The REMDACTA clinical trial of Actemra plus Veklury did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or its key secondary endpoints compared to Veklury alone
Genentech will submit the REMDACTA results to a peer-reviewed journal
SOUTH SAN FRANCISCO, CA, USA I March 10, 2021 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the global Phase III randomized, double-blind, multicenter REMDACTA study of Actemra® (tocilizumab) plus Veklury® (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint. This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra in the REMDACTA trial. The study was conducted in collaboration with Gilead Sciences, Inc.
Genentech will continue to evaluate data from the REMDACTA, COVACTA and EMPACTA studies as well as other studies of Actemra in COVID-19 pneumonia. The EMPACTA study met its primary endpoint, while COVACTA did not meet its primary endpoint. Both were recently published in the New England Journal of Medicine.
“Given the global impact of COVID-19 pneumonia on patients, we are disappointed that the REMDACTA study did not meet its endpoints,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We continue to believe that the totality of data suggests a potential role for Actemra in treating certain patients with COVID-19, and will discuss the results with health authorities. We thank our partners at Gilead, and all the patients, investigators and healthcare professionals for their participation.”
REMDACTA did not meet key secondary endpoints, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. The full results of the trial will be submitted for publication in a peer-reviewed journal later this year.
Actemra is not approved for the treatment of COVID-19 pneumonia.
The antiviral medication Veklury was invented and developed by Gilead Sciences and is approved by the U.S. Food and Drug Administration for the treatment of adults and pediatric patients at least 12 years of age and weighing at least 40 kilograms requiring hospitalization for COVID-19. Veklury is contraindicated in patients who are allergic to Veklury or any of its components. For more information, please see the U.S. full Prescribing Information at https://www.gilead.com.
For more information on how Genentech is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.
About the REMDACTA Trial
REMDACTA is a two-armed global Phase III, randomized, double-blind, multicenter study (REMDACTA, NCT04409262) to evaluate the efficacy and safety of Actemra plus Veklury, versus placebo plus Veklury in hospitalized patients with severe COVID-19 pneumonia receiving standard of care. Veklury is an antiviral medicine that works to stop replication of SARS-CoV-2, the virus that causes COVID-19. The REMDACTA trial is being conducted in collaboration with Gilead Sciences, Inc. The primary endpoint of the study is improvement in time to hospital discharge by day 28. Key secondary endpoints include likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. Clinical status is measured by the 7-category ordinal scale, which tracks patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. Patients will be followed for 60 days post-randomization.
About the COVACTA Trial
COVACTA is a global, randomized, double-blind, placebo-controlled Phase III study (COVACTA, NCT04320615) which evaluated the safety and efficacy of intravenous Actemra added to standard of care in adult patients hospitalized with severe COVID-19 pneumonia compared to placebo plus standard of care. The primary and secondary endpoints included clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients were followed for 60 days post-randomization.
About the EMPACTA Trial
EMPACTA (Evaluating Minority Patients with Actemra) is a Phase III, randomized, double-blind, placebo-controlled multicenter study (EMPACTA, NCT04372186) which evaluated the efficacy and safety of Actemra in the treatment of hospitalized COVID-19 pneumonia among patients that are often underrepresented in clinical trials.
The primary endpoint was the cumulative proportion of participants dying or requiring mechanical ventilation by day 28. Secondary endpoints included: time to clinical failure, defined as the time to death, mechanical ventilation, ICU admission, or withdrawal (whichever occurs first); mortality rate by day 28; and time to hospital discharge or “ready for discharge.”
About Actemra
Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.
Actemra is intended for use under the guidance of a healthcare practitioner.
Important Safety Information
Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.
Actemra can cause other serious side effects. These include:
- Tears of the stomach or intestines
- Liver problems (hepatotoxicity)
- Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
- An increased risk of certain cancers by changing the way a patient’s immune system works
- Hepatitis B infection
- Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection. If a patient has had hives, a rash, or experienced flushing after injecting, the patient should tell their doctor or nurse before their next injection
- Nervous system problems
Patients should not receive Actemra if they are allergic to Actemra or if they have had a bad reaction to Actemra previously.
Most common side effects in patients treated with Actemra:
Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:
- Upper respiratory tract infections (like common cold and sinus infections)
- Headache
- Increased blood pressure (also called hypertension)
- Injection site reactions
Actemra & pregnancy:
Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.
Patients should tell their doctor right away if they are experiencing any side effects. 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 visit http://www.actemra.comfor the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).
About Genentech
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.
SOURCE: Genentech
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The REMDACTA clinical trial of Actemra plus Veklury did not meet its primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or its key secondary endpoints compared to Veklury alone
Genentech will submit the REMDACTA results to a peer-reviewed journal
SOUTH SAN FRANCISCO, CA, USA I March 10, 2021 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the global Phase III randomized, double-blind, multicenter REMDACTA study of Actemra® (tocilizumab) plus Veklury® (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint. This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra in the REMDACTA trial. The study was conducted in collaboration with Gilead Sciences, Inc.
Genentech will continue to evaluate data from the REMDACTA, COVACTA and EMPACTA studies as well as other studies of Actemra in COVID-19 pneumonia. The EMPACTA study met its primary endpoint, while COVACTA did not meet its primary endpoint. Both were recently published in the New England Journal of Medicine.
“Given the global impact of COVID-19 pneumonia on patients, we are disappointed that the REMDACTA study did not meet its endpoints,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We continue to believe that the totality of data suggests a potential role for Actemra in treating certain patients with COVID-19, and will discuss the results with health authorities. We thank our partners at Gilead, and all the patients, investigators and healthcare professionals for their participation.”
REMDACTA did not meet key secondary endpoints, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. The full results of the trial will be submitted for publication in a peer-reviewed journal later this year.
Actemra is not approved for the treatment of COVID-19 pneumonia.
The antiviral medication Veklury was invented and developed by Gilead Sciences and is approved by the U.S. Food and Drug Administration for the treatment of adults and pediatric patients at least 12 years of age and weighing at least 40 kilograms requiring hospitalization for COVID-19. Veklury is contraindicated in patients who are allergic to Veklury or any of its components. For more information, please see the U.S. full Prescribing Information at https://www.gilead.com.
For more information on how Genentech is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.
About the REMDACTA Trial
REMDACTA is a two-armed global Phase III, randomized, double-blind, multicenter study (REMDACTA, NCT04409262) to evaluate the efficacy and safety of Actemra plus Veklury, versus placebo plus Veklury in hospitalized patients with severe COVID-19 pneumonia receiving standard of care. Veklury is an antiviral medicine that works to stop replication of SARS-CoV-2, the virus that causes COVID-19. The REMDACTA trial is being conducted in collaboration with Gilead Sciences, Inc. The primary endpoint of the study is improvement in time to hospital discharge by day 28. Key secondary endpoints include likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. Clinical status is measured by the 7-category ordinal scale, which tracks patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. Patients will be followed for 60 days post-randomization.
About the COVACTA Trial
COVACTA is a global, randomized, double-blind, placebo-controlled Phase III study (COVACTA, NCT04320615) which evaluated the safety and efficacy of intravenous Actemra added to standard of care in adult patients hospitalized with severe COVID-19 pneumonia compared to placebo plus standard of care. The primary and secondary endpoints included clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients were followed for 60 days post-randomization.
About the EMPACTA Trial
EMPACTA (Evaluating Minority Patients with Actemra) is a Phase III, randomized, double-blind, placebo-controlled multicenter study (EMPACTA, NCT04372186) which evaluated the efficacy and safety of Actemra in the treatment of hospitalized COVID-19 pneumonia among patients that are often underrepresented in clinical trials.
The primary endpoint was the cumulative proportion of participants dying or requiring mechanical ventilation by day 28. Secondary endpoints included: time to clinical failure, defined as the time to death, mechanical ventilation, ICU admission, or withdrawal (whichever occurs first); mortality rate by day 28; and time to hospital discharge or “ready for discharge.”
About Actemra
Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.
Actemra is intended for use under the guidance of a healthcare practitioner.
Important Safety Information
Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.
Actemra can cause other serious side effects. These include:
- Tears of the stomach or intestines
- Liver problems (hepatotoxicity)
- Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
- An increased risk of certain cancers by changing the way a patient’s immune system works
- Hepatitis B infection
- Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection. If a patient has had hives, a rash, or experienced flushing after injecting, the patient should tell their doctor or nurse before their next injection
- Nervous system problems
Patients should not receive Actemra if they are allergic to Actemra or if they have had a bad reaction to Actemra previously.
Most common side effects in patients treated with Actemra:
Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:
- Upper respiratory tract infections (like common cold and sinus infections)
- Headache
- Increased blood pressure (also called hypertension)
- Injection site reactions
Actemra & pregnancy:
Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.
Patients should tell their doctor right away if they are experiencing any side effects. 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 visit http://www.actemra.comfor the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).
About Genentech
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.
SOURCE: Genentech
Post Views: 264
