirmed RECIST v1.1 ORR per central IRF and investigator-assessed modified RECIST ORR. Secondary endpoints included duration of response, overall survival, progression-free survival 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 test that is being developed by Roche Tissue Diagnostics.
In addition to IMvigor 210, Roche has an ongoing randomised phase III study, IMvigor 211, comparing atezolizumab with standard-of-care chemotherapy in people who have mUC that worsened after initial treatment. All studies include the evaluation of a companion test developed by Roche Tissue Diagnostics to determine PD-L1 status.
About metastatic urothelial cancer
Metastatic urothelial cancer is associated with a poor prognosis and limited treatment options. It is a disease that has seen no major advancements for nearly 30 years. Urothelial cancer is the ninth most common cancer worldwide, with 430,000 new cases diagnosed in 2012, and it results in approximately 145,000 deaths globally each year. Men are three times more likely to suffer from urothelial cancer compared with women, and it is also three times more common in developed countries than in less developed countries.
About atezolizumab
Atezolizumab (also known as MPDL3280A) is an investigational monoclonal antibody designed to target and bind to a protein called PD-L1, which is expressed on TCs and tumour-infiltrating ICs. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this interaction, atezolizumab may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.