Syros Provides Update on SELECT-AML-1 Phase 2 Clinical Trial
Syros Pharmaceuticals (NASDAQ:SYRS) announced the discontinuation of enrollment in its SELECT-AML-1 Phase 2 clinical trial for acute myeloid leukemia (AML) treatment. The trial compared a triplet regimen (tamibarotene, venetoclax, and azacitidine) to a doublet regimen (venetoclax and azacitidine) in newly diagnosed, unfit AML patients with RARA gene overexpression.
The decision was based on a prespecified interim analysis of 51 patients, which showed similar complete response rates in both arms (65% triplet vs. 70% doublet). No new safety concerns were identified. Syros will present the trial data at the SOHO Annual Meeting in September 2024.
Despite this setback, Syros remains committed to evaluating tamibarotene in combination with azacitidine for higher-risk myelodysplastic syndrome (MDS) in the ongoing SELECT-MDS-1 Phase 3 trial, with pivotal data expected by mid-fourth quarter 2024.
Syros Pharmaceuticals (NASDAQ:SYRS) ha annunciato la sospensione dell'arruolamento nel suo studio clinico di Fase 2 SELECT-AML-1 per il trattamento della leucemia mieloide acuta (AML). Lo studio confrontava un regime triplo (tamibarotene, venetoclax e azacitidina) con un regime doppio (venetoclax e azacitidina) in pazienti con AML recentemente diagnosticata e non idonei, con sovraespressione del gene RARA.
La decisione è stata basata su un'analisi intermedia predefinita di 51 pazienti, che ha mostrato tassi di risposta completa simili in entrambi i bracci (65% del triplo rispetto al 70% del doppio). Non sono state identificate nuove preoccupazioni per la sicurezza. Syros presenterà i dati dello studio al SOHO Annual Meeting nel settembre 2024.
Nonostante questo contrattempo, Syros rimane impegnata a valutare il tamibarotene in combinazione con l'azacitidina per sindrome mielodisplastica (MDS) ad alto rischio nel trial di Fase 3 SELECT-MDS-1, con dati fondamentali attesi entro la metà del quarto trimestre 2024.
Syros Pharmaceuticals (NASDAQ:SYRS) anunció la suspensión de la inscripción en su ensayo clínico de Fase 2 SELECT-AML-1 para el tratamiento de la leucemia mieloide aguda (LMA). El ensayo comparó un régimen de tres fármacos (tamibaroteno, venetoclax y azacitidina) con un régimen de dos fármacos (venetoclax y azacitidina) en pacientes recién diagnosticados de LMA no aptos, con sobrerexpresión del gen RARA.
La decisión se basó en un análisis intermedio predefinido de 51 pacientes, que mostró tasas de respuesta completa similares en ambos grupos (65% en el grupo de tres fármacos frente al 70% en el grupo de dos fármacos). No se identificaron nuevas preocupaciones de seguridad. Syros presentará los datos del ensayo en la Reunión Anual de SOHO en septiembre de 2024.
A pesar de este contratiempo, Syros sigue comprometida a evaluar el tamibaroteno en combinación con azacitidina para el síndrome mielodisplásico (SMD) de alto riesgo en el ensayo de Fase 3 SELECT-MDS-1, con datos clave esperados para mediados del cuarto trimestre de 2024.
Syros Pharmaceuticals (NASDAQ:SYRS)는 급성 골수성 백혈병(AML) 치료를 위한 2상 임상시험인 SELECT-AML-1의 등록 중단을 발표했습니다. 본 시험은 최근 진단된 AML 환자 중 RARA 유전자 과발현을 가진 비적합 환자에게 삼중 요법(타미바로텐, 베네토클락스, 아자시티딘)과 이중 요법(베네토클락스, 아자시티딘)을 비교했습니다.
이번 결정은 51명의 환자에 대한 지정된 중간 분석을 기반으로 했으며, 두 그룹 모두 유사한 완전 반응률을 보였습니다(삼중 요법 65% vs. 이중 요법 70%). 새로운 안전성 문제는 식별되지 않았습니다. Syros는 2024년 9월 SOHO 연례 회의에서 시험 데이터를 발표할 예정입니다.
이러한 좌절에도 불구하고 Syros는 진행 중인 SELECT-MDS-1 3상 시험에서 고위험 골수형성이상증후군(MDS) 환자에게 아자시티딘과 병용하여 타미바로텐을 평가하기 위해 최선을 다하고 있으며, 결정적인 데이터는 2024년 4분기 중반에 기대되고 있습니다.
Syros Pharmaceuticals (NASDAQ:SYRS) a annoncé l'arrêt de l'inscription dans son essai clinique de phase 2 SELECT-AML-1 pour le traitement de la leucémie myéloïde aiguë (LMA). L'essai a comparé un régime à trois médicaments (tamibarotène, venetoclax et azacitidine) à un régime à deux médicaments (venetoclax et azacitidine) chez des patients nouvellement diagnostiqués, non éligibles à la LMA, présentant une surexpression du gène RARA.
Cette décision était basée sur une analyse intermédiaire prédéfinie de 51 patients, qui a montré des taux de réponse complète similaires dans les deux groupes (65 % pour le triple régime contre 70 % pour le double régime). Aucune nouvelle préoccupation concernant la sécurité n'a été identifiée. Syros présentera les données de l'essai lors de la réunion annuelle de SOHO en septembre 2024.
Malgré ce revers, Syros demeure déterminé à évaluer le tamibarotène en association avec l'azacitidine pour le syndrome myélodysplasique (SMD) à haut risque dans l'essai SELECT-MDS-1 en phase 3 en cours, avec des données essentielles attendues d'ici la mi-quatrième trimestre 2024.
Syros Pharmaceuticals (NASDAQ:SYRS) hat die Einstellung der Rekrutierung für seine klinische Studie der Phase 2 SELECT-AML-1 zur Behandlung der akuten myeloischen Leukämie (AML) bekannt gegeben. Die Studie verglich ein Triple-Regime (Tamibaroten, Venetoclax und Azacitidin) mit einem Double-Regime (Venetoclax und Azacitidin) bei neu diagnostizierten, nicht geeigneten AML-Patienten mit RARA-Genüberexpression.
Die Entscheidung basierte auf einer vordefinierten Zwischenanalyse von 51 Patienten, die ähnliche komplette Ansprechquoten in beiden Gruppen zeigte (65 % Triple vs. 70 % Double). Es wurden keine neuen Sicherheitsbedenken festgestellt. Syros wird die Studiendaten auf dem SOHO-Jahrestreffen im September 2024 präsentieren.
Trotz dieses Rückschlags bleibt Syros engagiert, Tamibaroten in Kombination mit Azacitidin für hochriskierte myelodysplastische Syndrome (MDS) in der laufenden SELECT-MDS-1-Studie der Phase 3 zu bewerten, mit entscheidenden Daten, die bis zur Mitte des vierten Quartals 2024 erwartet werden.
- No new safety signals were associated with the tamibarotene combination therapy
- The ongoing SELECT-MDS-1 Phase 3 trial for higher-risk MDS passed a prespecified futility analysis in Q1 2024
- Pivotal data from SELECT-MDS-1 trial is expected by mid-fourth quarter 2024
- Discontinuation of enrollment in the SELECT-AML-1 Phase 2 clinical trial for AML treatment
- Similar complete response rates observed in triplet (65%) and doublet (70%) arms, indicating low probability of demonstrating superiority
- Unexpected outcome in AML trial despite previous positive results in Phase 2 trial with tamibarotene and azacitidine combination
Insights
The discontinuation of the SELECT-AML-1 Phase 2 trial is a significant setback for Syros Pharmaceuticals. The trial's failure to demonstrate superiority of the triplet regimen (tamibarotene, venetoclax, azacitidine) over the standard doublet (venetoclax, azacitidine) in AML patients with RARA overexpression is unexpected and disappointing. This outcome may impact investor confidence in Syros' AML program.
However, it's important to note that the company's focus now shifts to the ongoing SELECT-MDS-1 Phase 3 trial in higher-risk MDS. This trial, which passed a futility analysis in Q1 2024, represents a potential near-term catalyst with pivotal data expected by mid-Q4 2024. The
This news is likely to have a negative short-term impact on Syros' stock price. The discontinuation of a Phase 2 trial represents a setback in the company's pipeline and may raise concerns about the potential market for tamibarotene in AML. Investors should closely monitor the company's cash position and burn rate, as the failure of this trial may affect future financing options.
However, the ongoing SELECT-MDS-1 Phase 3 trial in higher-risk MDS patients represents a significant near-term opportunity. If successful, this could potentially offset the AML setback. The MDS market, while smaller than AML, still represents a substantial opportunity. Investors should focus on the upcoming pivotal data from SELECT-MDS-1, expected in Q4 2024, as a key inflection point for Syros' valuation.
The similar CR/CRi rates between the triplet and doublet arms (
The focus on higher-risk MDS in the ongoing SELECT-MDS-1 trial is scientifically sound. MDS and AML are related but distinct diseases and the efficacy of tamibarotene may differ between them. The previous positive results in the Phase 2 AML trial with tamibarotene and azacitidine provide a rational basis for continuing to evaluate this combination in MDS. The upcoming data from SELECT-MDS-1 will be important in determining the therapeutic potential of tamibarotene in hematologic malignancies.
Data from 51 patients enrolled in SELECT-AML-1 were reviewed on August 9, 2024. This review included a prespecified non-binding futility analysis conducted on the first 40 randomized patients after the fortieth randomized patient received approximately three months of study drug or discontinued treatment. A similar complete response (CR)/complete response with incomplete hematologic recovery (CRi) rate was observed in the triplet arm (n=20;
“We are disappointed by this unexpected outcome, especially for people living with AML," said David A. Roth, M.D., Chief Medical Officer of Syros. “In our prior Phase 2 clinical trial, the doublet combination of tamibarotene and azacitidine delivered a
Syros continues to evaluate tamibarotene, an oral, selective, retinoic acid receptor alpha (RARα) agonist, in combination with azacitidine in the SELECT-MDS-1 Phase 3 clinical trial in newly diagnosed higher-risk myelodysplastic syndrome (MDS) patients with RARA gene overexpression. The SELECT-MDS-1 trial passed a prespecified futility analysis in the first quarter of 2024 and is continuing as planned, with pivotal CR data expected by the middle of the fourth quarter of 2024.
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, the progression of its clinical trials, the timing to report clinical data, and the ability to commercialize tamibarotene and deliver benefit to patients. 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 Syros’ ability to: advance the development of its programs under the timelines it projects in current and future clinical trials; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; sustain the response rates and durability of response seen to date with its drug candidates; successfully develop a diagnostic test to identify patients with the RARA biomarker; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third parties; manage competition; manage expenses; raise the substantial additional capital needed to achieve its business objectives; attract and retain qualified personnel; and successfully execute on its business strategies; 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 quarters ended March 31, 2024 and June 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/20240812166419/en/
Syros Contact
Karen Hunady
Director of Corporate Communications & Investor Relations
1-857-327-7321
khunady@syros.com
Investor Contact
Amanda Isacoff
Precision AQ
212-362-1200
amanda.isacoff@precisionaq.com
Source: Syros Pharmaceuticals
FAQ
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