ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, provided an update on the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).
The CADENZA study is enrolling frontline BPDCN patients, including patients with de novo disease and those with a prior or concomitant hematologic malignancy (PCHM). Although complete responses have been observed in BPDCN patients who present with PCHM, most will not achieve full hematologic recovery due to the impact of their prior or concomitant malignancy. For these patients, achieving a complete response with partial hematological recovery (CRh) is a potentially important measure of clinical benefit. The Company has aligned with FDA that the efficacy analysis will be conducted in de novo BPDCN patients with CR/CRc as the primary endpoint and the key secondary endpoint of duration of CR/CRc. The Company will also continue to enroll PCHM patients in CADENZA to further explore the potential benefits of pivekimab in this population. Based upon this guidance from FDA, the Company will enroll up to 20 de novo patients for purposes of the efficacy analysis. To date, a total of 6 de novo BPDCN patients have enrolled in CADENZA. Given this is an ultra-rare disease, the Company now expects to report top-line data on the primary and key secondary endpoints in 2024.
Read more here