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Association details:
| Biomarker: | CCND1 overexpression |
|---|---|
| Cancer: | Mantle Cell Lymphoma |
| Drug: | parsaclisib (INCB50465) (PI3Kδ inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
An open-label study of INCB050465 in patients with relapsed or refractory Mantle Cell Lymphoma with or without prior exposure to a BTK inhibitor.
Excerpt:
...Subjects with pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or t(11;14), who have had at least 1 but no more than 3 prior systemic treatment regimens. ...
Trial ID:
Source:
Title:
Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Not Previously Treated with a BTK Inhibitor: Primary Analysis from a Phase 2 Study (CITADEL-205)
Published date:
11/04/2021
Excerpt:
Eligible pts were ≥18 years old, had pathologically confirmed MCL with documented cyclin D1 overexpression or t(11;14) translocation…The ORR (95% CI) was 68.5% (58.9–77.1) for all pts and 70.1% (58.6–80.0) for the DG (Table 1); CRR (95% CI) was 17.6% (10.9–26.1) for all pts and 15.6% (8.3–25.6) for the DG. Among all treated pts with complete or partial response, 89.2% of responses occurred at the first disease assessment. Median (95% CI) DOR was 13.7 (9.0–19.9) months for all pts and 12.1 (9.0–not estimable) months for the DG. Median (95% CI) PFS was 11.99 (8.3–16.9) months for all pts and 13.6 (10.0–16.9) months for the DG. Parsaclisib monotherapy demonstrated a rapid and durable response, had an acceptable safety profile, and was generally well tolerated in BTK inhibitor–naive pts with R/R MCL.
DOI:
10.1182/blood-2021-147867
Trial ID:
Source:
Title:
1121 Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Not Previously Treated with a BTK Inhibitor (CITADEL-205)
Published date:
11/04/2020
Excerpt:
Pts must be ≥18 years of age with pathologically confirmed MCL, R/R to the most recent treatment, documented cyclin D1 overexpression...Parsaclisib demonstrated a high rate of rapid and durable response, and had an acceptable safely profile and was generally well tolerated. These preliminary results suggest that parsaclisib represents a potentially new drug class and treatment option for BTKi-naïve, R/R MCL.
Trial ID:
