A Bristol-Myers Squibb cancer drug made by engineering a patient’s own immune cells is now on the market officially recognized Treating patients in the early stages of disease is a regulatory decision that could expand the number of patients this personalized cell therapy can cover. The decision could also give BMS an edge over rival cell therapies marketed by Gilead Sciences.
CAR T therapy for BMS, named Breyanzi, originally approved last year for diffuse large B-cell lymphoma, (DLBCL) A type of non-Hodgkin lymphoma in which the body makes abnormal B lymphocytes. Standard treatment is chemotherapy plus the antibody drug rituximab. When this treatment fails or the cancer recurs, the next treatment option is autologous stem cell transplantation.
The initial approval of Breyanzi makes it a third-line treatment for DLBCL patients whose cancer has returned or has not responded to two earlier therapies. The expanded approval of the drug, announced late Friday, moves the drug up the treatment hierarchy, making it a second-line treatment for patients whose disease has relapsed within 12 months of their initial chemotherapy regimen.This matches Extended approval Earlier this year, Gilead Sciences’ cell therapy Yescarta. In addition, Breyanzi’s additional approval includes those who are ineligible for stem cell transplants.
Factors that may make a patient ineligible for a stem cell transplant include age, poor kidney or heart function, or a low score based on an assessment of frailty, said Leo Gordon, a researcher in Breyanzi’s PILOT study and a professor of medicine at Northwestern University. Often, these patients receive palliative care to relieve symptoms of the cancer.
“We think there’s a place for CAR T therapy,” Gordon said in an interview earlier this month at the annual meeting of the American Society of Clinical Oncology. “The purpose of this is to provide patients with an alternative that is considered to be the standard [of care treatment]. That’s why this is an important group to watch. “
CAR T therapy is a personalized treatment that works by harvesting a patient’s T cells and engineering them to target proteins on the surface of cancer cells. These immune cells are multiplied in the laboratory and then infused back into the patient. The expanded approval of Breyanzi is based on the results of two studies evaluating the drug as a second-line treatment.
The TRANSFORM study evaluated Breyanzi in 184 patients who remained eligible for stem cell transplantation. The main goal is to measure how long patients are free of certain cancer complications. Within one year, 45% of patients treated with Breyanzi met this criterion, compared with 24% of patients treated with standard care. Event-free survival was estimated at 10.1 months in the treatment group and 2.3 months in the control group. Nearly half of the patients who received standard care went on to receive autologous stem cell transplants.
Measuring complete and overall responses is the primary goal of PILOT, an open-label study enrolling patients with a median age of 73 years. Gordon said PILOT’s efficacy was similar to what was seen in healthier and younger patients evaluated in the test, using the drug as a third-line treatment. The median duration of response has not been reached, but of 61 patients, 54% achieved a complete response. “This was actually better than what we expected from a transplant,” Gordon said.
The main safety risks for CAR T therapy as a class include an immune response called cytokine release syndrome and toxic effects in the brain. The cases of cytokine release syndrome observed in the latest Breyanzi study were mild to moderate, Gordon said. While some patients had severe neurotoxicity, Gordon said no one had to go to intensive care and everyone recovered. About 20% of patients are treated on an outpatient basis.
In a research note to investors on Monday, William Blair analyst Matt Phipps noted that Breyanzi’s broader label as a second-line treatment allows it to reach more patients than Yescarta, while Gilead’s The drug is not approved for treatment.
“We assume that approximately 40% of patients will be refractory at some point after first-line therapy or will relapse at some point, and that 50% of these patients are not eligible for transplantation, according to PILOT, approximately 6,000 patients per year may have Eligibility to accept Breyanzi,” Phipps wrote. “Therefore, this approval clearly provides a greater opportunity for Bristol-Myers Squibb while reducing CAR T competition.”
Breyanzi’s total revenue in 2021 is $87 million, according to BMS’ financial report. Sales of the drug hit $44 million in the first quarter of this year. Phipps said Breyanzi’s new approval and broad label are positive signs for BMS as the company looks for other drugs that could offset patent expirations on key products in the coming years. He added that BMS expects Breyanzi to have annual sales of more than $3 billion by the end of the decade.
Photo by Bristol-Myers Squibb
