Rebecca Araujo

DocwireNews

Findings from the CARTITUDE clinical program found that ciltacabtagene autoleucel (cilta-cel), an anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for <a href="https://www.docwirenews.com/urban-health-today/urban-health-multiple-myeloma-knowledge-hub/urban-health-multiple-myeloma-picks/multiple-myeloma-cases-have-more-than-doubled-since-1990/">multiple myeloma (MM)</a>, achieved high response rates and durable responses in patients with relapsed/refractory and earlier-stage disease. These findings will be featured at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Virtual Congress.<h2>Durable Response in Heavily Pre-treated MM</h2>Safety and efficacy of cilta-cel was tested in the phase 1b/2 CARTITUDE-1 trial of 97 patients with relapsed/refractory MM. Patients had received a median of six prior lines of therapy and 42% were penta-refractory.At a median follow-up of 18 months, most patients (98%) responded to treatment, including 80% who achieved a stringent complete response (sCR). Progression-free survival (PFS) at median follow-up was 66% (95% confidence interval [CI], 54.9&ndash;75.0) and overall survival (OS) was 81% (95% CI, 71.4&ndash;87.6). Results were comparable regardless of factors such as prior lines of therapy or <a href="https://www.docwirenews.com/condition-center/multiple-myeloma-knowledge-hub/multiple-myeloma-kol-video/defining-high-risk-multiple-myeloma-with-dr-martin/">cytogenetic risk</a>. In patients with minimal residual disease (MRD) evaluations (n = 61), 92% achieved MRD negativity at a median one month post-infusion.&ldquo;What is remarkable about this study is that these patients, who had previously received multiple treatment regimens, have responded to cilta-cel without their disease progressing,&rdquo; said Saad Z. Usmani, MD, of the Levine Cancer Institute, in a <a href="https://www.businesswire.com/news/home/20210601005212/en/Legend-Biotech-Announces-New-and-Updated-Data-for-Investigational-BCMA-CAR-T-Ciltacabtagene-Autoleucel-cilta-cel-for-the-Treatment-of-Relapsed-or-Refractory-Multiple-Myeloma-at-2021-ASCO-and-EHA-Meetings">press release</a>. &ldquo;These compelling results, paired with the manageable safety profile and sustained efficacy, demonstrate the potential of cilta-cel for patients with relapsed and refractory MM.&rdquo;The most common hematologic adverse events (AEs) were neutropenia (96%), anemia (81%), thrombocytopenia (79%); leukopenia (62%); and lymphopenia (53%). Cytokine release syndrome (CRS) was observed in most patients (95%) and resolved in 99% of patients within 14 days of onset. Grade &ge;3 neurotoxicity was observed in 10% of patients.<h2>New Phase 2 Data from CARTITUDE-2</h2>In addition to findings from CARTITUDE-1, the ASCO and EHA annual meetings will also feature presentations on new phase 2 data from a cohort from CARTITUDE-2 trial, which evaluated cilta-cel in earlier-phase MM.The investigators evaluated 20 patients who had progressive MM, received one to three prior lines of therapy, and were refractory to lenalidomide. At a median follow-up of 5.8 months, the overall response rate was 95%, with three-quarters of patients achieving an sCR or a complete response. Neurotoxicity occurred in 20% of patients in this cohort (n = 4), which were generally manageable, according to the authors. No neurocognitive treatment-emergent AEs or grade &ge;3 neurotoxicity have occurred.&ldquo;Our aim is to develop therapies that improve patient outcomes, and importantly in patients with heavily pretreated multiple myeloma who have no other options,&rdquo; said Sen Zhuang, MD, PhD, Vice President of Clinical Research and Development at Janssen Research &amp; Development, LLC, in a <a href="https://www.prnewswire.com/news-releases/janssen-reports-new-data-for-bcma-car-t-cilta-cel-showing-deep-and-durable-responses-in-patients-with-relapsed-or-refractory-multiple-myeloma-301302779.html">press release</a>. &ldquo;The results from the CARTITUDE clinical development program continue to show the promise of cilta-cel and support our efforts to bring this important treatment to patients in need in the near future.&rdquo;&ldquo;With the possibility of achieving the progression-free survival reported and responses deepening as observed in the longer-term follow-up, I&rsquo;m hopeful that cilta-cel will be part of the armamentarium in the future for patients in need of an additional treatment option,&rdquo; said Dr. Usmani.

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Findings from the CARTITUDE clinical program found that ciltacabtagene autoleucel (cilta-cel), an anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell ...

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