SOUTH SAN FRANCISCO, CA, USA I March 3, 2014 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that an independent data monitoring committee has recommended that the Phase III METLung study be stopped due to a lack of clinically meaningful efficacy.
The study evaluated if onartuzumab (MetMab) in combination with Tarceva® (erlotinib) helped people with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumors were identified as MET-positive live longer compared to Tarceva alone. Overall adverse event rates were generally similar between the two groups. Data will be submitted for presentation at an upcoming medical meeting.
“These results are disappointing because new options are needed for people with lung cancer, the most common and deadly cancer worldwide,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We remain committed to helping people with lung cancer and are studying several investigational medicines in this disease.”
Genentech is evaluating the implications of the METLung study results across the ongoing onartuzumab clinical program.
About the METLung Study (NCT01456325)
- METLung is a Phase III, randomized, double-blind study evaluating the efficacy and safety profile of onartuzumab in combination with Tarceva in patients with previously treated (second- or third-line) advanced NSCLC identified to be MET-positive. The METLung study included a companion diagnostic immunohistochemistry (IHC) test that was co-developed with Ventana Medical Systems, Inc., a member of the Roche Group.
- Four hundred and ninety-nine patients were randomized to receive 150 mg of Tarceva taken daily plus either:
- Intravenous 15 mg/kg of onartuzumab every three weeks
- Intravenous placebo every three weeks
- The primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and safety profile.
- The results announced today are from a pre-specified interim analysis.
About Lung Cancer
According to the American Cancer Society, it is estimated that more than 224,000 Americans will be diagnosed with lung cancer in 2014, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.
About the MET Pathway
MET is a protein found on the surface of cells and acts as a receptor that binds to another protein called Hepatocyte Growth Factor (HGF), also known as “Scatter Factor.” When HGF binds to MET, it causes MET proteins to form pairs (dimerize), which triggers a signaling cascade that tells cells to grow, divide and spread (metastasize) to other parts of the body. Activation of the MET pathway has been proposed as a mechanism of tumor growth and spread.
About Onartuzumab
Onartuzumab, an investigational monovalent (one-armed) monoclonal antibody designed to specifically target the MET receptor, is being studied in various cancers.
Tarceva Indications in NSCLC
First-Line, Maintenance Therapy, and Second- or Third-Line Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC):
- Tarceva is prescribed for the initial treatment for patients with NSCLC, whose cancer has spread to other parts of the body, that has epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test (first-line treatment).
- Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has not spread or grown after prior treatment with certain types of chemotherapy (maintenance treatment).
- Tarceva is prescribed for patients with advanced-staged NSCLC whose cancer has spread or grown after receiving at least one round of chemotherapy. (second/third-line treatment).
Limitations of Use:
- Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
- For initial treatment with NSCLC whose cancer has spread to other parts of the body, it is not known if Tarceva is safe and effective in other EGFR mutations.
Important Safety Information
The following serious adverse reactions, which may include deaths, were reported in patients taking Tarceva: Interstitial Lung Disease (ILD)-like events; liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); serious skin conditions; blood, bleeding and clotting problems (heart attack or stroke); eye disorders (eye irritation and damage to the cornea); bleeding events when taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs); pregnancy (women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva).
Patients should call their doctor right away if they have these signs or symptoms:
Serious or ongoing diarrhea, nausea (feeling sick to the stomach), loss of appetite, or vomiting; new or worsening shortness of breath or cough; eye irritation; new or worsening rash, blistering or skin peeling; any changes in smoking habits.
The most common serious side effects include:
First-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of breath, and loss of appetite.
Maintenance/Second- or Third-Line NSCLC treatment: Rash and diarrhea.
Patients should call their healthcare provider for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
For full prescribing information, please call (877) TARCEVA or visit http://www.tarceva.com.
Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas global group of companies.
About Genentech
Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or 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.
SOURCE: Genentech
Post Views: 479
SOUTH SAN FRANCISCO, CA, USA I March 3, 2014 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that an independent data monitoring committee has recommended that the Phase III METLung study be stopped due to a lack of clinically meaningful efficacy.
The study evaluated if onartuzumab (MetMab) in combination with Tarceva® (erlotinib) helped people with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumors were identified as MET-positive live longer compared to Tarceva alone. Overall adverse event rates were generally similar between the two groups. Data will be submitted for presentation at an upcoming medical meeting.
“These results are disappointing because new options are needed for people with lung cancer, the most common and deadly cancer worldwide,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We remain committed to helping people with lung cancer and are studying several investigational medicines in this disease.”
Genentech is evaluating the implications of the METLung study results across the ongoing onartuzumab clinical program.
About the METLung Study (NCT01456325)
- METLung is a Phase III, randomized, double-blind study evaluating the efficacy and safety profile of onartuzumab in combination with Tarceva in patients with previously treated (second- or third-line) advanced NSCLC identified to be MET-positive. The METLung study included a companion diagnostic immunohistochemistry (IHC) test that was co-developed with Ventana Medical Systems, Inc., a member of the Roche Group.
- Four hundred and ninety-nine patients were randomized to receive 150 mg of Tarceva taken daily plus either:
- Intravenous 15 mg/kg of onartuzumab every three weeks
- Intravenous placebo every three weeks
- The primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and safety profile.
- The results announced today are from a pre-specified interim analysis.
About Lung Cancer
According to the American Cancer Society, it is estimated that more than 224,000 Americans will be diagnosed with lung cancer in 2014, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.
About the MET Pathway
MET is a protein found on the surface of cells and acts as a receptor that binds to another protein called Hepatocyte Growth Factor (HGF), also known as “Scatter Factor.” When HGF binds to MET, it causes MET proteins to form pairs (dimerize), which triggers a signaling cascade that tells cells to grow, divide and spread (metastasize) to other parts of the body. Activation of the MET pathway has been proposed as a mechanism of tumor growth and spread.
About Onartuzumab
Onartuzumab, an investigational monovalent (one-armed) monoclonal antibody designed to specifically target the MET receptor, is being studied in various cancers.
Tarceva Indications in NSCLC
First-Line, Maintenance Therapy, and Second- or Third-Line Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC):
- Tarceva is prescribed for the initial treatment for patients with NSCLC, whose cancer has spread to other parts of the body, that has epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test (first-line treatment).
- Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has not spread or grown after prior treatment with certain types of chemotherapy (maintenance treatment).
- Tarceva is prescribed for patients with advanced-staged NSCLC whose cancer has spread or grown after receiving at least one round of chemotherapy. (second/third-line treatment).
Limitations of Use:
- Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
- For initial treatment with NSCLC whose cancer has spread to other parts of the body, it is not known if Tarceva is safe and effective in other EGFR mutations.
Important Safety Information
The following serious adverse reactions, which may include deaths, were reported in patients taking Tarceva: Interstitial Lung Disease (ILD)-like events; liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); serious skin conditions; blood, bleeding and clotting problems (heart attack or stroke); eye disorders (eye irritation and damage to the cornea); bleeding events when taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs); pregnancy (women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva).
Patients should call their doctor right away if they have these signs or symptoms:
Serious or ongoing diarrhea, nausea (feeling sick to the stomach), loss of appetite, or vomiting; new or worsening shortness of breath or cough; eye irritation; new or worsening rash, blistering or skin peeling; any changes in smoking habits.
The most common serious side effects include:
First-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of breath, and loss of appetite.
Maintenance/Second- or Third-Line NSCLC treatment: Rash and diarrhea.
Patients should call their healthcare provider for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
For full prescribing information, please call (877) TARCEVA or visit http://www.tarceva.com.
Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas global group of companies.
About Genentech
Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or 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.
SOURCE: Genentech
Post Views: 479
