Syros Announces Topline Data from SELECT-MDS-1 Phase 3 Trial of Tamibarotene in Higher-Risk Myelodysplastic Syndrome with RARA Gene Overexpression
Syros Pharmaceuticals (NASDAQ:SYRS) announced that its SELECT-MDS-1 Phase 3 trial of tamibarotene combined with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression failed to meet its primary endpoint. The complete response rate in the treatment arm was 23.8% compared to 18.8% in the control arm, which was not statistically significant. The safety profile was generally well-tolerated. The company will discontinue the study and evaluate next steps. The trial failure triggers a default event under Syros' secured loan facility with Oxford Finance
Syros Pharmaceuticals (NASDAQ:SYRS) ha annunciato che il suo studio di fase 3 SELECT-MDS-1 su tamibarotene combinato con azacitidina per pazienti con sindrome mielodisplastica ad alto rischio (HR-MDS) appena diagnosticati e con sovraespressione del gene RARA non ha raggiunto il suo obiettivo primario. Il tasso di risposta completa nel braccio di trattamento è stato del 23,8% rispetto al 18,8% nel braccio di controllo, risultato che non è stato statisticamente significativo. Il profilo di sicurezza è stato generalmente ben tollerato. L'azienda interromperà lo studio e valuterà i prossimi passi. Il fallimento della sperimentazione innesca un evento di default nell'ambito del prestito garantito di Syros con Oxford Finance.
Syros Pharmaceuticals (NASDAQ:SYRS) anunció que su ensayo de fase 3 SELECT-MDS-1 sobre tamibarotene combinado con azacitidina para pacientes con síndrome mielodisplástico de alto riesgo (HR-MDS) recién diagnosticados y con sobreexpresión del gen RARA no cumplió con su objetivo principal. La tasa de respuesta completa en el grupo de tratamiento fue del 23.8% en comparación con el 18.8% en el grupo de control, cifra que no fue estadísticamente significativa. El perfil de seguridad fue generalmente bien tolerado. La compañía discontinuará el estudio y evaluará los próximos pasos. El fracaso del ensayo desencadena un evento de incumplimiento bajo la facilidad de préstamo garantizada de Syros con Oxford Finance.
Syros Pharmaceuticals (NASDAQ:SYRS)는 RARA 유전자 과발현이 있는 새롭게 진단된 고위험 골수형성이상증후군(HR-MDS) 환자를 위한 타미바로텐과 아자시티딘의 병용에 대한 SELECT-MDS-1 3상 시험이 주요 평가 기준을 충족하지 못했다고 발표했습니다. 치료 군의 완전 반응률은 23.8%로, 대조 군의 18.8%와 비교되었으나 통계적으로 유의미하지 않았습니다. 안전성 프로필은 일반적으로 잘 견디는 것으로 나타났습니다. 회사는 연구를 중단하고 향후 조치를 평가할 것입니다. 시험의 실패는 Oxford Finance와의 Syros의 담보 대출 시설에서 디폴트 이벤트를 촉발합니다.
Syros Pharmaceuticals (NASDAQ:SYRS) a annoncé que son essai de phase 3 SELECT-MDS-1 sur tamibarotene associé à l'azacitidine pour des patients récemment diagnostiqués avec un syndrome myélodysplasique à haut risque (HR-MDS) et une surexpression du gène RARA n'a pas atteint son objectif principal. Le taux de réponse complète dans le groupe de traitement était de 23,8 % contre 18,8 % dans le groupe témoin, ce qui n'était pas statistiquement significatif. Le profil de sécurité a généralement été bien toléré. L'entreprise mettra fin à l'étude et évaluera les prochaines étapes. L'échec de l'essai déclenche un événement de défaut dans le cadre de la facilité de prêt garanti de Syros avec Oxford Finance.
Syros Pharmaceuticals (NASDAQ:SYRS) gab bekannt, dass die SELECT-MDS-1 Phase-3-Studie zu tamibarotene in Kombination mit Azacitidin für neu diagnostizierte Hochrisiko-MDS-Patienten (HR-MDS) mit RARA-Gen-Überexpression nicht den primären Endpunkt erreicht hat. Die vollständige Ansprechraten in der Behandlungsgruppe betrugen 23,8% im Vergleich zu 18,8% in der Kontrollgruppe, was statistisch nicht signifikant war. Das Sicherheitsprofil war im Allgemeinen gut verträglich. Das Unternehmen wird die Studie abbrechen und die nächsten Schritte evaluieren. Das Scheitern der Studie löst ein Default-Ereignis im Rahmen der gesicherten Kreditfazilität von Syros mit Oxford Finance aus.
- Safety profile was generally well-tolerated with similar adverse events to previous studies
- Phase 3 trial failed to meet primary endpoint of complete response rate
- Treatment arm showed non-statistically significant results (23.8% vs 18.8% control)
- Company forced to discontinue the study
- Trial failure triggers default event on secured loan facility
Insights
The failure of Syros' Phase 3 SELECT-MDS-1 trial represents a significant setback for both the company and its tamibarotene program. The trial's inability to demonstrate statistical significance in complete response rates (
While the safety profile appears acceptable, the marginal efficacy improvement of only
This Phase 3 failure represents a material adverse event for Syros, triggering loan default provisions that could severely impact its financial stability. With a small market cap and the loss of its lead program, the company faces significant challenges:
- Immediate termination of the trial will preserve some cash, but restructuring costs may offset savings
- The loan default with Oxford Finance creates urgent refinancing needs
- Pipeline reprioritization and potential strategic alternatives will likely be necessary
Investors should expect increased volatility and potential dilutive financing as management evaluates options. The company's ability to advance other pipeline assets will be constrained by this setback.
-- SELECT-MDS-1 Did Not Meet its Primary Endpoint --
-- Company to Discontinue Study, Review Full Data Set, and Evaluate Next Steps --
In the first 190 enrolled patients, the CR rate by intent-to-treat (ITT) in the tamibarotene/azacitidine treatment arm was
Syros also reported that, as previously disclosed in its filings with the SEC, the failure of the SELECT-MDS-1 trial to achieve its primary endpoint constitutes an event of default under its secured loan facility with Oxford Finance LLC.
“We are deeply disappointed by this outcome, particularly for the HR-MDS patients who are seeking a new treatment option for this challenging disease,” said Conley Chee, Chief Executive Officer of Syros. “We plan to stop the study, review the clinical data more thoroughly, and evaluate the next steps. We want to express our sincere appreciation for the patients, caregivers and healthcare professionals who took part in the SELECT-MDS-1 trial and to all the employees of Syros for their exceptional work on the tamibarotene program.”
About SELECT-MDS-1 Phase 3 Trial
SELECT-MDS-1 is a multinational Phase 3 randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of tamibarotene in combination with azacitidine compared to placebo and azacitidine in HR-MDS patients with RARA overexpression. The primary endpoint of the trial was the CR rate in the first 190 patients.
About Syros Pharmaceuticals
Syros is committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. Driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches, Syros is developing tamibarotene, an oral selective RARα agonist in frontline patients with higher-risk myelodysplastic syndrome with RARA gene overexpression. For more information, visit www.syros.com and follow us on X (@SyrosPharma) and LinkedIn.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding Syros’ clinical development plans and the ongoing review of clinical data from the SELECT-MDS-1 trial. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including those risks described under the caption “Risk Factors” in Syros’ Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, each of which is on file with the Securities and Exchange Commission, and risks described in other filings that Syros makes with the Securities and Exchange Commission in the future.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112019957/en/
Syros
Karen Hunady
Director of Corporate Communications & Investor Relations
1-857-327-7321
khunady@syros.com
Investor
Amanda Isacoff
Precision AQ
212-362-1200
amanda.isacoff@precisionaq.com
Source: Syros Pharmaceuticals
FAQ
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