Alveolar Soft Part Sarcoma

Tecentriq is the first immune checkpoint inhibitor in Japan for unresectable alveolar soft part sarcoma, a disease with no standard treatment established Approval for unresectable alveolar soft part sarcoma in adults and children over 2 years, which is a type of alveolar soft part sarcoma of high incidence in the AYA (Adolescent and Young Adult) generation The approval is based on the results from an investigator-initiated Japanese phase II clinical study and a U.S. NCI-initiated overseas phase II clinical study TOKYO, February 20, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained regulatory approval today from 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 unresectable alveolar soft part sarcoma. Tecentriq is the first immune checkpoint inhibitor in Japan for the treatment of this disease. “We are very pleased that we can offer Tecentriq as a new treatment for unresectable alveolar soft part sarcoma in adults and children over 2 years. This very rare disease, which occurs most often in the adolescents and young adults (AYA) generation, is known to have a poor prognosis with no standard treatment if it becomes unresectable. We will continue our efforts to provide information on the proper use of Tecentriq in order to contribute to the patients with unresectable alveolar soft part sarcoma,” said Chugai’s President and CEO, Dr. Osamu Okuda. This approval is based on the results from a phase II ALBERT study initiated by investigators in Japan including National Cancer Center Hospital and an overseas phase II clinical study conducted by the National Cancer Institute (NCI), which evaluated the efficacy and safety of Tecentriq in patients with unresectable alveolar soft part sarcoma. Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals. Approval Information *Newly added description Indications: unresectable alveolar soft part sarcoma Dosage and administrations: The usual adult dosage is 1200 mg atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. The usual dose for children over 2 years old is 15 mg/kg (weight) (max 1200 mg) atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes. About the ALBERT study1 The ALBERT study is a domestic Phase II, multicenter, open-label, single-arm study led by physicians including National Cancer Center Hospital in Japan to evaluate the efficacy and safety of Tecentriq in patients aged 16 years and older with unresectable alveolar soft part sarcoma. The study enrolled 20 patients to investigate safety and efficacy. The ALBERT 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 alveolar soft part sarcoma2, 3 Alveolar soft part sarcoma is one of the ultra-rare cancers accounting for less than 1% of soft tissue sarcomas. It is estimated to occur in 15-40 Japanese people annually. It most commonly affects the limbs, mainly the thighs, and is more common among adolescents and young adults (15-35 years old, AYA (Adolescent and Young Adult) generation). Unresectable alveolar soft part sarcoma has a poor prognosis, and no standard treatment has been established. About Tecentriq 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). Trademarks used or mentioned in this release are protected by law. Sources

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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Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous(IV) Tecentriq1,2 New subcutaneous (SC) option reduces treatment time to approximately seven minutes, compared with 30-60 minutes for IV infusion2 13 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab).2 It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer. “By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased to introduce this new subcutaneous formulation that builds on the established safety and efficacy profile of intravenous Tecentriq and can treat patients faster and in more accessible settings.” “This approval represents a significant option to improve the patient experience,” said Ann Fish-Steagall, RN, senior vice president of Patient Services at the LUNGevity Foundation. “When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option." The FDA approval is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.1,2 The Phase II IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab, and the most common reasons were less time in the clinic, increased comfort during treatment and reduced emotional distress.4 4 out of 5 patients (79%) chose Tecentriq Hybreza to continue their treatment, after experiencing both formulations.4 Developing new formulations of our medicines is part of our commitment to improve the patient experience and support people living with different illnesses at every step of their treatment journey. With Tecentriq Hybreza and Roche’s 13 other subcutaneous therapies – available across various diseases – we offer additional administration options to meet the diverse preferences of patients. The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in 50 countries (outside the U.S. marketed as Tecentriq SC).5 Regulatory reviews in other countries and regions are ongoing. IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of Tecentriq Hybreza, compared with Tecentriq IV, in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The study enrolled 371 patients. The study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements; observed serum Ctrough and model-predicted area under the curve. Efficacy, as measured by the objective response rate, progression-free survival, overall survival and duration of response, was similar between the SC and IV treatment arms and consistent with the known profile of Tecentriq IV. The safety profile of Tecentriq Hybreza was also consistent with that of Tecentriq IV.1,2 IMscin002 is a Phase II, global crossover study evaluating patient preference between the SC and IV formulations of Tecentriq. The study enrolled 179 patients, including people with PD-L1- positive resected Stage II-IIIB NSCLC who have completed adjuvant platinum-based chemo- therapy without evidence of disease recurrence, and untreated patients with PD-L1-high Stage IV NSCLC. The study met its primary endpoint, showing that 71% of participants preferred the SC formulation (21% preferred IV and 8% stated no preference); 79% opted for Tecentriq Hybreza to complete their treatment, after experiencing both formulations of Tecentriq. The study confirmed that switching between Tecentriq Hybreza and Tecentriq IV was well tolerated, with no new safety signals.4 Tecentriq Hybreza combines Tecentriq with Halozyme Therapeutics’ Enhanze® drug delivery technology. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream. Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS). In addition to intravenous infusion, Tecentriq has been approved as a subcutaneous formulation in 50 countries (outside the U.S. marketed as Tecentriq SC). The approved indications for Tecentriq Hybreza and Tecentriq SC mirror those of Tecentriq IV. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link. Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. References [1] Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023;34(8):693-702. [2] Burotto M, et al. IMscin001 Part 2 updated results: Efficacy, safety, immunogenicity and patient-reported outcomes (PROs) from the randomised Phase III study comparing atezolizumab (atezo) subcutaneous (SC) vs intravenous (IV) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Presented at ESMO 2023 Congress. Poster #1447P, on display 23 October 2023. [3] FDA - U.S. Food and Drug Administration. Tecentriq: highlights of prescribing information. Last updated April 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761034s053lbl.pdf. Accessed July 2024. [4] Cappuzzo F, et al. Primary results from IMscin002: A study to evaluate patient- and healthcare professional reported preferences for atezolizumab subcutaneous vs intravenous for the treatment of NSCLC. Presented at ELCC on 21 March 2024. Abstract 244MO. [5] Roche. Roche’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes. Last updated 29 August 2024. https://www.roche.com/media/releases/med-cor-2023-08-29b. Accessed July 2024. The content above comes from the network. if any infringement, please contact us to modify.