Genentech’s hopes to expand applications of a cancer immunotherapy treatment to more cancers were dealt a blow with the failure of that drug in a late-stage clinical trial.
South San Francisco, CA-based Genentech, a division of Swiss pharmaceutical giant Roche, announced Wednesday that its drug atezolizumab (Tecentriq), failed a Phase 3 clinical trial testing the drug in people who have advanced bladder cancer. Last year, the FDA approved the drug as a treatment for urothelial carcinoma, the most common form of bladder cancer.
Genentech was testing its drug in bladder cancer patients whose disease had progressed after previous treatments. The 931 patients in the Phase 3 trial were randomized to receive either Genentech’s drug or chemotherapy. The main goal of the study was to show improvement in overall survival. Genentech said that the results seen in patients treated with its drug were consistent with observations in an earlier Phase 2 study. But in the latest trial, the drug did not improve overall survival when compared with the group of patients treated with chemotherapy.
The Genentech drug is what’s called a checkpoint inhibitor. It blocks a protein called PD-L1, which is part of a signaling system that tumors use to hide from immune system attack. This class of class immunotherapy drugs includes Bristol-Myers Squibb (NYSE: BMY) drugs ipilimumab (Yervoy), approved to treat skin cancer, and nivolumab (Opdivo), which has FDA approval to treat lung and kidney cancers.
Last year’s accelerated approval required Genentech to confirm the results in additional studies. Some analysts have speculated that the latest trial results could threaten the future of the drug in bladder cancer and other types of cancer. But there has been no indication today that last year’s conditional approval would be overturned or otherwise affected.
Besides FDA approval of Genentech’s atezolizumab for treating the most common form of bladder cancer, the regulator last month granted an additional approval for the drug as a treatment for bladder cancer patients who are not eligible for cisplatin chemotherapy, a type of chemo that contains platinum. But Genentech’s plans for the drug go beyond bladder cancer. The company says it has more than 30 ongoing clinical trials testing the drug in lung, kidney, breast, colorectal, prostate, ovarian, and blood cancers.
Genentech now says it will review the results from the failed bladder cancer trial to better understand the results. The company plans to present full data from the trial later this year.