BMS’s liso-cel met primary, secondary endpoints in TRANSCEND NHL 001

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Bristol-Myers Squibb Co. said the pivotal study of lisocabtagene maraleucel (liso-cel) an investigational CD19-directed CAR T-cell therapy with a defined composition of purified CD8+ and CD4+ CAR T cells in relapsed/refractory large B-cell lymphomas (TRANSCEND NHL 001) met its primary and secondary endpoints while demonstrating durable responses.

The data were presented during an oral session at the 2019 ASH annual meeting.

“Longer-term follow-up from the TRANSCEND study shows that liso-cel resulted in a rapid, high rate of durable complete responses with low incidence of severe cytokine release syndrome and neurologic events in two and 10 percent, respectively, among patients with relapsed/refractory large B-cell lymphomas,” said Jeremy Abramson, associate professor of medicine at Harvard Medical School and director of the Lymphoma Center at Massachusetts General Hospital. “Additionally, responses with liso-cel were seen across patient groups including high-risk patients such as those with refractory disease, older patients and those with high tumor burden.”

In the study, 344 patients were leukapheresed and 269 patients received liso-cel at one of three dose levels (50 x 106 n=51; 100 x 106 n=177; and 150 x 106 n=41). There were 25 patients that received nonconforming product and there were two instances where product could not be manufactured. Patients were heavily pretreated and had aggressive disease with a median of three prior therapies including 35% with prior autologous or allogeneic hematopoietic stem cell transplant and 67% with chemotherapy-refractory disease. Bridging therapy was administered to 59% of patients.

Among patients evaluable for efficacy (n=256), the overall response rate was 73% (187/256, 95% CI: 67 – 78) with 53% of patients (136/256, 95% CI: 47 – 59) achieving a complete response. Responses were similar across all patient subgroups. The median duration of response for all patients was not reached (95% CI: 8.6 months – NR) at a median follow-up of 12 months (95% CI: 11.2 – 16.7). Median progression-free survival was 6.8 months (95% CI: 3.3 – 14.1) and median overall survival was 21.1 months (95% CI: 13.3 – NR). The median PFS and OS for patients who achieved a CR was not reached with 65.1% of patients progression free and 85.5% of patients alive at 12 months, respectively.

BMS said that based on results from TRANSCEND NHL 001 it expects to complete the submission of a Biologics License Application to FDA by the end of the year.

Table of Contents

YOU MAY BE INTERESTED IN

Just consider for a minute if this was the first year of running your lab, if you were on the job market as a physician or scientist right now, if you were a resident contemplating a career in cancer research after fellowship, if you were a graduate student or postdoc, if you were an undergraduate or a technician who was looking toward graduate school.
The immune system can be a powerful tool to control cancer. Immune cells within our body detect cancer cells and release payloads that kill them. Transformative science in the last decade has led to the development of therapies that enhance the ability of our immune cells to carry out this function. These therapies, including checkpoint blockade and CAR-T cells, have been lifesaving for many patients that before had untreatable cancer. But, sadly, a majority of patients with advanced solid tumors still succumb to their disease. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login