RP1 and Nivolumab Show Promising Results in Melanoma Treatment
RP1 combined with nivolumab exhibits strong responses in melanoma, particularly with deep injections, alongside a favorable safety profile.
ASCO 2025 Findings
Replimune Group, Inc. announced results at the 2025 ASCO Annual Meeting, showing that RP1 plus nivolumab had a 32.9% objective response rate in melanoma patients who previously failed anti-PD-1 treatments. The IGNYTE clinical trial indicated that deep injections into organs such as the liver and lungs led to higher response rates compared to superficial injections. This resulted in significant tumor reduction in both injected and non-injected lesions while maintaining a favorable safety profile. A biosafety analysis confirmed that RP1 DNA typically remains localized at the injection site, with standard disinfection adequate for clean-up. These findings support RP1’s effectiveness as an oncolytic immunotherapy.
Highlights
- The combination of RP1 and nivolumab showed a 32.9% objective response rate, and a 15.0% complete response rate in anti-PD-1 resistant melanoma patients.
- Deep injections proved more effective than superficial ones, shedding light on the treatment’s enhanced efficacy.
- Minimal adverse events were reported for deep injections into vital organs, underscoring a good safety profile.
- RP1 can be managed with standard disinfection protocols, reducing operational safety burdens.
Concerns
- The 32.9% objective response rate may suggest limited effectiveness in the studied population of anti-PD-1 resistant melanoma patients.
- Replimune has a limited operational history, facing significant risks regarding clinical trial advancements and regulatory approvals.
- Lack of long-term efficacy data and potential side effects following deeper injections could raise concerns among medical professionals.
Frequently Asked Questions
What were the main findings presented at ASCO 2025 regarding RP1 plus nivolumab?
The results showcased strong responses in both injected and non-injected lesions, along with a solid safety profile for deep injections.
How effective was RP1 in the clinical trials for melanoma?
The objective response rate was noted at 32.9%, with a complete response rate of 15.0% among patients resistant to anti-PD-1 therapies.
What types of injections were used in the RP1 study?
Both deep/visceral and superficial injections were employed, with deep injections significantly outperforming superficial ones.
Was RP1 safe for administration during the trials?
Yes, the RP1 injections were generally well-tolerated, with manageable adverse events reported.
How does RP1 align with standard safety protocols?
RP1 is neutralized by standard disinfectants within thirty seconds, indicating that traditional clean-up methods are sufficient.
Disclaimer: This summary is based on a press release from GlobeNewswire. Errors may exist in the AI-generated content.
$REPL Insider Trading Activity
In the past six months, insiders have traded $REPL stock 7 times, with no purchases and 7 sales.
- SUSHIL PATEL (CEO): 0 purchases, 2 sales—35,105 shares sold for an estimated $326,546.
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$REPL Hedge Fund Activity
Recent institutional investment activity shows 83 investors increased their positions in $REPL stock while 81 decreased theirs in the last quarter.
- MARSHALL WACE, LLP: Added 1,591,501 shares (+177.6%), valued at approximately $15,517,134.
- SOFINNOVA INVESTMENTS, INC.: Removed 669,583 shares (-21.3%), valued at around $6,528,434.
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$REPL Analyst Ratings
Recent analyst reports on $REPL indicate that 2 firms have assigned buy ratings, while no firms have issued sell ratings.
- BMO Capital: “Outperform” rating issued on 01/22/2025.
- Jefferies: “Buy” rating given on 12/03/2024.
$REPL Price Targets
Two analysts recently provided price targets for $REPL, with a median target set at $23.0.
- Evan Seigerman (BMO Capital): Target price of $27.0 set on 01/22/2025.
- Roger Song (Jefferies): Target price of $19.0 set on 12/03/2024.
Conclusion
Data presented highlights the effectiveness of RP1 plus nivolumab, especially in deep injection contexts while noting the need for further research on long-term implications.
# Replimune Reports Encouraging RP1 Data at ASCO 2025
**WOBURN, Mass., June 01, 2025** – Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology firm, presented new findings for RP1 (vusolimogene oderparepvec) at the 2025 ASCO Annual Meeting from May 30 to June 3 in Chicago.
Dr. Kostas Xynos, Chief Medical Officer, stated that the latest analyses from the IGNYTE clinical trial of RP1 combined with nivolumab in melanoma patients failed by anti-PD-1 therapy reveal systemic activity and robust responses in liver and lung lesions, with an acceptable safety profile.
### Key Findings from the Trial:
#### Poster Presentation on Response Analysis
– The IGNYTE trial examined 140 patients; the objective response rate (ORR) was 32.9% per RECIST 1.1. The complete response rate stood at 15.0%. Landmark overall survival (OS) rates at one, two, and three years were 75.3%, 63.3%, and 54.8%, respectively; the median OS has not been reached.
– Patients receiving deep injections had higher ORRs compared to those with only superficial injections. The ORR breakdown was 29.8% for superficial lesions alone, 42.9% for deep/visceral plus superficial, and 40.9% for deep/visceral injections only.
– Approximately 93.6% of injected lesions and 79.0% of non-injected lesions demonstrated a ≥30% reduction, with 96.2% of non-injected visceral organ lesions showing a reduction from baseline.
– Injections into the lung and liver were generally well tolerated, with limited adverse events. No bleeding occurred after liver injections, and lung injections had low rates of pneumothorax.
### Poster Presentation on Biosafety Analysis
– RP1 was assessed in various patient samples. RP1 DNA was primarily found at injection sites, with minimal detection elsewhere, and live RP1 was rarely detected. There were no reported systemic herpetic infections.
– Standard disinfectants neutralized RP1 within 30 seconds, confirming the sufficiency of standard cleanup procedures. Overall, the risk of RP1 transmission to contacts or the environment was minimal.
Both posters will be available on Replimune’s website under Events and Presentations.
### About RP1
RP1 is Replimune’s lead product candidate, engineered from a proprietary herpes simplex virus strain to enhance tumor killing and stimulate an immune response.
### Company Overview
Founded in 2015 and based in Woburn, MA, Replimune focuses on developing groundbreaking oncolytic immunotherapies. Their proprietary RPx platform is designed to support both local and systemic anti-tumor activity.
For further details, visit [www.replimune.com](http://www.replimune.com).
### Forward-Looking Statements
This release includes forward-looking statements related to clinical trial advancements, potential product approvals, and commercialization goals.# Important Forward-Looking Statements and Risk Disclosures
Forward-looking statements include estimates regarding clinical trials, as well as terms like “could,” “expects,” “intends,” and similar expressions. These statements do not guarantee future outcomes and involve various risks and uncertainties beyond our control. As a result, actual results may differ significantly from these predictions.
Key risks include our limited operating history and challenges in achieving favorable clinical trial results for our products. Other concerns involve the costs tied to our in-house manufacturing, the approval timeline from regulators, and the need for combination therapies in our studies. Additionally, changes in laws, competitive factors, and global issues such as the coronavirus pandemic and geopolitical conflicts also pose risks.
These elements, among others detailed in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, could lead to outcomes differing from our forward-looking statements. Note that these statements reflect views only as of the date made, and we do not commit to update them, except when required by law.
Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
This article was initially published on Quiver News. The views expressed are solely those of the author and do not reflect those of Nasdaq, Inc.
