IL-611 Apr 2020 08:47
NCI to distribute IL-6 inhibitor for cancer patients with COVID-19 lung inflammation
By Matthew Bin Han Ong
This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full directory of our coverage is available here.
NCI is finalizing plans to use its clinical trials networks to administer a compassionate use protocol for distribution of tocilizumab, a drug that blocks the inflammatory protein IL-6.
Tocilizumab, an immunosuppressive agent also known by its brand name Actemra, is sponsored by Genentech. Under NCI’s protocol, the drug will be made available to cancer patients at institutions that are not participating in Genentech’s phase III trial of the drug.
The IL-6 inhibitor was approved by FDA for rheumatology indications in 2011, and has been used for mitigation of cytokine release syndrome caused by CAR T-cell therapy.
According to Genentech, the federal government has obtained 10,000 vials of tocilizumab for the U.S. Strategic National Stockpile “for potential future use at the direction of the HHS.”
It is one of three drugs—the other two being sarilumab and siltuximab—that are now being rushed into late-stage clinical trials for assessment of efficacy in treatment of acute respiratory distress syndrome caused by immune response to SARS-CoV-2 infection (The Cancer Letter, March 27, 2020).
“We are going to, in concert with Genentech, run a treatment referral trial for the Genentech Roche IL-6 receptor antibody for COVID-related ARDS,” James Doroshow, deputy director for clinical and translational research at NCI, said April 9 in an emergency virtual joint meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board.
“We wrote a trial, I would like to say—just like in the old days—in four days, a trial was put up. It’s been reviewed by Genentech Roche,” said Doroshow, who is also director of NCI’s Division of Cancer Treatment and Diagnosis and head of the Oxidative Signaling and Molecular Therapeutics Group of NCI’s Developmental Therapeutics Branch. “I hope to be able to have a final version of this to the central IRB very quickly.”
NCI’s protocol for tocilizumab is designed to rapidly make the drug available to cancer patients, who face a particularly high fatality risk from severe complications stemming from COVID-19.
“Why do this? Well, because we know that there are multiple randomized trials and multiple institutional trials,” Doroshow said. “There are some folks who simply can’t afford to get this drug, and we wanted to have a very broadly eligible study, eligible even for patients very young in age, which is not addressed by most of the trials that are out there, to try to see whether we can move the needle in terms of decreasing ICU time, ventilator time, time in the hospital.
“We will collect some clinical data. It’ll be a modest set of data,” Doroshow said. “There will be blood obtained for biomarker evaluation.