IO Biotech Announces Positive Results from Phase 2 Trial of IO102-IO103 in the First-line Treatment of Advanced Head and Neck Cancer
IO Biotech (Nasdaq: IOBT) announced positive results from its Phase 2 trial of IO102-IO103, a therapeutic cancer vaccine, in combination with Merck's KEYTRUDA® for advanced head and neck cancer. The study met its primary endpoint with a 44.4% overall response rate in PD-L1 high patients. Key findings include:
- 6.6-month median progression-free survival
- 66.7% disease control rate
- Safety profile consistent with previous data
- T-cell responses detected for both IO102 and IO103
The trial enrolled patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 CPS ≥ 20. These results support further investigation of the combination as a potential first-line treatment for metastatic and difficult-to-treat cancers.
IO Biotech (Nasdaq: IOBT) ha annunciato risultati positivi dal suo studio di Fase 2 su IO102-IO103, un vaccino terapeutico contro il cancro, in combinazione con KEYTRUDA® di Merck per il carcinoma avanzato della testa e del collo. Lo studio ha raggiunto il suo obiettivo principale con un 44,4% di tasso di risposta globale nei pazienti con PD-L1 elevato. I risultati principali includono:
- 6,6 mesi di sopravvivenza libera da progressione mediana
- 66,7% di tasso di controllo della malattia
- Profilo di sicurezza coerente con i dati precedenti
- Risposte delle cellule T rilevate sia per IO102 che per IO103
Lo studio ha arruolato pazienti con carcinoma squamoso della testa e del collo (SCCHN) ricorrente o metastaticamente con PD-L1 CPS ≥ 20. Questi risultati supportano ulteriori indagini sulla combinazione come potenziale trattamento di prima linea per i tumori metastatici e difficili da trattare.
IO Biotech (Nasdaq: IOBT) anunció resultados positivos de su ensayo de Fase 2 de IO102-IO103, una vacuna terapéutica contra el cáncer, en combinación con KEYTRUDA® de Merck para el cáncer avanzado de cabeza y cuello. El estudio alcanzó su objetivo primario con una tasa de respuesta global del 44,4% en pacientes con PD-L1 alto. Los hallazgos clave incluyen:
- 6,6 meses de supervivencia libre de progresión mediana
- 66,7% de tasa de control de la enfermedad
- Perfil de seguridad consistente con datos anteriores
- Respuestas de células T detectadas tanto para IO102 como para IO103
El ensayo incluyó pacientes con carcinoma de células escamosas de cabeza y cuello (SCCHN) recurrente o metastásico con PD-L1 CPS ≥ 20. Estos resultados respaldan una mayor investigación de la combinación como posible tratamiento de primera línea para cánceres metastásicos y difíciles de tratar.
IO Biotech (Nasdaq: IOBT)은 메르크의 KEYTRUDA®와 함께 고급 두경부 암 환자에 대한 치료적 암 백신인 IO102-IO103의 2상 시험에서 긍정적인 결과를 발표했습니다. 이 연구는 PD-L1이 높은 환자에서 44.4%의 전체 응답률로 주요 목표를 달성했습니다. 주요 발견 사항은 다음과 같습니다:
- 6.6개월의 중간 무진행 생존 기간
- 66.7%의 질병 조절률
- 이전 데이터와 일치하는 안전성 프로파일
- IO102와 IO103 모두에 대한 T세포 반응 검출
이 시험은 PD-L1 CPS ≥ 20을 가진 재발성 또는 전이성 편평세포암(환자)을 등록했습니다. 이러한 결과는 전이성 및 치료가 어려운 암에 대한 1차 치료제로서의 조합에 대한 추가 조사를 지원합니다.
IO Biotech (Nasdaq: IOBT) a annoncé des résultats positifs de son essai de Phase 2 sur IO102-IO103, un vaccin thérapeutique contre le cancer, en combinaison avec le KEYTRUDA® de Merck pour le cancer avancé de la tête et du cou. L'étude a atteint son objectif principal avec un taux de réponse global de 44,4% chez les patients ayant un PD-L1 élevé. Les principales conclusions comprennent :
- 6,6 mois de survie sans progression médiane
- 66,7% de taux de contrôle de la maladie
- Profil de sécurité cohérent avec les données précédentes
- Réponses des cellules T détectées pour IO102 et IO103
L'essai a recruté des patients atteints de carcinome à cellules squameuses avancé de la tête et du cou (SCCHN) récurrent ou métastatique avec un PD-L1 CPS ≥ 20. Ces résultats soutiennent une enquête plus approfondie sur la combinaison en tant que traitement de première ligne potentiel pour les cancers métastatiques et difficiles à traiter.
IO Biotech (Nasdaq: IOBT) gab positive Ergebnisse aus seiner Phase-2-Studie zu IO102-IO103, einem therapeutischen Krebsimpfstoff, in Kombination mit Mercks KEYTRUDA® für fortgeschrittenen Kopf- und Halskrebs bekannt. Die Studie erreichte ihr primäres Ziel mit einer Gesamtansprechrate von 44,4% bei Patienten mit hohem PD-L1. Wichtige Ergebnisse umfassen:
- Median von 6,6 Monaten progressionsfreier Überlebenszeit
- 66,7% Krankheitskontrollrate
- Sicherheitsprofil konsistent mit vorherigen Daten
- T-Zell-Antworten sowohl für IO102 als auch für IO103 festgestellt
Die Studie rekrutierte Patienten mit rekurrentem oder metastasiertem plattenepithelialen Karzinom des Kopfes und Halses (SCCHN) mit PD-L1 CPS ≥ 20. Diese Ergebnisse unterstützen eine weitere Untersuchung der Kombination als potenzielle Erstlinientherapie für metastasierte und schwer zu behandelnde Krebserkrankungen.
- Phase 2 trial met primary endpoint with 44.4% overall response rate in PD-L1 high SCCHN patients
- Encouraging 6.6-month median progression-free survival observed
- 66.7% disease control rate achieved
- Safety profile consistent with previous data, no new safety signals observed
- T-cell responses detected for both IO102 and IO103 vaccine components
- Results support potential of IO102-IO103 as first-line treatment for advanced head and neck cancer
- None.
Insights
The Phase 2 trial results for IO102-IO103 in combination with pembrolizumab are promising for advanced head and neck cancer treatment. The 44.4% overall response rate in PD-L1 high SCCHN patients is clinically significant, surpassing historical benchmarks for pembrolizumab monotherapy. The 6.6-month median progression-free survival is encouraging, suggesting durable responses. The 66.7% disease control rate further supports the combination's efficacy. Importantly, the safety profile aligns with previous studies, indicating no added significant toxicity compared to anti-PD1 monotherapy. The detection of T-cell responses to both IO102 and IO103 provides mechanistic support for the vaccine's immunomodulatory effects. These results warrant further investigation in larger trials to confirm the potential of this combination as a first-line treatment option for SCCHN patients.
As an oncologist, I find these results particularly intriguing for head and neck cancer treatment. The 44.4% ORR in PD-L1 high SCCHN patients, regardless of HPV status, is noteworthy. This suggests potential broad applicability across SCCHN subtypes. The 6.6-month median PFS is promising, especially considering the aggressive nature of this cancer. The 66.7% disease control rate indicates that a majority of patients derived some benefit. The safety profile is reassuring, as managing toxicities is important in this patient population. The T-cell response data provides valuable insights into the vaccine's mechanism of action. While these results are encouraging, it's important to note the small sample size (18 patients) and await larger, randomized trials to confirm efficacy and safety in a broader population.
From a financial perspective, these results are positive for IO Biotech. The company's lead candidate, IO102-IO103, has demonstrated promising efficacy in a difficult-to-treat cancer, potentially expanding its market opportunity. The combination with Merck's Keytruda, a blockbuster drug, could lead to lucrative partnership opportunities. The positive data in both head and neck cancer and melanoma suggests broad applicability, which could increase the therapy's commercial potential. However, investors should note that this is still a Phase 2 trial with a small sample size. The company will need to conduct larger, pivotal trials to seek regulatory approval. The financial implications will depend on the outcome of these future studies and potential partnerships. While promising, it's important to consider the long development timeline and substantial costs associated with bringing a novel cancer therapy to market.
-- Study Meets Overall Response Rate Primary Endpoint, Encouraging Secondary Endpoint Progression-Free Survival Data in Squamous Cell Carcinoma of the Head and Neck Cohort --
-- No New Safety Signals or Added Systemic Safety Concerns Observed --
-- Data Presented at the European Society for Medical Oncology (ESMO) Congress --
NEW YORK, Sept. 14, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines, announced promising data from the Phase 2 basket trial of IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) (IOB-022/KN-D38) at the 2024 ESMO Congress in Barcelona from September 13-17.
The presentation contained clinical and biomarker data from a cohort of patients with recurrent or metastatic (advanced) squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 CPS ≥ 20 (PD-L1 high), contributing to the growing body of research supporting the potential clinical benefit of this combination regimen for these patients. The data from 18 efficacy evaluable patients demonstrated:
- Achievement of the primary endpoint – confirmed
44.4% overall response rate (ORR) in a PD-L1 high population of patients with SCCHN irrespective of HPV status. - An encouraging 6.6-month median progression-free survival (PFS).
- A
66.7% disease control rate (DCR). - A safety profile consistent with previously reported data when combined with anti-PD-1 monotherapy.
- T-cell responses to both IO102 (targeting IDO) and IO103 (targeting PD-L1) were detected after treatment.
“These encouraging data further support the potential of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with recurrent or metastatic SCCHN including HPV-positive and -negative patients,” stated Jonathan Riess, MD, principal investigator of the trial and Director, Thoracic Oncology at the UC Davis Comprehensive Cancer Center. “Given the need for new treatment options that are effective, safe and accessible for head and neck cancer patients, further investigation of this combination should be conducted to build on the findings of this Phase 2 trial.”
“With the data we’ve presented from studies in head and neck cancer and in melanoma, evidence is accumulating that the combination of IO102-IO103 with the anti-PD-1 therapy pembrolizumab could be a safe and efficacious first-line treatment for patients with a range of cancers, including those with metastatic and difficult-to-treat disease,” said Qasim Ahmad, MD, Chief Medical Officer of IO Biotech. “Importantly, with mPFS of 6.6 months, more than half of the patients in this trial had over 180 days of progression-free survival. These data are supportive of further investigation of this combination regimen as part of our commitment to transform the lives of cancer patients through our novel therapeutic vaccine.”
The Phase 2 basket study (IOB-022/KN-D38; NCT05077709) is a non-comparative, open-label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab as a first-line treatment in up to 60 patients with metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥
To date, the safety profile observed in this study (OB-022/KN-D38) is consistent with prior studies of IO102-IO103 in combination with checkpoint inhibitors, with no added significant systemic toxicity compared to anti-PD1 monotherapy and low-grade transient injection site reactions reported as the most common treatment related adverse events. The trial has completed enrollment of patients in all cohorts. Data from the non-small cell lung cancer (NSCLC) cohort of this study will also be presented at another medical meeting in the fall.
The poster can be found on the “Posters & Publications” page of the IO Biotech website. Details for the presentation are below:
Poster Title: A phase 2 trial of the IO102-IO103 vaccine plus pembrolizumab: completed cohort for first line (1L) treatment of advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Presentation number: 1022P
Presenter: Jonathan W. Riess, MD, MS (UC Davis Comprehensive Cancer Center)
Date: Saturday, September 14, 2024
Time: 12:00 PM – 1:00 PM CEST
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 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 IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial
IOB-022/KN-D38 (NCT05077709) is a non-comparative, open-label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
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 or outcome of primary analysis of the company’s Phase 3 trial, other current or future clinical trials, their progress, enrollment or results, 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
Salutem
917-498-1967
Julie.Funesti@salutemcomms.com
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