- Developers of cancer cell therapies have begun to put clinical trials of the complex treatments on hold as hospitals in the U.S. and Europe grapple with the sudden and dramatic influx of patients infected with the new coronavirus.
- This week, Bristol Myers Squibb announced the suspension of patient screening, enrollment and treatment initiation in all of its cancer cell therapy studies, including three multiple myeloma trials testing a CAR-T treatment developed by Bluebird bio. French pharma Servier, meanwhile, halted enrollment into two leukemia studies.
- Dozens of clinical studies are affected by the health system disruption caused by the coronavirus pandemic. Cell therapy trials could be particularly vulnerable, however, as they require extensive patient screening and, for some, the collection of patients' own immune cells. The risk of severe side effects often requires in-hospital monitoring and, potentially, stays in intensive care units now dedicated to COVID-19 treatment.
Cell therapy developers are taking different approaches to safeguarding their studies.
While Bristol Myers and Servier have announced enrollment halts, Gilead and Novartis, two other leading companies in the field, said their studies are proceeding for now.
"All Kite clinical trials remain open at this time," Gilead, which bought Kite Pharma two years ago, said in a statement to BioPharma Dive. "We continue to monitor the COVID-19 situation closely and implement any changes to our clinical program that are needed as a result of this pandemic."
Novartis has set up a team dedicated to monitoring its trials globally and said in a statement it's "prepared for a number of scenarios."
Bristol Myers, Gilead and Novartis are developers of what's known as autologous CAR-T therapy, a type of personalized cancer treatment that involves the genetic engineering of immune cells drawn from patients' blood.
Cells must be extracted at a certified treatment center, frozen and shipped to a company manufacturing plant, where they are modified to seek out certain cancers. The cell treatment is then shipped back across the country and infused into the patient.
It's a complex, carefully timed process and must be done quickly, as many patients who receive it are very sick, having failed other previous treatments. Compared to other types of drugs, CAR-T therapies are more dependent on shipping and logistic providers which ferry the cells back and forth from trial site to the manufacturers and back.
In their statements, Gilead and Novartis said they have plans in place should existing transportation options be disrupted by the pandemic or related government responses.
"In order to mitigate potential interruption of supply we have established alternative transportation routes for our CAR-T therapies," Novartis said in a statement. "These alternatives include use of cargo flights and supplement our use of passenger flights."
Both Gilead and Novartis have won approvals for their CAR-T therapies, respectively sold as Yescarta and Kymriah, while Bristol Myers intends to ask the Food and Drug Administration for an OK this year.
Novartis primarily makes Kymriah at its facility in Morris Plains, New Jersey, although it has added production sites in Europe as well. Kite's main manufacturing center is near Los Angeles.
Bristol Myers' decision to halt enrollment into its cell therapy studies won't affect plans to file its experimental candidates liso-cel or ide-cel to the FDA for approval, as the studies supporting those applications have been completed.
But plans to expand ide-cel into earlier lines of multiple myeloma therapy will be affected, as three trials enrolling some 600 cancer patients are put on pause.
Bluebird bio, which developed ide-cel and is partnered with Bristol Myers, expects the impact to trial timelines to be temporary.
"As we emerge, that will be something that will rapidly pick back up," said Bluebird bio CEO Nick Leschly in a conference call with analysts on Thursday.