IO Biotech Updates on Pivotal Phase 3 Trial of IO102-IO103 in Combination with KEYTRUDA® (pembrolizumab) as a First-Line Treatment for Patients with Advanced Melanoma
IO Biotech (Nasdaq: IOBT) announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of its pivotal Phase 3 trial for IO102-IO103, a novel therapeutic cancer vaccine, in combination with KEYTRUDA® (pembrolizumab) for advanced melanoma. Key points:
1. No new safety signals observed
2. Primary endpoint of progression-free survival (PFS) projected for first half of 2025
3. Trial powered at 89% to detect a 35% reduction in event risk
4. 407 patients randomized
5. Interim analysis did not meet criteria for superiority in overall response rate (ORR)
6. Company remains optimistic based on Phase 1/2 results showing 25.5 months median PFS
IO Biotech also reported promising preliminary data from a Phase 2 basket trial in NSCLC and SCCHN, with upcoming presentations at medical conferences.
IO Biotech (Nasdaq: IOBT) ha annunciato che il Comitato Indipendente per il Monitoraggio dei Dati (IDMC) ha raccomandato la continuazione del suo cruciale studio di Fase 3 per IO102-IO103, un nuovo vaccino terapeutico contro il cancro, in combinazione con KEYTRUDA® (pembrolizumab) per il melanoma avanzato. Punti chiave:
1. Non sono stati osservati nuovi segnali di sicurezza
2. L'endpoint primario di sopravvivenza libera da progressione (PFS) è previsto per la prima metà del 2025
3. Lo studio è potenziato all'89% per rilevare una riduzione del 35% del rischio di eventi
4. 407 pazienti randomizzati
5. L'analisi intermedia non ha soddisfatto i criteri per la superiorità nel tasso di risposta globale (ORR)
6. L'azienda rimane ottimista sulla base dei risultati della Fase 1/2 che mostrano una PFS mediana di 25,5 mesi
IO Biotech ha anche riportato dati preliminari promettenti da uno studio di Fase 2 a cestello in NSCLC e SCCHN, con presentazioni imminenti a conferenze mediche.
IO Biotech (Nasdaq: IOBT) anunció que el Comité Independiente de Monitoreo de Datos (IDMC) recomendó la continuación de su ensayo pivotal de Fase 3 para IO102-IO103, una nueva vacuna terapéutica contra el cáncer, en combinación con KEYTRUDA® (pembrolizumab) para el melanoma avanzado. Puntos clave:
1. No se observaron nuevas señales de seguridad
2. El objetivo primario de supervivencia libre de progresión (PFS) está proyectado para la primera mitad de 2025
3. El ensayo tiene un poder del 89% para detectar una reducción del 35% en el riesgo de eventos
4. 407 pacientes randomizados
5. El análisis interino no cumplió con los criterios de superioridad en la tasa de respuesta global (ORR)
6. La empresa se mantiene optimista basándose en los resultados de Fase 1/2 que muestran una PFS mediana de 25,5 meses
IO Biotech también informó datos preliminares prometedores de un ensayo de Fase 2 en cesta en NSCLC y SCCHN, con presentaciones próximas en conferencias médicas.
IO Biotech (Nasdaq: IOBT)는 독립 데이터 모니터링 위원회(IDMC)가 IO102-IO103에 대한 결정적인 3상 시험의 지속을 추천했다고 발표했습니다. 이는 KEYTRUDA®(펨브롤리주맙)와 함께 사용되는 새로운 치료 암 백신으로, 진행된 흑색종 치료에 관한 것입니다. 주요 사항:
1. 새로운 안전 신호가 관찰되지 않음
2. 무진행 생존 기간(PFS)의 주요 목표가 2025년 상반기에 예상됨
3. 89%의 힘으로 이벤트 위험을 35% 줄이는 것을 탐지할 수 있음
4. 407명의 환자 무작위 배정
5. 중간 분석이 전체 반응률(ORR)에서 우위를 위한 기준을 충족하지 못함
6. 회사는 25.5개월의 중앙 PFS를 보여주는 1상/2상 결과를 바탕으로 낙관적임
IO Biotech는 NSCLC 및 SCCHN에 대한 2상 바스켓 시험에서 유망한 초기 데이터를 보고했으며, 의학 회의에서의 발표가 예정되어 있습니다.
IO Biotech (Nasdaq: IOBT) a annoncé que le Comité Indépendant de Surveillance des Données (IDMC) a recommandé la poursuite de son essai de Phase 3 pour IO102-IO103, un nouveau vaccin thérapeutique contre le cancer, en combinaison avec KEYTRUDA® (pembrolizumab) pour le mélanome avancé. Points clés :
1. Aucun nouveau signal de sécurité observé
2. L'objectif principal de survie sans progression (PFS) projeté pour la première moitié de 2025
3. Essai alimenté à 89 % pour détecter une réduction de 35 % du risque d'événements
4. 407 patients randomisés
5. L'analyse intermédiaire n'a pas satisfait aux critères de supériorité en termes de taux de réponse global (ORR)
6. L'entreprise reste optimiste sur la base des résultats de la Phase 1/2 montrant une PFS médiane de 25,5 mois
IO Biotech a également rapporté des données préliminaires prometteuses d'un essai de Phase 2 dans le cadre de NSCLC et SCCHN, avec des présentations à venir lors de conférences médicales.
IO Biotech (Nasdaq: IOBT) hat angekündigt, dass das Unabhängige Datenüberwachungskomitee (IDMC) die Fortsetzung seiner entscheidenden Phase-3-Studie für IO102-IO103, einen neuartigen therapeutischen Krebsimpfstoff, in Kombination mit KEYTRUDA® (Pembrolizumab) für fortgeschrittenes Melanom empfohlen hat. Wichtige Punkte:
1. Es wurden keine neuen Sicherheitszeichen beobachtet
2. Der primäre Endpunkt des progressionsfreien Überlebens (PFS) wird für die erste Hälfte von 2025 prognostiziert
3. Die Studie hat eine Power von 89%, um eine 35%ige Risikominderung zu erkennen
4. 407 Patienten randomisiert
5. Die Zwischenanalyse erfüllte nicht die Kriterien für Überlegenheit in der Gesamtansprechrate (ORR)
6. Das Unternehmen bleibt optimistisch aufgrund der Ergebnisse der Phase 1/2, die ein medianes PFS von 25,5 Monaten zeigen
IO Biotech berichtete auch von vielversprechenden vorläufigen Daten aus einer Phase-2-Basket-Studie bei NSCLC und SCCHN, mit bevorstehenden Präsentationen auf medizinischen Konferenzen.
- Phase 3 trial continues without modifications, as recommended by IDMC
- No new safety signals observed in the interim analysis
- Trial powered at 89% to detect a 35% reduction in the risk of disease progression or death
- Promising preliminary data from Phase 2 basket trial in NSCLC and SCCHN
- Interim efficacy analysis did not meet criteria to declare superiority of ORR
- Primary endpoint of progression-free survival projected for first half of 2025, indicating a longer wait for definitive results
Insights
The interim analysis of IO Biotech's pivotal Phase 3 trial for IO102-IO103 in combination with KEYTRUDA® presents a mixed outlook. While the trial continues without modifications, it didn't meet the high statistical bar for superiority in Overall Response Rate (ORR). However, this isn't uncommon in melanoma immunotherapy trials. The key focus now shifts to the Progression-Free Survival (PFS) endpoint, projected for
The trial's 89% power to detect a
Investors should note that while the interim results aren't overwhelmingly positive, they don't necessarily predict the final outcome. The PFS data will be crucial in determining the therapy's true potential and market prospects.
The continuation of IO Biotech's Phase 3 trial without modifications is cautiously positive. While not meeting the interim ORR superiority criteria, this isn't unusual in melanoma immunotherapy trials. The safety profile remains consistent, which is important for potential long-term use.
The projected PFS of 25.5 months from the Phase 1/2 trial is intriguing. If replicated in Phase 3, it could represent a significant improvement over current standards. However, it's important to note that Phase 1/2 results don't always translate to Phase 3.
The potential for a low toxicity profile combined with improved efficacy could be game-changing in melanoma treatment. However, we must await the final PFS data to draw definitive conclusions. This therapy's potential expansion into NSCLC and SCCHN is also worth monitoring, as it could broaden its impact and market potential.
IO Biotech's Phase 3 trial update presents a nuanced financial outlook. The continuation of the trial without modifications averts immediate concerns about the therapy's viability, but the failure to meet the interim ORR superiority criteria may temper short-term investor enthusiasm.
The key financial catalyst now shifts to the PFS data expected in
The potential expansion into NSCLC and SCCHN markets could significantly broaden the therapy's commercial prospects. However, investors should be cautious about pricing in this potential before seeing more robust data. Overall, while the update doesn't dramatically alter IO Biotech's prospects, it does reinforce the binary nature of biotech investing, with significant value hinging on the final PFS results.
- Based on a per-protocol interim analysis of safety and efficacy data, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue without modifications
- No new safety signals observed at interim analysis
- Primary endpoint of progression free survival projected to be reached in the first half of 2025
NEW YORK, Aug. 30, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that an Independent Data Monitoring Committee (IDMC) recommended continuation of the company’s pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) of its lead investigational therapeutic vaccine, IO102-IO103, following a per-protocol interim analysis. The trial is evaluating IO102-IO103 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as a first-line treatment for patients with unresectable or metastatic (advanced) melanoma. Based on their review of the safety and efficacy data, the IDMC recommended that the trial continue without modifications and noted that no new safety signals were observed. The primary endpoint of progression-free survival (PFS) is projected to be reached in the first half of 2025.
The per-protocol interim analysis was performed one year after 225 patients were randomized in the trial. The interim efficacy analysis was intentionally set with a high statistical bar (p≤0.005), and based on the analysis, the IDMC determined that the data did not meet the criteria to declare superiority of ORR. The trial was designed to preserve most of the statistical alpha for the trial’s primary endpoint of PFS. The PFS analysis is event-driven and will be conducted when 226 events (disease progression or death) have been reported in the trial with independent central review. With 407 patients randomized, the trial is powered at
“To date, none of the approved immunotherapeutic combinations for the treatment of advanced melanoma demonstrated statistical significance in ORR in large Phase 3 trials; nevertheless, these trials achieved statistical significance on PFS,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “Based on the 25.5 months median PFS we observed in the Phase 1/2 trial of IO102-IO103 in combination with a PD-1 inhibitor in advanced melanoma, with no added significant systemic toxicity than that typically seen with anti-PD-1 monotherapy, we remain optimistic about meeting the primary endpoint of PFS, projected to occur in the first half of 2025.”
Igor Puzanov, MD, MSCI, FACP, Director, Center for Early Phase Clinical Trials, Chief, Division of Melanoma, Department of Medicine and Investigator for the Phase 3 Study at Roswell Park Comprehensive Cancer Center, Buffalo, New York commented, “The incidence of melanoma is on the rise and new treatments are needed. This is a novel investigational immune-modulatory therapeutic cancer vaccine combined with an anti-PD-1 therapy that has the potential to transform the treatment paradigm with a new and better option for people battling advanced melanoma. I am eagerly awaiting the PFS primary endpoint readout of this Phase 3 trial that could further validate this novel cancer vaccine’s ability to help patients with advanced melanoma who are seeking more efficacious, low treatment-induced toxicity therapy options.”
Jessica Hassel, MD, Head of the Section for Dermato-Oncology at the University Hospital Heidelberg, investigator and lead enroller for the Phase 3 trial added, “We have been seeing promising results using combination immunotherapeutic treatments and I remain confident that IO102-IO103 in combination with pembrolizumab could offer new hope for treating patients with advanced melanoma. I look forward to the full readout of data at the end of this trial to further understand the full potential of this investigational therapeutic cancer vaccine combined with an anti-PD-1 agent.”
Dr. Zocca continued, “We continue to be enthusiastic about the encouraging preliminary data from our Phase 2 basket trial evaluating IO102-IO103 in combination with pembrolizumab for the treatment of metastatic non-small cell lung cancer (NSCLC) or recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Data from the SCCHN cohort has been accepted for poster presentation at the ESMO congress, and data from the NSCLC cohort has been accepted to another medical meeting in the fall. We believe these data could provide further evidence to support the broader potential of therapeutic cancer vaccines for the benefit of patients in additional cancer indications.”
About the IOB-013/KN-D18 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. A total of 407 patients have been enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression-free survival, an event-driven analysis conducted when 226 events, defined as disease progression or death, have been reported in the study. Secondary endpoints include overall response rate (ORR), overall survival (OS), durable objective response (DRR), complete response rate (CRR), duration of response (DoR), time to complete response (TTCR), disease control rate (DCR), and incidence of AEs and SAEs (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.
About IO102-IO103
IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.
The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.
For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing of the completion of the company’s Phase 3 trial, current or future clinical trials, their progress, enrollment or results, timing of submission of marketing applications, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Contact:
Investors
Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com
Media
Julie Funesti, National Health Media
Edelman
917-498-1967
Julie.Funesti@salutemcomms.com
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