Extranodal NK-T-Cell Lymphoma

SHANGHAI and HONG KONG, Dec. 9, 2024 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that it presented the latest data from two clinical studies of selinexor in two posters at the 2024 American Society of Hematology Annual Meeting (ASH 2024). Details on the Posters: Title: Weekly Selinexor, Bortizomib and Dexamethasone (SVd) Versus Twice Weekly Bortizomib and Dexamethasone (Vd) in Chinese Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase III Bench Study Publication Number: 4748 Session: 654. Multiple Myeloma: Pharmacologic Therapies: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Pacific time) 10:00 AM - 12:00 PM, December 10, 2024 (Beijing time) The BENCH study is a Phase III randomized, open-label, multicenter clinical trial, aiming to evaluate the efficacy and safety of selinexor, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with R/R MM who have received one to three prior lines of therapy. At present, a New Drug Application (NDA) based this study has already been submitted to and accepted by China's National Medical Products Administration (NMPA). As of May 9, 2024, a total of 154 Chinese R/R MM patients were randomized to SVd group (n=101) or Vd group (n=53) and 152 patients received at least one dose of study drug (safety population). Efficacy results showed that the median progression-free survival (mPFS) was 8.1 months with SVd group and 6.3 months with Vd group. The overall response rate (ORR) was higher in SVd group than in Vd group. SVd group had a significantly higher proportion of patients with a very good partial response (VGPR) or better responses. The median time to response and the median duration of response were 0.8 vs 1.4 months and 9.7 vs 7.2 months (SVd vs Vd), respectively. During the study, some subjects experienced treatment emergent adverse events (TEAEs). The most frequent Grade 3-4 adverse events (AEs) for SVd and Vd (≥10%) included thrombocytopenia, lymphocytopenia, and anemia. The incidence of Grade≥2 peripheral neuropathy (PN) was significantly lower in SVd than in Vd group. The BENCH study has met its primary and key secondary endpoints, with results consistent with the BOSTON study. These results showed that the SVd regimen decreased the risk of progression and obtained much more profound responses compared to standard Vd regimen in Chinese patients with R/R MM. The incidence of Grade ≥2 PN were significantly reduced. Title: Selinexor Combined with Tislelizumab in Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL): Preliminary Results of Arm C, from a Multicenter, Single-Arm, Phase I/II Study, Touch Publication Number: 4448 Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Pacific time) 10:00 AM - 12:00 PM, December 10, 2024 (Beijing time) The Phase I/II TOUCH study is investigating selinexor combined with different drugs in R/R ENKTL. Arm C of the study aims to evaluate the safety, tolerability and preliminary efficacy of selinexor in combination with anti-PD-1 antibody tislelizumab. As of 18 May 2024, 17 R/R ENKTL patients were enrolled in Arm C [Sel 40mg (n=3); Sel 60mg (n=14)]. Sixteen patients previously exposed to both L-asparaginase (L-Asp) and checkpoint inhibitors (CPIs) including 8 patients who had received prior Tislelizumab (Tis); eleven (64.7%) patients were refractory to their last-line therapy. Efficacy results showed that, of 16 CPIs exposed patients (one patient was efficacy non-evaluable), the ORR was 75% (12/16), including 7 CRs and 5 PRs; and the median PFS was 6.7 months (95% CI 1.5, NE). During the study, all patients experienced TEAEs. The most common TEAEs included anemia, neutropenia, asthenia, decreased appetite, weight loss, and thrombocytopenia. Ten patients (58.8%) experienced Grade≥3 TEAEs. Treatment emergent serious adverse events (TESAEs) occurred in 4 patients (23.5%), of which two were considered treatment related. No patient discontinued due to TEAEs. Most of toxicities were manageable by dose modification and supportive care. In the study, the chemo-free regimen, Sel plus Tis, showed a favorable response rate and manageable safety profile in R/R ENKTL. This approach may probably reverse drug resistance in ENKTL that has progressed after prior CPI treatment. About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI and HONG KONG, Nov. 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced that it will present the latest data from two clinical studies of selinexor in two Posters at the 2024 American Society of Hematology Annual Meeting (ASH 2024), taking place on December 7-10, 2024, in San Diego, CA, the United States. Details on the Posters: Title: Weekly Selinexor, Bortizomib and Dexamethasone (SVd) Versus Twice Weekly Bortizomib and Dexamethasone (Vd) in Chinese Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase III Bench Study Publication Number: 4748 Session: 654. Multiple Myeloma: Pharmacologic Therapies: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Eastern time) 7:00 AM - 9:00 AM, December 10, 2024 (Beijing time) First Author: Dr. Jin Lu (Peking University People's Hospital) Corresponding Author: Dr. Jian Hou (Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine) Title: Selinexor Combined with Tislelizumab in Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL): Preliminary Results of Arm C, from a Multicenter, Single-Arm, Phase I/II Study, Touch Publication Number: 4448 Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Eastern time) 7:00 AM - 9:00 AM, December 10, 2024 (Beijing time) First Author: Dr. Rong Tao (Fudan University Shanghai Cancer Center) Corresponding Author: Dr. Huiqiang Huang (Sun Yat-Sen University Cancer Center) About XPOVIO® (selinexor) XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses. By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO® in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]). About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

All html pdf doc xls ppt match recent 10 20 30 none small medium large Home About Chugai News Chugai Files for Additional Indication of Tecentriq for the Treatment of Extranodal Natural Killer/T-cell Lymphoma, Nasal Type, a Rare Disease The filing is based on the results from an investigator-initiated Japanese phase II clinical study in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (R/R ENKL) If approved, Tecentriq is expected to be the first immune checkpoint inhibitor in Japan for R/R ENKL, a disease with poor prognosis for which no standard treatment has been established. TOKYO, October 31, 2024 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq® Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (R/R ENKL). “ENKL is a rare type of malignant lymphoma that primarily develops in the nose. It is known to have a poor prognosis, with about 60% of patients in advanced stages relapsing after initial treatment, and there is no standard therapy for relapsed cases. We are working to obtain approval so that Tecentriq, a cancer immunotherapy that demonstrated favorable efficacy, can be delivered to patients as soon as possible as a new therapeutic option for ENKL,” said Chugai’s President and CEO, Dr. Osamu Okuda. This filing is based on the results from a phase II ATTACK study initiated by investigators in Japan including National Cancer Center Hospital, which evaluated the efficacy and safety of Tecentriq in patients with R/R ENKL. Response was shown in 7 out of 13 cases and the study met its primary endpoint with an overall response rate of 53.8% (95% CI: 25.1-80.8%). The safety profile was consistent with that in other tumors. Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical need in cancer treatment with innovative medicines for patients and healthcare professionals. About ATTACK study1 ATTACK study (NCCH1903, jRCT2031190177) is a Japanese Phase II, multicenter, open-label, single-arm study led by physicians including National Cancer Center Hospital to evaluate the efficacy and safety of Tecentriq in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type. The study enrolled 14 patients to investigate safety and efficacy. The primary endpoint is independent review committee (IRC)-assessed overall response rate. Key secondary endpoints include progression-free survival, overall survival, and safety. ATTACK study is being conducted as a substudy of the MASTER KEY project, which promotes the development of treatments for rare cancers through industry-academia collaboration with the National Cancer Center Hospital. About extranodal natural killer/T-cell lymphoma, nasal type (ENKL) ENKL is a form of malignant lymphoma that primarily affects the nasal cavity. It can occur in individuals of all ages, from children to adults.2,3,4 ENKL is rare, accounting for approximately 0.68% of all malignant lymphoma cases (annual incidence: about 36,000 cases) in Japan.5 For patients with advanced ENKL, about 60% experience relapse following initial treatment.6,7 Relapsed or refractory ENKL has a poor prognosis, and there is currently no established standard treatment. About Tecentriq8 Tecentriq is a cancer immune checkpoint inhibitor targeting PD-L1, which is a protein expressed on tumor and tumor-infiltrating immune cells. PD-L1 blocks T cell activity by binding with PD-1 and B7.1 receptors on T cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T cells and boost immune response against cancer cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 4 indications (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, and hepatocellular carcinoma). Tecentriq was filed for additional indication of alveolar soft part sarcoma in March 2024. Trademarks used or mentioned in this release are protected by law. Sources Makita S, et al. Phase 2 study of anti-PD-L1 antibody atezolizumab in patients with relapsed/refractory extranodal natural killer/T-cell lymphoma: NCCH1903/ATTACK study. European Hematology Association 2024 (Abstract: P1170) Swerdlow SH, et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues WHO Classification of Tumours, Revised 4th Edition. International Agency for Research on Cancer. Makita S, et al. Clinical Features and Current Optimal Management of Natural Killer/T-Cell Lymphoma. Hematol Oncol Clin North Am. 2017;31(2):239-253 R Suzuki, et al. Prognostic factors for mature natural killer (NK) cell neoplasms: aggressive NK cell leukemia and extranodal NK cell lymphoma, nasal type. Ann Oncol. 2010;21(5):1032-40 Reiji M, et al. Epidemiology and secular trends of malignant lymphoma in Japan: Analysis of 9426 cases according to the World Health Organization classification. Cancer Med. 2018;7(11):5843-5858. M. Yamaguchi, et al. Phase II study of SMILE chemotherapy for newly diagnosed stage IV, relapsed, or refractory extranodal natural killer (NK)/T-cell lymphoma, nasal type: the NK-Cell Tumor Study Group study. J Clin Oncol, 29 (2011), pp. 4410-6. Xin Li, et al. DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China. Clin Cancer Res. 2016 Nov 1;22(21):5223-5228. Tecentriq for injection 840 mg/ 1200 mg. Electronic package insert. July 2024 (Version 7) [PDF 248KB] Contact: For Media Chugai Pharmaceutical Co., Ltd. Media Relations Group, Corporate Communications Dept., Hideki Sato Tel: +81-3-3273-0881 E-mail: pr@chugai-pharm.co.jp For Investors Chugai Pharmaceutical Co., Ltd. Investor Relations Group, Corporate Communications Dept., Takayuki Sakurai Tel: +81-3-3273-0554 E-mail: ir@chugai-pharm.co.jp Back Home About Chugai News Chugai Files for Additional Indication of Tecentriq for the Treatment of Extranodal Natural Killer/T-cell Lymphoma, Nasal Type, a Rare Disease About Chugai Message from the CEO Chugai’s Five Strengths Company Outline Our Vision Our Strategy History of Chugai Pharmaceutical Chugai Group R&D Digital Transformation "CHUGAI DIGITAL" Videos & Advertisements Press Room News Media Conference Partnering To our suppliers Investor Relations Management Policy Financial Results Reports & Downloads Shareholder Information Corporate Governance ESG at Chugai Main Products / Development Pipeline See how Chugai compares to other companies Strategic Alliance with Roche Chugai’s Five Strengths Events & Presentations Contacts & Information FAQs Recruitment Chugai Recruiting Site Sustainability Basic Policy (Creation of Shared Value) Sustainability and Business Strategy Sustainable Patient-Centric Healthcare Global Health Human Resources and Diversity & Inclusion Ethics and Compliance Supply Chain Management Human Rights Social Contribution Global Environment Health and Productivity Management Governance External Evaluations Activity Reports Data Chugai's Transparency Guidelines You are now moving to an external website. 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