Meeting
2016 ASCO Annual Meeting
Dana-Farber Cancer Institute, Boston, MA
Jennifer R. Brown , Paolo Ghia , Jeffrey Alan Jones , Andrew Pettitt , Jeff Porter Sharman , Loic Ysebaert , Stephan Stilgenbauer , Yeonhee Kim , Terry Newcomb , Nai-Shun Yao , Richard R. Furman
Background: Idelalisib (IDELA) is effective in the treatment of patients (pts) with relapsed/refractory (R/R) CLL. Nonetheless, pts may discontinue (D/C) IDELA due to progressive disease (PD) or adverse events (AEs). In this post hoc analysis, we examined the outcomes of pts with R/R CLL who D/C IDELA and the relationship of these outcomes to IDELA exposure. Methods: Data were pooled for pts treated with IDELA + rituximab (NCT01539512, n = 110), IDELA monotherapy (NCT01539291, extension study), and IDELA + ofatumumab (NCT01659021, n = 173). Time-dependent endpoints, including time to next therapy (TTNT), time to PD (TTPD), and time to death (TTD), were calculated from the dates of permanent IDELA D/C. Kaplan-Meier analysis was used to estimate overall survival (OS) from the date of randomization. Subgroup analyses of OS were performed using the integrated safety data set. Results: Of 283 pts in the safety population, 124 (44%) remained on IDELA, 28 (10%) D/C due to PD, and 131 (46%) D/C for non-PD reasons (AEs, n = 87; “other” reasons, n = 44 [death, n = 7; study withdrawal, n = 21; physician’s decision, n = 14; other, n = 2]). Clinical outcomes for these D/C groups (excluding “other”) are presented in the table. Pts who D/C IDELA due to PD also had longer median IDELA exposure (11 vs 8 mo) than those who D/C due to AEs. Conclusions: Pts who were required to discontinue IDELA due to AEs survived no longer than those required to discontinue due to PD. OS was similar among pts who D/C IDELA, regardless of reason for D/C. Analyses of patient characteristics, type of PD and dose intensities associated with IDELA D/C, as well as outcomes based on timing of D/C due to AEs (early vs late), are ongoing. Clinical trial information: NCT01539512, NCT01539291, NCT01659021
IDELA Ongoing (n = 124) | D/C IDELA Due to PD (n = 28) | D/C IDELA Due to AE (n = 87) | |
---|---|---|---|
Baseline -17p/TP53mut, n (%) | 46 (37.1) | 15 (53.6) | 36 (41.4) |
Median (95% CI) OS, mo | NR (NR, NR) | 18.8 (15.5, NR) | 20.9 (15.8, NR) |
OS at 24 mo, % | 100 | 44.4 | 33.4 |
TTPD | n = 0 | n = 28 | n = 41 |
Median (95% CI), mo | N/A | N/A | 0.8 (0.0, 8.7) |
TTNT | n = 0 | n = 7 | n = 15 |
Median (95% CI), mo | N/A | 0.9 (0.2, 3.7) | 4.6 (1, 20.7) |
TTD | n = 0 | n = 9 | n = 32 |
Median (95% CI), mo | N/A | 2.4 (0.1, 9.9) | 0.7 (0.1, 9.1) |
NR = not reached.
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2016 ASCO Annual Meeting
Poster Session
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia (CLL) and Hairy Cell
NCT01539512, NCT01539291, NCT01659021
J Clin Oncol 34, 2016 (suppl; abstr 7531)
10.1200/JCO.2016.34.15_suppl.7531
7531
87
Abstract Disclosures
2022 ASCO Annual Meeting
First Author: Wojciech Jurczak
2016 ASCO Annual Meeting
First Author: Jacob Drobnyk Soumerai
2022 ASCO Annual Meeting
First Author: Sandro Pignata
2018 ASCO Annual Meeting
First Author: Robert Z. Orlowski