Ascendis to Present First Results from Platinum-Resistant Ovarian Cancer (PROC) Cohort of the Phase 1/2 IL-Believe Trial at ESMO 2024
Ascendis Pharma A/S (Nasdaq: ASND) has announced initial data from its Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ in platinum-resistant ovarian cancer (PROC) patients. The study showed anti-tumor clinical responses in 29% (4/14) of efficacy-evaluable patients treated with TransCon IL-2 β/γ in combination with chemotherapy. These results suggest clinical activity in heavily pre-treated PROC patients, including those who had previously progressed on Elahere®. The treatment was generally well-tolerated, with most treatment-emergent adverse events being grade 1 or 2. The data will be presented at ESMO 2024 in Barcelona. This follows promising results in melanoma announced at ASCO 2024, indicating potential efficacy across multiple cancer types.
Ascendis Pharma A/S (Nasdaq: ASND) ha annunciato dati iniziali dal suo studio di Fase 1/2 IL-Believe sul TransCon IL-2 β/γ in pazienti con cancro ovarico resistente al platino (PROC). Lo studio ha mostrato risposte cliniche anti-tumorali nel 29% (4/14) dei pazienti valutabili per l'efficacia trattati con TransCon IL-2 β/γ in combinazione con la chemioterapia. Questi risultati suggeriscono un'attività clinica in pazienti PROC fortemente pre-trattati, inclusi quelli che erano già progrediti dopo l'uso di Elahere®. Il trattamento è stato generalmente ben tollerato, con la maggior parte degli eventi avversi emergenti da trattamento classificati come di grado 1 o 2. I dati saranno presentati a ESMO 2024 a Barcellona. Questo segue risultati promettenti nel melanoma annunciati all'ASCO 2024, indicando una potenziale efficacia attraverso diversi tipi di cancro.
Ascendis Pharma A/S (Nasdaq: ASND) ha anunciado datos iniciales de su ensayo de Fase 1/2 IL-Believe sobre TransCon IL-2 β/γ en pacientes con cáncer de ovario resistente al platino (PROC). El estudio mostró respuestas clínicas anti-tumorales en el 29% (4/14) de los pacientes evaluables para eficacia tratados con TransCon IL-2 β/γ en combinación con quimioterapia. Estos resultados sugieren actividad clínica en pacientes PROC con múltiples tratamientos previos, incluidos aquellos que habían progresado previamente con Elahere®. El tratamiento fue generalmente bien tolerado, con la mayoría de los eventos adversos emergentes del tratamiento clasificados como de grado 1 o 2. Los datos se presentarán en ESMO 2024 en Barcelona. Esto sigue a resultados prometedores en melanoma anunciados en ASCO 2024, lo que indica una eficacia potencial en múltiples tipos de cáncer.
Ascendis Pharma A/S (Nasdaq: ASND)는 백금 내성 난소암 (PROC) 환자에 대한 TransCon IL-2 β/γ의 1/2 단계 IL-Believe 시험의 초기 데이터를 발표했습니다. 이 연구는 치료 효능이 평가 가능한 환자의 29% (4/14)에서 항종양 임상 반응을 나타냈습니다 TransCon IL-2 β/γ가 화학요법과 병용되었을 때. 이러한 결과는 엘라헤르®로 진행된 환자를 포함한 치료를 많이 받은 PROC 환자에서 임상적 활성이 있음을 시사합니다. 치료는 일반적으로 잘 견디지며, 치료로 인한 부작용의 대부분은 1도 또는 2도로 분류되었습니다. 데이터는 바르셀로나에서 열리는 ESMO 2024에서 발표될 예정입니다. 이는 ASCO 2024에서 발표된 흑색종에 대한 유망한 결과를 따르며, 여러 암 유형에 대한 잠재적 효능을 나타냅니다.
Ascendis Pharma A/S (Nasdaq: ASND) a annoncé des données préliminaires de son essai de Phase 1/2 IL-Believe sur TransCon IL-2 β/γ chez des patientes atteintes de cancer de l'ovaire résistant au platine (PROC). L'étude a révélé des réponses cliniques anti-tumorales chez 29% (4/14) des patientes évaluables en termes d'efficacité traitées avec TransCon IL-2 β/γ en association avec une chimiothérapie. Ces résultats suggèrent une activité clinique chez des patientes PROC ayant subi de nombreux traitements, y compris celles qui avaient déjà progressé sous Elahere®. Le traitement a généralement été bien toléré, la majorité des événements indésirables ayant émergé étant classés de grade 1 ou 2. Les données seront présentées lors de ESMO 2024 à Barcelone. Cela fait suite à des résultats prometteurs dans le mélanome annoncés lors de l'ASCO 2024, ce qui indique une efficacité potentielle dans plusieurs types de cancer.
Ascendis Pharma A/S (Nasdaq: ASND) hat erste Daten aus seiner Phase 1/2 IL-Believe-Studie zu TransCon IL-2 β/γ bei platiniumresistenten Ovarialkrebspatienten (PROC) veröffentlicht. Die Studie zeigte anti-tumorale klinische Reaktionen bei 29% (4/14) der hinsichtlich der Wirksamkeit bewertbaren Patienten, die mit TransCon IL-2 β/γ in Kombination mit Chemotherapie behandelt wurden. Diese Ergebnisse deuten auf eine klinische Aktivität bei stark vorbehandelten PROC-Patienten hin, einschließlich solcher, die zuvor auf Elahere® fortgeschritten sind. Die Behandlung wurde im Allgemeinen gut vertragen, wobei die meisten behandlungsbedingten Nebenwirkungen als Grad 1 oder 2 eingestuft wurden. Die Daten werden auf der ESMO 2024 in Barcelona präsentiert. Dies folgt auf vielversprechende Ergebnisse bei Melanomen, die auf dem ASCO 2024 angekündigt wurden und eine potenzielle Wirksamkeit in mehreren Krebsarten anzeigen.
- 29% (4/14) of efficacy-evaluable PROC patients showed anti-tumor clinical responses
- Clinical activity observed in heavily pre-treated patients, including those who progressed on Elahere®
- TransCon IL-2 β/γ in combination with chemotherapy was generally well-tolerated
- Expanding potential efficacy across multiple cancer types (melanoma and ovarian cancer)
- Small sample size of only 18 patients in the initial data
- 4 out of 18 patients discontinued treatment before the first post-baseline tumor assessment
Insights
The initial data from Ascendis Pharma's Phase 1/2 IL-Believe Trial shows promising results for TransCon IL-2 β/γ in combination with chemotherapy for platinum-resistant ovarian cancer (PROC). The 29% response rate in heavily pre-treated patients is noteworthy, especially considering some had previously progressed on Elahere®. This suggests potential efficacy in a difficult-to-treat population.
The safety profile appears manageable, with most treatment-related adverse events being grade 1 or 2. However, the small sample size (18 patients) limits the strength of these conclusions. Further data will be important to confirm these early signals of efficacy and safety. The combination approach with chemotherapy is interesting and may offer a new strategy for PROC patients who have exhausted standard options.
These preliminary results for TransCon IL-2 β/γ in PROC are intriguing. The 29% response rate in heavily pre-treated patients, including those who progressed on Elahere®, is encouraging. However, it's important to note that half of these responses are still unconfirmed and the sample size is small.
The tolerability profile seems acceptable for this patient population, with fatigue and hematological toxicities being the most common adverse events. This is consistent with what we'd expect from IL-2 based therapies and chemotherapy. The potential of this combination to offer a new option for PROC patients who have exhausted standard treatments is exciting, but we need more data on durability of response and overall survival before drawing firm conclusions.
While these early results are promising for Ascendis Pharma, it's important to temper expectations. The small sample size and preliminary nature of the data mean it's too early to predict commercial success. However, the positive signals in a difficult-to-treat population could potentially expand Ascendis' oncology portfolio.
Investors should watch for more comprehensive data, including durability of response and overall survival metrics. The PROC market is competitive, with recent approvals like Elahere®. If TransCon IL-2 β/γ continues to show efficacy in patients who've progressed on such treatments, it could carve out a valuable niche. The safety profile seems manageable, which is important for regulatory and commercial prospects. Overall, this news is modestly positive for Ascendis, but significant uncertainties remain.
- Anti-tumor clinical responses were observed in
29% (4/14) of efficacy-evaluable patients with PROC treated with TransCon IL-2 β/γ in combination with chemotherapy - Initial data suggest clinical activity in heavily pre-treated PROC patients and that TransCon IL-2 β/γ in combination with chemotherapy was generally well-tolerated
COPENHAGEN, Denmark, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced initial data showing signs of clinical activity in heavily pre-treated patients with platinum-resistant ovarian cancer (PROC) treated with TransCon IL-2 β/γ in combination with chemotherapy in its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ. First results will be shared in Poster 762P at ESMO 2024, the annual meeting of the European Society of Medical Oncology being held in Barcelona from September 13-17, 2024.
Of the 18 patients (median age 64 years) included in the initial data, 14 were efficacy evaluable patients who had 1 or more post-baseline tumor assessment(s), plus an additional 4 who discontinued treatment before the first post-baseline tumor assessment due to disease progression or death. Anti-tumor clinical responses were observed in
“Building on results announced at ASCO 2024 in melanoma, we are excited now to see meaningful signs of anti-tumor activity in combination with chemotherapy in our second indication-specific cohort of heavily pretreated patients who have exhausted standard-of-care options,” said Stina Singel, M.D., Ph.D., Executive Vice President, Head of Clinical Development, Oncology, at Ascendis Pharma. “We look forward to providing further updates as patients continue on study treatment.”
About TransCon IL-2 β/γ & IL-Believe
TransCon IL-2 β/γ is a novel prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 analogue (IL-2 β/γ). IL-2 β/γ is transiently attached to an inert carrier by a TransCon linker, which under physiological conditions releases active IL-2 β/γ in a predictable, sustained manner. This results in lower Cmax and longer half-life, which is expected to widen the therapeutic index.
TransCon IL-2 β/γ is being investigated in IL Believe, a multicenter Phase 1/2, multi-cohort study in adult patients with locally advanced or metastatic solid tumors. As of the July 29, 2024, data cut off, 42 patients whose disease had progressed within six months after completing platinum-based chemotherapy were enrolled in the PROC dose expansion cohort (Cohort 3 in the trial). Treatment for patients in Cohort 3 included intravenous TransCon IL-2 β/γ at the recommended Phase 2 dose of 120 μg/kg every 3 weeks in combination with the physician’s choice of paclitaxel, docetaxel, or pemetrexed. Disease response was assessed every 9 weeks using RECIST v1.1. and safety, efficacy, and biomarkers were evaluated.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ intent to provide further updates as patients continue on treatment with TransCon IL-2 β/γ in combination with chemotherapy, (ii) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (iii) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 7, 2024, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. Elahere® is a registered trademark of ImmunoGen, Inc.
© September 2024 Ascendis Pharma A/S.
| Investor Contacts: Tim Lee Ascendis Pharma +1 (650) 374-6343 tle@ascendispharma.com ir@ascendispharma.com | Media Contact: Melinda Baker Ascendis Pharma +1 (650) 709-8875 media@ascendispharma.com | |
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FAQ
What were the results of Ascendis Pharma's PROC cohort in the IL-Believe Trial?
When and where will Ascendis Pharma (ASND) present the PROC cohort results?
How well-tolerated was TransCon IL-2 β/γ in the PROC cohort of the IL-Believe Trial?
What were the most common side effects of TransCon IL-2 β/γ plus chemotherapy in the PROC study?
