ESMO Direct Hit ORR 42.2% and DCR 75.6%! Preliminary results of a Phase I study on the treatment of relapsed refractory B-NHL by TRS005 were published

The 2022 Annual Meeting of the European Society of Oncology (ESMO) was held

Research background

TRS005 is a newly developed anti-CD20-MMAE antibody drug conjugate that delivers the highly toxic anti-mitosis drug MMAE to CD20+ tumor cells through receptor-mediated endocytosis

Research methodology

This is a single-arm, multi-center Phase I study

Figure 1

Research results

From 24 August 2020 to 31 July 2022, 48 patients were enrolled in groups, all of whom were relapsed or refractory

Table 1

As of 31 July 2022, efficacy was available in 45 patients with an objective response rate (ORR) of 42.
2% (19/45), including 14 cases of PR and 5 cases of CR
.

The disease control rate (DCR) was 75.
6%.


Efficacy in patients with different histological subtypes is detailed in Table 2
.

The ORRs in the 0.
5 mg/kg, 1 mg/kg, 1.
5 mg/kg, and 1.
8 mg/kg dose groups were 42.
9%, 33.
3%, 43.
8%, and 50%, respectively (Table 3
).

Progression-free survival (PFS) was assessed in 48 patients with a median follow-up of 4.
1 months and a median PFS of 4 months
(Figure 2).

Table 2

Table 3

Figure 2

In terms of safety, 48 patients received at least 1 dose of TRS005, 38 patients received 4-6 doses of TRS005, and no treatment-related deaths occurred
.

The most common ≥-3 treatment-related adverse events (TRAEs) included neutropenia (39.
6%), decreased white blood cell count (18.
8%), and decreased lymphocyte count (12.
5%)
.

The most common TRAE is hematology-associated AE, and the most common non-hematologic AE includes elevated AST, fever, and elevated ALT, as detailed in Tables 4 and 5
.

Table 4

Table 5

Conclusions of the study

The results of this Phase I study show that TRS005 is well tolerated and good efficacy in patients with relapsing refractory B-cell NHL, and further studies
of TRS005 are needed in this population.

Reference: Y-K.
Shi, et al.
2022ESMO.
Abstract#618O.

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