- |||||||||| tobemstomig (RG6139) / Roche, tiragolumab (RG6058) / Roche
Enrollment closed, Trial completion date, Trial primary completion date, Checkpoint inhibition, Metastases: A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - Oct 1, 2024 P2, N=210, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Mar 2026 --> Oct 2026 | Trial primary completion date: Sep 2024 --> May 2025
- |||||||||| tobemstomig (RG6139) / Roche, tiragolumab (RG6058) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma) (clinicaltrials.gov) - May 1, 2024 P1/2, N=110, Completed, Active, not recruiting --> Recruiting Recruiting --> Completed | N=336 --> 110 | Trial completion date: Jul 2025 --> Mar 2024 | Trial primary completion date: Jan 2025 --> Sep 2023
- |||||||||| tobemstomig (RG6139) / Roche
Tobemstomig, a novel bispecific checkpoint inhibitory antibody to preferentially block PD-1 and LAG-3 on CD8 TILs over Tregs (Section 42) - Mar 5, 2024 - Abstract #AACR2024AACR_9198; LAG-3 is constitutively expressed by regulatory T cells (on Tregs) and it has been reported that its blockade increases Treg suppressive function which could potentially off-sets the benefit of blocking LAG-3 on tumor-reactive CD8 T cells.We therefore developed a 1+1 PD1-LAG3 bispecific antibody, Tobemstomig, with a unique PD-1 binder recognizing a glycoepitope and more than 20 fold higher affinity than the LAG-3 binder which recognizes a novel and differentiated binding epitope (E3). This difference in affinities allows for an avidity driven selectivity gain to PD-1 and LAG-3 double positive T cells over and the following advantages over monospecific and other bispecific aPD-1/-L1 and aLAG-3 antibodies:1.improved targeting to tumor-reactive T cells rather than Tregs due to the selectivity gain and different expression patterns of PD-1 and LAG-3 on these two T cell types, 2.reduced internalization, 3.resistance to drug-shaving by macrophages due to Fc -silencing via P329G LALA,4.increased in vitro T cell effector functions even in the presence of Tregs, 5.in-vivo targeting and expansion of CD8 TILs, including stem-like T cells, and increase in T cell effector functions and6.superior in vivo tumor control/eradication compared to combination of monospecific anti-PD1 and anti-LAG3 antibodies,in several mouse models including Panc02 in syngeneic huPD-1xhuLAG3 dtg mice and BXPC3, WSU, OCI-Ly18 and BC004 in humanized mice Tobemstomig has completed dose escalation and is currently tested in a composite proof of concept Ph2 trial in several solid tumor indications.
- |||||||||| Trial completion date, Trial primary completion date: A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma (clinicaltrials.gov) - Feb 25, 2024
P1/2, N=150, Recruiting, This difference in affinities allows for an avidity driven selectivity gain to PD-1 and LAG-3 double positive T cells over and the following advantages over monospecific and other bispecific aPD-1/-L1 and aLAG-3 antibodies:1.improved targeting to tumor-reactive T cells rather than Tregs due to the selectivity gain and different expression patterns of PD-1 and LAG-3 on these two T cell types, 2.reduced internalization, 3.resistance to drug-shaving by macrophages due to Fc -silencing via P329G LALA,4.increased in vitro T cell effector functions even in the presence of Tregs, 5.in-vivo targeting and expansion of CD8 TILs, including stem-like T cells, and increase in T cell effector functions and6.superior in vivo tumor control/eradication compared to combination of monospecific anti-PD1 and anti-LAG3 antibodies,in several mouse models including Panc02 in syngeneic huPD-1xhuLAG3 dtg mice and BXPC3, WSU, OCI-Ly18 and BC004 in humanized mice Tobemstomig has completed dose escalation and is currently tested in a composite proof of concept Ph2 trial in several solid tumor indications. Trial completion date: Feb 2027 --> Sep 2028 | Trial primary completion date: May 2025 --> Sep 2025
- |||||||||| tobemstomig (RG6139) / Roche, tiragolumab (RG6058) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment change, Trial completion date, Trial primary completion date: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma) (clinicaltrials.gov) - Jul 20, 2023 P1/2, N=336, Recruiting, Secondary endpoints include PFS, OS, DOR, DCR and safety. N=191 --> 336 | Trial completion date: Mar 2024 --> Jul 2025 | Trial primary completion date: Nov 2023 --> Oct 2024
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