New Crown Outbreak: 16.93 million! Roche IL-6 receptor inhibitor Actemra (tozhuzumab) treatment of severe COVID-19 pneumonia III clinical failure!

29 July 2020 // At present, the outbreak of new crown pneumonia is still spreading around the world.
According to Baidu's "Real-Time Big Data Report on the Outbreak of New Coronavirus Pneumonia", as of 20:00 on July 29, 2020, more than 16.93 million cases and more than 664,000 deaths had been confirmed worldwide.
the unprecedented situation of the new crown outbreak, governments are urgently authorizing the potential for the treatment of severe new coronavirus pneumonia (COVID-19).
, Roche recently released updated data for the evaluation of the IL-6 receptor inhibitor Actemra/RoActemra (Amero ®, generic name: tocilizumab, tozhuzumab) for the treatment of COVID-19-related pneumonia in patients with COVID-19 hospitalization sII COVACTA trial (NCT04320615).
the trial was conducted by Roche in collaboration with the U.S. Bureau of Advanced Biomedical Research and Development (BARDA).
results showed that the study did not reach the primary endpoint of improved clinical conditionand and did not reach the critical secondary endpoint (including differences in mortality in patients in week 4).
however, patients receiving tozhuzumab treatment showed a positive trend in discharge time.
COVACTA study did not find any new safety signals for tozhumono.
Roche will further analyze the results of the trial to fully understand the data.
results will be published in the peer-reviewed journal. "People around the world are waiting for further effective treatment for COVID-19 and we are disappointed that COVACTA has not shown any clinical status or mortality outcomes in week 4," said Dr. Levi Garraway, chief medical officer and global product development officer at
Roche.
we will continue to gather evidence to gain a more comprehensive understanding of the role of tobead sebutaininin in COVID-19-related pneumonia.
we thank patients and doctors around the world who helped us complete this study quickly in the public health crisis, while adhering to the highest standards of scientific rigour.
we will continue to work to help fight the COVID-19 pandemic.
"RoActemra/Actemra(Yamaro ®, tozhuzumab) is a monoantipod developed by Roche that targets IL-6 receptors and is already available in China for the treatment of rheumatoid arthritis (RA) and systemic juvenile isoarthritis (sJIA).
in the United States and the European Union, tocilizumab has also been approved for the treatment of severe and life-threatening cytokine release syndrome (CRS) associated with the treatment of chimeric antigen receptor T-cell therapy (CAR-T).
note, tozhuzumab is the first drug approved for CRS treatment.
, scientists have found that in the treatment of COVID-19, in the treatment of severe isolation, IL-6-based cytokine storm, or CRS, is the disease turn dangerous, the important cause of patient death.
COVACTA is the first global, randomized, double-blind, placebo-controlled phase III trial to evaluate toluvicitozumab treatment for severe COVID-19-related pneumonia, evaluating the safety and effectiveness of placebo-standard care, intravenous toth-bead-statin-plus-standard care.
primary and secondary endpoints include the clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables for week 4.
study, patients were followed for 60 days after being treated in random groups. the main endpoint of the clinical status of adult patients hospitalized with
severe COVID-19-related pneumonia was measured using a 7-point scale that tracked the patient's clinical status based on the use of intensive care and/or ventilators and the need for supplementary oxygen.
the study's key clinical and safety results are summarized as follows: - No major endpoint: At week 4, the difference in clinical status in patients in the tobead monobresistance group and those in the placebo group was not statistically significant (p.0.36; advantage ratio of OR (95% CI) to 1.19 .81,1.76 A statistically significant advantage ratio greater than 1 would be beneficial to tozhuzumab, and there was no difference in mortality at 4 weeks: 19.7% in the tozhuzumab group and 19.4% in the placebo group during 4 weeks of treatment, with a difference of 0.3% (95% CI:7.6%, 8.2% ;p x 0.9410).
- Time to be discharged or ready to be discharged: The tozhuzumab group had shorter time to be discharged or ready to be discharged from the hospital than in the placebo group.
specific data are: the median time for discharge or preparation for discharge from the tozhuzumab group was 20 days (95% CI:17, 27), and the placebo group was 28 days (95% CI:20, NE) (p.0370).
However, this difference is not considered statistically significant because the primary endpoint has not been achieved.
- Days without ventilators: The difference in the number of days without ventilators in the tobead monotorinflight group was not statistically significant compared to the placebo group. the
the specific data were: the median number of days without ventilators in the tozhuzumab group was 22 days, and the placebo group was 16.5 days, with a difference of 5.5 days (95% CI:2.8, 13.0; p-0.3202).
- There was no difference in infection rates: in the fourth week of treatment, the infection rates were 38.3% and 40.6% respectively in the tozhuzumab group and the placebo group, respectively, and the rates were 21.0% and 25.9%, respectively.
- Safety: No new safety signals were found in the study.
in addition to COVACTA, Roche has initiated several studies to further investigate the potential treatments for PATIENTs with COVID-19-related pneumonia, including two Phase III clinical trials REMDACTA and EMPACTA, and the Stage II MARIPOSA trial.
in addition, there are a number of independent trials that are being evaluated for COVID-19-related pneumonia in the treatment of tozhuzumab.
() Original source: Roche provides an update on phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 oped pneumonia.