Dr. Changcheng Zheng of the University of Science, China, recently spoke to Cancer Network about a case study indicating that tocilizumab (Actemra) could effectively treat people with multiple myeloma and various blood cancers.
Dr. Zheng, who co-authored the study, added that these patients are immunosuppressed and therefore at a much higher risk for COVID-19 infection. He also noted that blood cancer patients may have unusual COVID-19 symptoms or none at all.
About the Case Study
The sixty-year-old male subject was working in Wuhan in 2015 when he was diagnosed with multiple myeloma. He has been on maintenance therapy since 2015.
In February of this year, a CT image detected possible lung disease, and the patient was hospitalized. The patient did not exhibit any of the usual COVID-19 symptoms other than some tightness in his chest and shortness of breath.
Tests confirmed that the patient had COVID-19 but corticosteroid and antiviral treatment gave him only partial relief.
Eighth Day
On the eighth day of hospitalization, chest imaging showed that the patient’s lungs had not fully recovered. Lab tests showed his serum IL-6 was elevated.
Interleukin-6 (IL-6) is a protein that is produced by cells. It assists in regulating immune responses. Inflammation, autoimmune disorders, infection, and inflammation can cause IL-6 to be elevated.
Ninth Day – tocilizumab
On the ninth day of his hospital stay, the patient was administered one dose of tocilizumab intravenously. By the twelfth day he no longer experienced tightness in his chest.
Then during the next ten days and after a temporary spike, IL-6 finally decreased to a low level.
The Third CT Scan – Nineteenth Day
The third chest scan confirmed that his air sacs, which had initially indicated lung disease, were clear. The patient was discharged from the hospital.
It is noteworthy that the patient was also free of multiple myeloma symptoms at this time. Lab tests showed his counts to be in a normal range.
The Cytokine Storm
Cytokine release syndrome often occurs during treatment with certain immunotherapies. The body attacks its own cells causing an inflammatory response. The syndrome has been treated successfully with tocilizumab.
Researchers suggest that tocilizumab may also be effective against the cytokine storm that occurs during COVID-19. They believe that tocilizumab shows the potential to benefit multiple myeloma patients as immunotherapy.
The case presented by the University is the first of its kind for multiple myeloma. Tocilizumab’s effectiveness is proven as a therapy for COVID-19 in multiple myeloma with clinical recovery.
Phase III Clinical Trial (COVACTA)
In March of this year the FDA gave its approval for a clinical trial to assess the efficacy and safety of tocilizumab when it is added to a hospital’s standard of care.
The trial will be double-blind. Neither clinicians nor patients know whether the participant is receiving the drug or a placebo.
The Phase III trial investigators will be treating hospitalized adult patients who developed severe pneumonia after a coronavirus infection.
The announcement was made by Genentech in collaboration with BARDA. Genetech has also made a commitment to provide ten thousand vials of the medicine to the U.S. Strategic National Stockpile. The vials will be available for use in the future under the direction of the U.S. HHS.
The Trial Endpoints
Tocilizumab and standard of care will be compared to a placebo and standard of care.
The primary and secondary endpoints are mortality, ICU, mechanical ventilation, and clinical status variables. Patients will be observed for sixty days with an interim analysis to identify any early signs of efficacy.
About Tocilizumab (Actemra)
Actemra was first approved to treat patients with rheumatoid arthritis (RA). The clinical development program for Actemra was extensive. It included five Phase III studies with an enrollment of over four thousand people diagnosed with RA in forty-one countries.
The Actemra RA subcutaneous program involved two Phase III studies with an enrollment of over eighteen thousand people in thirty-three countries.
Actemra has been approved in the intravenous form for patients two years of age and older for CAR T cell-induced cytokine release syndrome.
About Genentech
Genentech, a forty-year-old biotechnology company, develops and manufactures medicine that treats patients with life-threatening medical conditions. The company is headquartered in South San Francisco, California.
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