ADC Therapeutics SA
ADC Therapeutics Presents Clinical Data on ADCT-402 and ADCT-301 in Subtypes of Relapsed or Refractory Lymphoma at the 15th International Conference on Malignant Lymphoma
EQS Group-News: ADC Therapeutics SA / Key word(s): Conference ADC Therapeutics Presents Clinical Data on ADCT-402 and ADCT-301 in Subtypes of Relapsed or Refractory Lymphoma at the 15th International Conference on Malignant Lymphoma Ongoing pivotal Phase II clinical trial of ADCT-402 in patients with relapsed or refractory diffuse large B-cell lymphoma anticipated to complete enrollment in third quarter of 2019 Pivotal Phase II clinical trial of ADCT-301 in relapsed or refractory Hodgkin lymphoma expected to commence in coming months “The ADCT-402 data presented at 15-ICML demonstrate its signficant anti-tumor activity and manageable tolerability profile at doses greater than or equal to 120 μg /kg in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL),” said John Radford, MD, FRCP, FMedSci, Professor of Medical Oncology at The University of Manchester and Director of Research at The Christie NHS Foundation Trust, Manchester, UK. “It is particularly encouraging to see the responses in older patients and patients with transformed or primary refractory disease, as in many cases these are very frail and sick patients who have not responded to multiple previous therapies. I believe ADCT-402 has the potential to become an important part of the treatment paradigm for patients with relapsed or refractory DLBCL, if approved, and look forward to the forthcoming interim results of the pivotal Phase II trial.” Regarding the ADCT-301 data, Graham P. Collins, MB, BS, DPhil, Consultant and Lymphoma Lead, Oxford University Hospitals, said, “The response rates we have observed in patients with relapsed or refractory Hodgkin lymphoma in the Phase I trial of ADCT-301 are very encouraging, as these patients have been heavily pretreated with a median of five prior therapies, including stem cell transplantation and highly active agents like brentuximab vedotin and checkpoint inhibitors. The data support further evaluation of ADCT-301 in a pivotal Phase II trial in relapsed or refractory Hodgkin lymphoma.” Chris Martin, PhD, Chief Executive Officer of ADC Therapeutics, added, “On the heels of these encouraging data, we look forward to completing enrollment in the pivotal 140-patient Phase II trial of ADCT-402 in patients with relapsed or refractory DLBCL and, if successful, preparing to file a potential Biologics License Application in the second half of 2020. In addition, based on the compelling data from our 128-patient Phase I trial of ADCT-301 and recent end of Phase I meeting with the U.S. Food and Drug Administration, we plan to start a pivotal Phase II trial in 100 patients with relapsed or refractory Hodgkin lymphoma in the coming months.”
ADCT-402 Oral Presentations at ICML Analysis of Efficacy and Safety of Loncastuximab Tesirine (ADCT-402) by Demographic and Clinical Characteristics in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Abstract 054) Data were presented from Phase I clinical trial subgroup analyses of response to ADCT-402 at doses >=120 μg/kg in 129 patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). As of the October 16, 2018 data cutoff, 129 patients were evaluable for safety and 127 patients were evaluable for efficacy. Key findings from the oral presentation include: – Older patients had a higher overall response rate (ORR) than younger patients (>= 75 years: 59.1%; 65-74 years: 52.8%; <65 years: 33.3%) – Patients with transformed disease had a higher ORR than those with de novo DLBCL (54.8% vs 39.6%) – Median duration of response (DoR) was longer for refractory patients than relapsed patients, and median DoR was comparable for patients to their most recent therapy vs relapsed patients – No difference in ORR was observed between patients who had received <=3 lines vs >3 lines of prior therapy – The most common grade >=3 treatment-emergent adverse events were: gamma-glutamyltransferase increased (20.2%), neutropenia (17.8%), neutrophil count decreased (14%), anaemia (11.6%), thrombocytopenia (11.6%) and platelet count decreased (10.9%)
This preclinical study evaluated the activity of ADCT-402 as a single agent and in combination with approved drugs in lymphoma cell lines. The findings support the continued evaluation of ADCT-402 in ongoing clinical trials in patients with R/R DLBCL and other types of non-Hodgkin lymphoma. Key findings from the oral presentation include: – ADCT-402 demonstrated significant activity in vitro in a wide panel of lymphoma cell lines and sensitivity to ADCT-402 was higher in B-cell lymphomas than T-cell lymphomas – ADCT-402 in vitro activity correlated with CD19 expression at both the cell surface and RNA level – When tested in combination with other drugs, ADCT-402 demonstrated strong synergy with BCL2 inhibitor venetoclax (4/4 cell lines), PI3K-delta inhibitor idelalisib (4/4 cell lines) and chemotherapy agent bendamustine (3/4 cell lines)
Analysis of Clinical Determinants Driving Safety and Efficacy of Camidanlumab Tesirine (ADCT301, Cami) in Relapsed/Refractory (R/R) Classical Hodgkin Lymphoma (cHL) (Abstract 055) Data were presented from Phase I clinical trial subgroup analyses of response to ADCT-301 in patients with R/R classical Hodgkin lymphoma (cHL). At the time of the data cutoff of April 14, 2019, 77 patients were evaluable for safety and 75 patients were evaluable for efficacy. Key findings from the oral presentation include: – ORR for ADCT-301 45 μg/kg was 86.5% and ORR was high across all subgroups, suggesting significant anti-tumor activity across the R/R cHL population – The recommended dose for the pivotal Phase II trial of ADCT-301 in cHL is 45 μg/kg every three weeks (Q3W) dosed for two cycles, followed by 30 μg/kg Q3W to improve tolerability while maintaining anti-cancer activity – Previously reported cases of Guillain-Barré syndrome/radiculopathy did not appear related to prior checkpoint inhibitor exposure
This preclinical study evaluated activity of ADCT-301 as a single agent in 57 lymphoma cell lines and in combination with select drugs in T-cell lymphoma-derived cell lines. The findings support the continued clinical development of ADCT-301 in Hodgkin lymphoma, T-cell lymphomas and other types of non-Hodgkin lymphoma, and identify potential agents for future ADCT-301 combination clinical trials. Key findings from the poster include: – ADCT-301 in vitro activity was highly correlated with CD25 expression at both the cell surface and RNA level – When tested in combination with other drugs, ADCT-301 demonstrated strong synergy with the mTOR inhibitor everolimus (4/4 cell lines), PI3K inhibitor copanlisib (3/4 cell lines), BCL2 inhibitor venetoclax (3/4 cell lines) and HDAC inhibitor vorinostat (3/4 cell lines) Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, “Our presentations at 15-ICML represent the strong dataset we continue to amass for ADCT-402 and ADCT-301 in difficult-to-treat patients, both young and old, with subtypes of relapsed or refractory lymphoma, including DLBCL and Hodgkin lymphoma. The clinical activity we have observed in these populations, which include heavily pretreated patients with unfavorable genetics and primary refractory disease, increases our enthusiasm for the potential utility of ADCT-402 and ADCT-301 as single agents and in combination with other agents, if approved.” The three oral presentations and one poster will be available after 15-ICML under “Posters & Presentations” in the News & Media section of ADC Therapeutics’ web site at www.adctherapeutics.com.
Additional features: Document: http://n.eqs.com/c/fncls.ssp?u=SXWRGCIGSA Document title: ADCT_ICML Data_21.06.2019
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