SEAGEN


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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

Retrieved on: 
Monday, December 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).

TUKYSA® (tucatinib) in Combination with Antibody-Drug Conjugate ado-Trastuzumab Emtansine Improves Progression-Free Survival in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer

Retrieved on: 
Wednesday, December 6, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Capecitabine, Trastuzumab, Senior, Food, Progression-free survival, RECIST, National Comprehensive Cancer Network, Tablet, Breast cancer, Brain, Taxane, Patient, Research and development, PFS, Corr, Division, FDA, Hematology, University, Development, HR, Tucatinib, HER2, Inc., Confidence interval, News, Professor, HIV disease progression rates, Medical imaging, Medicinal plants, Seagen

Seagen Inc. (Nasdaq: SGEN) today announced data from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®).

Key Points: 
  • Seagen Inc. (Nasdaq: SGEN) today announced data from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®).
  • The combination showed a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint, in patients with unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer who had been previously treated with trastuzumab and a taxane, compared to those who received placebo plus ado-trastuzumab emtansine.
  • Discontinuations due to adverse events were more common in the combination arm of the trial, but no new safety signals were observed for the combination.
  • Please see Important Safety Information at the end of this news release for TUKYSA (tucatinib) tablets.

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Retrieved on: 
Thursday, November 30, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Cisplatin, Priority review, Safety, Food, Progression-free survival, Breakthrough therapy, Transitional cell carcinoma, Carcinoma, Ureter, Bladder cancer, Patient, PFS, Pembrolizumab, Brentuximab vedotin, PDUFA, Inc., Pharmaceutical industry

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.
  • The FDA is reviewing the application under its Real-Time Oncology Review (RTOR) program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
  • If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients.
  • In February 2020, PADCEV in combination with KEYTRUDA was granted Breakthrough Therapy designation by the FDA and the EV-103 sBLA received Priority Review designation in December 2022.

PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Retrieved on: 
Friday, December 15, 2023
Cisplatin, NYSE, PFE, Food, Platinum, Progression-free survival, Carcinoma, ADC, ESMO, Patient, PFS, Astellas Pharma, FDA, Pembrolizumab, PD-1, Survival, Death, Oncology, Pfizer, Congress, OS, Confidence interval, Pharmaceutical industry, Dietary supplement

TOKYO and NEW YORK, Dec. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

Key Points: 
  • This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.
  • "Today's FDA approval represents a paradigm change in the treatment of advanced bladder cancer and provides hope to the thousands of Americans impacted by this aggressive disease.
  • "Despite advances in the treatment of advanced bladder cancer, there remains a need for therapies that extend patients' lives.
  • Our network is thrilled that the FDA has approved a new treatment option, and we are excited about the hope it will provide to members of the bladder cancer patient community."

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Retrieved on: 
Thursday, November 30, 2023
Cisplatin, Priority review, Safety, Food, Progression-free survival, Breakthrough therapy, Transitional cell carcinoma, Carcinoma, Ureter, Bladder cancer, Patient, PFS, Astellas Pharma, FDA, Pembrolizumab, Brentuximab vedotin, PDUFA, Pharmaceutical industry

TOKYO and BOTHELL, Wash., Nov. 30, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.
  • If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients.
  • We are committed to delivering on our goal of helping patients with advanced urothelial cancer live longer."
  • "Through our clinical development program, data have consistently shown the impact of combining enfortumab vedotin with pembrolizumab for advanced bladder cancer.

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

Retrieved on: 
Friday, November 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

Retrieved on: 
Thursday, November 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.

Seagen Third Quarter 2023 Financial Results Reflect Strong Product Sales Growth, and Significant Portfolio and Pipeline Progress

Retrieved on: 
Wednesday, November 1, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology

Seagen Inc. (Nasdaq:SGEN) (Seagen or the Company) reported financial results today for the third quarter ended September 30, 2023.

Key Points: 
  • Seagen Inc. (Nasdaq:SGEN) (Seagen or the Company) reported financial results today for the third quarter ended September 30, 2023.
  • David Epstein, Chief Executive Officer of Seagen said, “Seagen continues to build momentum in 2023 and delivered strong performance, marked by record quarterly net product sales, with significant year-over-year growth of 33%, contributing to total revenues of $649 million.
  • The PADCEV EV-302 study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer.
  • The safety results in EV-302 were consistent with those previously reported with this combination in EV-103 in cisplatin-ineligible patients with la/mUC.

TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared with Chemotherapy in Global Phase 3 innovaTV 301 Trial

Retrieved on: 
Sunday, October 22, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, European Society for Medical Oncology, Cervical cancer, ESMO, Congress, PFS, Hazard, HIV disease progression rates, Clinical trial, Network, Risk, European Society of Gynaecological Oncology, Progression-free survival, Patient, Death, CI, Pharmaceutical industry

Topline results from innovaTV 301 were disclosed earlier this year following a pre-specified interim analysis conducted through an independent data monitoring committee.

Key Points: 
  • Topline results from innovaTV 301 were disclosed earlier this year following a pre-specified interim analysis conducted through an independent data monitoring committee.
  • The additional results were presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress 2023.
  • In innovaTV 301, treatment-related adverse events (TRAEs) occurring in patients with TIVDAK were generally low grade and manageable with supportive care or dose modifications.
  • “We are excited to share the additional results of the innovaTV 301 trial, which demonstrated benefit in prolonging survival in patients with recurrent or metastatic cervical cancer compared with chemotherapy,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab.

Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) in First-Line Advanced Bladder Cancer

Retrieved on: 
Sunday, October 22, 2023
Research, General Health, Radiology, Pharmaceutical, Oncology, Public Relations, Investor Relations, Clinical Trials, Science, Biotechnology, Communications, FDA, Health, Other Science, Patient, ESMO, Progression-free survival, Pembrolizumab, Congress, PFS, European Society for Medical Oncology, Multimedia, Inc., Confidence interval, Brentuximab vedotin, Risk, Platinum, OS, Death, Abstract, Pharmaceutical industry

The combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

Key Points: 
  • The combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
  • View the full release here: https://www.businesswire.com/news/home/20231017754680/en/
    The EV-302 study met its dual primary endpoints of OS and PFS, compared to platinum and gemcitabine chemotherapy.
  • 55% reduction in the risk of cancer progression or death compared to treatment with chemotherapy (HR=0.45; 95% CI: (0.38-0.54); P
  • The EV-302 trial is part of an extensive program evaluating this combination in multiple stages of urothelial cancer and other solid tumors.