July 17, 2020
- ADC Therapeutics has dosed the first patient in the pivotal phase 2 portion of its phase 1/2 LOTIS 3 trial (NCT03684694) of loncastuximab tesirine plus ibrutinib in R/R DLBCL or MCL (Mantle Cell Lymphoma).
- The phase 2 portion is to enroll three cohorts: non-germinal center B cell (GCB)-like DLBCL, GCB DLBCL, and MCL.
- Interim data for the phase 1 portion was presented at EHA 2020, as follows:
- Overall response rate (ORR): 75% (complete response [CR] rate: 58.3%)
- Grade ≥3 treatment-emergent adverse events (TRAE): thrombocytopenia (20%), anemia (12%).
- Recommended phase 2 dose: 60 µg/kg.
ADC Therapeutics is working on an aggressive timeline for submission of loncastuximab tesirine. The company disclosed plans to submit a BLA to FDA in 3Q20 based on interim phase 2 results from the LOTIS 3 trial. Data presented at EHA 2020 were an improvement on already impressive data shown at ASH 2019 (with ORR: 44%). It is currently the most advanced of anti-CD19 ADC compounds in the DLBCL pipeline, and if successful, will follow tafasitamab and liso-cel into market. Like tafasitamab, loncastuximab faces the same competitive threats from CAR-T therapies, where oncologists may hesitate to risk future anti-CD19 CAR-T efficacy by prior use of an anti-CD19 antibody, and the encroachment of CAR-T therapies into earlier lines of therapy.
Source: ADC Therapeutics Press Release