ICMR recommends dropping Interferon, adding cancer drug Acalabrutinib to WHO Solidarity trial

ICMR has submitted a proposal to the Modi govt recommending the cancer drug developed by AstraZeneca, which apparently improved clinical outcomes of patients with severe Covid-19.

AstraZeneca sells the drug Acalabrutinib under the brand name Calquence | Image: ThePrint Team

New Delhi: The Indian Council of Medical Research (ICMR) has submitted a proposal before the Narendra Modi government’s panel of experts, calling for the dropping of “Interferon treatment” as part of the World Health Organization’s Solidarity trial.

The Solidarity trial, an international clinical trial meant to help find an effective treatment for Covid-19, compares options against standard of care and assesses their relative effectiveness against the disease.

ICMR’s National AIDS Research Institute (NARI) — the institute responsible for conducting WHO’s trial in India — has presented its interim analysis to the government’s Subject Expert Committee (SEC). The SEC advises the country’s apex drug regulator, the Drug Controller General of India, on applications seeking approvals for new drugs, vaccines and clinical trials. 

Along with the analysis, NARI has submitted the “proposal for dropping of interferon arm and addition of Acalabrutinib arm in the study”.

Acalabrutinib is a cancer drug developed by British pharmaceutical giant AstraZeneca and is branded as Calquence.  

This is the second time NARI has proposed to include the Acalabrutinib for Covid treatment. Its addition was earlier discussed on 9 October when the committee had sought more “clarifications and justifications”. 

Now, the panel, which deliberated over the proposal on 20 October, has asked NARI to “present the latest version of protocol, before the committee for further deliberation,” according to the minutes of the meeting. 

Results of Solidarity trial 

Solidarity is the largest multi-country trial that was started by WHO to estimate the impact of four repurposed drugs — Remdesivir, Hydroxychloroquine, Lopinavir and Interferon — on reducing deaths in hospitalised patients of Covid-19, compared to the existing standard of care. 

While the trial arms related to Hydroxychloroquine and Lopinavir were earlier discontinued when interim analyses showed no benefit, Interferon is likely to be replaced by Acalabrutinib. 

“These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalised Covid-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” researchers from the Solidarity trial reported in the pre-print paper on Medrxiv. “The mortality findings contain most of the randomised evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.”

The cancer drug

Acalabrutinib was approved by the US Food and Drug Administration in 2019 for the treatment of certain types of cancers.

Acalabrutinib belongs to a class of medications called Bruton’s tyrosine kinase (BTK) inhibitor. These drugs block the action of the abnormal protein that signals cancer cells to multiply, stopping the growth of cancer cells.

In June, AstraZeneca had announced in the peer-reviewed journal Science Immunology that the drug “reduced markers of inflammation and improved clinical outcomes of patients with severe Covid-19”.

According to the company’s website, “The science supporting investigation of the use of Calquence in patients with severe Covid-19 is strong.”