The P-II (CAPTIVATE) study evaluates I+V in 323 patients with prior untreated CLL & SLL. The results from the 3yr. follow-up showed deep & durable responses, 36mos. PFS & OS (88% & 98% in all patients, 80% & 96% in del(17p)/TP53 mutated & 86% & 97% in unmutated IGHV), CR rate (57%) & consistent for high-risk subgroups, & m-DoR (not reached), 24mos. CR (94%)
79% with undetectable uMRD & 78% maintained uMRD @12mos. posttreatment with no new SAEs or secondary malignancies
The MRD-guided cohort showed a reduction in circulating CLL cell count in patients with uMRD over those not confirmed uMRD, patients with confirmed uMRD had similar cell counts over healthy donors from cycles 16 – 29, with normalization of critical immune cells
Ref: Janssen | Image: Janssen
