Replimune Announces First Patient Dosed in IGNYTE-3 Clinical Trial in Advanced Melanoma
Replimune Group, Inc. (NASDAQ: REPL) has initiated the IGNYTE-3 study, a global Phase 3 clinical trial evaluating RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The trial, which has dosed its first patient, aims to support global regulatory interactions and confirm clinical benefits reported in the Phase 2 IGNYTE cohort. With 400 patients enrolled, the study will compare RP1 plus nivolumab against physician's choice treatments, focusing on overall survival as the primary endpoint. Secondary endpoints include progression-free survival and objective response rate. This trial is important for Replimune's planned BLA submission for RP1 in advanced melanoma later this year.
Replimune Group, Inc. (NASDAQ: REPL) ha avviato lo studio IGNYTE-3, uno studio clinico globale di Fase 3 che valuta RP1 (vusolimogene oderparepvec) in combinazione con nivolumab in pazienti con melanoma avanzato che hanno avuto progressione dopo terapie anti-PD1 e anti-CTLA-4 o che non sono idonei per il trattamento anti-CTLA-4. Lo studio, che ha già somministrato il primo dosaggio, mira a sostenere le interazioni regolatorie globali e confermare i benefici clinici segnalati nel gruppo di Fase 2 IGNYTE. Con 400 pazienti arruolati, lo studio confronterà RP1 più nivolumab con i trattamenti scelti dai medici, ponendo l'accento su la sopravvivenza globale come obiettivo primario. Tra gli obiettivi secondari vi sono la sopravvivenza libera da progressione e il tasso di risposta obiettiva. Questo studio è significativo per la pianificata sottomissione della BLA per RP1 nel melanoma avanzato entro la fine di quest'anno.
Replimune Group, Inc. (NASDAQ: REPL) ha iniciado el estudio IGNYTE-3, un ensayo clínico global de Fase 3 que evalúa RP1 (vusolimogene oderparepvec) junto con nivolumab en pacientes con melanoma avanzado que han progresado en terapias anti-PD1 y anti-CTLA-4 o que no son elegibles para tratamiento anti-CTLA-4. El ensayo, que ha administrado su primer paciente, tiene como objetivo apoyar las interacciones regulatorias globales y confirmar los beneficios clínicos reportados en la cohorte de Fase 2 IGNYTE. Con 400 pacientes inscritos, el estudio comparará RP1 más nivolumab con tratamientos a elección del médico, enfocándose en la supervivencia global como el objetivo primario. Los objetivos secundarios incluyen la supervivencia libre de progresión y la tasa de respuesta objetiva. Este ensayo es importante para la presentación de la BLA planificada de Replimune para RP1 en melanoma avanzado más tarde este año.
Replimune Group, Inc. (NASDAQ: REPL)은 IGNYTE-3 연구를 시작했습니다, 이는 RP1 (vusolimogene oderparepvec)와 nivolumab을 평가하는 글로벌 3상 임상 시험으로, 고급 흑색종 환자를 대상으로 하며, 이들은 항-PD1 및 항-CTLA-4 치료에 반응하지 않거나 항-CTLA-4 치료를 받을 수 없는 환자들입니다. 첫 번째 환자가 투약된 이 시험은 글로벌 규제 상호작용을 지원하는 것과 2상 IGNYTE 코호트에서 보고된 임상적 이점을 확인하는 것을 목표로 하고 있습니다. 400명의 환자가 등록되었습니다, 이 연구는 RP1과 nivolumab의 조합과 의사의 선택 치료를 비교하며 전체 생존율을 주요 목표로 하고 있습니다. 2차 목표에는 무진행 생존율과 객관적 반응률이 포함됩니다. 이 시험은 올해 말 고급 흑색종에 대한 RP1의 BLA 제출 계획에 중요합니다.
Replimune Group, Inc. (NASDAQ: REPL) a initié l'étude IGNYTE-3, un essai clinique mondial de Phase 3 évaluant RP1 (vusolimogene oderparepvec) en association avec nivolumab chez des patients atteints de mélanome avancé ayant progressé après des traitements anti-PD1 et anti-CTLA-4 ou n'étant pas éligibles au traitement anti-CTLA-4. L'essai, qui a déjà administré son premier patient, vise à soutenir les interactions réglementaires mondiales et à confirmer les avantages cliniques rapportés dans la cohorte de Phase 2 IGNYTE. Avec 400 patients inscrits, l'étude comparera RP1 plus nivolumab aux traitements choisis par les médecins, en mettant l'accent sur la survie globale comme objectif principal. Les objectifs secondaires incluent la survie sans progression et le taux de réponse objective. Cet essai est important pour la soumission de la BLA prévue pour RP1 dans le mélanome avancé plus tard cette année.
Replimune Group, Inc. (NASDAQ: REPL) hat die IGNYTE-3-Studie initiiert, eine globale Phase-3-Studie, die RP1 (vusolimogene oderparepvec) zusammen mit Nivolumab bei Patienten mit fortgeschrittenem Melanom evaluiert, die auf Therapien mit Anti-PD1 und Anti-CTLA-4 nicht angesprochen haben oder für eine Behandlung mit Anti-CTLA-4 nicht in Frage kommen. Die Studie, die ihren ersten Patienten behandelt hat, zielt darauf ab, globale regulatorische Interaktionen zu unterstützen und klinische Vorteile zu bestätigen, die in der Phase-2-IGNYTE-Kohorte berichtet wurden. Mit 400 eingeschriebenen Patienten wird die Studie RP1 plus Nivolumab mit den vom Arzt gewählten Behandlungen vergleichen und legt einen Schwerpunkt auf die Gesamtüberlebensrate als primären Endpunkt. Sekundäre Endpunkte umfassen das progressionsfreie Überleben und die objektive Ansprechrate. Diese Studie ist wichtig für die geplante BLA-Einreichung für RP1 bei fortgeschrittenem Melanom später in diesem Jahr.
- Initiation of Phase 3 IGNYTE-3 trial for RP1 in advanced melanoma
- First patient dosed in the trial, marking a significant milestone
- Trial designed to support global regulatory interactions and access
- Planned BLA submission for RP1 in advanced melanoma later this year
- Large-scale trial with 400 patients enrolled
- None.
The initiation of the IGNYTE-3 Phase 3 trial marks a significant milestone for Replimune's RP1 therapy. This confirmatory study aims to validate the promising results from the earlier Phase 2 trial in advanced melanoma patients who have failed anti-PD1 treatment. The trial's design, focusing on overall survival as the primary endpoint, is robust and clinically relevant.
The 400-patient enrollment target and comparison against physician's choice treatment options strengthen the study's potential to demonstrate meaningful clinical benefit. If successful, this trial could position RP1 as a new standard of care for a patient population with treatment options. The inclusion of patients ineligible for anti-CTLA-4 treatment also broadens the potential applicant pool, addressing an unmet medical need.
The IGNYTE-3 trial addresses a critical gap in melanoma treatment. With
The focus on patients who've progressed on both anti-PD1 and anti-CTLA-4 therapies targets a particularly challenging subset. If successful, this combination could offer hope to patients with options. The inclusion of overall survival as the primary endpoint is clinically meaningful and aligns with regulatory expectations for breakthrough therapies in oncology.
Replimune's advancement to a Phase 3 trial signifies strong confidence in RP1's potential, backed by promising Phase 2 data. This de-risks the development pipeline and could accelerate the path to market. The planned BLA submission later this year, coupled with this confirmatory trial, suggests a strategic approach to regulatory approval.
Melanoma's market size, with 100,000 new cases annually in the U.S., presents a substantial opportunity. If RP1 demonstrates superiority over current second-line options, it could capture a significant market share. Investors should monitor trial progress and interim analyses, as positive data could be a major catalyst for Replimune's stock. However, the competitive landscape and potential regulatory hurdles remain key risk factors to consider.
Confirmatory Phase 3 Trial to assess efficacy and safety of the investigational oncolytic immunotherapy, RP1 (vusolimogene oderparepvec) in combination with nivolumab in patients with advanced melanoma
WOBURN, Mass., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that the first patient has been randomized and dosed in the IGNYTE-3 study – a global Phase 3 clinical trial assessing the efficacy and safety of RP1 (vusolimogene oderparepvec) plus nivolumab in patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 drugs or are ineligible for anti-CTLA-4 treatment.
“The start of the IGNYTE-3 trial and randomization of the first patient is an important milestone in advance of our planned BLA submission of RP1 in advanced melanoma later this year,” said Kostas Xynos, MD, PhD, MBA, Chief Medical Officer at Replimune. “This trial is important because it is intended to both support global regulatory interactions and access, and to serve to confirm the clinical benefit reported from the registration intended Phase 2 IGNYTE cohort in anti-PD1 failed melanoma in June.”
Melanoma is the fifth most common cancer with approximately 100,000 new cases and 8,000 deaths estimated in the U.S. in 2024. Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress following treatment. Treatment options are limited after immune checkpoint blockade therapy, with no standard of care available to patients.
“Clinical trials like IGNYTE-3 are important in the melanoma community and we are excited that another study is open for physicians and patients to consider,” said Kyleigh LiPira, CEO of the Melanoma Research Foundation. “As a patient advocacy organization, our mission is to eradicate melanoma by accelerating medical research while educating to and advocating for the melanoma community. Creating awareness for clinical trials is an important part of that mission.”
The IGNYTE-3 trial (NCT06264180) will enroll 400 patients and evaluate RP1 plus nivolumab versus a defined list of physician’s choice treatment options, in patients with advanced melanoma who progressed on anti-PD1 and anti-CTLA-4 therapy or who are ineligible for anti-CTLA-4 treatment. The primary endpoint of the study is overall survival (OS). Key secondary endpoints are progression free survival (PFS) and objective response rate (ORR). For additional information about the IGNYTE-3 trial and to learn more about eligibility, please visit https://replimune.com/clinical-trials/ignyte-3/.
About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Forward Looking Statements
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, including statements regarding the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
ICR Westwicke
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
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