GlobeNewswire

ADC Therapeutics Presents Updated Data from Clinical Trials of Novel Antibody Drug Conjugates

Share

ADCT-402 (loncastuximab tesirine) continues to demonstrate acceptable safety profile and anti-tumor activity in patients with relapsed or refractory diffuse large B-cell lymphoma; data from 183-patient study supports continued evaluation in ongoing pivotal Phase II trial

ADCT-301 (camidanlumab tesirine) achieves 86.5 percent overall response rate in heavily pretreated patients with Hodgkin lymphoma; data from 113-patient study supports further investigation in pivotal Phase II trial

Data presented at 60th American Society of Hematology (ASH) Annual Meeting

LAUSANNE, Switzerland, Dec. 05, 2018 (GLOBE NEWSWIRE) -- ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), presented updated data from ongoing Phase I clinical trials of ADCT-402 (loncastuximab tesirine) and ADCT-301 (camidanlumab tesirine) in multiple subtypes of lymphoma during oral and poster presentations at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego.

“We are encouraged by the safety profiles and strong single-agent anti-tumor activity we continue to observe in the 183-patient first-in-human clinical trial of ADCT-402 and the 113-patient trial of ADCT-301,” said Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics. “The updated ADCT-402 data presented at ASH support its continued evaluation in our ongoing pivotal clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma. For ADCT-301, we now have the dosing data to support further investigation in a planned pivotal Phase II trial in patients with relapsed or refractory Hodgkin lymphoma, which we look forward to initiating in 2019.”  

ADCT-402 Oral and Poster Presentations at ASH

Interim Results from the First-in-Human Clinical Trial of ADCT-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Abstract 398)
Oral presentation: John Radford, MD, FRCP, Manchester Academic Health Centre, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK

Data were presented from a subpopulation of 139 evaluable patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had failed or were intolerant to established therapies. The patients had a median age of 63 years and had received a median of three previous therapies. Patients received doses of ADCT-402 ranging from 15 to 200 µg/kg every three weeks. The median number of cycles received was two and the median duration of treatment was 43 days.

Key findings from the oral presentation include:

  • ADCT-402 has demonstrated manageable toxicity in patients with R/R DLBCL
  • At doses >120 µg/kg, the overall response rate (ORR) was 43.3% (55/127 patients with DLBCL), comprising 23.6% complete responses and 19.7% partial responses
  • At doses >120 µg/kg, after a median follow up of 5.5 months, median duration of response (DoR) was not reached in patients achieving a complete response

A pivotal Phase II study is currently enrolling patients with R/R DLBCL to evaluate the efficacy and safety of ADCT-402 at dose 150 µg/kg every three weeks for two cycles followed by dose 75 µg/kg every three weeks (NCT03589469).

Safety and Efficacy of ADCT-402 (Loncastuximab Tesirine), a Novel Antibody Drug Conjugate, in Relapsed/Refractory Follicular Lymphoma and Mantle Cell Lymphoma: Interim Results from the Phase I First-in-Human Study (Abstract 2874)
Poster presentation: Paolo Caimi, MD, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH

Data were presented from a subgroup of 29 patients, including 14 patients with follicular lymphoma (FL) and 15 patients with mantle cell lymphoma (MCL). The median age of the FL patients was 60.5 years and the median age of the MCL patients was 64 years. Patients received infusions every three weeks at doses ranging from 15 to 200 µg/kg. Patients with FL and MCL received a median of three and two cycles of ADCT-402, respectively.

Key findings from the poster presentation include:

  • ADCT-402 has demonstrated manageable toxicity in patients with R/R FL and R/R MCL
  • In patients with FL, ORR was 78.6% (11/14) and median DoR was not reached after a median follow-up time of 11.6 months
  • In patients with MCL, ORR was 46.7% (7/15) and median DoR was not reached after a median follow-up time of 8.7 months

ADCT-301 Oral and Poster Presentations at ASH

Phase I Study of ADCT-301 (Camidanlumab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory Classical Hodgkin Lymphoma (Abstract 928)
Oral presentation: Mehdi Hamadani, MD, Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI

Data were presented from 67 evaluable, heavily pretreated patients with relapsed/refractory (R/R) classical Hodgkin Lymphoma (HL) who had failed or were intolerant to any established therapy known to provide clinical benefit. The median age of the patients was 38 years and they had received a median of five prior therapies. Patients were treated with doses of ADCT-301 ranging from 5 to 300 µg/kg. They completed a median of three cycles of treatment and median treatment duration was 43 days.

Key findings from the oral presentation include:

  • ADCT-301 has demonstrated manageable toxicity in patients with R/R HL
  • The most common Grade 3 or 4 treatment-emergent adverse events occurring in at least 5 percent of patients, regardless of attribution, at the 45 µg/kg dose in 37 patients were: maculopapular rash (18.9 percent),elevated gamma-glutamyltransferase (8.1 percent), elevated alanine aminotransferase (8.1 percent), elevated aspartate aminotransferase (2.7 percent),  anemia (8.1 percent), Guillain-Barré syndrome / radiculopathy (8.1 percent) and increased lipase (8.1 percent)
  • In patients with R/R HL, therapy with ADCT-301 achieved an overall response rate (ORR) of 86.5% in the 37 patients in the 45 µg/kg dose group who had received and failed prior brentuximab vedotin and most of whom had failed prior checkpoint inhibitor treatment
  • These data support further investigation of the 45 µg/kg dose of ADCT-301 in a planned pivotal Phase II study anticipated to commence in 2019

ADCT-301 (Camidanlumab Tesirine), a Novel Pyrrolobenzodiazepine-Based CD25-Targeting Antibody Drug Conjugate, in a Phase I Study of Relapsed/Refractory Non-Hodgkin Lymphoma Shows Activity in T-Cell Lymphoma (Abstract 1658)
Poster presentation: Graham P. Collins, MB, BS, DPhil, Oxford University Hospitals, NHS Trust, Oxford, UK

Data were presented from 44 patients with R/R non-Hodgkin lymphoma (NHL) with a median age of 65.5 years who had received a median number of four previous systemic therapies (including prior stem cell transplant). Of those, 22 patients were in a T-cell lymphoma subgroup. Patients were treated with doses of ADCT-301 ranging from 3 to 150 µg/kg and received a median number of two cycles. Median treatment duration was 22 days.

Key findings from the poster presentation include:

  • ADCT-301 demonstrated an acceptable safety profile during dose-escalation
  • Overall, in patients with R/R NHL, therapy with ADCT-301 achieved an ORR of 31.7% (13/41) at doses >60 µg/kg
  • In the R/R T-cell lymphoma subgroup, therapy with ADCT-301 achieved an ORR of 53.8% (7/13) in the 60 and 80 µg/kg dose groups
  • These data support further investigation of ADCT-301 in T-cell lymphoma

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (NCT03589469). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of DLBCL and mantle cell lymphoma.

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax®-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235), as well as a Phase Ib clinical trial in solid tumors (NCT03621982).

About ADC Therapeutics

ADC Therapeutics SA is an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs) targeting major hematological malignancies and solid tumors. The Company’s ADCs are highly targeted biopharmaceutical drugs that combine monoclonal antibodies specific to surface antigens present on particular tumor cells with a novel class of highly potent pyrrolobenzodiazepine (PBD)-based warheads via a chemical linker. The Company has multiple PBD-based ADCs in ongoing clinical trials in the USA and Europe, and a deep pipeline of other preclinical ADCs in development. ADC Therapeutics has world-class partners, including AstraZeneca and its global biologics research and development arm, MedImmune. The Company is based in Lausanne (Biopôle), Switzerland and has operations in London, San Francisco and New Jersey. For more information, visit www.adctherapeutics.com.

         
Investors Contact   EU Media Contact   USA Media Contact
Dr. Chris Martin   Alexandre Müller   Tony Plohoros
Chief Executive Officer   Dynamics Group   6 Degrees
Chris.martin@adctherapeutics.com    amu@dynamicsgroup.ch    tplohoros@6degreespr.com 
Tel.: +41 (0) 21 653 0200   Tel: +41 (0) 43 268 3231   Tel.: +1 908-591-2839

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Nordisk næringsliv fokuserer på innovasjon og forbedring av kundeopplevelsen27.1.2020 10:00:00 CETPressemelding

Rapporten ISG Provider Lens™ viser at selskaper i regionen henvender seg til leverandører av digitale forretningstjenester for hjelp med analyse, kunstig intelligens og andre teknologier STOCKHOLM i Sverige, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Næringslivet i de nordiske landene fokuserer på å forbedre kundeopplevelsen og innovasjonen, og kontakter leverandører av digitale forretningstjenester for å nå målene sine. Dette viser en ny rapport som ble publisert i dag av Information Services Group ( ISG ) (Nasdaq: III ), et verdensledende teknologisk forsknings- og rådgivningsselskap. Rapporten 2019-2020 ISG Provider Lens™ Digital Business – Solutions and Service Partners for Norden viser at bedrifter i regionen omfavner teknologier som dataanalyse, kunstig intelligens, tingenes internett og blokkjeder for å levere kvalitetstjenester til kundene sine og for å skille ut seg fra konkurrenter. «Nordiske bedrifter søker transformasjonstjenester fra IT-leverandører for ikke bare å bli veiledet gje

UPM commits to UN Business Ambition for 1.5°C to mitigate climate change27.1.2020 10:00:00 CETPress release

(UPM, Helsinki, 27 January 2020 at 11:00 EET) – UPM commits to the United Nations Global Compact’s Business Ambition for 1.5°C, joining leading companies in a promise to pursue science-based measures to limit global temperature rise to 1.5°C. UPM will strive to mitigate climate change and drive value creation through innovating novel products, committing to a 65% CO2 emission reduction and by practicing sustainable forestry. The 1.5°C ambition is a response to increasing concern about the severe consequences of a failure to stop global warming. UPM is among the first global forest industry companies making this commitment. “UPM has a unique opportunity to make a positive impact and contribute to mitigating climate change by tangible actions. We innovate climate-positive products and turn them into growing businesses. At the same time, we limit risks from climate mitigation policies and physical impacts of changing climate. This is important for the long-term value of the company,” says

Valmet to supply a board machine rebuild to Umka in Serbia27.1.2020 10:00:00 CETPress release

Valmet Oyj’s press release on January 27, 2020 at 11:00 a.m . EET Valmet will supply a board machine rebuild to Umka Cardboard Mill in Serbia. The main target of the rebuild is to increase the customer’s production capacity. The start-up of the rebuilt paper machine PM 1 is scheduled for the second half of 2021. The order is included in Valmet's orders received of the fourth quarter 2019. The value of the order will not be disclosed. The total value of an order of this type is typically around EUR 15-20 million. "This rebuild is one of the most important strategic decisions we have made in the course of 80 years long history of the mill. We are pleased that this project is going to be completed by Valmet, a global leader in the supply of process technology in the paper industry. I strongly believe in the success and bright future of Umka Cardboard Mill, with planned capacity of over 200,000 tonnes, further quality improvements and wider product portfolio,” says Milos Ljusic, Managing D

Nordic Enterprises Focus on Innovation and Improving Customer Experience27.1.2020 10:00:00 CETPress release

ISG Provider Lens™ report finds companies in the region turning to digital business services providers for help with analytics, artificial intelligence and other technologies STOCKHOLM, Sweden, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Enterprises in the Nordic countries are focused on improving customer experience and enhancing innovation, and they are turning to digital business service providers to achieve their goals, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2019-2020 ISG Provider Lens™ Digital Business – Solutions and Service Partners Report for the Nordics finds enterprises in the region embracing technologies such as data analytics, artificial intelligence, the Internet of Things and blockchain to deliver quality services to their customers and to differentiate themselves from competitors. “Nordic enterprises are seeking transformation services from IT providers to not only ta

Nordiska företag fokuserar på innovation och förbättrar kundupplevelsen27.1.2020 10:00:00 CETPressemelding

Rapport från ISG Provider Lens™ visar att företag i regionen vänder sig till leverantörer av digitala företagstjänster för hjälp med analys, artificiell intelligens och annan teknik STOCKHOLM, Sverige, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Företag i Norden är inriktade på att förbättra kundupplevelse och innovation, och de vänder sig till leverantörer av digitala företagstjänster för att uppnå sina mål, enligt en ny rapport publicerad idag av Information Services Group ( ISG ) (Nasdaq: III ), ett ledande företag inom global teknikforskning och -rådgivning. Rapporten Digital verksamhet – lösningar och servicepartners2019–2020 från ISG Provider Lens™ för Norden visar att företag i regionen anammar teknik som dataanalys, artificiell intelligens, sakernas internet och blockkedja för att leverera kvalitetstjänster till sina kunder och för att utmärka sig bland konkurrenterna. ”De nordiska företagen söker transformationstjänster från IT-leverantörer för att inte bara ta dem genom sina digitala r

Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer27.1.2020 07:00:00 CETPress release

·Application is being reviewed under FDA’s Real-Time Oncology Review pilot programme Basel, 27 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In July 2018, the FDA granted Breakthrough Therapy Designation for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial. “Liver cancer is the most rapidly increasing cause of cancer-related death in the United States. In the IMbrave150 study, Tece