{"id":44690,"date":"2022-06-03T22:01:32","date_gmt":"2022-06-03T20:01:32","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/yescarta-car-t-cell-therapy-demonstrates-consistent-survival-outcomes-and-safety-in-real-world-setting-regardless-of-race-and-ethnicity\/"},"modified":"2022-06-03T22:01:32","modified_gmt":"2022-06-03T20:01:32","slug":"yescarta-car-t-cell-therapy-demonstrates-consistent-survival-outcomes-and-safety-in-real-world-setting-regardless-of-race-and-ethnicity","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/yescarta-car-t-cell-therapy-demonstrates-consistent-survival-outcomes-and-safety-in-real-world-setting-regardless-of-race-and-ethnicity\/","title":{"rendered":"Yescarta\u00ae CAR T-cell Therapy Demonstrates Consistent Survival Outcomes and Safety in Real-World Setting Regardless of Race and Ethnicity"},"content":{"rendered":"
\n

\n— Largest Analysis Examining Use of CAR T-cell Therapy Across Race and Ethnicity —<\/i><\/b>\n<\/p>\n

\n—<\/i> Black or African American Patients Experienced Longer Time from Diagnosis to Infusion Compared to White Patients, Possibly Impacting Overall and Complete Response Rates; More Study Warranted —<\/i><\/b>\n<\/p>\n

\n—<\/i> Clinical Trials of Yescarta in the U.S. and Real-World Use from CIBMTR Registry Show Consistent Participation of Approximately 5% Black or African American Patients <\/i>—<\/b>\n<\/p>\n

SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), today announced findings from a safety and efficacy retrospective analysis by race and ethnicity from the ongoing post-authorization study of Yescarta\u00ae<\/sup> (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL). In the largest real-world analysis of its kind evaluating data from the CIBMTR\u00ae<\/sup> (Center for International Blood and Marrow Transplant Research\u00ae<\/sup>), overall outcomes including overall survival (OS) and progression-free survival (PFS) rates were consistent with Yescarta in the real-world setting, regardless of race and ethnicity. The findings were presented today in an oral session during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7571).\n<\/p>\n

<\/a><\/p>\n

\nThe incidence of diffuse LBCL in the U.S. is 4.8 per 100,000 per year in non-Hispanic Black or African Americans and 7.1 per 100,000 per year in non-Hispanic Whites. Clinical trials of Yescarta in the U.S. have enrolled an average of 6% Black or African American patients, consistent with the roughly 5% of patients in the real-world CIBMTR registry.* Further research is ongoing to investigate whether or not there is under-representation by race and ethnicity in both clinical trials and the real-world usage of CAR T-cell therapy.\n<\/p>\n

\n\u201cThe investigation of CAR T-cell therapy outcomes by race and ethnicity is important to the continued understanding of the impact of these innovative therapies, and an area in which there is a significant deficit in clinical trials and real-world studies published to date,\u201d said Frederick L. Locke, MD, lead author and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida. \u201cThe results of this analysis are encouraging in that axi-cel was safe and effective regardless of race or ethnicity, and also warrant further investigation to understand the lower rate of response among Black or African American patients and the potential role of factors such as higher disease burden, disease biology and, importantly, differential access to care.\u201d\n<\/p>\n

\nA total of 1,389 adult patients with LBCL treated with Yescarta in the commercial setting in the U.S. from October 2017 to August 2020 were included in the analysis. Race and ethnicity (Hispanic or Latino vs. not Hispanic or Latino) were self-reported and included: White (81%); Black or African American (5%); Asian (6%); American Indian or Alaska Native <1%; Native Hawaiian or other Pacific Islander <1%; More than one race <1%; Race not reported (7%). Eleven percent of patients evaluated self-identified as Hispanic or Latino.\n<\/p>\n

\nAt a median follow-up of 12.7 months, outcomes for objective response rate (ORR), complete response (CR), duration of response (DOR) at 6 months, PFS at 12 months, and OS were as follows:\n<\/p>\n\n\n\n\n\n\n\n
\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nBlack or
\n
African American<\/b>\n<\/p>\n<\/td>\n

\n

\nAsian<\/b>\n<\/p>\n<\/td>\n

\n

\nWhite<\/b>\n<\/p>\n<\/td>\n

\n

\nHispanic
\n
or Latino<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nObjective response rate (ORR)<\/b>\n<\/p>\n<\/td>\n

\n

\n57%\n<\/p>\n<\/td>\n

\n

\n67%\n<\/p>\n<\/td>\n

\n

\n74%\n<\/p>\n<\/td>\n

\n

\n73%\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nComplete response (CR)<\/b>\n<\/p>\n<\/td>\n

\n

\n45%\n<\/p>\n<\/td>\n

\n

\n53%\n<\/p>\n<\/td>\n

\n

\n57%\n<\/p>\n<\/td>\n

\n

\n55%\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nDuration of response (DOR; 6-month)<\/b>\n<\/p>\n<\/td>\n

\n

\n66%\n<\/p>\n<\/td>\n

\n

\n81%\n<\/p>\n<\/td>\n

\n

\n70%\n<\/p>\n<\/td>\n

\n

\n71%\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPFS at 12 months<\/b>\n<\/p>\n<\/td>\n

\n

\n36%\n<\/p>\n<\/td>\n

\n

\n55%\n<\/p>\n<\/td>\n

\n

\n48%\n<\/p>\n<\/td>\n

\n

\n50%\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nOS at 12 months<\/b>\n<\/p>\n<\/td>\n

\n

\n62%\n<\/p>\n<\/td>\n

\n

\n65%\n<\/p>\n<\/td>\n

\n

\n63%\n<\/p>\n<\/td>\n

\n

\n65%\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nMultivariable analyses found no statistical differences in OS and PFS across races. Efficacy outcomes across patients who were Hispanic or Latino and not Hispanic or Latino were also consistent. Among Black or African American patients, ORR and CR were lower compared to White patients [(Odds Ratio (OR) 0.40; 95% Confidence Interval [CI], 0.24\u20130.69) and (OR 0.55; 95% CI 0.32\u20130.93), respectively]. Black or African American patients, compared to White patients, were more likely to have moderate to severe pulmonary impairment (41% vs. 28%) and tended to have a longer time from diagnosis to infusion of Yescarta (\u226512 months: 71% vs. 59%). DOR rates among Asian patients were more favorable compared to both White patients (Hazard Ratio (HR) 0.46; 95% CI 0.24\u20130.87) and Black or African American patients (HR 0.39; 95% CI 0.17\u20130.88). No differences in cytokine release syndrome (CRS; any grade) and Grade \u22653 CRS by race and ethnicity were observed. Asian patients (OR 0.52; 95% CI 0.29\u20130.96 vs. White) and Hispanic or Latino patients (OR 0.51; 95% CI 0.31\u20130.85 vs. not Hispanic or Latino) experienced a lower risk of Grade \u22653 ICANS (ASTCT consensus grade).\n<\/p>\n

\n\u201cAs the global leader in CAR T-cell therapy, it is important to Kite that we support research to help better understand outcomes of CAR T-cell therapy across different races and ethnicities,\u201d said Frank Neumann, MD, PhD, SVP & Global Head of Clinical Development, Kite. \u201cThrough ongoing data generation, increasing diversity in Kite\u2019s clinical trials, and partnerships with patient advocacy organizations and community partners to reduce barriers to care, we are actively working to increase our understanding of CAR T-cell therapy in diverse populations and treatment settings.\u201d\n<\/p>\n

\nYescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy. Yescarta was also approved by the FDA in April 2022 as the first CAR T-cell therapy for adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.\n<\/p>\n

\n*Average is based on combined enrollment in ZUMA-1 and ZUMA-7 trials. Terminology for self-reporting of race has changed during the time period of these trials.\n<\/p>\n

\nAbout LBCL<\/span><\/b>\n<\/p>\n

\nGlobally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. The incidence of diffuse LBCL per 100,000 people per year in the U.S. is 4.8 in non-Hispanic Black or African American, 7.1 in non-Hispanic White, 6.8 in Hispanic or Latino, and 5.9 in Asian\/Pacific Islander populations, respectively.\n<\/p>\n

\nAbout Yescarta<\/span><\/b>\n<\/p>\n

\nPlease see full Prescribing Information<\/a>, including BOXED WARNING<\/b> and Medication Guide.\n<\/p>\n

\nYESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:\n<\/p>\n