Roche posts positive mid-stage trial results for atezolizumab
pharmafile | July 13, 2015 | News story | Research and Development | Genentech, PD-L1, Phase II, Roche, anti-PD-L1, atezolizumab, clinical trial, immuno-oncology, personalised medicine
A cancer drug in development by Roche has performed well in a mid-phase clinical trial – prompting the Swiss firm to begin plotting their conversations with regulators.
Atezolizumab is an immunotherapy drug that targets a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 is the same protein that is targeted by several other immuno-oncology drugs, including Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda.
But Roche is targeting a different group of patients with this immuno-oncology drug. The IMvigor-210 study looked at people with locally advanced or metastatic urothelial bladder cancer, whose cancer had progressed despite initial treatment.
Atezolizumab shrank tumours and met the primary endpoints of a significant difference in objective response rate in the single-arm study. People whose tumours expressed high amounts of PD-L1 had an increased response to the medicine.
“We are encouraged by the number of people who responded to atezolizumab and maintained their response during the study, because minimal progress has been made in advanced bladder cancer for nearly 30 years,” says Dr Sandra Horning, chief medical officer and head of global product development at Roche. “We plan to present results at an upcoming medical meeting and will discuss next steps with health authorities to bring a new treatment option to patients as soon as possible.”
Atezolizumab is developed by Genentech, Roche’s biotech arm. Last year the FDA granted the drug Breakthrough Therapy Designation as a treatment for people whose metastatic bladder cancer expressed PD-L1. This designation is designed to expedite the development and review of new medicines.
Roche is also conducting an ongoing randomised Phase III study of atezolizumab with chemotherapy in people who have relapsed urothelial bladder cancer. The Swiss firm is also planning a Phase III study of atezolizumab compared with observation in people with early-stage muscle-invasive bladder cancer.
All three studies will also look at the efficacy of a companion test developed by Roche Diagnostics, to find people whose tumours express high levels of PD-L1 – in a further nod to the importance of personalised medicines in the treatment of cancer.
Lilian Anekwe
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