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2ms
New trial • Combination therapy • Real-world evidence • Real-world • Metastases
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Opdivo (nivolumab) • vusolimogene oderparepvec (RP1)
3ms
Enrollment open • Combination therapy • Metastases
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • temozolomide • albumin-bound paclitaxel • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016) • vusolimogene oderparepvec (RP1)
6ms
"neoBREASTIM": Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer (clinicaltrials.gov)
P1/2, N=51, Recruiting, Institut Curie | Not yet recruiting --> Recruiting | Initiation date: Dec 2023 --> Apr 2024
Enrollment open • Trial initiation date • Oncolytic virus
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HER-2 (Human epidermal growth factor receptor 2)
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Tecentriq (atezolizumab) • vusolimogene oderparepvec (RP1)
8ms
RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis (clinicaltrials.gov)
P1, N=25, Recruiting, Yana Najjar | Not yet recruiting --> Recruiting
Enrollment open
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vusolimogene oderparepvec (RP1)
9ms
New P3 trial • Combination therapy • Metastases
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Keytruda (pembrolizumab) • temozolomide • albumin-bound paclitaxel • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016) • vusolimogene oderparepvec (RP1)
10ms
New P1 trial
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vusolimogene oderparepvec (RP1)
11ms
Phase classification • Metastases
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vusolimogene oderparepvec (RP1)
1year
Initial efficacy and safety of RP1 + nivolumab in patients with anti–PD-1–failed melanoma from the ongoing phase 1/2 IGNYTE study (ADO 2023)
A total of 91 pts are included in this analysis (initial melanoma cohort, 16 pts; R-D cohort, 75 pts; data cut: Dec 30, 2022). The overall objective response rate (ORR) was 37.4% (initial cohort, 37.5%; R-D cohort, 37.3%), and 18.7% of pts achieved complete response (CR; Table). The response rates seen were also encouraging when evaluated by prior anti–PD-1 therapy setting and disease stage (Table).
Clinical • P1/2 data
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PD-L1 (Programmed death ligand 1) • CSF2 (Colony stimulating factor 2)
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PD-L1 expression • PD-L1 negative • CSF2 expression
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Opdivo (nivolumab) • vusolimogene oderparepvec (RP1)
1year
New P1/2 trial • Oncolytic virus • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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PD-L1 expression • HER-2 overexpression
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Tecentriq (atezolizumab) • vusolimogene oderparepvec (RP1)
over1year
Initial Results from an Open-Label, Multicenter, Phase 1b/2 Study of RP1 Oncolytic Immunotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Advanced Cutaneous Malignancies (ARTACUS) [Board No. D323] (ATC 2023)
This is the first trial demonstrating single-agent RP1 antitumor effect in immunocompromised pts. RP1 monotherapy was well tolerated and the safety profile was similar to non-immunocompromised pts with advanced SC (IGNYTE study). Of note, no immune-mediated adverse events or evidence of allograft rejection were observed.
Clinical • P1/2 data • Oncolytic virus • Metastases
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CSF2 (Colony stimulating factor 2)
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vusolimogene oderparepvec (RP1)
over1year
Safety, efficacy, and biomarker assessment of RP1 in combination with nivolumab in patients with advanced skin cancers (EADO 2023)
RP1+nivo induced deep and durable antitumor activity in patients with advanced skin cancers, including anti–PD-1 and anti–PD-1/anti–CTLA-4–failed melanoma. The combination was generally well tolerated, consistent with prior data. Enrollment into a registration-directed cohort of patients with anti–PD-1–failed cutaneous melanoma (n=125) and a cohort with anti–PD-1–failed NMSC (n=30) is ongoing.
Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2) • FOXP3 (Forkhead Box P3)
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PD-L1 expression • CSF2 expression • FOXP3 expression
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Opdivo (nivolumab) • vusolimogene oderparepvec (RP1)
almost2years
Safety, efficacy, and biomarker assessment of RP1 in combination with nivolumab in patients with advanced skin cancers (SSO 2023)
RP1 + nivo induced a deep and durable antitumor activity in pts with advanced skin cancers, including anti-PD-1 and anti-PD-1/anti-CTLA-4 failed mel. The combination was generally well tolerated, consistent with prior data. Enrollment into a registration-directed cohort of pts with anti-PD-1 failed cutaneous mel (n=125) and a cohort with anti-PD-1 failed NMSC (n=30) is ongoing.
Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2) • FOXP3 (Forkhead Box P3)
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PD-L1 expression • CSF2 expression • FOXP3 expression
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Opdivo (nivolumab) • vusolimogene oderparepvec (RP1)
2years
Immune biomarker analysis of RP1 in combination with nivolumab in patients with advanced solid tumors (SITC 2022)
A notable reversal of CD8 T cell exclusion was observed in a melanoma patient who failed prior ipilimumab and nivo treatment. The data indicate the potential for broad utility of RP1 in a range of tumor types, including in patients with primary or acquired resistance to immune checkpoint blockade. Trial Registration NCT03767348
Combination therapy • Clinical • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CD27 (CD27 Molecule) • CSF2 (Colony stimulating factor 2) • TRB (T Cell Receptor Beta Locus)
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PD-L1 expression • CSF2 expression • PD-L1 expression + CD8 positive
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PD-L1 IHC 28-8 pharmDx • nCounter® PanCancer IO 360™ Panel
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Opdivo (nivolumab) • Yervoy (ipilimumab) • vusolimogene oderparepvec (RP1)
almost3years
Clinical • P1/2 data • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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MSI (Microsatellite instability) • CSF2 (Colony stimulating factor 2)
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MSI-H/dMMR
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Opdivo (nivolumab) • vusolimogene oderparepvec (RP1)
over3years
[VIRTUAL] Immunomodulatory effects of a novel, enhanced potency gibbon ape leukaemia virus (GALV) fusogenic membrane glycoprotein-expressing herpes simplex virus platform with increased efficacy combined with anti PD-1 therapy (AACR 2021)
Co-treatment with RP1 and an anti-mouse PD-1 antibody increased anti-tumor effects and the levels of CD3+ cells in uninjected tumors. Data from detailed RNAseq transcriptional analyses from injected and uninjected tumors will also be presented.
Clinical
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PD-L1 (Programmed death ligand 1) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CSF2 (Colony stimulating factor 2) • ITGAM (Integrin, alpha M)
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CSF2 expression
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vusolimogene oderparepvec (RP1)
over3years
[VIRTUAL] Clinical biomarker studies with two fusion-enhanced versions of oncolytic HSV (RP1 and RP2) alone and in combination with nivolumab in cancer patients indicate potent immune activation (AACR 2021)
The tumor inflammation signature score (TIS) was also calculated.Preliminary Phase 1/2 biomarker data from paired tumor biopsies include the following: Immunohistochemistry for CD8 and PD-L1 (n=30) indicated robust and increased infiltration of CD8+ T cells and PD-L1 expression, both after combined treatment with RP1 and nivolumab and after single agent RP2 across different tumor types, and including reversal of T cell exclusion following prior combined treatment with ipilimumab and nivolumab in melanoma. Consistent with the pre-clinical data, preliminary clinical biomarker data indicate substantial increase in CD8 T cell infiltration and PD-L1 expression, as well as increased TIS score in the majority of patients treated with RP2 alone or RP1 and nivolumab combination. Particularly marked effects were seen in some patients with clinical responses which occurred independent of both baseline PD-L1 and prior anti-PD1 therapy status, which suggests potential broad utility of the RP1/2 treatment approach in igniting an anti-tumor immune response. Tumor mutation burden analysis and T cell receptor sequencing are currently underway and further updates of the dataset will be presented.
Combination therapy • Late-breaking abstract • Clinical • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CD27 (CD27 Molecule) • CSF2 (Colony stimulating factor 2)
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PD-L1 expression • CSF2 expression • CTLA4 expression • High inflammation signature scores
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PD-L1 IHC 28-8 pharmDx
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Opdivo (nivolumab) • Yervoy (ipilimumab) • RP2 • vusolimogene oderparepvec (RP1)
almost4years
IGNYTE: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (clinicaltrials.gov)
P2, N=300, Recruiting, Replimune Inc. | Phase classification: P1/2 --> P2 | Trial completion date: Dec 2021 --> Nov 2024 | Trial primary completion date: Nov 2021 --> Nov 2024
Clinical • Phase classification • Trial completion date • Trial primary completion date • Combination therapy
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BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
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MSI-H/dMMR • BRAF mutation
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Opdivo (nivolumab) • vusolimogene oderparepvec (RP1)
over4years
Clinical • Enrollment open
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CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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vusolimogene oderparepvec (RP1)
over4years
[VIRTUAL] An open-label, single-arm, phase II clinical trial of RP1, an enhanced potency oncolytic herpes virus, combined with nivolumab in four solid tumor types: Initial results from the skin cancer cohorts. (ASCO 2020)
RP1 and nivo has continued to be well tolerated, with promising signs of efficacy in patients with skin cancers, including with anti-PD1 refractory disease. These data support the further development of RP1 combined with anti-PD1 blockade. Research Funding: Replimune
Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CSF2 (Colony stimulating factor 2)
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PD-L1 expression
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Opdivo (nivolumab) • vusolimogene oderparepvec (RP1)
over4years
Clinical • Enrollment change • Combination therapy
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
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MSI-H/dMMR • BRAF mutation
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Opdivo (nivolumab) • vusolimogene oderparepvec (RP1)