Oncology

Celltrion Healthcare presents the first real-world data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress

Saturday, June 12, 2021 - 4:45pm

CT-P10 also appeared to be generally well tolerated by patients, with adverse events (AEs) consistent with those reported for reference rituximab.

Key Points: 
  • CT-P10 also appeared to be generally well tolerated by patients, with adverse events (AEs) consistent with those reported for reference rituximab.
  • Over three quarters of patients initiated on CT-P10 achieved complete or partial response by 30 months.
  • We are encouraged by the results of the study as Truxima has demonstrated a similar IRR rate to reference rituximab.
  • Real World Clinical Effectiveness and Safety of CT-P10 in Patients with Diffuse Large B-Cell Lymphoma: Results from a European Non-Interventional Post Authorization Safety Study.

Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis

Saturday, June 12, 2021 - 3:00pm

We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.

Key Points: 
  • We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.
  • In an indolent disease like follicular lymphoma, longer-term data that demonstrate durable responses are critical.
  • The continued durable benefit demonstrated by axicabtagene ciloleucel at nearly two years is exciting, and the substantial survival benefit over current therapies that were seeing in the SCHOLAR-5 analysis is encouraging.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia

Saturday, June 12, 2021 - 8:00am

Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.

Key Points: 
  • Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.
  • Waldenstrms macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients.
  • Fixed-Duration Ibrutinib Plus Venetoclax (I+V) Versus Chlorambucil Plus Obinutuzumab (Clb+O) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL): Primary Analysis of the Phase 3 GLOW Study.
  • Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study Leukemia.

CEL-SCI Announces the Closing of $31.7 Million Bought Deal Offering

Friday, June 11, 2021 - 4:49pm

Additionally, the Company has granted the underwriter a 30-day option to purchase up to 210,000 additional shares to cover over-allotments.

Key Points: 
  • Additionally, the Company has granted the underwriter a 30-day option to purchase up to 210,000 additional shares to cover over-allotments.
  • Kingswood Capital Markets, division of Benchmark Investments, LLC acted as sole book-running manager for the offering.
  • The shares of common stock described above were offered by CEL-SCI pursuant to a "shelf" registration statement on Form S-3 (File No.
  • A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering was filed with the SEC.

Global Next-Generation Sequencing Market to 2025 - Impact of COVID-19 - ResearchAndMarkets.com

Friday, June 11, 2021 - 3:43pm

The "Next-Generation Sequencing: Emerging Clinical Applications and Global Markets 2020-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Next-Generation Sequencing: Emerging Clinical Applications and Global Markets 2020-2025" report has been added to ResearchAndMarkets.com's offering.
  • The global market for clinical next-generation sequencing (NGS) should grow from $5.9 billion in 2020 to $22.9 billion by 2025 with a compound annual growth rate (CAGR) of 31.4% for the period of 2020-2025.
  • This report reviews the main sequencing technologies and explains why genetic variation is important in clinical testing.
  • Industry sectors analyzed include DNA sequencing instruments; long-read sequencing; sequencing informatics; target enrichment; CTC capture and detection; liquid biopsy; cancer screening/early detection; direct to consumer testing; and noninvasive prenatal testing.

Valemetostat Data at EHA Shows Promising Durable Tumor Response in Patients with Peripheral T-Cell Lymphoma and Adult T-Cell Leukemia/Lymphoma

Friday, June 11, 2021 - 3:00pm

Data from the phase 1 study of valemetostat presented at EHA informed the design of the recently initiated pivotal VALENTINE-PTCL01 study.

Key Points: 
  • Data from the phase 1 study of valemetostat presented at EHA informed the design of the recently initiated pivotal VALENTINE-PTCL01 study.
  • The first cohort will enroll patients with PTCL, and a second cohort will enroll patients with ATL.
  • The study will analyze safety endpoints including adverse events as well as pharmacokinetic and exploratory biomarker endpoints.
  • Up to 176 patients will be enrolled at approximately 70 sites in Asia, Europe, North America and Oceania.

Kyowa Kirin welcomes the decision that NICE will revisit their appraisal of the innovative systemic treatment, POTELIGEO®▼ (mogamulizumab), for adults living with two forms of ultra-rare non-Hodgkin lymphoma

Friday, June 11, 2021 - 1:51pm

Kyowa Kirin remains committed to finding a solution for people living with SS or MF to have access to POTELIGEO and will continue discussions with NICE and NHS England to find a resolution.

Key Points: 
  • Kyowa Kirin remains committed to finding a solution for people living with SS or MF to have access to POTELIGEO and will continue discussions with NICE and NHS England to find a resolution.
  • We strongly believe in the clinical and cost effectiveness of POTELIGEO and will continue a dialogue with NICE and NHS England.
  • We are hopeful that NICEs reassessment might bring parity with the SMCs decision to make mogamulizumab available in Scotland.
  • You can learn more about the business of Kyowa Kirin at:

Telix Launches “Gallium Wave” Awareness Website

Friday, June 11, 2021 - 1:04pm

Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announced the launch of a new website Gallium Wave ( galliumwave.com ), as part of the Company's gallium awareness campaign.

Key Points: 
  • Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announced the launch of a new website Gallium Wave ( galliumwave.com ), as part of the Company's gallium awareness campaign.
  • The website illustrates how Telix, in partnership with suppliers, manufacturers and distributors, is paving a new path to increase future access to gallium-68 (68Ga) based radiopharmaceuticals.
  • We are excited to launch this educational resource to increase physician awareness of the reliability, flexibility and accessibility of 68Ga.
  • Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases.

Avacta Announces Registration of its AffiDX SARS-CoV-2 Antigen Lateral Flow Test in EU

Friday, June 11, 2021 - 12:25pm

Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.

Key Points: 
  • Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.
  • The clinical data for Avactas AffiDX SARS-CoV-2 antigen lateral flow test reported 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct
  • The product registration by a Competent Authority in the EU allows the Company to sell the product in the EU for professional use.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: We are delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test in the EU.

Forma Therapeutics Presents New Phase 1 Data on Etavopivat (formerly referred to as FT-4202) at 26th European Hematology Association Congress

Friday, June 11, 2021 - 12:05pm

Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX) a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced new data from its ongoing Phase 1 trial of etavopivat (formerly referred to as FT-4202) being presented at the 26th Annual European Hematology Association (EHA) 2021 Virtual Congress.

Key Points: 
  • Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX) a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced new data from its ongoing Phase 1 trial of etavopivat (formerly referred to as FT-4202) being presented at the 26th Annual European Hematology Association (EHA) 2021 Virtual Congress.
  • Patient data indicated a durable response for those patients receiving treatment beyond two weeks, for up to 12 weeks, with improved hematologic and hemolytic parameters.
  • These initial OLE data support the combined MAD cohort results and show that daily etavopivat treatment also significantly improved hematologic and hemolytic parameters.
  • In preclinical safety studies, etavopivat did not inhibit aromatase activity or affect steroidogenesis, important biological processes responsible for sexual development.