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FDA grants Roche’s cancer immunotherapy Atezolizumab Priority Review

Friday, March 18, 2016

The FDA has accepted Roche’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

“Atezolizumab was granted Priority Review designation based on results of the IMvigor 210 study, which showed the medicine shrank tumors in a type of advanced bladder cancer, and the majority responding to treatment continued to respond after nearly a year of follow up,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The treatment options available for advanced bladder cancer are very limited, and we are committed to working with the FDA to bring the first anti-PDL1 cancer immunotherapy to people with this disease as quickly as possible.”

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Atezolizumab was granted Breakthrough Therapy Designation by the FDA in May 2014 for the treatment of people whose metastatic bladder cancer expresses the protein PD-L1 (programmed death ligand-1). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results of the IMvigor 210 phase II study, and the FDA will make a decision on approval by Sept. 12, 2016. Atezolizumab is also being studied in a number of other cancers.

IMvigor 210 is an open-label, multicenter, 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 whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen (n=311) received a 1200-mg intravenous dose of atezolizumab on day one of 21-day cycles until loss of clinical benefit. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR), overall survival, progression-free survival and safety.

In an updated analysis based on 11.7 months of median follow up, atezolizumab shrank tumors (ORR) in 15% (95% CI: 11, 19) of people evaluable for efficacy and safety (n=310) whose disease progressed after platinum-based chemotherapy. Atezolizumab shrank tumors in 26 percent (95% CI: 18, 36) of people whose disease had medium and high levels of PD-L1 expression (n=100). Median DOR was not reached at the time of analysis; with a median duration of follow up of 11.7 months, 84% (38/45) of people had an ongoing response. The most common grade 3 to 4 treatment-related adverse events included: fatigue (2%), decreased appetite, fever (pyrexia), anemia, enzymes in the blood (ALT and AST increase), joint pain (arthralgia), difficulty breathing (dyspnea), inflammation of the lung wall (pneumonitis), inflammation of the lining of the colon (colitis), hypertension and hypotension (all 1%). There were no treatment-related grade 5 adverse events.

In addition to IMvigor 210, Genentech has an ongoing, confirmatory phase III study (IMvigor 211), which compares atezolizumab to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.

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