BioCentury
ARTICLE | Clinical News

Dec. 9 ASH Quick Takes: Kite, Principia, Blueprint, Precision and Rocket

December 10, 2019 2:09 AM UTC

Kite plans marketing applications for CD19 CAR T on pivotal MCL data
Kite Pharma Inc. reported a 93% best objective response rate including a 67% complete response rate -- secondary endpoints -- in 60 evaluable relapsed or refractory mantle cell lymphoma patients who received a single infusion of KTE-X19 in the Phase II ZUMA-2 trial. The Gilead Sciences Inc. (NASDAQ:GILD) unit also reported an ongoing response in 57% of patients who had received the anti-CD19 CAR T cells at a median follow-up of 12.3 months. Median duration of response, progression-free survival and overall survival have not yet been reached. Kite plans to submit a BLA by year end for the CD19 CAR T and an MAA next quarter.

Principia gains after immune thrombocytopenia readout
Principia Biopharma Inc. (NASDAQ:PRNB) gained $4.59 (12%) to $41.98 Monday after reporting preliminary data showing PRN1008 improved platelet counts in a Phase I/II trial in treatment-resistant and refractory immune thrombocytopenia. The covalent Btk inhibitor met the primary endpoint of platelet counts of ≥50,000/µL and an increase of ≥20,000/µL vs. baseline in 39% of patients across all dosing arms...