ADCETRIS

ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 100% Progression Free Survival at 12 months in Phase 2 Trial of Patients with Early Stage Classical Hodgkin Lymphoma

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星期一, 十二月 11, 2023
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Doxorubicin, Safety, Toxicity, Rollcage Stage II, AVD, Progression-free survival, Progressive multifocal leukoencephalopathy, ADC, Febrile neutropenia, Brentuximab vedotin, Patient, Research and development, PFS, Bleomycin, DOR, PML, Hodgkin lymphoma, PD-1, CHL, Lymphoma, Vinblastine, Dacarbazine, Development, Nivolumab, Survival, Massachusetts General Hospital, ADCETRIS, Immunotherapy, Society, Inc., Hospital, Ima Hogg, Pharmaceutical industry, Vaccine, Medical device, Birth control, Seagen

This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.

Key Points: 
  • This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.
  • The PFS rate was 100% (95% CI: 100, 100) at 12 months and 97% (95% CI: 90.3, 99.1) at 18 months.
  • Among 56 efficacy-evaluable patients, 95% had an OR (95% CI: 85.1, 98.9) and 89% had a CR (95% CI: 78.1, 96.0).
  • The estimated PFS rate at 24 months was 88% (95% CI: 75.7, 94.6), with a median follow-up of 24.2 months (95% CI: 23.4, 26.9).

Seagen Highlights First Solid Tumor Data for an ADCETRIS® (brentuximab vedotin) Immunotherapy Combination and Preclinical Data for Novel CD30-Directed Antibody-Drug Conjugate at Society for Immunotherapy of Cancer (SITC) Annual Meeting

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星期五, 十一月 3, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Brentuximab vedotin, DCR, Society for Immunotherapy of Cancer, Pembrolizumab, Head, PD-1, Development, CD8, SITC, Immunotherapy, ADC, CD30, Inc., Clinical trial, Transportation Research Part E, Research and development, Annual general meeting, ORR, Seagen, RECIST, Tumor microenvironment, Lung cancer, Melanoma, Safety, Society, ADCETRIS, Patient, Toxicity, Neck, Pharmaceutical industry, Vaccine, NSCLC

The studies were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place November 3-5, 2023, in San Diego.

Key Points: 
  • The studies were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place November 3-5, 2023, in San Diego.
  • “The combination of ADCETRIS and a PD-1 inhibitor to treat solid tumors are intriguing and support continued research,” said Roger Dansey, M.D., President, Research and Development and Chief Medical Officer at Seagen.
  • The study design included melanoma patients who were treated in the study within 90 days of receiving prior anti-PD-1 therapy.
  • Preclinical data suggest that SGN-35T may be highly effective, like ADCETRIS, with the potential for improved tolerability.

New Data for ADCETRIS® (brentuximab vedotin) with Immunotherapy Combination in Hodgkin Lymphoma to be Featured at 2023 ASH Annual Meeting, and Seagen to Unveil Novel CD30-Directed Antibody-Drug Conjugate

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星期四, 十一月 2, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Brentuximab vedotin, Lymphoma, Society, Development, ASH, CHL, Hodgkin lymphoma, ADC, Inc., Research and development, Immunotherapy, Exposition, ADCETRIS, Patient, Pharmaceutical industry, Seagen

The data will be featured in two oral presentations at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, taking place December 9-12, 2023 in San Diego.

Key Points: 
  • The data will be featured in two oral presentations at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, taking place December 9-12, 2023 in San Diego.
  • The ongoing Phase 2 clinical trial, SGN35-027, is evaluating ADCETRIS in combination with immunotherapy and chemotherapy.
  • In addition, pre-clinical data will be presented for a next-generation novel CD30-directed antibody-drug conjugate (ADC), SGN-35C, that uses a topoisomerase I inhibitor payload.
  • ADCETRIS is a proven foundation of care for certain CD30-expressing lymphomas with more than 120,000 patients treated globally across seven indications.

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD

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星期三, 十月 18, 2023
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Survival, Brentuximab vedotin, Christie, TAK, Progression-free survival, CHMP, European Commission, IRF, Committee, Bleomycin, Vinblastine, European Directive on Traditional Herbal Medicinal Products, AVD, Doxorubicin, PFS, EC, University of Manchester, Civil service commission, Hodgkin lymphoma, ADC, CD30, ABVD, Risk, Dacarbazine, University, The Christie NHS Foundation Trust, Committee for Medicinal Products for Human Use, Hatim al-Awni, Overalls, Safety, ADCETRIS, Patient, OS, Lymphoma, Medical device, Medical imaging, Pharmaceutical industry, Takeda, Fellow of the Academy of Medical Sciences

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.
  • ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in Europe in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma.
  • The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.
  • “We are thrilled with the decision of the European Commission to approve ADCETRIS in combination with chemotherapy as a treatment for adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma, particularly as up to one third of patients with Stage III & IV disease are at risk of experiencing treatment failure with current regimens,” said Awny Farajallah, M.D., head of global medical affairs oncology, Takeda.

Phase 3 Trial of ADCETRIS® (brentuximab vedotin) with Modified Chemo Regimen Shows Non-Inferiority with Unprecedented 3-Year Progression Free Survival of 94.9% vs Less Tolerable International Standard of Care in Advanced Classical Hodgkin Lymphoma

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星期二, 六月 20, 2023
Science, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Other Health, Hodgkin lymphoma, Doxorubicin, Inc., Vincristine, Brentuximab vedotin, Vinblastine, PML, Takeda, Progression-free survival, Hematology, ABVD, ICML, Procarbazine, Survival, Lymphoma, PET, Cyclophosphamide, Bleomycin, ADCETRIS, CHL, PFS, Teaching hospital, Dexamethasone, FSH, Research and development, Dacarbazine, Prednisone, Development, Etoposide, International Conference on Nuclear Disarmament, Oslo, 2008, Patient, Risk, Progressive multifocal leukoencephalopathy, Fertility, BEACOPP, Peripheral neuropathy, Death, Society, Conference, Pharmaceutical industry, Birth control, Seagen

The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.

Key Points: 
  • The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.
  • 12-month post-treatment safety data were consistent with previously presented HD21 data results at the American Society of Hematology 2022 Annual Meeting.
  • Preservation of fertility potential was indicated by measurement of follicle-stimulating hormone (FSH) and was available for 597 patients.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Six-Year Overall Survival Results Added to U.S. Prescribing Information for ADCETRIS® (brentuximab vedotin) as First-Line Treatment for Advanced Hodgkin Lymphoma

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星期四, 六月 15, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hodgkin lymphoma, Doxorubicin, Inc., Brentuximab vedotin, Vinblastine, European Hematology Association, Progression-free survival, ABVD, Survival, American Society of Clinical Oncology, Bleomycin, ADCETRIS, AVD, Patient, Peripheral neuropathy, Death, Society, Disease, Dacarbazine, Pharmaceutical industry

The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.

Key Points: 
  • The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.
  • ADCETRIS was approved for advanced Hodgkin lymphoma in 2018 based on an improvement in progression-free survival in combination with chemotherapy agents AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) in the ECHELON-1 trial.
  • Patients with advanced classical Hodgkin lymphoma are often young adults with their whole lives ahead of them,” said David Epstein, Chief Executive Officer, Seagen.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Seagen Announces ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 98% Overall Response Rate and 93% Complete Response Rate in Patients with Early-Stage Classical Hodgkin Lymphoma (cHL)

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星期二, 六月 13, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hodgkin lymphoma, Doxorubicin, Inc., Febrile neutropenia, Brentuximab vedotin, Vinblastine, PML, Takeda, Progression-free survival, European Hematology Association, ICML, Lymphoma, Survival, Aes, Trae tha Truth, EOT, Bleomycin, Toxicity, ADCETRIS, CHL, PFS, Diabetic neuropathy, Research and development, Dacarbazine, Congress, Development, Hair, International Conference on Population and Development, MD, Patient, Risk, Progressive multifocal leukoencephalopathy, BEACOPP, CR, Nausea, Hospital, PD-1, Massachusetts General Hospital, Death, Conference, ORR, Safety, Fatigue, Nivolumab, Pharmaceutical industry, Vaccine, Birth control, Part, Seagen

Data results will be presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland June 13-17.

Key Points: 
  • Data results will be presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland June 13-17.
  • The study will be presented on June 17, 2023.
  • Immune-mediated AEs observed to date are consistent with the individual safety profile of nivolumab.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Takeda Delivers Strong Revenue and Profit Growth in FY2022; Updated Capital Allocation Policy Reflects Deleveraging Progress and Confidence in Growth Outlook

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星期四, 五月 11, 2023
Research, Pharmaceutical, Oncology, Infectious Diseases, Genetics, Clinical Trials, Science, Biotechnology, Neurology, FDA, Health, Diabetes, CD, Civil service commission, CER, Takeda, Hypovolemia, Hereditary angioedema, ADHD, PDT, Neuroscience, ADCETRIS, Multifocal motor neuropathy, Lung cancer, Ulcerative colitis, Lymphoma, Inflammatory bowel disease, HAE, Emerging market, Acquisition, UC, Investment, Patient, EGFR, Growth, PP, Primary immunodeficiency, Immunology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, European Commission, PP&E, Pharmaceutical industry, Hypoalbuminemia

Rare Diseases, with 723.4 billion yen in reported revenue, grew 4.8% on a CER basis.

Key Points: 
  • Rare Diseases, with 723.4 billion yen in reported revenue, grew 4.8% on a CER basis.
  • Plasma-Derived Therapies (PDT) Immunology, with 678.4 billion yen in reported revenue, delivered outstanding growth of 15.3% on a CER basis.
  • ALUNBRIG® (for non-small cell lung cancer) also grew 35% on a CER basis with strong demand in Europe, China, and Growth & Emerging Markets.
  • This approval marks the first approval of QDENGA in Latin America as Takeda continues to progress additional regulatory filings in other dengue-endemic countries.

Seagen Reports First Quarter 2023 Financial Results

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星期四, 四月 27, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Trastuzumab, Head, NCCN, RAS, Patient, Merck, Spacecraft, BLA, Inc., SGN, Lymphoma, CDE, Accelerated approval (FDA), ADC, Gender representation on corporate boards of directors, Growth, PD-1, Center for Drug Evaluation and Research, FDA, NMPA, Bladder cancer, Hodgkin lymphoma, Abstract, ODE, AACR, American Association for Cancer Research, ADCETRIS, Cohort study, Immunotherapy, National Medical Products Administration, Sanofi, Brentuximab vedotin, Pembrolizumab, Abstract (summary), Clinical trial, Cisplatin, Category, Part, Neck, CEACAM5, ASCO, American Society of Clinical Oncology, Annual general meeting, Society, Pfizer, Pharmaceutical industry, Seagen

Seagen Inc. (Nasdaq:SGEN) (Seagen or the Company) reported financial results today for the first quarter ended March 31, 2023.

Key Points: 
  • Seagen Inc. (Nasdaq:SGEN) (Seagen or the Company) reported financial results today for the first quarter ended March 31, 2023.
  • “Seagen delivered strong performance in the first quarter, with significant growth of 22 percent for both total revenue and net product sales, compared to 2022, driven by our multi-product commercial portfolio,” said David Epstein, Chief Executive Officer of Seagen.
  • Proposed Acquisition of Seagen by Pfizer: In March 2023, Seagen and Pfizer announced they have entered into a definitive merger agreement under which, on the terms and subject to the conditions thereof, Pfizer will acquire Seagen for $229 in cash per Seagen share for a total enterprise value of $43 billion.
  • Revenues: Total revenues for the first quarter of 2023 were $520 million, compared to $426 million for the same period in 2022, primarily driven by growth in net product sales.

Seagen Reports Fourth Quarter and Full Year 2022 Financial Results

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星期三, 二月 15, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Trastuzumab, Brentuximab vedotin, Carcinoma, Head, Research and development, Priority review, SITC, Lung cancer, Journal of the National Comprehensive Cancer Network, Woman, Cancer, Society, Novartis, Georgetown University Medical Center, Interim, RAS, FDA, Growth, MedStar Health, ASCO, Cervical cancer, Genetic distance, Society for Immunotherapy of Cancer, Breast cancer, PDUFA, SGN, Patient, Dean (education), Clinical trial, Accelerated approval (FDA), PDUFA date, Merck, NCCN, Cervical, Pembrolizumab, Food, Immunotherapy, Hodgkin lymphoma, ADCETRIS, Flagship Pioneering, Esophageal cancer, Inc., American Society of Clinical Oncology, Pharmaceutical industry, Birth control, Seagen, Medicine

Seagen Inc. (Nasdaq:SGEN) today reported financial results for the fourth quarter and year ended December 31, 2022.

Key Points: 
  • Seagen Inc. (Nasdaq:SGEN) today reported financial results for the fourth quarter and year ended December 31, 2022.
  • “We delivered total revenue of nearly $2 billion in 2022, reflecting 25 percent growth compared to 2021 driven by strong demand for our portfolio of approved products,” said David Epstein, Chief Executive Officer of Seagen.
  • Revenues: Total revenues in the fourth quarter and year ended December 31, 2022 were $528 million and $2.0 billion, respectively, compared to $430 million and $1.6 billion for the same periods in 2021.
  • Revenues in the 2022 periods reflected higher net product sales across the Company’s commercial portfolio.