Replimune Presents Positive Data from RP1 and RP2 Clinical Programs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Replimune presented positive data from its RP1 and RP2 clinical programs at the 2024 ASCO Annual Meeting. The IGNYTE trial showed a 32.7% overall response rate (ORR) for RP1 plus nivolumab in anti-PD-1 failed melanoma, with responses lasting over six months and a median duration exceeding 36 months. RP2, both as monotherapy and in combination with nivolumab, achieved an ORR of nearly 30% in uveal melanoma. The company plans a registration-directed trial for RP2 and will submit a Biologics License Application for RP1 in the second half of 2024. These results indicate a promising risk-benefit profile, particularly in hard-to-treat cancers.
- 12-month IGNYTE trial: RP1 plus nivolumab showed a 32.7% overall response rate in anti-PD-1 failed melanoma.
- All responses in RP1 plus nivolumab lasted over six months, with a median duration exceeding 36 months.
- RP2 alone or with nivolumab demonstrated an overall response rate of 29.4% in uveal melanoma.
- RP2 data indicates immune cell infiltration and increased PD-L1 expression in tumors.
- Planning for a registration-directed trial for RP2 is underway.
- Replimune will submit a Biologics License Application for RP1 in the second half of 2024.
- Favorable safety profile for RP1 and RP2, indicating manageable adverse events.
- RP1 trial showed only a 27.3% overall response rate in patients who progressed on prior anti-PD-1 combined with anti-CTLA-4 therapy.
- Currently, RP2 data is based on a small patient population (n=17), which may limit broader applicability.
- Pending primary analysis results and regulatory approval for RP1 could introduce uncertainty in timelines and outcomes.
Insights
The results from Replimune's IGNYTE clinical trial and the RP2 data in uveal melanoma are significant in the field of oncology. The IGNYTE trial shows a notable 32.7% overall response rate (ORR) in anti-PD-1 failed melanoma, which is particularly meaningful considering the difficult-to-treat nature of this cancer. The durability of responses, with all responses lasting over six months and a median duration exceeding 36 months, indicates strong and sustained efficacy of the treatment.
Regarding the RP2 data, the ORR of 29.4% in uveal melanoma is promising, especially given the limited options available for this patient group. The strong disease control rate (DCR) of 58.8% suggests the treatment is effectively managing the disease progression. Considering uveal melanoma’s aggressive nature and poor prognosis, these results offer hope for better outcomes for patients.
Overall, both sets of data present encouraging evidence that these novel therapies could significantly benefit patients with limited treatment alternatives, potentially leading to new standards of care in oncology.
From a financial standpoint, the data presented by Replimune has several implications. The positive results from the IGNYTE trial and the RP2 program enhance the company's prospects for securing approvals and subsequent market entry, which could significantly boost revenues. The planned submission of a biologics license application (BLA) for RP1 to the FDA in the second half of 2024 is a critical milestone and indicates the company's progress towards commercialization.
The ongoing discussions with the FDA and the initiation of a Phase 3 trial for RP1 further support the credibility and potential of Replimune's pipeline. If these trials confirm the efficacy and safety profiles observed so far, Replimune could see substantial market adoption, given the unmet needs in treating anti-PD-1 failed melanoma and uveal melanoma.
Investors should monitor regulatory updates and trial results closely, as successful outcomes could drive significant value creation. However, it is important to note the inherent risks in clinical development, including potential delays or unforeseen adverse events.
The presentation of Replimune's clinical data at the ASCO Annual Meeting is a strong indicator of the company's standing within the biotech community. ASCO is a high-profile platform and presenting data there underscores the importance of these findings. The apparent efficacy and safety of RP1 and RP2 not only position Replimune favorably within the oncology market but also highlight the growing interest in oncolytic immunotherapies, which leverage viruses to target and destroy cancer cells.
Oncolytic immunotherapies are gaining traction due to their potential to overcome resistance seen with traditional therapies. Replimune is well-placed within this niche and positive clinical data can enhance its competitive advantage. As more data becomes available and assuming it remains positive, the company's visibility and attractiveness to potential partners or investors will likely increase.
For retail investors, it is important to consider the potential market size and adoption rates for these therapies post-approval. While initial results are promising, long-term success will depend on continued clinical efficacy, favorable safety profiles and successful regulatory approvals.
-- Investigator-assessed 12-month results from the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD-1 failed melanoma demonstrate an overall response rate of
-- RP2 as monotherapy and in combination with nivolumab in uveal melanoma demonstrates overall response rate of nearly 30 percent; planning for registration-directed trial underway --
WOBURN, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today presented two oral presentations highlighting promising clinical data from its RP1 and RP2 programs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4 in Chicago.
“The strength of the RP1 and RP2 data being presented at ASCO in two hard-to-treat tumor types further validates the potential of the RPx platform,” said Sushil Patel, Ph.D., CEO of Replimune. “In the IGNYTE trial, the investigator-assessed 12-month results show an overall response rate of
Key findings are outlined below.
Oral Presentation: Efficacy and Safety of RP1 Combined with Nivolumab in Patients with anti-PD-1-Failed Melanoma from the IGNYTE Clinical Trial (Session: Melanoma/Skin Cancers; June 3, 2024, 10:57AM CDT; Location: S406; Abstract: 9517)
- The data continues to show that the combination of RP1 and nivolumab in anti-PD-1 failed melanoma (n=156) provides deep and durable responses with an "on-target" safety profile with generally transient grade 1/2 adverse events, indicative of systemic immune activation.
- Approximately one third of patients experienced a response, with an overall response rate (ORR) by investigator assessment of
32.7% . - In the 94 patients who had primary resistance to their immediate prior anti-PD-1 therapy, the ORR was
34% . - In the 66 patients who progressed on prior anti-PD-1 combined with anti-CTLA-4 therapy, the ORR was
27.3% . - All responses lasted greater than six months from enrollment, with a median duration of response exceeding 36 months.
- Clinically meaningful activity was observed across all enrolled subgroups, with over half of patients experiencing either a complete response (CR), partial response (PR) or stable disease (SD).
Primary analysis results by independent central review from the IGNYTE anti-PD-1 failed melanoma cohort are expected later in Q2 2024 with the Company on track to submit a biologics license application (BLA) for RP1 to the U.S. Food and Drug Administration (FDA) in 2H 2024. The Company also has agreed on a protocol for a Phase 3 confirmatory study with the FDA (IGNYTE-3; NCT06264180; poster TPS9603, ASCO 2024) and expects to initiate the trial prior to the RP1 BLA in anti-PD-1 failed melanoma being submitted.
“The findings shared for the IGNYTE clinical trial underscore the promising effects of RP1 shown to date, including overall response rate, durability and safety,” said Michael Wong, M.D., Ph.D., Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and presenter of the study. “RP1 plus nivolumab provides an attractive risk-benefit profile for melanoma patients who have progressed on PD1 based treatment, particularly when compared with other therapies. For this population – the unmet need is significant as there are limited options with only about half of patients with melanoma responding to first line treatment.”
Oral Presentation: Safety, Efficacy, and Biomarker Results from an Open-Label, Multicenter, Phase 1 Study of RP2 Alone or Combined with Nivolumab in a Cohort of Patients with Uveal Melanoma (Session: Melanoma/Skin Cancers, June 3, 2024, 9:57AM CDT; Location: S406; Abstract: 9511)
- The data suggest that RP2, which expresses an anti-CTLA-4 antibody, dosed both alone and in combination with an anti-PD-1 agent in metastatic uveal melanoma patients (n=17), including those with both liver and extra-hepatic metastases, had a favorable safety profile and durable anti-tumor activity.
- RP2 administered as monotherapy or in combination with nivolumab demonstrated an ORR of
29.4% , with a disease control rate (DCR) of58.8% . - Biomarker data indicate immune cell infiltration and increased PD-L1 expression in tumors, together with changes in the systemic T cell repertoire following RP2 plus nivolumab.
- Based on the encouraging ORR observed amongst a patient population with historically poor treatment outcomes, Replimune is currently finalizing the protocol for a registration-directed study based on FDA input.
Both presentations will be available on the Company website under Events and Presentations.
About RP1
RP1 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 RP2
RP2 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. 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 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, 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 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
FAQ
What is the overall response rate of RP1 plus nivolumab in the IGNYTE trial for REPL?
How long did the responses last in the IGNYTE trial for REPL's RP1 plus nivolumab?
What is the overall response rate of RP2 in uveal melanoma for REPL?
When does Replimune plan to submit a Biologics License Application for RP1?
What safety profile was observed for RP1 and RP2 in Replimune's trials?
