Bristol Myers Squibb on Wednesday issued an update on how the COVID-19 pandemic is affecting its clinical trials, saying that for new studies, no sites will be initiated nor activated until at least April 13. Similarly, for studies that are already under way, no new sites will be activated until April 13 at the earliest, although the company said existing sites can continue to recruit new patients when appropriate. "The decisions [we have] 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 explained.
The moves, disclosed in a US Securities and Exchange Commission filing, follow similar actions by other drugmakers recently, including Eli Lilly, Pfizer, Galapagos and Ampio Pharmaceuticals (for related analysis, see ViewPoints: Impact of COVID-19 on clinical trial enrolment comes into view).
In regards to cell therapy trials, Bristol Myers Squibb said it has temporarily suspended screening, enrollment and apheresis. However, the company indicated that this particular move is "not considered an urgent safety measure" and will not affect ongoing activities for its FDA filings for either of the CAR-T cell therapies idecabtagene vicleucel (ide-cel) or lisocabtagene maraleucel (liso-cel), being investigated as potential treatments for multiple myeloma and non-Hodgkin's lymphoma, respectively. The drugmaker added that the clinical trials that form the basis for these applications have already completed enrollment.
Meanwhile, Bristol Myers Squibb said it is engaging with regulatory authorities around the world and has been "encouraged by their continued commitment in ongoing regulatory processes." The company says it continues to "monitor the situation closely," but reiterated some previously announced upcoming action dates, including an FDA decision for ozanimod in multiple sclerosis anticipated on Wednesday. The drugmaker also expects the agency to decide on its Reblozyl (luspatercept-aamt) filing by April 4 for use in myelodysplastic syndrome-associated anaemia, while a decision on Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line non-small-cell lung cancer is scheduled by May 15. Marketing applications for ozanimod and Reblozyl are also currently under review in Europe.
In addition, the FDA is slated to make a decision on Bristol-Myers Squibb's filing for liso-cel in third-line B-cell lymphoma by August 17, and the company plans to submit an application for ide-cel to treat multiple myeloma patients in the fourth-line setting some time during the first half of 2020.
In terms of COVID-19 impacts on manufacturing and supply, the drugmaker stated that "at this time, [it] does not anticipate disruptions to the supply of our medicines" as a result of the pandemic. "All of our internal manufacturing facilities are operating as usual, along with our key contract manufacturers," Bristol Myers Squibb said, and while "logistics considerations have been increasingly complex due [to] COVID-19…operational plans have been [put] in place and are successfully mitigating these challenges."
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