Tempest Announces Successful End-of-Phase 2 Meeting with FDA for Amezalpat (TPST-1120) to Treat First-Line Hepatocellular Carcinoma
Tempest Therapeutics (Nasdaq: TPST) announced a successful end-of-Phase 2 meeting with the FDA for amezalpat (TPST-1120) in treating first-line hepatocellular carcinoma (HCC). The FDA and Tempest reached broad agreement on the pivotal Phase 3 study plan, including:
1. Using the current amezalpat dose and schedule
2. Setting overall survival as the primary endpoint
3. Implementing an early efficacy analysis that could significantly reduce time to primary read-out
The planned Phase 3 study closely mirrors the randomized Phase 2 study, which showed a strongly favorable hazard ratio for overall survival. This outcome gives Tempest confidence in the potential success of the Phase 3 trial for amezalpat in combination with atezolizumab and bevacizumab for first-line unresectable or metastatic HCC.
Tempest Therapeutics (Nasdaq: TPST) ha annunciato un incontro di successo con la FDA al termine della Fase 2 per amezalpat (TPST-1120) nel trattamento del carcinoma epatocellulare (HCC) di prima linea. La FDA e Tempest hanno raggiunto un ampio accordo sul piano di studio pivotale di Fase 3, che include:
1. Utilizzare la dose e il programma attuali di amezalpat
2. Stabilire la sopravvivenza globale come endpoint primario
3. Implementare un’analisi precoce dell’efficacia che potrebbe ridurre significativamente il tempo per il risultato primario
Lo studio di Fase 3 pianificato rispecchia da vicino lo studio randomizzato di Fase 2, che ha mostrato un rapporto di rischio fortemente favorevole per la sopravvivenza globale. Questo risultato conferisce a Tempest fiducia nel potenziale successo della sperimentazione di Fase 3 per amezalpat in combinazione con atezolizumab e bevacizumab per HCC inoperabile o metastatico di prima linea.
Tempest Therapeutics (Nasdaq: TPST) anunció una reunión exitosa de fin de Fase 2 con la FDA para amezalpat (TPST-1120) en el tratamiento de carcinoma hepatocelular (HCC) de primera línea. La FDA y Tempest llegaron a un amplio acuerdo sobre el plan de estudio pivotal de Fase 3, que incluye:
1. Usar la dosis y el programa actuales de amezalpat
2. Establecer la supervivencia global como el objetivo primario
3. Implementar un análisis de eficacia temprano que podría reducir significativamente el tiempo hasta la lectura primaria
El estudio de Fase 3 planificado se asemeja estrechamente al estudio aleatorizado de Fase 2, que mostró una relación de peligro muy favorable para la supervivencia global. Este resultado le da a Tempest confianza en el potencial éxito del ensayo de Fase 3 para amezalpat en combinación con atezolizumab y bevacizumab para HCC irresecable o metastásico de primera línea.
Tempest Therapeutics (Nasdaq: TPST)가 amezalpat (TPST-1120)을 헤파토셀룰라 암(HCC) 1차 치료제로 사용하기 위한 FDA의 2상 종료 회의에서 성공적으로 합의했다. FDA와 Tempest는 3상 주요 연구 계획에 대해 광범위하게 동의했다. 여기에는 다음이 포함된다:
1. 현재의 amezalpat 용량 및 일정 사용
2. 전체 생존을 주요 목표로 설정
3. 주요 결과의 시간을 크게 단축할 수 있는 조기 유효성 분석 시행
계획된 3상 연구는 전체 생존에 대해 강력히 유리한 위험 비율을 보여준 무작위 2상 연구를 밀접하게 반영한다. 이 결과는 Tempest에 amezalpat의 3상 시험이 atezolizumab 및 bevacizumab과 병행하여 1차 불가침 또는 전이성 HCC에서 성공할 수 있는 잠재력에 대한 자신감을 부여한다.
Tempest Therapeutics (Nasdaq: TPST) a annoncé une réunion réussie de fin de Phase 2 avec la FDA pour amezalpat (TPST-1120) dans le traitement du carcinome hépatocellulaire (CHC) en première ligne. La FDA et Tempest ont obtenu un large accord sur le plan d'étude pivot de Phase 3, qui comprend :
1. Utiliser la dose et le calendrier actuels d'amezalpat
2. Fixer la survie globale comme objectif principal
3. Mettre en œuvre une analyse précoce de l'efficacité qui pourrait réduire considérablement le temps jusqu'à l'évaluation principale
La phase 3 prévue reflète de près l'étude randomisée de Phase 2, qui a montré un rapport de risque fortement favorable pour la survie globale. Ce résultat donne à Tempest la confiance dans le succès potentiel de l'essai de Phase 3 pour amezalpat en association avec atezolizumab et bevacizumab pour le CHC en première ligne irrésecable ou métastatique.
Tempest Therapeutics (Nasdaq: TPST) gab bekannt, dass das Ende der Phase-2-Sitzung mit der FDA für amezalpat (TPST-1120) bei der Behandlung von hepatozellulärem Karzinom (HCC) in der ersten Linie erfolgreich war. Die FDA und Tempest einigten sich umfassend auf den Plan für die Phase-3-Studie, der Folgendes umfasst:
1. Verwendung der aktuellen Dosis und des Zeitplans von amezalpat
2. Festlegung der Gesamtüberlebensrate als primäres Ziel
3. Durchführung einer frühen Wirksamkeitsanalyse, die die Zeit bis zur primären Auswertung erheblich verkürzen könnte
Die geplante Phase-3-Studie spiegelt die randomisierte Phase-2-Studie wider, die ein stark günstiges Hazard-Verhältnis für das Gesamtüberleben zeigte. Dieses Ergebnis gibt Tempest Zuversicht in das potenzielle Gelingen der Phase-3-Studie für amezalpat in Kombination mit Atezolizumab und Bevazizumab bei unresezierbarem oder metastatischem HCC in der ersten Linie.
- FDA agreement on Phase 3 study design, including control arm and endpoints
- Approval to use current amezalpat dose and schedule in Phase 3
- Agreement on statistical plan with early efficacy analysis, potentially shortening time to primary analysis by up to 8 months
- Strong overall survival results from Phase 2 trial, confirmed in latest follow-up
- None.
Insights
The FDA's agreement on the Phase 3 study design for amezalpat in first-line HCC treatment is a significant milestone for Tempest Therapeutics. The confirmation of overall survival as the primary endpoint is particularly noteworthy, as it's the gold standard for oncology trials. The agreed-upon early efficacy analysis could potentially accelerate the drug's path to market by up to 8 months, which is important in the competitive oncology landscape.
The favorable hazard ratio for overall survival observed in the Phase 2 trial is a strong indicator of amezalpat's potential efficacy. However, it's important to note that Phase 3 trials often yield different results than earlier studies. The agreement on the current dose and schedule suggests a good safety profile, which is essential for combination therapies in cancer treatment.
The development of amezalpat for first-line HCC treatment is promising. HCC is a challenging cancer with treatment options and the current standard of care (atezolizumab plus bevacizumab) has room for improvement. The triple combination of amezalpat with atezolizumab and bevacizumab could potentially enhance efficacy without significantly increasing toxicity, given the FDA's agreement on the current dose.
The focus on overall survival as the primary endpoint is clinically relevant and aligns with what we, as oncologists, value most in patient care. If successful, this trial could lead to a new first-line standard of care for HCC patients, potentially improving outcomes in this difficult-to-treat population. However, we must await the Phase 3 results to confirm the promising Phase 2 data.
Tempest Therapeutics' successful end-of-Phase 2 meeting with the FDA is a positive development for the company. The agreement on the Phase 3 trial design, including the potential for early efficacy analysis, could accelerate the timeline for amezalpat's potential market entry. This is important for a small biotech company, as it could lead to earlier revenue generation and potentially attract partnership or acquisition interest.
However, investors should note that Tempest still faces significant challenges. The company will need substantial funding to conduct the Phase 3 trial and success is not guaranteed. The HCC market is competitive, with several large pharmaceutical companies already present. While positive Phase 3 results could significantly boost Tempest's value, the company remains a high-risk, high-reward investment typical of early-stage biotech firms.
- Broad agreement on pivotal Phase 3 study plan, including use of current amezalpat dose and schedule
- Overall survival, the strongest result from the Phase 2 trial, will be the primary study endpoint
- Agreed-upon early efficacy analysis could reduce time to primary read-out significantly
BRISBANE, Calif., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced positive feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC).
"We are thrilled with the positive outcome of our end-of-Phase 2 meeting with the FDA,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest. “Tempest and the FDA are in broad agreement on all major aspects of the proposed pivotal Phase 3 clinical trial for amezalpat in patients with hepatocellular carcinoma in the first line setting. This planned Phase 3 study closely mirrors the randomized Phase 2 study and the strongly favorable hazard ratio for overall survival observed at top-line analysis of the Phase 2, confirmed at the latest survival follow-up, give us confidence in the potential success of the Phase 3.”
Key outcomes of the FDA meeting include:
- Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints
- Agreement on appropriateness of the current amezalpat dose and schedule for the Phase 3 study
- Agreement on the Phase 3 statistical plan including a pre-specified early efficacy analysis that the company currently estimates could shorten the time to primary analysis by up to 8 months
About the TPST-1120-301 Study
The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab vs. atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC treated in the first line setting. The company is preparing for the Phase 3 study start in the first quarter of 2025.
About Amezalpat (TPST-1120)
Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Tempest’s data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global randomized phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors.
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated Phase 3 study for amezalpat; anticipated therapeutic benefit and regulatory development of the Company’s product candidates; the Company’s ability to deliver on potential value-creating milestones; the Company’s ability to advance into a late-stage clinical company; and the Company’s ability to achieve its operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 filed on August 8, 2024 and other documents filed by the Company from time to time with the Securities and Exchange Commission. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.
Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
| i If approved by the FDA |
FAQ
What is the purpose of Tempest's Phase 3 trial for amezalpat (TPST-1120)?
What was the outcome of Tempest's end-of-Phase 2 meeting with the FDA for amezalpat (TPST-1120)?
How might the early efficacy analysis impact the timeline for Tempest's amezalpat (TPST-1120) Phase 3 trial?
What were the key results from the Phase 2 trial of amezalpat (TPST-1120) that support Tempest's confidence in the Phase 3 study?
