Teruisi announced that the Investigational New Drug (IND) application for the phase 2 trial of TRS005 has been accepted by China's Center for Drug Evaluation (CDE). TRS005 is an antibody-drug conjugate (ADC) targeting CD20, utilizing anti-CD20 antibodies conjugated with MMAE (monomethyl auristatin E) for a more targeted therapeutic approach, with a drug-antibody ratio of 4:2. They have now progressed the candidate to a potential registrational study.
| TRS005 |
The single-arm Phase 2 study is aimed at rrDLBCL, with an estimated enrollment of 120-140 participants. The completion of the study may take two years, followed by an additional year for the Biologics License Application (BLA) review.
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| Phase 1 Study Review Meeting |
The results of the Phase 1 trial in pts with rrNHL after receiving at least 2 standard treatment regimens, initiated in November 2018, were reported in 2022: "From Aug 24, 2020 to Apr 29, 2022, 40 pts received treatment, including 14 pts in dose-escalation phase and 26 in dose expansion phase. The dose limiting toxicity was observed in first patient in the 2.1mg/kg cohort due to grade 3 drug-induced liver injury, and dose maximum tolerated dose was not reached by now. Overall, 78% of pts experienced treatment-related adverse events (TRAEs). TRAEs of ≥3 grade occurred in 34.1% of pts, with the most common being neutropenia (10.1%). At the data cutoff date on Apr 29, 2022, 35 pts were evaluable for efficacy and the confirmed objective response rate (ORR) was 37.1%, with a disease control rate (DCR) of 60%. ORR/DCR in different dose cohorts : 42.9% and 57.1% in 0.5mg/kg (n=7), 16.7% and 16.7% in 1.0mg/kg（n=6）, 43.8% and 68.8% in 1.5mg/kg, 50% and 100% in 1.8mg/kg (4 pts), 1 SD in 0.1mg/kg (1pt). ORR/DCR in different histology subtypes : 46.7% and 66.7% in DLBCL (n=15 ), 21.4% and 42.9% in FL (n=14), 100% and 100% in MCL(n=2), 50% and 100% in MZL (n=2)." The ORR data was updated at the ESMO congress as follows.
| Results of Phase 1 Study |
For reference, Glofitamab and Epcoritamab (both anti-CD20xCD3 BsAbs) yielded a 56% overall response rate (ORR) and 61% in rrDLBCL, respectively.
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