Jazz: Positive Data from Phase 2/3 Trial of Rylaze in Acute Lymphoblastic Leukemia

  Jazz Pharmaceuticals, Inc.   (Nasdaq: JAZZ) today announced positive results from a Phase 2/3 trial, developed and conducted in close collaboration with the Children's Oncology Group (COG), evaluating the intramuscular (IM) administration of Rylaze^® (asparaginase erwinia chrysanthemi (recombinant)-rywn) in adult and pediatric patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed hypersensitivity to an E. coli-derived asparaginase. These results will be presented as an oral presentation today at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.

These results confirm the interim trial analysis presented in December 2021 at the 63^rd American Society of Hematology (ASH) Annual Meeting, and demonstrated that ≥90% of patients in Cohort 1c receiving the IM dosing regimen of 25/25/50 mg/m² administered Monday/Wednesday/Friday (MWF) achieved nadir serum asparaginase activity (NSAA) levels ≥0.1 IU/mL at 48 and 72 hours, with a safety profile consistent with what has been described for other asparaginases.

"We are excited to share these results from the Phase 2/3 trial of Rylaze highlighting the clinically meaningful nadir serum asparaginase activity from the Monday/Wednesday/Friday dosing regimen, which supports a new dosing schedule that aligns with current clinical practice," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Rylaze is an example of how Jazz and the Children's Oncology Group have advanced a critically needed treatment from development through FDA approval, and then continue to explore additional dosing and administration options to address the needs of patients."

"Asparaginase-based therapies remain a cornerstone in ALL and LBL treatment, and Rylaze has been an important option for patients who develop a hypersensitivity to an E. coli-derived asparaginase since its approval last year," said trial primary investigator Dr. Luke Maese, associate professor of pediatric hematology-oncology at the University of Utah, Primary Children's Hospital and Huntsman Cancer Institute. "It's encouraging to see these data further support an IM Monday/Wednesday/Friday dosing schedule for Rylaze, which is more in line with clinical practice in the U.S., in addition to the currently approved schedule of every 48 hours."

Rylaze was approved in the U.S. in 2021 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. It was approved with an IM dosing schedule of 25 mg/m² every 48 hours based on observed data from the Phase 2/3 trial, in conjunction with data produced by a population pharmacokinetic (PPK) model. Data from the Phase 2/3 trial supported additional regulatory filings for Rylaze, including two supplemental Biologics Licensing Applications (sBLA) to the U.S. FDA to support MWF IM dosing completed in January 2022 and IV administration options completed in April 2022.

https://www.biospace.com/article/releases/jazz-pharmaceuticals-presents-positive-data-from-phase-2-3-trial-of-rylaze-asparaginase-erwinia-chrysanthemi-recombinant-rywn-in-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-at-the-asco-2022-annual-meeting/