GlycoMimetics Announces National Cancer Institute Phase 2/3 Study of Uproleselan Did Not Meet Primary Endpoint
GlycoMimetics announced that the Phase 2 analysis of its uproleselan study, conducted by the National Cancer Institute and the Alliance for Clinical Trials in Oncology, did not achieve its primary endpoint. The trial evaluated the drug in combination with 7+3 chemotherapy versus chemotherapy alone in newly diagnosed acute myeloid leukemia (AML) patients aged 60 or older. The study failed to demonstrate statistically significant improvement in event-free survival. The company is now working with the Alliance to analyze the full trial data to identify potential efficacy signals in specific patient subgroups for future clinical trials.
GlycoMimetics ha annunciato che l'analisi della Fase 2 del suo studio uproleselan, condotto dal National Cancer Institute e dall'Alliance for Clinical Trials in Oncology, non ha raggiunto il suo obiettivo primario. Lo studio ha valutato il farmaco in combinazione con la chemioterapia 7+3 rispetto alla chemioterapia da sola nei pazienti con leucemia mieloide acuta (LMA) recentemente diagnosticata, di età pari o superiore a 60 anni. Lo studio non è riuscito a dimostrare un miglioramento statisticamente significativo nella sopravvivenza libera da eventi. L'azienda sta ora collaborando con l'Alliance per analizzare i dati completi della sperimentazione al fine di identificare potenziali segnali di efficacia in specifici sottogruppi di pazienti per futuri studi clinici.
GlycoMimetics anunció que el análisis de la Fase 2 de su estudio uproleselan, realizado por el National Cancer Institute y la Alliance for Clinical Trials in Oncology, no alcanzó su objetivo primario. El ensayo evaluó el fármaco en combinación con quimioterapia 7+3 frente a quimioterapia sola en pacientes de leucemia mieloide aguda (LMA) recién diagnosticados, de 60 años o más. El estudio no logró demostrar una mejora estadísticamente significativa en la supervivencia libre de eventos. La compañía está trabajando ahora con la Alliance para analizar los datos completos del ensayo a fin de identificar posibles señales de eficacia en subgrupos específicos de pacientes para futuros ensayos clínicos.
GlycoMimetics는 National Cancer Institute와 Alliance for Clinical Trials in Oncology가 진행한 uproleselan 연구의 2상 분석이 주요 목표를 달성하지 못했다고 발표했습니다. 이 임상 연구는 60세 이상의 새롭게 진단된 급성 골수성 백혈병 (AML) 환자에서 약물을 단독 화학요법과 7+3 화학요법 병용으로 평가했습니다. 연구는 사건 발생 없는 생존에서 통계적으로 유의미한 개선을 입증하지 못했습니다. 회사는 현재 Alliance와 협력하여 전체 연구 데이터를 분석하고 특정 환자 하위 그룹에서 향후 임상 시험을 위한 잠재적인 효과 신호를 확인하고 있습니다.
GlycoMimetics a annoncé que l'analyse de la phase 2 de son étude uproleselan, réalisée par le National Cancer Institute et l'Alliance for Clinical Trials in Oncology, n'a pas atteint son objectif principal. L'essai a évalué le médicament en combinaison avec une chimiothérapie 7+3 par rapport à une chimiothérapie seule chez des patients de leucémie myéloïde aiguë (LMA) nouvellement diagnostiqués, âgés de 60 ans ou plus. L'étude n'a pas réussi à démontrer une amélioration statistiquement significative de la survie sans événement. L'entreprise travaille maintenant avec l'Alliance pour analyser l'ensemble des données de l'essai afin d'identifier d'éventuels signaux d'efficacité chez des sous-groupes spécifiques de patients pour de futurs essais cliniques.
GlycoMimetics hat angekündigt, dass die Analyse der Phase 2 ihrer Studie uproleselan, die vom National Cancer Institute und der Alliance for Clinical Trials in Oncology durchgeführt wurde, nicht das primäre Ziel erreicht hat. Die Studie bewertete das Medikament in Kombination mit einer 7+3 Chemotherapie im Vergleich zur Chemotherapie alleine bei Patienten mit neu diagnostizierter akuter myeloischer Leukämie (AML), die 60 Jahre oder älter sind. Die Studie konnte keine statistisch signifikante Verbesserung des ereignisfreien Überlebens zeigen. Das Unternehmen arbeitet jetzt mit der Alliance zusammen, um die vollständigen Studiendaten zu analysieren und potenzielle Wirksamkeitssignale in spezifischen Patientengruppen für zukünftige klinische Studien zu identifizieren.
- Potential for identifying efficacy signals in specific patient subgroups through additional analysis
- Phase 2/3 study failed to meet primary endpoint
- No statistically significant improvement in event-free survival
- Clinical trial setback in key AML treatment program
Insights
The failure of uproleselan in the NCI-sponsored Phase 2/3 study represents a significant setback for GlycoMimetics' lead drug candidate in treating newly diagnosed AML patients. The lack of statistical significance in event-free survival, a critical endpoint for cancer trials, severely impacts the drug's commercial prospects in this indication.
GlycoMimetics is coordinating with the Alliance for transfer of full trial data for additional analysis, including subgroup analysis to evaluate if there are efficacy signals in any patient population that may merit further study in future clinical trials. Top-line results from NCI/Alliance trial are expected to be presented by the NCI at a future medical conference.
About GlycoMimetics, Inc.
GlycoMimetics is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including AML, and for inflammatory diseases. The company’s scientific approach is based on an understanding of the role that carbohydrates play in cell recognition. Its specialized chemistry platform can be used to discover small molecule drugs, known as glycomimetics, that alter carbohydrate-mediated recognition in diverse disease states, including cancers and inflammation. The company’s goal is to develop transformative therapies for diseases with high unmet medical need. GlycoMimetics is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements may include, but are not limited to, statements regarding the conduct of, and timing for analysis and presentation of data from, clinical trials; and potential development and regulatory activities. Actual results may differ materially from those described in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the company’s Annual Report on Form 10-K filed with the
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Investor:
Argot Partners
Leo Vartorella
212-600-1902
Glycomimetics@argotpartners.com
Source: GlycoMimetics, Inc.
FAQ
What was the primary endpoint result of GlycoMimetics (GLYC) Phase 2/3 uproleselan trial?
What patient population was studied in the GlycoMimetics (GLYC) uproleselan trial?
What are the next steps for GlycoMimetics (GLYC) following the uproleselan trial results?
