June 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CHICAGO – Genentech ’s atezolizumab, an anti-PD-L1 immunotherapy, continues to show efficacy in treating cancer patients. This time the drug is showing promise in treating bladder cancer in patients with untreated advanced forms of the disease. On Sunday the company, a division of Roche , announced atezolizumab (Tecentriq), which was recently granted accelerated approval in the U.S. for the treatment of people with locally advanced or metastatic urothelial carcinoma, not only shrank tumors, but increased the median survival rates to more than a year.
Data from the Phase II IMvigor study was presented Sunday at the American Society of Clinical Oncology meeting in Chicago. Trial results showed Tecentriq shrank tumors in about 24 percent of the patient population with locally advanced or metastatic urothelial carcinoma (mUC) who have not received a prior treatment or were ineligible for cisplatin-based chemotherapy. Seven percent of all people in the study achieved a complete response, Genentech said in a statement.
“These Tecentriq results are highly encouraging because about half of all people with this type of bladder cancer are not able to tolerate a cisplatin-based chemotherapy, and alternative treatments bring very limited duration of response,” Sandra Horning, chief medical officer and head of global product development at Genentech said in a statement. “This is why we are particularly pleased that the majority of people who responded to Tecentriq continued to respond at the time of analysis.”
Approximately 50 percent of people with this type of bladder cancer cannot tolerate a cisplatin-based chemotherapy because of age or other medical conditions, Genentech said in a statement to BioSpace. For those patients, there are no proven survival-prolonging therapies. That makes the information presented at ASCO even more positive for those patients with bladder cancer. Typical survival rates are about 10 months for patients who receive carboplatin or some other therapy because of their ineligibility for cisplatin. However, Tecentriq increased median survival rates to 14.8 months. As the trials continue, the data could become even more positive for patients in need of hope. Genentech said the data presented Sunday at ASCO was immature, with about 75 percent of patients in the study still undergoing therapy.
The drug was also well tolerated, with only about 6 percent of patients discontinuing therapy due to side effects, Genentech said.
During Sunday’s presentation, Arjun Balar of New York University Langone Medical Center, the lead investigator of the Phase II IMvigor study, said the response of patients in the trial strengthened his opinion that Tecentriq be considered as a potential new first-line standard of care, Fox News reported.
It is estimated that more than 76,000 Americans will be diagnosed with bladder cancer in 2016, the American Cancer Society estimates. Bladder cancer is the fifth-most common form of cancer to be diagnosed in the United States. About 11 percent of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. Approximately 96 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 39 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are about three to four times more likely to get bladder cancer during their lifetime than women.
Atezolizumab is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Last month the drug, which has also shown promise in the treatment of locally advanced or metastatic non-small cell lung cancer with a PD-L1 expression, was granted accelerated approval for the treatment of people with locally advanced mUC who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit.
