ADC Therapeutics SA (NYSE:ADCT) has submitted a Biologics Licence Application (BLA) to the FDA for loncastuximab tesirine for treating patients with refractory or relapsed diffuse large B-cell lymphoma (DCBCL).
BLA submission for Lonca a huge milestone
Chris Martin, the company’s CEO, stated that completing the first BLA submission was a huge milestone for the company, which takes it a step further in the evolution towards becoming a commercial-stage organization. Martin added that they were thankful to the study participants and investigators to commit to the clinical program. He added that ADC Therapeutics is looking forward to working with the FDA to deliver Lonca to patients as soon as possible.
The BLA application is supported by data from the pivotal Phase 2 multi-center, single-arm, open-label, LOTIS 2 clinical study. The trial evaluated the safety and efficacy of Lonca in treating patients with refractory or relapsed DLBCL after more than two lines of previous systemic therapy. In June, ADC Therapeutics presented maturing LOTIS 2 data at the 25Th virtual European Haematology Association Congress. Around 145 patients had enrolled in the study as of April 6, 2020, with the patients having received a median of 3 lines of therapy before.
Lonca showed manageable tolerability
Lonca showed an overall response rate of 48.3%, which was 70 out of the 145 patients, while there were complete responses in 35 of the 145 patients, which are a rate of 24.1%. There was a manageable tolerability profile with the most common treatment adverse event shown in around 10% of the patients being thrombocytopenia at 17.9%, anemia at 10.3%, GGT increased 16.6%, and neutropenia at 25.55 with a low occurrence of febrile neutropenia. AD
The company’s SVP and Chief Medical officer Jay Feingold said that there is a critical unmet need for heavily pre-treated patients having refractory or relapsed DLBCL. This includes those with poor prognosis, those that didn’t respond to previous therapy, and those that had received previous stem cell transplant. Jay said that lonca showed in LOTIS 2 that it can fill the need.