Wednesday, May 9, 2018
South San Francisco, CA -- May 9, 2018 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMblaze370 study evaluating the combination of TECENTRIQ® (atezolizumab) and COTELLIC ® (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.
More than 95 percent of patients in IMblaze370 have microsatellite stable (MSS) tumors and based on the available data, checkpoint inhibitors as monotherapy have not demonstrated clinically meaningful efficacy in MSS mCRC. The results from IMblaze370 were consistent with this prior monotherapy experience, showing that treatment with TECENTRIQ alone did not provide a meaningful clinical benefit compared to regorafenib in this patient population.
Safety for the combination of TECENTRIQ and COTELLIC appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The results from IMblaze370 will be further examined and presented at an upcoming medical meeting.
“While these results are not what we hoped for, we remain committed to applying our deep experience to develop medicines that will improve outcomes for people living with gastrointestinal cancers,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “In particular, we have a number of studies evaluating medicines in colorectal cancer that could play an important role in the treatment of people with this disease in the future.”
Genentech has an extensive clinical trial development program for TECENTRIQ, with more than 50 studies ongoing, including multiple Phase III studies across lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, blood, liver and head and neck cancers. This includes studies evaluating TECENTRIQ both alone and in combination with other medicines.
About the IMblaze370 study
IMblaze370 is a Phase III, multi-center, open-label, three-arm, randomized study in people with difficult-to-treat locally advanced or metastatic colorectal cancer who have received at least two prior regimens of chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to COTELLIC plus TECENTRIQ and TECENTRIQ monotherapy. The study enrolled 363 people who were randomized (2:1:1) to receive:
People in the combination arm received COTELLIC on days 1 to 21 plus TECENTRIQ on day 1 and day 15 in a 28-day cycle, until loss of clinical benefit. People in the monotherapy arm received TECENTRIQ on day 1 of each 21-day cycle, until loss of clinical benefit. People in the control arm received regorafenib on days 1 to 21 in a 28-day cycle, until loss of clinical benefit. The primary endpoint was overall survival. Key secondary endpoints include progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR).
About colorectal cancer
According to the American Cancer Society, colorectal cancer (CRC) is the third most commonly diagnosed cancer in both men and women in the United States and the third leading cause of cancer deaths. In 2018, an estimated 97,000 people will be diagnosed with colorectal cancer and about 50,000 people are expected to die from the disease in the United States. If colorectal cancer spreads (metastasizes) to distant organs, such as the lungs or the liver, five-year survival is 14 percent.
About the TECENTRIQ (atezolizumab) and COTELLIC (cobimetinib) combination
Based on our pre-clinical data and Phase Ib data there was a strong scientific rationale to support the further investigation of TECENTRIQ and COTELLIC. The IMblaze370 data will be further examined in order to better understand the results and presented at an upcoming medical meeting. Genentech is continuing to investigate the TECENTRIQ and COTELLIC combination in other tumor types, including the IMspire150 and IMspire170 studies in melanoma.
About TECENTRIQ® (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ 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, TECENTRIQ may enable the re-activation of T cells. TECENTRIQ may also affect normal cells.
About COTELLIC® (cobimetinib)
COTELLIC is a prescription medicine used with Zelboraf for the treatment of people with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal BRAF gene. COTELLIC is not used to treat melanoma with a normal BRAF gene. COTELLIC was discovered by Exelixis Inc. and was developed by Genentech in collaboration with Exelixis. COTELLIC is also being investigated in combination with several investigational medicines, including TECENTRIQ, in several tumor types such as non-small cell lung cancer, melanoma and colorectal cancer.
TECENTRIQ U.S. Indication (pronounced ‘tē-SEN-trik’)
TECENTRIQ is a prescription medicine used to treat:
a type of bladder and urinary tract cancer called urothelial carcinoma.
The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC).
If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
It is not known if TECENTRIQ is safe and effective in children.
Important Safety Information
What is the most important information about TECENTRIQ?
TECENTRIQ can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
TECENTRIQ can cause serious side effects, including:
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if patients have severe side effects.
Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:
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 in people with urothelial carcinoma include:
The most common side effects of TECENTRIQ in people with non-small cell lung cancer include:
TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if you have concerns about fertility.
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effect to Genentech at 1-888-835-2555.
Please visit http://www.Tecentriq.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information.
Cotellic U.S. Indication
Cotellic is a prescription medicine that is used with the medicine Zelboraf to treat a type of skin cancer called melanoma:
A patient’s healthcare provider will perform a test to make sure that Cotellic is right for the patient. It is not known if Cotellic is safe and effective in children under 18 years of age.
Important Safety Information
Before taking Cotellic, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Certain medicines may affect the blood levels of Cotellic.
Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.
How should patients take Cotellic?
What should patients avoid during treatment with Cotellic?
Patients should avoid sunlight during treatment with Cotellic. Cotellic can make a patient’s skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn:
What are the possible side effects of Cotellic?
Cotellic may cause serious side effects, including:
Patients should check their skin regularly and tell their healthcare provider right away if they have any skin changes including:
A patient’s healthcare provider should check the patient’s skin before they start taking Cotellic, and every two months during treatment with Cotellic. A patient’s healthcare provider may continue to check the patient’s skin for six months after the patient stops taking Cotellic.
A patient’s healthcare provider should also check for cancers that may not occur on the skin. Patients should tell their healthcare provider about any new symptoms that develop during treatment with Cotellic.
Patients should call their healthcare provider and get medical attention right away if they get any signs of bleeding, including:
A patient’s healthcare provider should check the patient’s eyes if the patient notices any of the symptoms above.
See “What should patients avoid during treatment with Cotellic?” for information on protecting the skin during treatment with Cotellic.
The most common side effects of Cotellic include:
A patient’s healthcare provider will take blood tests during treatment with Cotellic. The most common changes to blood tests include:
These are not all the possible side effects of Cotellic. Patients should call their doctor for medical advice about side effects. Patients may report side effects to FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.
About Genentech in Personalized Cancer Immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 20 investigational medicines, 10 of which are in clinical trials. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.
Founded more than 40 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.