Replimune Announces RP2 Development Program Advances with First Patients Enrolled in Metastatic Uveal Melanoma and Hepatocellular Carcinoma Clinical Trials
Replimune Group (NASDAQ: REPL) has announced the enrollment of first patients in two clinical trials evaluating RP2: one for checkpoint naïve metastatic uveal melanoma and another for second-line recurrent or metastatic hepatocellular carcinoma (HCC).
The RP2-202 trial for uveal melanoma is a randomized, phase 2/3 study that will enroll approximately 280 patients, evaluating RP2 with nivolumab versus ipilimumab with nivolumab. Previous Phase 2 results showed a 29.4% overall response rate and 58.8% disease control rate.
The RP2-003 trial for HCC will enroll 30 patients to evaluate RP2 combined with atezolizumab and bevacizumab in advanced cases. This study is being conducted in collaboration with Roche. HCC represents 75-85% of primary liver cancer cases and is the third leading cause of cancer-related deaths globally.
Replimune Group (NASDAQ: REPL) ha annunciato l'arruolamento dei primi pazienti in due studi clinici che valutano RP2: uno per melanoma uveale metastatico naïve ai checkpoint e un altro per carcinoma epatocellulare (HCC) recidivante o metastatico in seconda linea.
Lo studio RP2-202 per il melanoma uveale è uno studio randomizzato di fase 2/3 che arruolerà circa 280 pazienti, valutando RP2 in combinazione con nivolumab rispetto a ipilimumab con nivolumab. I risultati precedenti della fase 2 hanno mostrato un tasso di risposta complessivo del 29,4% e un tasso di controllo della malattia del 58,8%.
Lo studio RP2-003 per l'HCC arruolerà 30 pazienti per valutare RP2 in combinazione con atezolizumab e bevacizumab in casi avanzati. Questo studio è condotto in collaborazione con Roche. L'HCC rappresenta il 75-85% dei casi di cancro primario al fegato ed è la terza causa di morte per cancro a livello globale.
Replimune Group (NASDAQ: REPL) ha anunciado la inclusión de los primeros pacientes en dos ensayos clínicos que evalúan RP2: uno para melanoma uveal metastásico naïve a puntos de control y otro para carcinoma hepatocelular (HCC) recidivante o metastásico en segunda línea.
El ensayo RP2-202 para melanoma uveal es un estudio aleatorizado de fase 2/3 que incluirá aproximadamente a 280 pacientes, evaluando RP2 con nivolumab frente a ipilimumab con nivolumab. Los resultados anteriores de fase 2 mostraron una tasa de respuesta general del 29,4% y una tasa de control de la enfermedad del 58,8%.
El ensayo RP2-003 para HCC incluirá a 30 pacientes para evaluar RP2 combinado con atezolizumab y bevacizumab en casos avanzados. Este estudio se realiza en colaboración con Roche. El HCC representa entre el 75 y el 85% de los casos de cáncer primario de hígado y es la tercera causa de muerte relacionada con el cáncer a nivel mundial.
Replimune Group (NASDAQ: REPL)는 체크포인트에 대한 면역이 없는 전이성 포도막 흑색종 및 2차 재발성 또는 전이성 간세포암(HCC)을 평가하는 두 개의 임상 시험에 첫 환자 등록을 발표했습니다.
포도막 흑색종을 위한 RP2-202 시험은 무작위 배정된 2/3상 연구로 약 280명의 환자를 등록하며, RP2와 nivolumab을 ipilimumab과 nivolumab과 비교하여 평가합니다. 이전 2상 결과는 전체 반응률이 29.4%이고 질병 조절률이 58.8%였음을 보여주었습니다.
HCC를 위한 RP2-003 시험은 30명의 환자를 등록하여 진행된 사례에서 RP2와 atezolizumab 및 bevacizumab의 조합을 평가합니다. 이 연구는 Roche와 협력하여 진행되고 있습니다. HCC는 75-85%의 원발성 간암 사례를 차지하며, 전 세계적으로 암 관련 사망의 세 번째 주요 원인입니다.
Replimune Group (NASDAQ: REPL) a annoncé le recrutement des premiers patients dans deux essais cliniques évaluant RP2 : l'un pour le mélanome uvéal métastatique naïf aux points de contrôle et un autre pour le carcinome hépatocellulaire (CHC) récurrent ou métastatique en deuxième ligne.
L'essai RP2-202 pour le mélanome uvéal est une étude randomisée de phase 2/3 qui enrollera environ 280 patients, évaluant RP2 avec nivolumab par rapport à ipilimumab avec nivolumab. Les résultats précédents de la phase 2 ont montré un taux de réponse global de 29,4 % et un taux de contrôle de la maladie de 58,8 %.
L'essai RP2-003 pour le CHC recrutera 30 patients pour évaluer RP2 combiné avec atezolizumab et bevacizumab dans des cas avancés. Cette étude est réalisée en collaboration avec Roche. Le CHC représente 75 à 85 % des cas de cancer du foie primaire et est la troisième cause de décès lié au cancer dans le monde.
Replimune Group (NASDAQ: REPL) hat die Einschreibung der ersten Patienten in zwei klinischen Studien zur Evaluierung von RP2 angekündigt: eine Studie für checkpoint-naives metastatisches uveales Melanom und eine andere für das rezidivierende oder metastatische hepatozelluläre Karzinom (HCC) in der zweiten Therapielinie.
Die RP2-202-Studie für uveales Melanom ist eine randomisierte Phase 2/3-Studie, die etwa 280 Patienten aufnehmen wird und RP2 in Kombination mit Nivolumab im Vergleich zu Ipilimumab mit Nivolumab bewertet. Frühere Ergebnisse der Phase 2 zeigten eine Gesamtansprechrate von 29,4 % und eine Krankheitskontrollrate von 58,8 %.
Die RP2-003-Studie für HCC wird 30 Patienten erfassen, um RP2 in Kombination mit Atezolizumab und Bevacizumab bei fortgeschrittenen Fällen zu bewerten. Diese Studie wird in Zusammenarbeit mit Roche durchgeführt. HCC macht 75-85 % der primären Leberkrebsfälle aus und ist die dritthäufigste Todesursache durch Krebs weltweit.
- Previous Phase 2 study showed promising results with 29.4% overall response rate
- Large-scale Phase 2/3 trial with 280 patients for uveal melanoma
- Strategic collaboration with Roche for HCC trial
- Recent BLA submission and breakthrough therapy designation for RP1
- None.
Insights
The initiation of two pivotal clinical trials for RP2 marks a strategic expansion in Replimune's oncology portfolio. The Phase 2/3 study in uveal melanoma targeting 280 patients is particularly noteworthy given the 29.4% response rate observed in earlier studies. This represents a significant opportunity in a rare cancer with treatment options, where 90-95% of metastases occur in the liver.
The HCC trial, though smaller with 30 patients, gains credibility through the collaboration with Roche and addresses the third leading cause of cancer-related deaths globally. The combination therapy approach with atezolizumab and bevacizumab in second-line treatment could potentially establish a new standard of care in this difficult-to-treat population.
This development program expansion demonstrates strong commercial potential in two distinct markets. The uveal melanoma trial positions Replimune to potentially capture a significant share of an underserved market, while the HCC study, backed by Roche's partnership, provides access to a larger commercial opportunity in liver cancer therapeutics.
The timing is strategic, following their recent BLA submission and breakthrough therapy designation for RP1, which enhances the company's credibility and could accelerate regulatory pathways. The dual-program advancement suggests robust pipeline progression and effective resource allocation, potentially strengthening Replimune's market position in oncology immunotherapies.
The mechanistic approach of combining RP2 with established checkpoint inhibitors represents a sophisticated therapeutic strategy. The preliminary 58.8% disease control rate in uveal melanoma is particularly impressive given the historically poor prognosis of this disease. The dual primary endpoints of overall survival and progression-free survival in the uveal melanoma study are robust measures that will provide comprehensive efficacy data.
The HCC trial's design, focusing on modified RECIST criteria, acknowledges the unique challenges in assessing liver tumor responses. This attention to endpoint selection demonstrates a deep understanding of the disease biology and could provide more accurate efficacy measurements.
WOBURN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the first patients have been enrolled in studies evaluating RP2 in two different settings: checkpoint naïve metastatic uveal melanoma; and second-line recurrent or metastatic hepatocellular carcinoma (HCC).
“On the heels of our BLA submission for RP1 and designation as breakthrough therapy, we are pleased that the first patients have been enrolled in both the RP2 HCC clinical trial and the registration intended study of RP2 in metastatic uveal melanoma,” said Sushil Patel, Ph.D., CEO of Replimune. “We are excited to explore the broader potential of the RPx platform and these RP2 clinical trials will play an important part of our future development plans.”
RP2-202 Clinical Trial in Metastatic Uveal Melanoma
Uveal melanoma is a type of cancer that occurs in the tissues of the eye. Up to 50 percent of patients with uveal melanoma may develop metastatic disease. The most common site of metastasis for uveal melanoma is the liver and is estimated to occur in 90
“We are honored and excited to be able to offer this clinical trial to our patients with uveal melanoma, a group of patients for whom treatment options are very limited,” said Dr. Justin Moser, an associate clinical investigator in the Cancer Research Division of HonorHealth Research Institute, where he specializes in uveal melanoma. “We hope that, by providing our patients with early access to treatments through clinical trials, that we will be able to help give them longer, higher-quality lives.”
During ASCO 2024, results from an open-label, multicenter, Phase 2 study of RP2 alone or combined with nivolumab in a cohort of patients with uveal melanoma (n=17) were presented. RP2 administered as monotherapy or in combination with nivolumab demonstrated an overall response rate of
The RP2-202 trial (NCT06581406) is a randomized, phase 2/3 study that will enroll approximately 280 patients and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in immune checkpoint inhibitor-naïve adult patients with metastatic uveal melanoma. The primary endpoints of the study are overall survival and progression free survival. Key secondary endpoints are overall response rate and disease control rate. For additional information about the RP2-202 clinical trial and to learn more about eligibility, please visit our clinical trials page here.
RP2-003 Clinical Trial in Hepatocellular Carcinoma
HCC is the third leading cause of cancer-related deaths in the world. Prognosis is generally poor with the majority of HCC cases diagnosed in the advanced stage. HCC comprises approximately 75 to 85 percent of primary liver cancer cases.
The RP2-003 trial (NCT05733598) is an open label trial that will enroll 30 patients and evaluate RP2 combined with the second-line therapy of atezolizumab and bevacizumab in patients with locally advanced unresectable, recurrent and/or metastatic HCC. The primary endpoint of the study is overall response rate (ORR) per modified RECIST 1.1 criteria. Key secondary endpoints are ORR per RECIST modified for HCC and duration of response. The study is being conducted under a collaboration and supply agreement with Roche. For additional information about the RP2-003 trial and to learn more about eligibility, please visit our clinical trials page here.
About RP2
RP2 is a derivative of RP1, Replimune’s lead product candidate that is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.
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 novel 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.
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ICR Healthcare
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1 Carvajal RD, Schwartz GK, Tezel T, Marr B, Francis JH, Nathan PD. Metastatic disease from uveal melanoma: treatment options and future prospects. Br J Ophthalmol. 2017 Jan;101(1):38-44. doi: 10.1136/bjophthalmol-2016-309034. Epub 2016 Aug 29. PMID: 27574175; PMCID: PMC5256122.
FAQ
What are the primary endpoints of REPL's RP2-202 trial for uveal melanoma?
How many patients will be enrolled in REPL's RP2-202 trial for uveal melanoma?
What was the overall response rate in REPL's previous Phase 2 study of RP2 for uveal melanoma?
How many patients will REPL's RP2-003 trial for hepatocellular carcinoma enroll?
What is the primary endpoint of REPL's RP2-003 trial for HCC?
