Calaspargase Pegol-MKNL(Shire Plc)

Adolescent and young adult patients treated with asparaginase containing pediatric-inspired regimens showed a 69% reduction in risk of death (HR: 0.31; 95% CI, 0.18-0.55) and higher overall survival compared to matched patients treated with non-pediatric-inspired regimens The two-year rate of stem cell transplant was lower in patients treated with pediatric-inspired regimens compared to patients treated with non-pediatric-inspired regimens BOSTON, Dec. 12, 2022 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced findings from a retrospective study observing higher overall survival (OS) in adolescent and young adult (AYA) newly-diagnosed acute lymphoblastic leukemia (ALL) patients treated with asparaginase containing pediatric-inspired regimens (PIR) versus non-pediatric-inspired regimens. Detailed results from the new real-world analysis were presented today in an oral session at the 64th Annual Meeting of the American Society of Hematology (ASH). "Pediatric oncologists have long understood the effectiveness of pediatric-inspired regimens for treating children and teenagers with most types of acute lymphoblastic leukemia, but this analysis indicates those benefits extend to a broader population of older adolescents and young adults," said David R. Freyer, DO, MS, study co-author, Co-Director of the AYA Cancer Program at the USC Norris Comprehensive Care Center, and member of the Leukemia Lymphoma Program at Children's Hospital Los Angeles. "Although the use of pediatric-inspired regimens in young adults is inconsistent across adult centers, we believe this analysis supports their use in this patient population and hope it promotes further investigation to better understand their impact on overall survival and long-term outcomes." Study Background: This real-world analysis initially looked at the administrative health claim records of 11,650 newly-diagnosed ALL patients on separate days between 2007-2020. Of those, 2,312 were aged 15-39, and 1,313 had at least one record of a PIR or HyperCVAD or ALL DRG code or other chemotherapy within six months of diagnosis. Patient records were then examined to ensure no evidence of ALL remission or relapse prior to the index date, no evidence of stem cell transplant prior to the index date and at least six months of continuous health plan enrollment before the index date, leaving a total of 596 patients in the analysis. Among the 596 patient records remaining in the analysis, 303 (51%) were confirmed to have not been treated with a PIR, while 187 (31%) were confirmed to have been treated with a PIR. An additional 15% received unknown therapy (due to limited available data) and 3% lacked sufficient information but received treatment that suggests a PIR (and were included in the sensitivity analysis). Non-PIR patients were matched to PIR patients based on propensity score matching to balance the baseline characteristics. A total of 374 matched patients (187 PIR vs. 187 non-PIR) were used in the primary analyses. This is a retrospective study not powered or adjusted for multiplicity to assess OS. P-values are for descriptive purposes only. Findings of sensitivity analyses were consistent with the primary analyses. Results: Overall, this real-world analysis suggests treatment with a PIR leads to higher OS in AYA patients with newly-diagnosed ALL. Patients treated with a PIR (n=187) had a 69% lower risk of death compared to matched patients who received non-PIR (n=187) (hazard ratio [HR]=0.31; 95% confidence interval [CI], 0.18-0.55; log-rank test p-value<0.0001). In addition, the two-year rate of allogeneic stem-cell transplant (SCT) was lower among AYA patients with newly-diagnosed ALL treated with a PIR (16.5%) versus non-PIR (33.4%). "While additional studies are needed, these real-world findings provide important insights into the benefits of pediatric-inspired regimens containing asparaginase in adolescent and young adult patients with newly-diagnosed acute lymphoblastic leukemia, who have a historically poorer survival rate in comparison to pediatric patients," said Susan Pandya, MD, Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. "We look forward to continuing our research efforts for ASPARLAS, one of our approved asparaginase products, and exploring the potential application in other indications including solid tumors where there is emerging preclinical rationale." The full abstract is available for viewing on the ASH 2022 website. About Servier Pharmaceuticals Servier Pharmaceuticals LLC is a commercial-stage company with a passion for innovation and improving the lives of patients, their families and caregivers. As a privately held company, Servier has the unique freedom to devote all of its time and energy towards patients who require our treatments, care and innovation in areas of unmet medical need. As a leader in oncology, Servier is committed to finding solutions that will address today's challenges. The company's oncology portfolio includes innovative medicines designed to bring more life-saving treatments to a greater number of patients, across the entire spectrum of disease and in a variety of tumor types. Servier has significantly accelerated its investment in hard-to-treat cancers with more than 50% of its research and development dedicated to delivering significant advances in areas of high unmet need that may truly move the needle for our patients. Servier believes co-creation is fundamental to driving innovation and is actively building alliances, acquisitions, licensing deals and partnerships that bring solutions and accelerate access to therapies. With the company's commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier Pharmaceuticals is dedicated to bringing the promise of tomorrow to the patients that we serve. For more information: . About Servier Founded to serve health, Servier is a global group governed by a Foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. With its unique governance model, it can fully serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. The 21,800 employees of the Group are committed to this shared vocation, source of inspiration every day. As a world leader in cardiology, Servier's ambition is to become a renowned, focused and innovative player in oncology by targeting hard-to-treat cancers. That is why the Group allocates over 50% of its R&D budget to developing targeted and innovative therapies in oncology. Neuroscience and immuno-inflammatory diseases are the future growth drivers. In these areas, Servier is focused on a limited number of diseases in which accurate patient profiling makes it possible to offer a targeted therapeutic response through precision medicine. To promote access to quality care for all at a lower cost, the Group also offers a range of quality generic drugs covering most pathologies, relying on strong brands in France, Eastern Europe, Brazil and Nigeria. In all these areas, the Group includes the patient voice at each stage of the life cycle of a medicine. Headquartered in France, Servier relies on a strong geographical footprint in over 150 countries and achieved a revenue of €4.7 billion in 2021. For more information on the new Group website: servier.com. Press contacts Servier Pharmaceuticals (U.S.) Julia Ferreira [email protected] Servier Group (France and worldwide) Sonia Marques [email protected] +33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13 Disclosures This release contains general information about the Servier Group and its entities (hereinafter "Servier and its Affiliates") and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect. 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