ADC Therapeutics and SOPHiA GENETICS have entered into a collaboration to identify genomic markers associated with clinical response to loncastuximab tesirine (ADCT-402), an antibody drug conjugate or ADC comprised of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin.
Loncastuximab tesirine is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)(NCT03589469), a Phase Ib trial in combination with ibrutinib in patients with R/R DLBCL or mantle cell lymphoma (MCL) (NCT03684694) and a Phase Ib trial in combination with durvalumab in patients with R/R DLBCL, MCL or follicular lymphoma (NCT03685344).
Somatic mutation analysis
As part of the collaboration, SOPHiA GENETICS will conduct somatic mutation analysis of more than 4,000 genes in cell-free DNA (cfDNA) samples extracted from blood of DLBCL patients participating in ADC Therapeutics’ Phase II trial.
The company will match detected genomic markers with clinical response to loncastuximab tesirine. The analytical power of SOPHiA, an advanced AI technology helping healthcare professionals make sense of the large amount of clinical data, will help scientists at ADC Therapeutics in detecting cancer mutations which is key for this new development phase. It illustrates the benefits of adopting Data-Driven Medicine applications for clinical trials.
“Our collaboration with SOPHiA GENETICS has the potential to uncover genomic mutations that correlate with clinical response to loncastuximab tesirine,” noted Patrick van Berkel, Senior Vice President of Research and Development at ADC Therapeutics.
“We have observed significant single-agent clinical activity in our pivotal Phase II trial of ADCT-402 in a broad population of patients with relapsed or refractory diffuse large B-cell lymphoma. The insights from this collaboration will allow us to better identify and understand the characteristics of patients who respond best to treatment. We look forward to the results of this research enabled by SOPHiA’s unique platform,” he added.
“We are pleased to partner with ADC Therapeutics, a leader in antibody drug conjugate development, to provide advanced biomarker analysis and turn the results into actionable insights that can improve clinical outcomes for patients and pave the way towards a new era in drug development,” said Esteban Czwan, Senior Vice President BioPharma at SOPHiA GENETICS.
The companies did not disclose financial terms of the collaboration.
Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma – NCT03589469
Safety and Antitumor Activity Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma – NCT03684694
Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma – NCT03685344