ESMO Strikes New Hope for Extranodal NK/T-cell Lymphoma Treatment? The safety and efficacy of PLM60+ Pecopetase treatment are encouraging!

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Extranodal NK/T cell lymphoma (ENKTCL) is a rare invasive, non-Hodgkin lymphoma that originates from NK cells and T lymphocytes and is highly aggressive, rapid progression, and poor
prognosis.

Research Methods

Patients included in the study were adult patients
with histology-confirmed initial or relapsed/refractory ENKTCL.

Figure 1 Study design

Results of the study

Patient baseline features

As of 15 February 2022, a total of 31 patients were enrolled (Phase I: 21, Phase II: 10).

Table 1 Patient baseline features

security

All 31 patients experienced "treatment-phase" adverse events (TEAE), and 87.
1% developed grade 3 TEAE
.
Hematological toxicities include neutropenia (77.
4%), leukopenia (74.
2%), anemia (54.
8%), thrombocytopenia (45.
2%), lymphopenia (16.
1%), and decreased fibrinogen levels (16.
1%); Nonhematologic toxicities include hypertriglyceridemia (22.
6%), infectious pneumonia (16.
1%), hypoglycemia (12.
9%), and elevated bilirubin (12.
9%) (Figure 2).

Figure 2 TEAE occurred in 31 patients

PK result

The PK profile of PLM60 did not change
after combination therapy with pepsonidase.
At doses of 12-24 mg/^m2, the ratio of free mitoxantraquinone to total mitoxantrone is fixed at 2%-4% (Table 2
).
The mean elimination half-life of total mitoxantraninone is 70-100 hours, and no drug accumulation occurs after multidose administration (Rac_Cmax/AUC: 0.
98-1.
25).

Table 2 PK results (left: total mitoxantrone; Right: Free mitoxantraquinone ( )

efficacy

Efficacy was assessed in all 31 patients, with a complete response (CR) rate of 61.
3% (95% CI: 42.
2% to 78.
2%) and an objective response rate (ORR) of 87.
1% (95% CI: 70.
2% to 96.
4%) (Table 3).

The CR rate was 68.
2% (95% CI: 45.
1% to 86.
1%) and the ORR was 90.
9% (95% CI: 70.
8% to 98.
9%) (Table 3, Figure 3).

Table 3 Efficacy results

Figure 3 Results of efficacy in patients treated at the beginning

Conclusion of the study

PLM60 has good PK characteristics, and the PK characteristics are not affected
after combination with pementlease.
The PLM60+ pementlease protocol has shown significant efficacy and manageable safety
in patients with initial treatment of ENKTCL.

Reference source:

Y.
Huang, et al.
2022ESMO.
Abstract #625MO.