Jeremy Moeller\/Getty Images<\/p>\n
Significant advancements in the treatment of relapsed or refractory large B-cell lymphoma are on the horizon. At the American Society of Hematology meeting, this weekend, both Bristol Myers Squibband Kite Pharma presented promising data from CAR-T programs aimed at this disease.<\/p>\n
At ASH, BMS unveiled data that showedBreyanzi(liso-cel), a CD19-directed CAR-T cell therapy, as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma,outperformed the current standard of carefor patients in second-line relapsed or refractory LBCL, significantly improving event-free survival (EFS). BMS said that only a small portion of patients who have relapsed or refractory large B-cell lymphoma (LBCL) experience long-term benefits with high-dose chemotherapy and stem cell transplant. Data from the pivotal Phase III TRANSFORM study showed that Breyanzi significantly improved median event-free survival with a median of 10.1 months. Standard of care treatment only offered an improvement of 2.3 months with a 65% improvement.<\/p>\n
Data showed that 86% of Breyanzi patients achieved a complete or partial response, with 66% of patients achieving a complete response. In comparison, only 48% of standard of care patients achieved the same response, with only 39% of those reaching a complete response.<\/p>\n
Median progression-free survival was significantly longer withBreyanzicompared to standard of care, 14.8 months vs. 5.7 months.<\/p>\n
Additionally, results from an analysis of patient reported outcomes from the TRANSFORM study showed favorable improvement in most patient reported outcomes. That includes an improved or maintained health-related quality of life for patients who were treated with Breyanzicompared to those treated with the standard of care treatment.<\/p>\n
Kite Pharma, a subsidiary of Gilead Sciences, showcased its own data in second-line relapsed\/refractory large B-cell lymphoma (LBCL), the same indication as BMS Breyanzi. Data from the landmark Phase III ZUMA-7 study of Yescarta (axicabtagene ciloleucel) showed a 2.5 fold increase in patients who were alive at two years and had not required the need for additional cancer treatment or experienced cancer progression. Also, the data showed a four-fold greater median event-free survival for Yescarta compared to standard of care.<\/p>\n
Kite said that improvements in EFS with Yescarta were consistent across patient subgroups, including the elderly, those with primary refractory disease, high-grade B-cell lymphoma including double-hit and triple-hit lymphoma and double expressor lymphoma.<\/p>\n
Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administrationfor the treatment of adult patients with relapsed or refractory large B-cell lymphoma.<\/p>\n
Additionally, Kite announced significant long-term data showcasing the CAR-T therapys ability to provide meaningful improvements in quality of life compared with standard of care. Also at ASH, Kite unveiled data that showed Yescarta provided a five-year overall survival rate of 42%. Among those patients who saw a complete response to the CAR-T treatment, the five-year overall survival rate was 64.4%.<\/p>\n
Perhaps most significantly, Kite said that among Yescarta patients who were still alive after five years, 92% needed no additional treatment since that first infusion of the CAR-T therapy. This suggests a potential cure for some of the patients, Kite said, in its announcement.<\/p>\n
Other cell therapy data presented at ASH include:<\/p>\n
bluebird Gene Therapy Improves Lives of Sickle Cell Patients<\/p>\n
bluebird bio'slovo-celis showing promisein a Phase I\/II study in sickle cell. Data from two cohorts of the largest sickle cell gene therapy program to date is showing patients treated with lovo-cel are seeing a continued complete resolution of severe vaso-occlusive events (VOE) after six years.<\/p>\n
The VOEs are defined as episodes of acute pain with no medically determined cause other than vaso-occlusion. That means that lovo-cel, a lentiviral gene therapy, has the potential to improve day-to-day life in sickle cell patients by eliminating the painful issues associated with the disease that can occur several times per month.<\/p>\n
Additionally, the patients have achieved near normal levels of key hemolysis markers and experienced sustained improvements in patient-reported quality of life following treatment.<\/p>\n
The bluebird gene therapy is designed to add functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients blood stem cells. Once the gene is added, their red blood cells are able to produce anti-sickling hemoglobin (HbAT87Q), which reduces the sickled blood cells that cause the disease.<\/p>\n
Janssens CAR-T Hammers Multiple Myeloma<\/p>\n
At ASH, Janssenannounced data from a Phase Ib\/II study that showed CAR-T therapy cilta-cel (ciltacabtagene autoleucel) provided anoverall response rate of 98%in patients with relapsed and\/or refractory multiple myeloma.<\/p>\n
The company said that cilta-cel, an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, showed that patients who received an infusion continued to demonstrate deep and durable responses. Data showed that 83% of patients in the study achieved a stringent complete response (sCR) at 22 months. That is an 80% increase from the 18-month median follow-up presented earlier this year at the American Society of Clinical Oncology meeting.<\/p>\n
Also, two-year progression free survival and overall survival rates were 61% and 74%, respectively.<\/p>\n
Poseida Sees Promise in CAR-T as it Winds Down Autologous Program<\/p>\n
Interim results from Poseida'sPhase I\/II PRIME study of P-BCMA-101for the treatment of relapsed\/refractory multiple myeloma show strong anti-tumor activity in patients with advanced forms of the disease. P-BCMA-101 in combination with rituximab achieved an improved overall response rate of 78% and 100% overall survival.<\/p>\n
P-BCMA-101 is a non-viral transposon-based autologous CAR-T. The data from the PRIME study have been used to inform the companys development of its first allogeneic program, P-BCMA-ALLO1, also being developed in the same indication. In November, Poseida announced that it iswinding down the P-BCMA-101 autologous programin favor of the allogeneic program, P-BCMA-ALLO1.<\/p>\n
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BMS and Kite Unveil CAR-T Successes in Lymphoma - BioSpace<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" Jeremy Moeller\/Getty Images Significant advancements in the treatment of relapsed or refractory large B-cell lymphoma are on the horizon. Continue reading