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BMS suspends new clinical trials as COVID-19 cases rise in US

Existing sites can continue to recruit new subjects

BMS

Bristol-Myers Squibb is the latest big pharma company to announce it will postpone clinical trials for the time being, as coronavirus cases worldwide climb above the 430,000 mark.

For new studies and ongoing studies, no investigation sites will be brought online until at least 13 April – a date that BMS says could well be extended – but existing sites can continue to recruit new subjects “when appropriate”.

It has also suspended screening, enrolment and apheresis in its cell therapy trials. That decision won’t however affect its two most advanced clinical programmes – idecabtagene vicleucel (ide-cel or bb2121) for multiple myeloma and B-cell lymphoma therapy lisocabtagene maraleucel (liso-cel, JCAR017) – as studies for those are already fully enrolled.

The move doesn’t go as far as the near-total lockdown on new trials at Eli Lilly, which announced a near-total halt on new studies and suspension of enrolment into existing trials last week.

“The decisions…taken are intended to protect the safety of study participants, our employees and staff at clinical trial sites and ensure regulatory compliance and scientific integrity of trial data," the drugmaker says in a filing with the US Securities and Exchange Commission.

The impact of the coronavirus outbreak on regulatory activities like new drug application reviews remains unclear, and BMS says it is encouraged by agencies’ “continued commitment in ongoing regulatory processes”.

Nevertheless, there are a few upcoming decisions that could be affected if pressure on regulators disrupts processes, as looks increasingly likely.

That includes an FDA decision on multiple sclerosis therapy ozanimod, which was due yesterday, and a verdict due by 4 April for Reblozyl (luspatercept) as a second-line therapy for anaemia associated with myelodysplastic syndromes (MDS). Both of those are also under review in Europe.

Following after is an FDA review of checkpoint inhibitor combination Opdivo (nivolumab) and Yervoy (ipilimumab) in first-line non-small cell lung cancer – due 15 May – a decision on liso-cel by 17 August and a filing for ide-cel scheduled for the first half of the year.

Meanwhile, an R&D day has also been postponed as the COVID-19 pandemic continues to disrupt the daily lives of millions around the world, but the company “does not anticipate disruptions to the supply of our medicines for patients due to COVID-19”.

It adds: “We continue to hold an adequate amount of safety stock and are at an appropriate level based on anticipated needs.”

While staff are being asked to operate from home, the company says its employees in China are starting to report back to work as the spread of the virus seems to be coming under control.

Article by
Phil Taylor

26th March 2020

From: Research

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