On June 3, 2024 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, reported two oral presentations highlighting promising clinical data from its RP1 and RP2 programs at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31-June 4 in Chicago (Press release, Replimune, JUN 3, 2024, View Source [SID1234644023]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The strength of the RP1 and RP2 data being presented at ASCO (Free ASCO Whitepaper) 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 32.7% that was highly durable, and the combination provided a favorable safety profile, all consistent with previous data. The data with RP2 as monotherapy and in combination with nivolumab in refractory patients highlights a strong and durable overall response rate of nearly 30 percent in uveal melanoma where treatment options are limited."
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 (Free ASCO Whitepaper) 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) of 58.8%.
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.