Antengene Limited, a number one innovative biopharmaceutical company, announced that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for ATG-010 (selinexor), an oral Selective Inhibitor of Nuclear Export (SINE) compound, together with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory myeloma (rrMM) in China.
The trial may be a randomized, controlled, open-label, multicenter, phase 3 trial, getting to evaluate the efficacy and safety of ATG-010, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with rrMM who have received one to 3 prior lines of therapy. a complete of 150 patients are going to be randomized during a 2:1 ratio to receive SVd or Vd treatment.
ATG-010 may be a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) and it’s now the primary and only drug approved by the Food and Drug Administration (FDA) to be used in both myeloma and diffuse large B-cell lymphoma. In China, Antengene is conducting a registrational phase 2 clinical test of ATG-010 for rrMM (MARCH). The trial is predicted to finish enrollment by the top of 2020.
“The results of the BOSTON study has demonstrated that the SVd regimen reduced the danger of disease progression or death with lower doses of bortezomib and dexamethasone within the triple combination in comparison to the quality Vd regimen. Addition of ATG-010 to Vd could also be more convenient and provides a more significant therapeutic effect in patients with rrMM.” said Dr. Jay Mei, founder, chairman and CEO of Antengene. “This planned phase 3 trial, which is that the registrational study supported BOSTON, goes to validate the SVd regimen’s efficacy and safety in Chinese population.”
ATG-010 (selinexor, Xpovio) may be a first-in-class and only-in-class oral selective inhibitor of nuclear export compound, developed by Antengene and Karyopharm Therapeutics. In July 2019, the US Food and Drug Administration (FDA) approved ATG-010 together with low-dose dexamethasone for the treatment of relapsed/refractory myeloma (rrMM) and in June 2020 approved ATG-010 as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 is thus far the primary and only oral SINE compound approved by the FDA. ATG-010 is additionally being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial carcinoma . In November 2020, at the animal tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm Therapeutics, presented positive results from the phase 3 randomized, test , placebo controlled, cross-over SEAL study evaluating single agent, oral ATG-010 versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the continued phase 3 SIENDO study of ATG-010 in patients with endometrial carcinoma passed planned interim futility analysis which Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned with none modifications. Top-line SIENDO study results are expected within the last half of 2021.
Antengene is conducting two registrational phase 2 clinical trials of ATG-010 in China for relapsed refractory myeloma (MARCH) and for relapsed refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for top prevalence cancer types within the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell carcinoma (TRUMP)