Philadelphia, PA – 13 January 2024: SERB Pharmaceuticals (SERB) announces the publication of the largest and most comprehensive study to date of patients with high-dose methotrexate (MTX)- induced acute kidney injury (MTX-AKI) treated with and without Voraxaze® (glucarpidase).
Researchers from Mass General Brigham and Harvard Medical School (Boston, MA) analyzed data from more than 700 adult patients with MTX-AKI across 28 major U.S. cancer centersi and found that patients who received Voraxaze® had significantly higher odds of kidney recovery as well as faster time to kidney recovery compared to those who did not receive Voraxaze®.ii
Results were published online ahead of print on 06 January 2025 in the peer-reviewed journal Blood, the flagship journal of the American Society of Hematology.
The data showed that:
• Treatment with Voraxaze® was associated with a 2.70-fold higher adjusted odds of kidney recovery at hospital discharge (95% CI, 1.69–4.31) compared to those not treated with Voraxaze®.
• Patients treated with Voraxaze® had faster time-to-kidney recovery (adjusted hazard ratio [aHR], 1.88, 95% CI, 1.18–3.33)
• Treatment with Voraxaze® was associated with a lower likelihood of grade ≥ 2 neutropenia (adjusted odds ratio [aOR] 0.50 [95% CI, 0.28–0.91]) and grade ≥ 2 transaminitis at day 7 (aOR 0.31 [95% CI, 0.13–0.77]).
“These findings underscore the significant impact Voraxaze® can have in improving clinical outcomes for cancer patients who develop AKI associated with high-dose methotrexate,” said Dr. Suzanne Ward, Sr. Director of Scientific Affairs at SERB. “The publication offers physicians additional evidence to support the appropriate use of Voraxaze® to treat patients with this severe and potentially life-threatening toxicity.”
A previous analysis of the data was shared on 9 December 2023 in an oral presentation at the American Society of Hematology meeting in San Diego, CA.iii
For the full press release from Mass General Brigham, please click here.
About SERB Pharmaceuticals
SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB is a leading provider of essential acute care medicines, addressing unmet medical needs and supplying antidotes and medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. Learn more at SERB.com.
For further information contact:
SERB Pharmaceuticals: Chris Sampson, Corporate Communications Director
chris.sampson@serb.com; Tel: +44 (0)7773 251 178
About Voraxaze® (glucarpidase)iv:
Indication and Limitations of Use
Voraxaze® is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function
Limitations of Use: Voraxaze® is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate
Important Safety Information
Warnings and Precautions
Serious Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylactic reactions, may occur. Serious hypersensitivity reactions occurred in less than 1% of patients
Monitoring Methotrexate Concentration/Interference with Assay
Methotrexate concentrations within 48 hours following Voraxaze® administration can only be reliably measured by a chromatographic method due to interference from metabolites. Measurement of methotrexate concentrations within 48 hours of Voraxaze® administration using immunoassays results in an overestimation of the methotrexate concentration
ADVERSE REACTIONS
In clinical trials, the most common related adverse events (occurring in >1% of patients) were paresthesia, flushing, nausea and/or vomiting, hypotension and headache
DRUG INTERACTIONS
Voraxaze® can decrease leucovorin concentration, which may decrease the effect of leucovorin rescue unless leucovorin is dosed as recommended, and may also reduce the concentrations other folate analogs or folate analog metabolic inhibitors
Please see Full Prescribing Information.
REFERENCES:
I Cancer Centers included: Brigham and Women’s Hospital, Boston, MA; Duke Cancer Center, Durham, NC; Dana-Farber Cancer Institute, Boston, MA; Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD; Massachusetts General Hospital, Boston, MA: Mayo Clinic, Rochester, MN; MD Anderson Cancer Center, Houston, TX; Memorial Sloan Kettering, New York, NY; Moffitt Cancer Center, Tampa, FL; Oschner Health System, New Orleans, LA; Ohio State University Comprehensive Cancer Care Center, Columbus, OH; Stanford Cancer Institute, Stanford, CA; Sidney Kimmel Cancer Center at Jefferson Health, Philadelphia, PA; University of Alabama Birmingham Hospital, Birmingham, AL; UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Florida Cancer Center, Gainesville, FL; University Hospitals Cleveland Medical Center, Cleveland, OH; University of Kentucky, Louisville, KY; University of Miami Sylvester Comprehensive Cancer Center, Miami, FL; Hospital of the University of Pennsylvania, Philadelphia, PA; University of Pittsburgh Medical Center, Pittsburgh, PA; University of Virginia Hospital, Charlottesville, VA; Vanderbilt University Medical Center, Nashville, TN; Washington University in St. Louis, St. Louis, MO; Yale New Haven Hospital, New Haven, CT
ii Gupta S et al. “Glucarpidase for Treatment of High-Dose Methotrexate Toxicity” Blood DOI: 10.1182/blood.2024026211.
iii Gupta S, LaCasce A, Leaf RK, Kaunfer S, Leaf DE. Clinical Outcomes in Patients with High Dose Methotrexate Toxicity Treated with Vs. without Glucarpidase [abstract 268]. In: 65th Annual American Society of Hematology Annual Meeting and Exposition; December 9-12 2023; San Diego, CA (https://ash.confex.com/ash/2023/webprogram/Paper189432.html, accessed November 10, 2023).
iv Voraxaze®. Prescribing information. BTG International Inc.; 2019.
