Genentech’s Immunotherapy Tecentriq Gets FDA Accelerated Approval for Specific Type of Advanced Bladder Cancer

Genentech’s Immunotherapy Tecentriq Gets FDA Accelerated Approval for Specific Type of Advanced Bladder Cancer

Genentech announced that the U.S. Food and Drug Administration (U.S. FDA) has given Accelerated Approval to Tecentriq (atezolizumab), a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of some patients with locally advanced or metastatic urothelial carcinoma (mUC) — representing nearly 90% of all bladder cancers.

“Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasn’t received the same attention within the cancer community as other common cancers,” President and Co-Founder of the Bladder Cancer Advocacy Network, Diane Zipursky Quale, stated in a press release. “TECENTRIQ is a new medicine for people whose locally advanced or metastatic bladder cancer has progressed on platinum-based chemotherapy and may have limited treatment options.”

This is the first time the U.S. FDA has approved an anti-PD-L1 cancer immunotherapy, and the first time in three decades that a treatment for a specific type of bladder cancer has been approved. “TECENTRIQ is a new medicine that can work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy,” explained Genentech’s Chief Medical Officer and Head of Global Product Development, Sandra Horning, M.D. “We thank the scientists, doctors, patients and their families who made it possible to bring TECENTRIQ to people with advanced urothelial carcinoma.”

Patients eligible to receive this new therapy must have experienced disease progression during or following platinum-containing chemotherapy; and/or whose disease progressed within 12 months of platinum-containing chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).

U.S. citizens will have access Tecentriq in one or two weeks and, for those who are eligible, Genentech plans to offer patient assistance programs for those initiating Tecentriq through Genentech Access Solutions.

This U.S. FDA’s Accelerated Approval is based on early evidence suggesting clinical benefit based on tumor response rate and duration of response from the Phase II IMvigor 210 study, an open-label, multicenter, two-cohort Phase II study that evaluated the safety and efficacy of Tecentriq in mUC patients, regardless of PD-L1 expression. A total of 310 individuals received a 1200-mg intravenous (IV) dose of Tecentriq on the first day of 21-day cycles until unacceptable toxicity or unwanted clinical progression.

The study’s primary endpoint was objective response rate (ORR). In a subset of people with disease progression after neoadjuvant or adjuvant platinum-based therapy, Tecentriq shrunk tumors (ORR) in 22% of patients.

In an exclusive interview with Immuno-Oncology News, Kevin Williamson, a patient who participated in the IMvigor 210 clinical trial and is currently taking Tecentriq said: “My cancer diagnosis was hard on my family, especially my wife, and she just kept researching and asking questions until we understood all of our options. I eventually entered two clinical trials for medicines being studied for bladder cancer. Many people have hesitations about participating in clinical trials, but for me, it was not a tough decision. When you have no other options, any option is a good option. In the first trial, the medicine worked for a while. But in May 2014 they found it wasn’t working anymore. So, in July of 2014, I switched to another clinical trial, this one investigating a cancer immunotherapy medicine. Over the last eight months, I’ve started being more active again, even lifting weights to keep in shape. It’s still too early to know what will happen, but for right now, I’m happy to take every day as it comes and spend time with my family.”

“In advanced bladder cancer, the gains over the past three decades have been mostly in patient safety, which means the treatments we use are more tolerable and we’ve been better able to manage side effects. But the efficacy of treatment, which means how long patients survive with cancer, has not changed in any meaningful way in nearly 30 years. So to have a drug like Tecentriq, while it works only in a minority, is very well tolerated and life-altering for the patients who respond to it. This drug represents a major leap forward in how we treat patients who afflicted with this dreadful disease,” Dr. Arjun Balar, medical oncologist and assistant professor of medicine at the Perlmutter Cancer Center at NYU Langone Medical Center, and a lead investigator on the IMvigor 210 clinical trial, exclusively told Immuno-Oncology News.

The continued approval is still contingent upon verification of clinical benefit in confirmatory trials. Genentech is now evaluating Tecentriq in a confirmatory Phase III IMvigor 211 study, comparing Tecentriq to chemotherapy in people whose bladder cancer has progressed on at least one previous platinum-containing regimen.