- First approved ctDNA MRD-guided therapy reinforcing Genentech’s commitment to innovation and practice-changing precision medicine
- New treatment approach enables healthcare professionals to tailor treatment with the goal of improving clinical benefit and reducing unnecessary intervention
- Approval marks the eleventh indication for Tecentriq in the U.S., providing a new option for an aggressive form of cancer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay.
“Combining our cancer immunotherapy Tecentriq with state-of-the-art MRD testing allows more precise identification of patients who are candidates for intervention and those who might safely avoid unnecessary treatment,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We look forward to delivering this first of its kind ctDNA-guided regulatory approval to bladder cancer physicians and patients in the U.S.”
“For the patients and families, the ‘watch and wait’ period after a cystectomy is often defined by uncertainty. This ctDNA-guided approach can enable doctors to use serial ctDNA MRD testing to identify who is at a higher risk of recurrence and move quickly toward immunotherapy for those who may benefit from it, while allowing others to safely avoid additional treatment and its associated side effects,” said Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network.
The FDA decision was based on positive results from the Phase III IMvigor011 study, which showed that Tecentriq reduced the risk of disease recurrence or death (DFS) by 36% and the risk of death (OS) by 41% in patients with detectable ctDNA MRD identified via serial testing within one year of cystectomy. The safety profile was generally consistent with previous studies of Tecentriq. IMvigor011 is the first prospective Phase III study to demonstrate that a ctDNA-guided approach to adjuvant therapy can significantly improve survival in MIBC.
Each year, over 150,000 people worldwide are diagnosed with MIBC and undergo bladder removal surgery to treat this aggressive disease. Even after surgery, nearly half of these patients see their cancer return. This represents the first approval of a ctDNA-guided therapy, an innovative approach that is currently being investigated in other types of cancer. Historically, doctors have relied on tumor staging to determine who needs treatment after surgery. The IMvigor011 study utilized the Natera Signatera™ personalized ctDNA assay to identify molecular evidence of cancer in the blood, before it becomes visible with standard imaging. This approach enabled adjuvant immunotherapy to be deployed selectively in patients who are at greatest risk of recurrence and most likely to benefit from it, while sparing others without molecular residual disease from the burden of treatment after surgery.
About the IMvigor011 study
IMvigor011 [NCT04660344] is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq® (atezolizumab) compared with placebo in adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy. ctDNA status was determined using Natera’s Signatera™ technology in the U.S. and in China. The Signatera™ CDx test received simultaneous authorization by the FDA for use as a companion diagnostic to Tecentriq. The surveillance phase of IMvigor011 included 761 people who underwent serial ctDNA testing for up to a year after surgery. Of these, 250 people who tested positive for ctDNA joined the treatment phase, where they received either Tecentriq or placebo. The primary endpoint is investigator-assessed disease-free survival (DFS). Secondary endpoints include overall survival (OS) and tolerability, amongst others.
About Tecentriq® (atezolizumab)
Tecentriq (atezolizumab) is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
What are Tecentriq and Tecentriq Hybreza?
Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat:
Adults with a type of bladder cancer called muscle-invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for their bladder cancer:
- to help prevent their bladder cancer from coming back after their bladder has been removed by surgery, and
- small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in their blood, showing that cancer cells remain in the body (molecular residual disease). A healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for them.
It is not known if Tecentriq or Tecentriq Hybreza is safe and effective when used:
- In children for the treatment of MIBC
Important Safety Information
What is the most important information about Tecentriq and Tecentriq Hybreza?
Tecentriq and Tecentriq Hybreza can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended.
Patients should call or see their healthcare provider right away if they develop any new or worsening signs or symptoms, including:
Lung problems
- cough
- shortness of breath
- chest pain
Intestinal problems
- diarrhea (loose stools) or more frequent bowel movements than usual
- stools that are black, tarry, sticky, or have blood or mucus
- severe stomach-area (abdomen) pain or tenderness
Liver problems
- yellowing of the skin or the whites of the eyes
- severe nausea or vomiting
- pain on the right side of their stomach area (abdomen)
- dark urine (tea colored)
- bleeding or bruising more easily than normal
Hormone gland problems
- headaches that will not go away or unusual headaches
- eye sensitivity to light
- eye problems
- rapid heartbeat
- increased sweating
- extreme tiredness
- weight gain or weight loss
- feeling more hungry or thirsty than usual
- urinating more often than usual
- hair loss
- feeling cold
- constipation
- their voice gets deeper
- dizziness or fainting
- changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems
- decrease in their amount of urine
- blood in their urine
- swelling of their ankles
- loss of appetite
Skin problems
- rash
- itching
- skin blistering or peeling
- painful sores or ulcers in their mouth or their nose, throat, or genital area
- fever or flu-like symptoms
- swollen lymph nodes
Problems can also happen in other organs.
These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Patients should call or see their healthcare provider right away for any new or worsening signs or symptoms, including:
- Chest pain, irregular heartbeat, shortness of breath, swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:
- chills or shaking
- itching or rash
- flushing
- shortness of breath or wheezing
- dizziness
- feeling like passing out
- fever
- back or neck pain
Rejection of a transplanted organ or tissue. A healthcare provider should tell the patients what signs and symptoms they should report and monitor the patients depending on the type of organ or tissue transplant they have had.
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if patients undergo transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. A healthcare provider will monitor for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq or Tecentriq Hybreza. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if patients have severe side effects.
Before receiving Tecentriq or Tecentriq Hybreza, patients should tell their healthcare provider about all of their medical conditions, including if they:
- have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- have received an organ or tissue transplant, including corneal transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have received radiation treatment to their chest area
- have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome
-
are pregnant or plan to become pregnant. Tecentriq and Tecentriq Hybreza can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq or Tecentriq Hybreza. Females who are able to become pregnant:
- A healthcare provider should do a pregnancy test before they start treatment with Tecentriq or Tecentriq Hybreza
- They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza
- are breastfeeding or plan to breastfeed. It is not known if Tecentriq or Tecentriq Hybreza passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Tecentriq when used alone include:
- feeling tired or weak
- decreased appetite
- nausea
- cough
- shortness of breath
The most common side effects of Tecentriq Hybreza when used alone include:
- feeling tired or weak
- muscle or bone pain
- cough
- shortness of breath
- decreased appetite
Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at 1-888-835-2555.
Please see full Prescribing Information for Tecentriq and Tecentriq Hybreza and the Medication Guides for Tecentriq and Tecentriq Hybreza for additional Important Safety Information.
About Genentech in cancer immunotherapy
To learn more about Genentech’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.gene.com/cancer-immunotherapy.
About Genentech
Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Contacts
Media Contact: Stella Belonwu (650) 467-6800
Advocacy Contact: Mychalleah Werner (650) 296-6218
Investor Contacts: Loren Kalm (650) 225-3217
Bruno Eschli +41 61 68-75284
Rebekka Schnell +41 79 20-52703
