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simlukafusp alfa (RG7461)
i
Other names: RG7461, RO-6874281, aFAP-IL2v, FAP-IL2v, FAP-IL2v FP, RG-7461, RO6874281, RG 7461
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Company:
Roche
Drug class:
IL-2 stimulant, FAP inhibitor, Immunoproteasome inhibitor
Related drugs:
13d
Simlukafusp alfa (FAP-IL2v) plus atezolizumab with or without bevacizumab in unresectable, metastatic renal cell carcinoma: a randomized, open-label phase Ib study. (PubMed, J Immunother Cancer)
The combination of FAP-IL2v plus atezolizumab with or without bevacizumab was consistent with the known safety profile of the individual drugs. The maximum tolerated dose was not reached, with a recommended FAP-IL2v dose of 10 mg. ORR was higher among patients receiving the triplet therapy compared with the doublet. Pharmacodynamic results were consistent with the mechanism of action of IL-2, supporting further research in this field.
Clinical • P1 data • Journal • PD(L)-1 Biomarker
|
CD8 (cluster of differentiation 8) • FAP (Fibroblast activation protein, alpha)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • simlukafusp alfa (RG7461)
1year
MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
P1/2, N=341, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
Trial completion
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
1year
IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov)
P3, N=1000, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
Enrollment closed
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Venclexta (venetoclax) • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • paclitaxel • sunitinib • Alecensa (alectinib) • Cotellic (cobimetinib) • Zejula (niraparib) • Xtandi (enzalutamide) • Cabometyx (cabozantinib tablet) • Rubraca (rucaparib) • pemetrexed • Cometriq (cabozantinib capsule) • emactuzumab (RG7155) • simlukafusp alfa (RG7461)
1year
Phase 1b study of immunocytokine simlukafusp alfa (FAP-IL2v) combined with pembrolizumab for treatment of advanced and/or metastatic melanoma. (PubMed, Cancer Res Commun)
The safety profile of FAP-IL2v in combination with pembrolizumab was manageable and consistent with the known safety profile. However, further exploration of FAP-IL2v and pembrolizumab was precluded in melanoma patients with prior CPI due to the lack of clinical activity.
P1 data • Journal
|
CD8 (cluster of differentiation 8)
|
Keytruda (pembrolizumab) • simlukafusp alfa (RG7461)
over1year
MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
P1/2, N=340, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Oct 2026 --> Jan 2025 | Trial primary completion date: Oct 2025 --> Jan 2025
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
over1year
Phase 1b Study of the Immunocytokine Simlukafusp alfa (FAP-IL2v), in Combination with Cetuximab in Patients with Head and Neck Squamous Cell Carcinoma. (PubMed, Clin Cancer Res)
The safety profile of FAP-IL2v in combination with cetuximab was acceptable and pharmacodynamic markers support the proposed mode-of-action of this combination, but the overall low antitumor activity does not warrant further clinical exploration in HNSCC. [Part C of Study BP29842 (NCT02627274).].
P1 data • Journal • Combination therapy
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
|
Erbitux (cetuximab) • simlukafusp alfa (RG7461)
over1year
Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. (PubMed, EBioMedicine)
FAP-IL2v plus atezolizumab is clinically active and has manageable safety in patients with recurrent and/or metastatic cervical SCC.
Clinical • P2 data • Preclinical • Retrospective data • Review • Journal • Metastases
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
|
PD-L1 expression • PD-L1 negative
|
Tecentriq (atezolizumab) • simlukafusp alfa (RG7461)
almost2years
Phase II study to determine the anti-tumor activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in esophageal cancer. (PubMed, Clin Cancer Res)
P2; FAP-IL2v plus atezolizumab demonstrated clinical activity and was tolerable in patients with previously treated esophageal SCC.
Journal • P2 data • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 negative
|
VENTANA PD-L1 (SP263) Assay
|
Tecentriq (atezolizumab) • simlukafusp alfa (RG7461)
2years
Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity from a Phase I Study of Simlukafusp Alfa (FAP-IL2v) in Advanced/Metastatic Solid Tumors. (PubMed, Clin Cancer Res)
FAP-IL2v had a manageable safety profile and showed initial signs of antitumor activity in advanced/metastatic solid tumors.
P1 data • PK/PD data • Journal • Metastases
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
|
simlukafusp alfa (RG7461)
over2years
MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
P1/2, N=340, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
Enrollment closed
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
over2years
IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov)
P3, N=1000, Recruiting, Hoffmann-La Roche | Phase classification: P4 --> P3
Phase classification
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • Venclexta (venetoclax) • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • paclitaxel • sunitinib • Alecensa (alectinib) • Cotellic (cobimetinib) • Zejula (niraparib) • Xtandi (enzalutamide) • Cabometyx (cabozantinib tablet) • Rubraca (rucaparib) • pemetrexed • Cometriq (cabozantinib capsule) • emactuzumab (RG7155) • simlukafusp alfa (RG7461)
over2years
MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
P1/2, N=340, Recruiting, Hoffmann-La Roche | Trial completion date: Jun 2024 --> Oct 2026 | Trial primary completion date: Jun 2024 --> Oct 2025
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
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