Bristol-Myers Squibb Co.'s chimeric antigen receptor T cell therapy, dubbed liso-cel, showed benefits for blood cancer patients in multiple studies presented at the 2019 American Society of Hematology's annual meeting.
Liso-cel, or lisocabtagene maraleucel, was evaluated for treating relapsed or refractory chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL, as well as for treating patients with relapsed or refractory large B cell non-Hodgkin lymphoma, or NHL. These cancers affect the white blood cells in the blood.
In Transcend CLL 004, a phase 1/2 study, 18 out of 22 patients with CLL or SLL responded to liso-cel, and 10 patients showed no signs of cancer following treatment. The company presented similar results at the annual meeting of the American Society of Clinical Oncology in June.
All the patients in the Transcend study experienced some type of treatment-emergent adverse event, with 96% having more serious events that were described as grade 3 or higher on a scale of grades 1 through 5. There were no deaths, known as grade 5 events.
The liso-cel therapy was also effective in a separate, phase 2 trial involving patients with large B-cell NHL. Results from the study, dubbed Pilot, showed all 12 patients who could be evaluated responding to the treatment. Six of them showed no signs of cancer.
About 62% of patients in the trial experienced at least one treatment-emergent adverse event grade 3 or higher, although there were no patient deaths reported.
In addition, Bristol-Myers also presented a report where liso-cel's safety and efficacy were evaluated in treating large B-cell NHL in the outpatient setting. Researchers analyzed data from three studies named Outreach, Transcend NHL 001 and Pilot. The analysis showed 35 out of 44, or 80% of patients, responding to the treatment. Twenty-four patients, or 55%, showed no signs of cancer.
At least 20% of the patients in the analysis experienced a treatment-emergent adverse event.
Liso-cel, which is not approved for marketing in any country, was originally developed by Celgene Corp. The therapy was one of a few assets on which Bristol-Myers based its $95 billion valuation of the company. Bristol-Myers intends to file for the U.S. Food and Drug Administration's approval for the product by the end of the year.
According to SVB Leerink analyst Geoffrey Porges the planned submission for liso-cel would place a potential FDA approval in mid-2020. The drug would compete with the already approved Yescarta from Gilead Sciences Inc. and Novartis AG's Kymriah.