Roche therapy helps 24 percent of untreated bladder cancer patients: study

Swiss drugmaker Roche's logo is seen at their headquarters in Basel (Copyright Reuters 2016)

A newly approved immunotherapy from Roche Holding proved effective as an initial treatment for some patients with advanced bladder cancer, according to data presented on Sunday.

Results of the mid-stage trial could help make the case that the drug, Tecentriq, should become the initial therapy of choice for patients with metastatic bladder cancer, according to a researcher leading the study.

Known chemically as atezolizumab, Tecentriq last month won U.S. approval for bladder cancer that had progressed following chemotherapy, becoming the first new drug for the disease in 30 years.

The latest study tested the Roche drug, given by injection every three weeks, in 119 patients deemed ineligible for standard cisplatin chemotherapy.

Nearly a quarter of the patients experienced at least 30 percent tumor shrinkage with no new lesions, including 7 percent who had no sign of cancer.

Dr. Arjun Balar of New York University Langone Medical Center, the study's lead investigator, said he did not expect to see complete responses in these patients, most of whom had seen their cancer spread to the lungs, liver or bones.

"In my opinion it absolutely needs to be considered as a potential new first-line standard of care," said Balar, who was presenting the data at the American Society of Clinical Oncology scientific meeting in Chicago.

Tecentriq belongs to a new class of biotechnology drugs called PD-L1 inhibitors that help the immune system fight cancer by blocking a mechanism tumors use to evade detection. They are similar to PD-1 inhibitors from Merck & Co and Bristol-Myers Squibb that have extended survival in advanced melanoma and lung cancer patients.

At a list price of $12,500 per month, Tecentriq costs roughly the same as Keytruda and Bristol's rival Opdivo.

After an average follow-up of 14.4 months into treatment, 75 percent of the responders had not experienced disease progression. Researchers estimate the median overall survival will be 14.8 months.

The typical survival prognosis for advanced bladder cancer patients who cannot receive cisplatin is 9 to 10 months, researchers said.

Dan Chen, head of cancer immunotherapy development for Roche's Genentech unit, said the data was even stronger than what was seen in the study of patients who had previously received chemotherapy that led to Tecentriq's approval. The overall response rate in that study was 16 percent versus the 24 percent who benefited among previously untreated patients.

The drug is far less toxic than chemotherapy, researchers said, with 6 percent of patients discontinuing therapy due to side effects. Far more patients typically discontinue chemotherapy, and many refuse it altogether.

An estimated 77,000 people in the United States will be diagnosed with bladder cancer this year, making it the fifth most common cancer in adults.