EPALINGES

Overland ADCT BioPharma Announces NMPA Accepts Biologics License Application and Grants Priority Review for ZYNLONTA® for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

Retrieved on: 
Monday, July 24, 2023
Biologics license application, Partnership, Blas, Diffuse large B-cell lymphoma, DLBCL, B-cell lymphoma, Trial of the century, Patient, Internal medicine, National Medical Products Administration, ADC, Hospital, Therapy, Party, Safety, BLA, NYSE, NMPA, Pharmaceutical industry

The BLA has been granted priority review by the NMPA.

Key Points: 
  • The BLA has been granted priority review by the NMPA.
  • The application was made based on the positive results from OL-ADCT-402-001, a Phase 2 bridging clinical trial for ZYNLONTA.
  • The study was designed to evaluate the efficacy and safety of ZYNLONTA as a single-agent treatment for Chinese patients with r/r DLBCL.
  • Overland ADCT BioPharma holds the exclusive rights to develop and commercialize ZYNLONTA in Greater China and Singapore.

ADC Therapeutics Announces Plan to Discontinue the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA® (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients

Retrieved on: 
Thursday, July 20, 2023
Rituximab, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, NYSE, Food, Diffuse large B-cell lymphoma, DLBCL, Pharmaceutical industry

LAUSANNE, Switzerland, July 20, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced that it plans to discontinue the Phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Key Points: 
  • LAUSANNE, Switzerland, July 20, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced that it plans to discontinue the Phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
  • Given the challenges of defining the addressable segment of the difficult-to-treat unfit or frail DLBCL patient population, including many patients with significant active underlying co-morbidities, the benefit-risk profile does not support continuation of the LOTIS-9 trial.
  • Following a meeting yesterday, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the trial for new patient enrollment but will allow patients already on therapy who are deriving clinical benefit to remain on therapy after being reconsented.
  • Following treatment of any reconsenting patients, the Company will conduct the necessary steps to conclude the trial and does not plan to continue studying this regimen in the unfit or frail previously untreated DLBCL patient population.

ADC Therapeutics Announces Voluntary Pause of Enrollment in the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA® (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients

Retrieved on: 
Tuesday, July 11, 2023
COPD, Rituximab, Table, Diffuse large B-cell lymphoma, DLBCL, Data monitoring committee, Safety, European Medicines Agency, EMA, Chronic obstructive pulmonary disease, Fibrosis, COVID-19, Patient, ADC, FDA, Therapy, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pulmonary edema, NYSE, DMC, Food, Pharmaceutical industry

These respiratory-related treatment-emergent adverse events (TEAEs) included seven Grade 5 fatal events and five Grade 3 or Grade 4 respiratory-related TEAEs.

Key Points: 
  • These respiratory-related treatment-emergent adverse events (TEAEs) included seven Grade 5 fatal events and five Grade 3 or Grade 4 respiratory-related TEAEs.
  • Four out of the five Grade 3 or Grade 4 events have since resolved and the patients have completed treatment per protocol.
  • The Company’s decision to pause enrollment enables time to evaluate data around the TEAEs and determine next steps.
  • “Our top priority is the safety of every patient who participates in our clinical trials,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics.

ADC Therapeutics Announces Evolution of Board of Directors

Retrieved on: 
Thursday, June 15, 2023
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LAUSANNE, Switzerland, June 15, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced the election of Robert W. Azelby to its Board of Directors. Mr. Azelby brings more than 30 years of biopharmaceutical leadership and commercial experience to ADC Therapeutics’ Board.

Key Points: 
  • Mr. Azelby brings more than 30 years of biopharmaceutical leadership and commercial experience to ADC Therapeutics’ Board.
  • “As the ADC space continues to gain positive momentum, I look forward to helping ADC Therapeutics leverage its strengths to achieve its objectives and drive growth.”
    Mr. Azelby currently serves on the Board of Directors of Clovis Oncology, Inc. and Chinook Therapeutics.
  • With these changes, ADC Therapeutics’ Board will now have nine directors, the majority of whom are independent under NYSE listing standards.
  • “On behalf of my fellow Board members and ADC Therapeutics’ employees, I’d like to thank Stephen, Michael, Chris and Jacques for their dedication and invaluable contributions to ADC Therapeutics since its inception,” said Mr. Squarer.

ADC Therapeutics Announces Updated LOTIS-2 Results Demonstrating Durable, Long-Term Responses of ZYNLONTA® in Relapsed/Refractory DLBCL

Retrieved on: 
Friday, June 9, 2023
Online, Lymphoma, Neutropenia, Abstract, Wiley (publisher), Diffuse large B-cell lymphoma, DLBCL, European Hematology Association, Non-Hodgkin lymphoma, OH, Doctor of Philosophy, Gamma-glutamyltransferase, B-cell lymphoma, ORR, Medical College of Wisconsin, International Conference on Conceptual Modeling, CEST, Ira Middleswarth & Son, Inc., EHA, CR, Pivotal, ADC, Therapy, NYSE, Thrombocytopenia, Conference, Safety, Disease, Pharmaceutical industry, Book, MD, Patient, Gallery

LAUSANNE, Switzerland, June 09, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Key Points: 
  • LAUSANNE, Switzerland, June 09, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
  • “We’re pleased to be sharing updated LOTIS-2 results demonstrating the long‐term efficacy and safety of ZYNLONTA with the lymphoma community at EHA2023 and 17-ICML,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics.
  • The median (range) time to response was 41.0 (35 to 247) days for all responders and 42.0 (36 to 247) days for patients with a CR.
  • All-grade treatment‐emergent adverse events occurring in ≥30% of all patients were increased gamma-glutamyltransferase (42%), neutropenia (40%), and thrombocytopenia (33%).

ADC Therapeutics to Participate in the Jefferies Healthcare Conference

Retrieved on: 
Thursday, June 1, 2023
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LAUSANNE, Switzerland, June 01, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced that Ameet Mallik, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference in New York City on Thursday, June 8th at 8:30 a.m. EDT.

Key Points: 
  • LAUSANNE, Switzerland, June 01, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced that Ameet Mallik, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference in New York City on Thursday, June 8th at 8:30 a.m. EDT.
  • A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com .
  • A replay of the webcast will be available for approximately 30 days.