Roche's Actemra Fails in Randomized Trial for Early-Stage COVID-19 Pneumonia

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Roche’s IL-6R inhibitor Actemra (tocilizumab) is one of several anti-inflammatory drugs being evaluated for the treatment of coronavirus disease 2019 (COVID-19), with previous studies demonstrating its efficacy in patients with severe and critical COVID-19.

Recently, a randomized study in Italy found that Actemra did not benefit patients with early-stage COVID-19 pneumonia, although it may still be useful for more advanced cases.

A report released by the Italian Medicines Agency (AIFA) indicated that, in patients with early-stage COVID-19, Acterma did not improve severe respiratory symptoms, reduce ICU admissions, or lower mortality compared to standard care. Reportedly, this study was the first randomized trial worldwide to investigate Acterma for the treatment of COVID-19. After enrolling 126 patients (one-third of the planned sample size), researchers prematurely concluded the efficacy assessment of early Acterma use. Enrolled patients required medical care but did not need invasive or non-invasive mechanical ventilation. Three of these patients were excluded from the analysis due to withdrawal of consent.

Analysis of the remaining 123 patients showed that Acterma demonstrated no benefit over standard care, either in terms of disease deterioration (admission to the intensive care unit) or survival rates. Specifically, there were no significant differences between patients receiving Acterma and those receiving standard care in the rate of disease deterioration within the first two weeks (28.3% vs. 27.0%), the total number of admissions to the intensive care unit (10.0% vs. 7.9%), and the 30-day mortality rate (3.3% vs. 3.2%).

AIFA stated that this randomized study conducted in patients with early-stage COVID-19 pneumonia was “important and conclusive.” This challenges the theory that IL-6 inhibitors have the potential to treat COVID-19, including not only Actemra but also Kevzara, the antibody drug developed by Sanofi/Regeneron.

For patients with severe COVID-19, other clinical trials of IL-6 inhibitors are still ongoing. Currently, Genentech, a member of the Roche Group, is conducting a trial that will provide robust evidence regarding the benefit-risk profile of Actemra. Roche is also evaluating Actemra in combination with remdesivir for the treatment of patients with severe COVID-19.

In early March this year, the National Health Commission of China already included Actemra in its treatment guidelines for COVID-19. The reason is that frontline doctors found Actemra effective in controlling lung inflammation in severe cases of COVID-19: fever rapidly decreased within a few days after administration, and the need for supplemental oxygen was also reduced. This has sparked significant interest across the industry, and throughout the pandemic response, researchers have launched a series of clinical trials evaluating anti-inflammatory drugs for treating COVID-19. However, in April this year, the results from a Phase II trial of Kevzara in patients with severe COVID-19 were disappointing. Currently, the drug is being tested in a Phase III clinical trial for the treatment of critically ill COVID-19 patients.

This week, Genentech CEO Alexander Hardy stated at a PhRMA webinar that the company is establishing an “end-to-end” Actemra supply chain in the United States. Currently, the drug is manufactured in Europe; the company has previously produced hundreds of thousands of doses and now plans to scale up production to millions of doses to address COVID-19.

Reference source: Roche's Actemra falls short in Italian study in early-stage COVID-19 pneumonia