TG Therapeutics amends GENUINE Phase 3 trial
TG Therapeutics announced that it has filed with the FDA an amended protocol for the GENUINE Phase 3 trial. Prior to the amendments, the GENUINE study consisted of two parts: Part I to evaluate the effect of the addition of TG-1101 to ibrutinib on overall response rate, or ORR, in approximately the first 200 patients enrolled, to support a filing for accelerated approval of TG-1101; and Part II to evaluate the effect of the addition of TG-1101 to ibrutinib on progression-free survival, or PFS, in all study patients, to support a filing for full approval of TG-1101. The amended protocol contains the following substantive changes: Part II of the study has been eliminated, and accordingly, the study's sole primary endpoint will be ORR as originally contemplated in Part I; and Target enrollment has been reduced to approximately 120 randomized patients. At the new study size, the study is 90% powered to show a statistically significant improvement in ORR, with the minimal detectable difference of approximately 20%. Additionally, patients will be followed until progression, but the study will no longer be powered for PFS.