DURABLE RESPONSES WITH IDELALISIB MONOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL)
(Abstract release date: 05/19/16)
EHA Library. Davies A. 06/09/16; 134774; PB1874
Andrew J. Davies
Contributions
Contributions
Abstract
Abstract: PB1874
Type: Publication Only
Background
SLL, an indolent non-Hodgkin lymphoma (iNHL), is often diagnosed at an advanced stage, and patients (pts) with relapsed or refractory (R/R) disease have a poor prognosis. Idelalisib (IDELA), is a selective, oral PI3Kδ inhibitor which as monotherapy (IDELA-mono) showed considerable anti-tumor activity in pts with R/R iNHL in phase 1 (Study 02; NCT00710528) and phase 2 studies (Study 09; NCT01282424; Gopal et al. NEJM. 2014;370:1008-18).
Aims
The objective of this post hoc analysis was to describe the efficacy and safety of IDELA-mono specifically in pts with R/R SLL enrolled in Study 02 or Study 09.
Methods
Eligible pts with previously-treated SLL were those with R/R disease (disease status defined by response to last prior regimen) treated with IDELA-mono across 7 dose cohorts (minimum dose 50 mg BID; maximum dose 350 mg BID) in Study 02, and those with double-refractory disease (to both rituximab and an alkylating agent) treated with IDELA-mono (150 mg BID) in Study 09. In both studies, IDELA was continued until progressive disease (PD) or unacceptable toxicity. Radiographic and pertinent clinical data were reviewed by an independent review committee (IRC) to determine response based on standard criteria for lymphomas (Cheson et al. J Clin Oncol. 2007;25:579-86).
Results
A total of 39 pts with R/R SLL participated in the 2 trials, 11 in Study 02, (5 on IDELA doses ˂100 mg BID; 6 on IDELA doses ˃100 mg BID), and 28 in Study 09 (IDELA 150 mg BID). The median age of pts was 69 and 65 yrs [range 34-87], and 73% and 75% were male, in Studies 02 and 09, respectively. In both studies, 82% of pts had Ann Arbor Stage IV disease at baseline and had received a median of 4 prior regimens [range 1-9]. In Study 02, 9 of the 11 pts (82%) had refractory disease; all 11 pts had received prior regimens containing fludarabine. In Study 09, 27/28 pts (96%) were refractory to both rituximab and an alkylating agent (1/28 pts had received insufficient cycles of bendamustine). Common prior therapies included: rituximab (n=28), cyclophosphamide (n=25), bendamustine (n=21), vincristine (n=19), and fludarabine (n=18). The overall response rate (ORR) was 6/11(55%) in Study 02, with all 6 responders achieving a partial response (PR) and 3/11 pts (27%) having stable disease (SD). In Study 09, the ORR was 17/28 (61%), with a complete response (CR) reported in 1/28 pts (4%), a PR in 16/28 pts (57%) and SD in 10/28 pts (36%); 1 pt (3.6%) was not evaluable. Among responders, median time to response was 0.9 mo and 1.9 mo, respectively; median duration of response (DOR) was 2.3 mo and 12.5 mo. Median progression-free survival (PFS) was 3.7 mo (Study 02) and 11.4 mo (Study 09). Median (KM-estimated OS was not reached for Study 02; OS was 88.9% at 12 mo, 88.9% at 24 mo and 59.3% at 36 mo. Median KM-estimated OS was 22.5 mo in Study 09; OS was 89.1% at 6 mo, 74.3% at 9 mo and 70.4% at 48 mo. In Study 02, grade ≥3 AEs and laboratory abnormalities occurring in ≥20% of pts included pneumonia (n=5), febrile neutropenia (n=3), and neutropenia (n=4). In Study 09, these AEs and laboratory abnormalities included pneumonia (n=7) and neutropenia (n=8).
Conclusion
IDELA-monotherapy provides clinical evidence of efficacy in pts with R/R SLL, with a safety profile similar to that described in other larger clinical trials.
Session topic: E-poster
Keyword(s): Indolent non-Hodgkin's lymphoma, Progression, Targeted therapy
Type: Publication Only
Background
SLL, an indolent non-Hodgkin lymphoma (iNHL), is often diagnosed at an advanced stage, and patients (pts) with relapsed or refractory (R/R) disease have a poor prognosis. Idelalisib (IDELA), is a selective, oral PI3Kδ inhibitor which as monotherapy (IDELA-mono) showed considerable anti-tumor activity in pts with R/R iNHL in phase 1 (Study 02; NCT00710528) and phase 2 studies (Study 09; NCT01282424; Gopal et al. NEJM. 2014;370:1008-18).
Aims
The objective of this post hoc analysis was to describe the efficacy and safety of IDELA-mono specifically in pts with R/R SLL enrolled in Study 02 or Study 09.
Methods
Eligible pts with previously-treated SLL were those with R/R disease (disease status defined by response to last prior regimen) treated with IDELA-mono across 7 dose cohorts (minimum dose 50 mg BID; maximum dose 350 mg BID) in Study 02, and those with double-refractory disease (to both rituximab and an alkylating agent) treated with IDELA-mono (150 mg BID) in Study 09. In both studies, IDELA was continued until progressive disease (PD) or unacceptable toxicity. Radiographic and pertinent clinical data were reviewed by an independent review committee (IRC) to determine response based on standard criteria for lymphomas (Cheson et al. J Clin Oncol. 2007;25:579-86).
Results
A total of 39 pts with R/R SLL participated in the 2 trials, 11 in Study 02, (5 on IDELA doses ˂100 mg BID; 6 on IDELA doses ˃100 mg BID), and 28 in Study 09 (IDELA 150 mg BID). The median age of pts was 69 and 65 yrs [range 34-87], and 73% and 75% were male, in Studies 02 and 09, respectively. In both studies, 82% of pts had Ann Arbor Stage IV disease at baseline and had received a median of 4 prior regimens [range 1-9]. In Study 02, 9 of the 11 pts (82%) had refractory disease; all 11 pts had received prior regimens containing fludarabine. In Study 09, 27/28 pts (96%) were refractory to both rituximab and an alkylating agent (1/28 pts had received insufficient cycles of bendamustine). Common prior therapies included: rituximab (n=28), cyclophosphamide (n=25), bendamustine (n=21), vincristine (n=19), and fludarabine (n=18). The overall response rate (ORR) was 6/11(55%) in Study 02, with all 6 responders achieving a partial response (PR) and 3/11 pts (27%) having stable disease (SD). In Study 09, the ORR was 17/28 (61%), with a complete response (CR) reported in 1/28 pts (4%), a PR in 16/28 pts (57%) and SD in 10/28 pts (36%); 1 pt (3.6%) was not evaluable. Among responders, median time to response was 0.9 mo and 1.9 mo, respectively; median duration of response (DOR) was 2.3 mo and 12.5 mo. Median progression-free survival (PFS) was 3.7 mo (Study 02) and 11.4 mo (Study 09). Median (KM-estimated OS was not reached for Study 02; OS was 88.9% at 12 mo, 88.9% at 24 mo and 59.3% at 36 mo. Median KM-estimated OS was 22.5 mo in Study 09; OS was 89.1% at 6 mo, 74.3% at 9 mo and 70.4% at 48 mo. In Study 02, grade ≥3 AEs and laboratory abnormalities occurring in ≥20% of pts included pneumonia (n=5), febrile neutropenia (n=3), and neutropenia (n=4). In Study 09, these AEs and laboratory abnormalities included pneumonia (n=7) and neutropenia (n=8).
Conclusion
IDELA-monotherapy provides clinical evidence of efficacy in pts with R/R SLL, with a safety profile similar to that described in other larger clinical trials.
Session topic: E-poster
Keyword(s): Indolent non-Hodgkin's lymphoma, Progression, Targeted therapy
Abstract: PB1874
Type: Publication Only
Background
SLL, an indolent non-Hodgkin lymphoma (iNHL), is often diagnosed at an advanced stage, and patients (pts) with relapsed or refractory (R/R) disease have a poor prognosis. Idelalisib (IDELA), is a selective, oral PI3Kδ inhibitor which as monotherapy (IDELA-mono) showed considerable anti-tumor activity in pts with R/R iNHL in phase 1 (Study 02; NCT00710528) and phase 2 studies (Study 09; NCT01282424; Gopal et al. NEJM. 2014;370:1008-18).
Aims
The objective of this post hoc analysis was to describe the efficacy and safety of IDELA-mono specifically in pts with R/R SLL enrolled in Study 02 or Study 09.
Methods
Eligible pts with previously-treated SLL were those with R/R disease (disease status defined by response to last prior regimen) treated with IDELA-mono across 7 dose cohorts (minimum dose 50 mg BID; maximum dose 350 mg BID) in Study 02, and those with double-refractory disease (to both rituximab and an alkylating agent) treated with IDELA-mono (150 mg BID) in Study 09. In both studies, IDELA was continued until progressive disease (PD) or unacceptable toxicity. Radiographic and pertinent clinical data were reviewed by an independent review committee (IRC) to determine response based on standard criteria for lymphomas (Cheson et al. J Clin Oncol. 2007;25:579-86).
Results
A total of 39 pts with R/R SLL participated in the 2 trials, 11 in Study 02, (5 on IDELA doses ˂100 mg BID; 6 on IDELA doses ˃100 mg BID), and 28 in Study 09 (IDELA 150 mg BID). The median age of pts was 69 and 65 yrs [range 34-87], and 73% and 75% were male, in Studies 02 and 09, respectively. In both studies, 82% of pts had Ann Arbor Stage IV disease at baseline and had received a median of 4 prior regimens [range 1-9]. In Study 02, 9 of the 11 pts (82%) had refractory disease; all 11 pts had received prior regimens containing fludarabine. In Study 09, 27/28 pts (96%) were refractory to both rituximab and an alkylating agent (1/28 pts had received insufficient cycles of bendamustine). Common prior therapies included: rituximab (n=28), cyclophosphamide (n=25), bendamustine (n=21), vincristine (n=19), and fludarabine (n=18). The overall response rate (ORR) was 6/11(55%) in Study 02, with all 6 responders achieving a partial response (PR) and 3/11 pts (27%) having stable disease (SD). In Study 09, the ORR was 17/28 (61%), with a complete response (CR) reported in 1/28 pts (4%), a PR in 16/28 pts (57%) and SD in 10/28 pts (36%); 1 pt (3.6%) was not evaluable. Among responders, median time to response was 0.9 mo and 1.9 mo, respectively; median duration of response (DOR) was 2.3 mo and 12.5 mo. Median progression-free survival (PFS) was 3.7 mo (Study 02) and 11.4 mo (Study 09). Median (KM-estimated OS was not reached for Study 02; OS was 88.9% at 12 mo, 88.9% at 24 mo and 59.3% at 36 mo. Median KM-estimated OS was 22.5 mo in Study 09; OS was 89.1% at 6 mo, 74.3% at 9 mo and 70.4% at 48 mo. In Study 02, grade ≥3 AEs and laboratory abnormalities occurring in ≥20% of pts included pneumonia (n=5), febrile neutropenia (n=3), and neutropenia (n=4). In Study 09, these AEs and laboratory abnormalities included pneumonia (n=7) and neutropenia (n=8).
Conclusion
IDELA-monotherapy provides clinical evidence of efficacy in pts with R/R SLL, with a safety profile similar to that described in other larger clinical trials.
Session topic: E-poster
Keyword(s): Indolent non-Hodgkin's lymphoma, Progression, Targeted therapy
Type: Publication Only
Background
SLL, an indolent non-Hodgkin lymphoma (iNHL), is often diagnosed at an advanced stage, and patients (pts) with relapsed or refractory (R/R) disease have a poor prognosis. Idelalisib (IDELA), is a selective, oral PI3Kδ inhibitor which as monotherapy (IDELA-mono) showed considerable anti-tumor activity in pts with R/R iNHL in phase 1 (Study 02; NCT00710528) and phase 2 studies (Study 09; NCT01282424; Gopal et al. NEJM. 2014;370:1008-18).
Aims
The objective of this post hoc analysis was to describe the efficacy and safety of IDELA-mono specifically in pts with R/R SLL enrolled in Study 02 or Study 09.
Methods
Eligible pts with previously-treated SLL were those with R/R disease (disease status defined by response to last prior regimen) treated with IDELA-mono across 7 dose cohorts (minimum dose 50 mg BID; maximum dose 350 mg BID) in Study 02, and those with double-refractory disease (to both rituximab and an alkylating agent) treated with IDELA-mono (150 mg BID) in Study 09. In both studies, IDELA was continued until progressive disease (PD) or unacceptable toxicity. Radiographic and pertinent clinical data were reviewed by an independent review committee (IRC) to determine response based on standard criteria for lymphomas (Cheson et al. J Clin Oncol. 2007;25:579-86).
Results
A total of 39 pts with R/R SLL participated in the 2 trials, 11 in Study 02, (5 on IDELA doses ˂100 mg BID; 6 on IDELA doses ˃100 mg BID), and 28 in Study 09 (IDELA 150 mg BID). The median age of pts was 69 and 65 yrs [range 34-87], and 73% and 75% were male, in Studies 02 and 09, respectively. In both studies, 82% of pts had Ann Arbor Stage IV disease at baseline and had received a median of 4 prior regimens [range 1-9]. In Study 02, 9 of the 11 pts (82%) had refractory disease; all 11 pts had received prior regimens containing fludarabine. In Study 09, 27/28 pts (96%) were refractory to both rituximab and an alkylating agent (1/28 pts had received insufficient cycles of bendamustine). Common prior therapies included: rituximab (n=28), cyclophosphamide (n=25), bendamustine (n=21), vincristine (n=19), and fludarabine (n=18). The overall response rate (ORR) was 6/11(55%) in Study 02, with all 6 responders achieving a partial response (PR) and 3/11 pts (27%) having stable disease (SD). In Study 09, the ORR was 17/28 (61%), with a complete response (CR) reported in 1/28 pts (4%), a PR in 16/28 pts (57%) and SD in 10/28 pts (36%); 1 pt (3.6%) was not evaluable. Among responders, median time to response was 0.9 mo and 1.9 mo, respectively; median duration of response (DOR) was 2.3 mo and 12.5 mo. Median progression-free survival (PFS) was 3.7 mo (Study 02) and 11.4 mo (Study 09). Median (KM-estimated OS was not reached for Study 02; OS was 88.9% at 12 mo, 88.9% at 24 mo and 59.3% at 36 mo. Median KM-estimated OS was 22.5 mo in Study 09; OS was 89.1% at 6 mo, 74.3% at 9 mo and 70.4% at 48 mo. In Study 02, grade ≥3 AEs and laboratory abnormalities occurring in ≥20% of pts included pneumonia (n=5), febrile neutropenia (n=3), and neutropenia (n=4). In Study 09, these AEs and laboratory abnormalities included pneumonia (n=7) and neutropenia (n=8).
Conclusion
IDELA-monotherapy provides clinical evidence of efficacy in pts with R/R SLL, with a safety profile similar to that described in other larger clinical trials.
Session topic: E-poster
Keyword(s): Indolent non-Hodgkin's lymphoma, Progression, Targeted therapy
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