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OS Therapies (NYSE-A: OSTX) announced positive results from their Phase 2b clinical trial of OST-HER2, a HER2-targeted immunotherapy for recurrent osteosarcoma with lung metastases. The study demonstrated statistically significant results in the primary endpoint, with 33.3% 12-month Event Free Survival (EFS) compared to 20% historical control (p=0.0158).
The trial included 39 evaluable patients aged 12-39 years across 21 centers, receiving 16 doses over 48 weeks. Interim analysis showed promising overall survival rates, with 91% 1-year survival and 61% 2-year survival compared to historical controls of 80% and 40% respectively. Notably, all patients achieving 12-month EFS remain alive.
Subgroup analyses revealed higher EFS rates in females (47%) versus males (20%), and in patients with multiple lung resections (55%) versus single resection (25%). The company is preparing to engage with FDA for an accelerated approval pathway, as there are currently no approved treatments for this indication.
OS Therapies (NYSE-A: OSTX) ha annunciato risultati positivi dal loro studio clinico di Fase 2b su OST-HER2, un'immunoterapia mirata al HER2 per l'osteosarcoma ricorrente con metastasi polmonari. Lo studio ha dimostrato risultati statisticamente significativi nel parametro primario, con un 33,3% di sopravvivenza libera da eventi a 12 mesi (EFS) rispetto al 20% di controllo storico (p=0,0158).
La sperimentazione ha incluso 39 pazienti valutabili di età compresa tra 12 e 39 anni, distribuiti su 21 centri, che hanno ricevuto 16 dosi nell'arco di 48 settimane. L'analisi intermedia ha mostrato tassi di sopravvivenza complessivi promettenti, con un 91% di sopravvivenza a 1 anno e un 61% di sopravvivenza a 2 anni rispetto ai controlli storici dell'80% e del 40% rispettivamente. È importante notare che tutti i pazienti che hanno raggiunto l'EFS a 12 mesi sono ancora vivi.
Le analisi di sottogruppo hanno rivelato tassi di EFS più elevati nelle femmine (47%) rispetto ai maschi (20%), e nei pazienti con resezioni polmonari multiple (55%) rispetto a una singola resezione (25%). L'azienda si sta preparando a interagire con la FDA per un percorso di approvazione accelerato, poiché attualmente non ci sono trattamenti approvati per questa indicazione.
OS Therapies (NYSE-A: OSTX) anunció resultados positivos de su ensayo clínico de Fase 2b de OST-HER2, una inmunoterapia dirigida a HER2 para el osteosarcoma recurrente con metástasis pulmonares. El estudio demostró resultados estadísticamente significativos en el objetivo primario, con un 33.3% de supervivencia libre de eventos a 12 meses (EFS) en comparación con el 20% de control histórico (p=0.0158).
El ensayo incluyó 39 pacientes evaluables de entre 12 y 39 años en 21 centros, recibiendo 16 dosis durante 48 semanas. El análisis intermedio mostró tasas de supervivencia general prometedoras, con un 91% de supervivencia a 1 año y un 61% de supervivencia a 2 años en comparación con controles históricos del 80% y 40% respectivamente. Cabe destacar que todos los pacientes que lograron EFS a 12 meses siguen vivos.
Los análisis de subgrupos revelaron tasas de EFS más altas en mujeres (47%) en comparación con hombres (20%), y en pacientes con múltiples resecciones pulmonares (55%) en comparación con una sola resección (25%). La empresa se está preparando para interactuar con la FDA para un camino de aprobación acelerada, ya que actualmente no hay tratamientos aprobados para esta indicación.
OS Therapies (NYSE-A: OSTX)는 폐 전이가 있는 재발성 골육종을 위한 HER2 표적 면역요법인 OST-HER2의 2b상 임상 시험에서 긍정적인 결과를 발표했습니다. 이 연구는 주요 목표에서 통계적으로 유의미한 결과를 보여주었으며, 12개월 사건 없는 생존율(EFS) 33.3%을 기록하여 역사적 대조군의 20%와 비교되었습니다 (p=0.0158).
이 시험에는 12세에서 39세 사이의 39명의 평가 가능한 환자가 21개 센터에서 포함되었으며, 48주 동안 16회의 투여를 받았습니다. 중간 분석에서는 전체 생존율이 유망하게 나타났으며, 1년 생존율 91% 및 2년 생존율 61%로 역사적 대조군의 80% 및 40%와 비교되었습니다. 특히, 12개월 EFS를 달성한 모든 환자가 생존하고 있습니다.
하위 그룹 분석에서는 여성(47%)과 남성(20%) 간의 EFS 비율, 그리고 단일 절제술(25%)에 비해 다수의 폐 절제술(55%)을 받은 환자 간의 EFS 비율이 더 높다는 결과가 나타났습니다. 현재 이 회사는 이 적응증에 대해 승인된 치료법이 없기 때문에 FDA와의 가속 승인 경로를 준비하고 있습니다.
OS Therapies (NYSE-A: OSTX) a annoncé des résultats positifs de son essai clinique de Phase 2b sur OST-HER2, une immunothérapie ciblant HER2 pour l'ostéosarcome récurrent avec métastases pulmonaires. L'étude a démontré des résultats statistiquement significatifs dans le critère principal, avec un 33,3% de survie sans événement à 12 mois (EFS) par rapport à un contrôle historique de 20% (p=0,0158).
L'essai a inclus 39 patients évaluables âgés de 12 à 39 ans dans 21 centres, recevant 16 doses sur 48 semaines. L'analyse intermédiaire a montré des taux de survie globaux prometteurs, avec un 91% de survie à 1 an et un 61% de survie à 2 ans par rapport à des contrôles historiques de 80% et 40% respectivement. Il est à noter que tous les patients ayant atteint une EFS de 12 mois sont toujours en vie.
Les analyses de sous-groupes ont révélé des taux d'EFS plus élevés chez les femmes (47%) par rapport aux hommes (20%), et chez les patients ayant subi plusieurs résections pulmonaires (55%) par rapport à une seule résection (25%). L'entreprise se prépare à interagir avec la FDA pour un chemin d'approbation accéléré, car il n'existe actuellement aucun traitement approuvé pour cette indication.
OS Therapies (NYSE-A: OSTX) hat positive Ergebnisse aus ihrer Phase 2b-Studie zu OST-HER2 bekannt gegeben, einer HER2-zielgerichteten Immuntherapie für wiederkehrendes Osteosarkom mit Lungenmetastasen. Die Studie zeigte statistisch signifikante Ergebnisse beim primären Endpunkt, mit einer 33,3% 12-Monats-Ereignisfreien Überlebensrate (EFS) im Vergleich zu 20% historischen Kontrollen (p=0,0158).
Die Studie umfasste 39 auswertbare Patienten im Alter von 12 bis 39 Jahren an 21 Zentren, die über 48 Wochen hinweg 16 Dosen erhielten. Die Zwischenanalyse zeigte vielversprechende Gesamtüberlebensraten, mit einer 91% 1-Jahres-Überlebensrate und einer 61% 2-Jahres-Überlebensrate im Vergleich zu historischen Kontrollen von 80% bzw. 40%. Bemerkenswert ist, dass alle Patienten, die eine 12-monatige EFS erreicht haben, noch leben.
Subgruppenanalysen zeigten höhere EFS-Raten bei Frauen (47%) im Vergleich zu Männern (20%) und bei Patienten mit mehreren Lungenresektionen (55%) im Vergleich zu einer einzigen Resektion (25%). Das Unternehmen bereitet sich darauf vor, mit der FDA einen beschleunigten Genehmigungsweg einzuleiten, da es derzeit keine zugelassenen Behandlungen für diese Indikation gibt.
- None.
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The primary endpoint of 12-month Event Free Survival (EFS) for OST-HER2- treated patients (
33.3% ) was statistically significant (p= 0.0158) when compared with peer-reviewed comparable historical control (20% ) - Ongoing follow up demonstrates strong trend in favor of OST-HER2 in 1-year and 2-year interim analyses of the secondary endpoint, 3-year overall survival (OS) when compared with comparable peer-reviewed historical control
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100% of patients who achieved 12-month EFS remain alive in OS follow-up - OST-HER2 was safe and well tolerated in the Phase 2b study
- OS Therapies reiterates clinical and regulatory path in recurrent, fully resected osteosarcoma with lung metastases, an indication with no currently approved treatments
“We are extremely pleased with these results of our Phase 2b clinical trial because they show that OST-HER2-treated patients achieved the primary endpoint of 12-month EFS in a statistically significantly higher ratio than comparable historical controls, in addition to increasing the likelihood of 1-year and 2-year survival as compared with comparable historical controls,” commented Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. “The strong safety profile shown in this study also supports the use of OST-HER2 in this incredibly difficult-to-treat population that has no currently approved therapies.”
“The achievement of the primary endpoint in the OST-HER2 phase 2b is a tremendous success that opens the possibility, for the first time, of meaningful therapy for patients suffering from osteosarcoma with lung metastases after resection. This is a leap forward in the development of OST-HER2 and we are pleased that our regulatory strategy is consistent with the FDA’s recent draft guidance update for accelerated approvals. With these positive data in hand, we are preparing to engage with
Phase 2b Clinical Trial Data
Enrollment Criteria:
- 12-39 years old
- Recurred, fully resected lung only metastatic (METS) Osteosarcoma
- 39 evaluable patients at 21 centers, single treatment arm
- 52 Weeks on Study: Dosed 16 times every 3 weeks for 48 weeks with 4-week follow-up final visit
Primary Endpoint of 12-month EFS:
-
33% for OST-HER2 vs.20% for historical control1 (p = 0.0158)
Interim Analysis of Ongoing Secondary Endpoint, OS:
-
1-year OS:
91% for OST-HER2 vs.80% for historical control2 (p = 0.0700) -
2-year OS:
61% for OST-HER2 vs.40% for historical control2 (p = 0.0576)
Post-Hoc Analyses
12-months EFS Subgroup Analysis in the OST-HER2 Treatment Group:
Gender (Males vs Females), n = 39:
-
Females (n=19) =
47% -
Males (n= 20) =
20%
(p= 0.0604)
Number of lung resections (1 Prior Resection vs. 2+ Prior Resections), n= 39:
-
1 Prior Resection (n= 28) =
25% -
2+ Prior Resections (n= 11) =
55%
(p = 0.1366)
12-month EFS Responders using a Non-Concurrent Control Group from the only existing US osteosarcoma database with patients qualified for disease-free status following a fully-resected lung-only metastasis of osteosarcoma origin:
-
OST-HER2, n=39
12-month EFS Responders = 13/39 (33% )
-
NCCG, n=9
12-month EFS Responders = 1/9 (11% )
(p = 0.1848)
Time to recurrence in patients who did not achieve 12-month EFS:
- OST-HER2, n=26 = 5.9 months
-
NCCG, n=8 = 4.7 months
(p = 0.1454)
About OST-HER2
OST-HER2 is an innovative immunotherapy using a HER2 bioengineered form of the bacteria Listeria monocytogenes (Lm) to trigger a strong immune response against cancer cells expressing HER2. This off-the-shelf immunotherapy treatment is designed to prevent metastasis, delay recurrence, kill primary tumors expressing HER2 alone and potentially in combination with existing approved therapies, and increase overall survival. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the FDA and Fast Track and Orphan Drug Designations from the FDA and European Medicines Agency (EMA).
The US FDA granted OST-HER2 rare pediatric disease designation for osteosarcoma in 2021. The US FDA rare pediatric disease PRV program aims to incentivize drug development for rare pediatric diseases. Under this voucher program, a sponsor who receives an approval for a drug or biological product for a rare pediatric disease qualifies for a voucher that can be redeemed to receive priority review for a different product. The sponsor may also transfer or sell the voucher to another sponsor. OS Therapies intends to sell the PRV it would earn upon receiving an approval of OST-HER2 for recurrent, fully resected, lung metastatic osteosarcoma. The most recent publicly disclosed sale price of a PRV was on November 27th, 2024 when PTC Therapeutics announced selling its PRV to Kebilidi for
The most recent continuing resolution (CR) negotiations in the US House of Representatives failed to reauthorize the PRV program for pediatric cancers such as osteosarcoma. Despite this, as a result of OS Therapies’ having been granted OST-HER2’s rare pediatric disease designation prior to December 20, 2024 in addition to the Company’s aim to receive an approval for OST-HER2 in the rare pediatric disease osteosarcoma in 2025, prior to the September 30, 2026 deadline, OS Therapies remains eligible to receive the PRV upon approval of OST-HER2 in recurrent, resected metastatic osteosarcoma.
The osteosarcoma treatment market was estimated at
About OS Therapies
OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma, with results expected in the fourth quarter of 2024. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s registration statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1 Lagmay JP, Krailo MD, Dang H, et al: Outcome of patients with recurrent osteosarcoma enrolled in seven Phase II trials through Children's Cancer Group, Pediatric Oncology Group, and Children's Oncology Group: learning from the past to move forward. J Clin Oncol. 2016;34:3031-8
2 A.H. Aljubran, A. Griffin, M. Pintilie, M. Blackstein; Osteosarcoma in adolescents and adults: survival analysis with and without lung metastases; Annals of Oncology; Volume 20, Issue 6; 2009;1136-41
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OS Therapies Contact Information:
Jack Doll
+1.571.243.9455
Irpr@ostherapies.com
https://x.com/OSTherapies
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https://www.linkedin.com/company/os-therapies/
Source: OS Therapies, Inc.
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