On September 22, 2018, at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) held in Xiamen, China, Antengene published the clinical data of the 2b phase clinical trial for oral ATG-010 (Selinexor) under research in combination with low-dose dexamethasone (Sd) for the treatment of refractory and/or relapsed multiple myeloma, 1b/2 phase clinical trial for oral ATG-010 (Selinexor) in combination with Bortezomib and low-dose dexamethasone (SVd) for the treatment of refractory and/or relapsed multiple myeloma, and 2b clinical trial for oral ATG-010 (Selinexor) monotherapy for the treatment of refractory diffuse large B-cell lymphoma.
“For penta-refractory myeloma and diffuse large B-cell lymphoma, Chinese patients need an innovative treatment with a new mechanism,” said Dr. Jay Mei, founder, chairman and CEO of Antengene. “Our U.S. partner Karyopharm has completed the rolling submission of new drug application (NDA) of ATG-010 (Selinexor) for the treatment of penta-refractory relapsed multiple myeloma. Up to now, more than 2,600 patients have been treated by Selinexor. We have reported positive clinical data of the phase 2b STORM clinical trial today and in this research, the refractory multiple myeloma patients who have previously failed in penta-refractory treatment treated by Selinexor in combination with low-dose dexamethasone are evaluated We have also reported on STOMP clinical trials of phase 2b and Selinexor in combination with bortezomib and low-dose dexamethasone for the treatment of multiple myeloma are evaluated. Besides, Phase III clinical trials (BOSTON) are in progress. We have also reported data on 2b clinical trial SADAL for the treatment of diffuse large B-cell lymphoma with Selinexor being the potential backbone drug. The above three sets of data fully show that Selinexor is supported by detailed clinical research data and that our U.S. partner Karyopharm has carried out a rigorous work with scientific spirit in the preclinical stage.”
According to Dr. Yang Yijun, vice president of clinical pharmacology and biostatistics of Antengene and a spokesman for the report: “Selinexor was able to achieve an overall response rate of 26.2% for patients with refractory relapsed and/or multiple myeloma who had previously received 5-line, mostly 7-line treatment. The median survival time of patients reached 15.6 months. Such clinical results are encouraging. “
“We’ve already established an in-depth strategic partnership with Antengene and we are honored today to share key data from the three clinical trials of STORM, STOMP and SADAL with Chinese clinical oncologists at this annual meeting of Chinese Society of Clinical Oncology” said Dr. Sharon Shacham, founder, Chairman, and Chief Scientific Officer of Karyopharm, “The Annual Meeting of Chinese Society of Clinical Oncology is the most renowned oncology conference in China. Through presenting the important data at this conference, we hope to promote Selinexor further into key markets around the world.”
Antengene Corporation is a biopharmaceutical company focused on drug discovery, clinical development and the commercialization of innovative therapeutics to meet unmet medical needs. Antengene aims to provide the most advanced and first-in-class anti-cancer drug treatments for patients around the world. On April 13, 2017, Celgene Corporation (NASDAQ: CELG), a global leading innovative biopharmaceutical company became a long-term strategic partner and obtained an equity position in Antengene. Antengene’s pipeline includes six commercial and clinical stage products: ATG-010 (selinexor), in combination with the corticosteroid dexamethasone, has been approved by the U.S. Food and Drug Administration, for the treatment of adult patients with relapsed or refractory multiple myeloma. The compound is also in late clinical development for various other hematologic malignancies and solid tumors. ATG-008, a second-generation dual mTORC1/2 inhibitor, is in a multi-regional clinical trial for treatment of hepatocellular carcinoma and multiple other solid tumors. Two other Phase 1 and Phase 2 clinical stage drugs, ATG-016 and ATG-019, are being studied in multiple cancer types, including MDS, colorectal and prostate cancers. ATG-527 is being explored for multiple anti-viral indications, including respiratory syncytial virus (RSV), and Epstein-Barr virus (EBV) related diseases, etc. ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor, in clinical development for multiple solid tumors. Antengene drug discovery team focuses on development of first-in-class novel products.