TGR-1202: Additional Phase I/II data

Additional data from 9 evaluable patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in the open-label, dose-escalation, U.S. Phase I UTX-TGR-103 trial showed that ublituximab in combination with TGR-1202 led to 6 partial responses. The remaining 3 patients achieved nodal reductions of about 15-45% accompanied by either normalization of absolute lymphocyte count (ALC) or a >50% reduction in ALC. In patients with diffuse large B cell lymphoma (DLBCL) (n=7), ublituximab plus TGR-1202 led to an ORR of 43%, including 2 complete responses. All 3 DLBCL responders remained progression free for >7 months. Additionally, all patients with follicular lymphoma (n=9) treated with ublituximab plus TGR-1202 were stable at first assessment and showed reduction in tumor mass. Patients received 600 or 900 mg ublituximab plus 800 or 1,200 mg TGR-1202 or 900 mg ublituximab plus 400 or 600 mg micronized TGR-1202. The trial continues to enroll patients to receive 900 mg ublituximab plus 800 or 1,200 mg micronized TGR-1202.

In 3 evaluable patients in the triple-combination cohort, ublituximab plus TGR-1202 and Imbruvica ibrutinib led to1 PET-negative complete response in a patient with mantle cell lymphoma (MCL) and 1 partial response in a patient with follicular lymphoma. Patients received 900 mg ublituximab plus 400 mg micronized TGR-1202 and Imbruvica. The triple combination cohort continues to enroll patients to receive 900 mg ublituximab plus 600 mg micronized TGR-1202 and Imbruvica. Data were presented at the American Society of Hematology meeting in San Francisco. TG Therapeutics previously reported data from the trial (see BioCentury, Aug. 11, 2014). ...