{"id":403308,"date":"2020-12-20T19:03:27","date_gmt":"2020-12-21T00:03:27","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=403308"},"modified":"2020-12-20T19:03:27","modified_gmt":"2020-12-21T00:03:27","slug":"antengene-announces-its-u-s-partner-karyopharm-therapeutics-inc-has-received-fda-approval-of-xpovio-selinexor-as-a-treatment-for-patients-with-multiple-myeloma-after-at-least-one-prior-the","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/antengene-announces-its-u-s-partner-karyopharm-therapeutics-inc-has-received-fda-approval-of-xpovio-selinexor-as-a-treatment-for-patients-with-multiple-myeloma-after-at-least-one-prior-the\/","title":{"rendered":"Antengene Announces its U.S. Partner, Karyopharm Therapeutics Inc., has received FDA Approval of XPOVIO\u00ae (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy"},"content":{"rendered":"
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–Oral XPOVIO\u00ae Approval as Combination Therapy in Patients with Multiple Myeloma After At Least One Prior Therapy Significantly Expands the XPOVIO\u00ae Addressable Patient Population –<\/h2>\n

— Oral XPOVIO\u00ae is Now the Only Approved Multiple Myeloma Drug Indicated as Part of a Once-Weekly Bortezomib Combination Regimen –<\/h2>\n

— First Multiple Myeloma Drug with a New Mechanism of Action Approved by the FDA in the Second-Line Setting Since 2016 –<\/h2>\n

— FDA Approval Comes Approximately Three Months Ahead of Target PDUFA Date –<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n SHANGHAI<\/span> and HONG KONG<\/span>, Dec. 20, 2020<\/span> \/PRNewswire\/ —\u00a0Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) submitted by its partner Karyopharm Therapeutics Inc. (Nasdaq: KPTI) for oral XPOVIO\u00ae<\/sup>\u00a0(selinexor, ATG-010), a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. This indication was approved three months ahead of its March Prescription Drug User Fee Act (PDUFA)\u00a0date based on the result of a confirmatory Phase 3 BOSTON study. <\/p>\n

XPOVIO\u00ae<\/sup>\u00a0was previously approved under the FDA’s Accelerated Approval Program for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. <\/p>\n

XPOVIO\u00ae<\/sup>, a first-in-class and only-in-class oral SINE compound, and now the first and only drug approved by FDA for use in both multiple myeloma and diffuse large B-cell lymphoma, discovered and developed by Karyopharm, is currently being developed by Antengene, who has the exclusive development and commercial rights in certain Asia-Pacific<\/span> markets, including China<\/span>. In December 2020<\/span>, National Comprehensive Cancer Network (NCCN\u00ae<\/sup>) added three different XPOVIO\u00ae<\/sup> combination regimens to its Clinical Practice Guidelines in Oncology (NCCN\u00ae<\/sup> Guidelines) for previously treated multiple myeloma. <\/p>\n

Antengene\u00a0has\u00a0conducted\u00a0two\u00a0Phase\u00a02\u00a0registrational\u00a0clinical\u00a0trials\u00a0of\u00a0XPOVIO\u00ae<\/sup>\u00a0in China<\/span> for\u00a0relapsed\u00a0or refractory\u00a0multiple\u00a0myeloma\u00a0(MARCH) and\u00a0for\u00a0relapsed or refractory\u00a0diffuse\u00a0large\u00a0B-cell\u00a0lymphoma\u00a0(SEARCH). A Phase 3 randomized, controlled, open-label and multicenter BENCH trial has also received the IND approval from the National Medical Products Administration (NMPA)\u00a0in China<\/span>. Antengene is working on making XPOVIO\u00ae<\/sup> commercially available in Asia Pacific<\/span> regions and has submitted the New Drug Applications (NDAs) for XPOVIO\u00ae<\/sup>\u00a0to\u00a0the Health Sciences Authority\u00a0(HSA) of Singapore<\/span> and the Australian Therapeutic Goods Administration (TGA) for three indications, including the treatment of patients with multiple myeloma who have received at least one prior therapy. <\/p>\n

\u00a0“This is the third approved indication for XPOVIO\u00ae<\/sup>, highlighting its potential of clinical application and broad market prospects. XPOVIO\u00ae<\/sup>\u00a0offers patients with rrMM and their physicians the first oral SINE compound and makes more treatment options available to cancer patients with critical unmet medical needs.”\u00a0Dr. Jay Mei<\/span>, M.D., Ph.D., Founder, Chairman and CEO of Antengene said,\u00a0“We plan to launch XPOVIO\u00ae<\/sup>\u00a0as soon as possible for the treatment of patients with rrMM and rrDLBCL in APAC following regulatory approvals, by leveraging our established commercial infrastructure and seasoned international team.”<\/p>\n

\n About the Phase 3 BOSTON Study <\/b>\n <\/p>\n

The approval of XPOVIO\u00ae<\/sup>\u00a0in combination with once-weekly bortezomib plus low-dose dexamethasone (SVd) is supported by the results of the multi-center, Phase 3, randomized study, which evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly XPOVIO\u00ae<\/sup>\u00a0(selinexor) in combination with once-weekly bortezomib plus low-dose dexamethasone (SVd) versus twice-weekly bortezomib plus dexamethasone (Vd). The primary endpoint of the study was progression-free survival (PFS) and key secondary endpoints included overall response rate (ORR), rate of peripheral neuropathy, and others. Additionally, the BOSTON<\/span> study allowed for patients on the Vd control arm to crossover to the SVd arm following objective (quantitative) progression of disease verified by an Independent Review Committee (IRC). The BOSTON<\/span> study was conducted at over 150 clinical sites internationally.<\/p>\n

Although the study had one of the highest proportions of patients with high-risk cytogenetics (~50%) as compared with other bortezomib-based studies in previously treated myeloma, the median PFS in the SVd arm was 13.9 months compared to 9.5 months in the Vd arm, representing a 4.4 month increase in median PFS (hazard ratio [HR] of 0.70; p=0.0075). The SVd group also demonstrated a significantly greater ORR compared to the Vd group (76.4% vs. 62.3%, p=0.0012). Importantly, SVd therapy compared to Vd therapy showed consistent PFS benefit and higher ORR across several important subgroups. <\/p>\n

In addition, the following results favored SVd therapy as compared to Vd therapy: <\/p>\n