Antengene has dosed the first subject in the Phase I/II SWATCH study of Xpovio (selinexor) plus lenalidomide and rituximab to treat relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) and relapsed/refractory indolent non-Hodgkin lymphoma (r/r iHNL).
Xpovio is claimed to hinder the nuclear export protein XPO1.
Selinexor can stimulate the intranuclear build up and activation of tumour suppressor proteins, growth-regulating proteins and down-regulate various oncogenic protein levels.
Based on the new mechanism of action, it is being analysed for usage in various combinations for haematological and solid tumour cancers.
The multicentre, open-label, single-arm trial will assess the safety, tolerability and initial efficacy of selinexor plus the R2 regimen of lenalidomide and rituximab to treat r/r DLBCL and r/r iNHL in adults in China.
It will have a dose-escalation phase and a dose-expansion phase.
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The maximum-tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of the SR2 regimen based on dose-limiting toxicity (DLT) in subjects with r/r DLBCL in the dose-escalation phase will be one of the trial’s primary endpoints.
The other primary endpoint includes the SR2 regimen’s safety and tolerability as evaluated by the crucial safety measures including adverse events (AEs) and serious AEs (SAEs).
Objective response rate (ORR), progression-free survival (PFS) and duration of response (DOR) of the combination treatment will be included as secondary endpoints.
Antengene chief medical officer Dr Kevin Lynch said: “While there have been promising advances in patient care for hematologic malignancies, including r/r DLBCL and r/r iNHL, these cancers are among the top-ten cancer types worldwide and there is still a major need for improved treatments.
“We are hopeful that the results of the SWATCH study will pave the way to further improve the care of patient with r/r DLBCL and r/r iNHL, in China.”
In February this year, the company obtained clearance from the Bellberry Human Research Ethics Committee in Australia to initiate the Phase I STAMINA trial of ATG-037 for locally advanced or metastatic solid tumour.