Matches in SemOpenAlex for { <https://semopenalex.org/work/W2604824031> ?p ?o ?g. }
- W2604824031 abstract "8519 Background: PI3K-delta signaling is critical for activation, proliferation and survival of B cells and plays a role in homing and retention in lymphoid tissues. PI3Kδ signaling is hyperactive in many B-cell malignancies. Idelalisib is a first-in-class, selective, oral inhibitor of PI3Kδ. Initial response rate of 42% was previously reported in MCL (Kahl, ICML 2011). Long-term follow-up is now presented. Methods: This phase 1 study evaluated the activity of continuous (48 weeks) idelalisib monotherapy in pts with relapsed or refractory hematologic malignancies. Doses ranged from 50 mg BID to 350 mg BID in 8 cohorts. Response was based on investigator assessments using standard criteria (Cheson et al, 2007). Patients who continued to benefit were able to enroll in an extension study. Results: 40 patients with recurrent MCL enrolled. Patients were 88% male, median age [range] of 69 [52-83] years, 43% with refractory disease. The median [range] number of prior therapies was 4 [1E14]. The median [range] duration of idelalisib treatment was 3.5 [1-26+] months, with 6 (15%) patients continuing on treatment in the extension protocol. Overall response rate (ORR) was 16/40 (40%), with 2/40 CR (5%). The median duration of response (mDOR) was 2.7 months, and median PFS (mPFS) was 3.7 months. The 1-year PFS was 22%. For patients dosed with ≥100 mg BID, ORR was 12/23 (52%), for patients dosed with ≥150 mg BID, ORR was 11/16 (69%) including both CR (12.5%). Most common adverse events included (total%/≥G3%); diarrhea (40/18), nausea (33/5), pyrexia (28/0), fatigue (25/3), rash (25/3), decreased appetite (20/15), URI (20/0), and pneumonia (13/13). Abnormal lab values included (total%/≥G3%) ALT/AST elevations (65/20). 6/40 (15%) patients discontinued therapy due to AEs, potentially treatment related. Conclusions: The oral PI3Kδ inhibitor idelalisib (GSE1101) is active and well tolerated in heavily pre-treated pts with MCL. A proportion of patients have long-term (>1 year) clinical benefit. These data support further clinical evaluation of idelalisib in MCL. Clinical trials with idelalisib in combination with other agents are in progress. Clinical trial information: NCT00710528." @default.
- W2604824031 created "2017-04-14" @default.
- W2604824031 creator A5000921376 @default.
- W2604824031 creator A5000959540 @default.
- W2604824031 creator A5003766253 @default.
- W2604824031 creator A5013974745 @default.
- W2604824031 creator A5015361329 @default.
- W2604824031 creator A5015491065 @default.
- W2604824031 creator A5016570475 @default.
- W2604824031 creator A5027453053 @default.
- W2604824031 creator A5037882455 @default.
- W2604824031 creator A5042317118 @default.
- W2604824031 creator A5048838398 @default.
- W2604824031 creator A5069054551 @default.
- W2604824031 creator A5073720570 @default.
- W2604824031 creator A5075675241 @default.
- W2604824031 creator A5081030176 @default.
- W2604824031 date "2013-05-20" @default.
- W2604824031 modified "2023-10-07" @default.
- W2604824031 title "Final results of a phase I study of idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase P110δ (PI3Kδ), in patients with relapsed or refractory mantle cell lymphoma (MCL)." @default.
- W2604824031 doi "https://doi.org/10.1200/jco.2013.31.15_suppl.8519" @default.
- W2604824031 hasPublicationYear "2013" @default.
- W2604824031 type Work @default.
- W2604824031 sameAs 2604824031 @default.
- W2604824031 citedByCount "9" @default.
- W2604824031 countsByYear W26048240312013 @default.
- W2604824031 countsByYear W26048240312014 @default.
- W2604824031 countsByYear W26048240312015 @default.
- W2604824031 crossrefType "journal-article" @default.
- W2604824031 hasAuthorship W2604824031A5000921376 @default.
- W2604824031 hasAuthorship W2604824031A5000959540 @default.
- W2604824031 hasAuthorship W2604824031A5003766253 @default.
- W2604824031 hasAuthorship W2604824031A5013974745 @default.
- W2604824031 hasAuthorship W2604824031A5015361329 @default.
- W2604824031 hasAuthorship W2604824031A5015491065 @default.
- W2604824031 hasAuthorship W2604824031A5016570475 @default.
- W2604824031 hasAuthorship W2604824031A5027453053 @default.
- W2604824031 hasAuthorship W2604824031A5037882455 @default.
- W2604824031 hasAuthorship W2604824031A5042317118 @default.
- W2604824031 hasAuthorship W2604824031A5048838398 @default.
- W2604824031 hasAuthorship W2604824031A5069054551 @default.
- W2604824031 hasAuthorship W2604824031A5073720570 @default.
- W2604824031 hasAuthorship W2604824031A5075675241 @default.
- W2604824031 hasAuthorship W2604824031A5081030176 @default.
- W2604824031 hasConcept C126322002 @default.
- W2604824031 hasConcept C142424586 @default.
- W2604824031 hasConcept C184235292 @default.
- W2604824031 hasConcept C185592680 @default.
- W2604824031 hasConcept C2777525834 @default.
- W2604824031 hasConcept C2777938653 @default.
- W2604824031 hasConcept C2778461978 @default.
- W2604824031 hasConcept C2779260929 @default.
- W2604824031 hasConcept C2779338263 @default.
- W2604824031 hasConcept C2779878957 @default.
- W2604824031 hasConcept C2780610907 @default.
- W2604824031 hasConcept C502942594 @default.
- W2604824031 hasConcept C55493867 @default.
- W2604824031 hasConcept C71924100 @default.
- W2604824031 hasConcept C86803240 @default.
- W2604824031 hasConcept C87355193 @default.
- W2604824031 hasConceptScore W2604824031C126322002 @default.
- W2604824031 hasConceptScore W2604824031C142424586 @default.
- W2604824031 hasConceptScore W2604824031C184235292 @default.
- W2604824031 hasConceptScore W2604824031C185592680 @default.
- W2604824031 hasConceptScore W2604824031C2777525834 @default.
- W2604824031 hasConceptScore W2604824031C2777938653 @default.
- W2604824031 hasConceptScore W2604824031C2778461978 @default.
- W2604824031 hasConceptScore W2604824031C2779260929 @default.
- W2604824031 hasConceptScore W2604824031C2779338263 @default.
- W2604824031 hasConceptScore W2604824031C2779878957 @default.
- W2604824031 hasConceptScore W2604824031C2780610907 @default.
- W2604824031 hasConceptScore W2604824031C502942594 @default.
- W2604824031 hasConceptScore W2604824031C55493867 @default.
- W2604824031 hasConceptScore W2604824031C71924100 @default.
- W2604824031 hasConceptScore W2604824031C86803240 @default.
- W2604824031 hasConceptScore W2604824031C87355193 @default.
- W2604824031 hasLocation W26048240311 @default.
- W2604824031 hasOpenAccess W2604824031 @default.
- W2604824031 hasPrimaryLocation W26048240311 @default.
- W2604824031 hasRelatedWork W1858739728 @default.
- W2604824031 hasRelatedWork W2025786205 @default.
- W2604824031 hasRelatedWork W2027971058 @default.
- W2604824031 hasRelatedWork W2038053631 @default.
- W2604824031 hasRelatedWork W2056952913 @default.
- W2604824031 hasRelatedWork W2059492063 @default.
- W2604824031 hasRelatedWork W2074224383 @default.
- W2604824031 hasRelatedWork W2130669641 @default.
- W2604824031 hasRelatedWork W2133934152 @default.
- W2604824031 hasRelatedWork W2154066874 @default.
- W2604824031 hasRelatedWork W2169209759 @default.
- W2604824031 hasRelatedWork W2242685318 @default.
- W2604824031 hasRelatedWork W2471878594 @default.
- W2604824031 hasRelatedWork W2498201639 @default.
- W2604824031 hasRelatedWork W2552025694 @default.
- W2604824031 hasRelatedWork W2602086903 @default.
- W2604824031 hasRelatedWork W2796067237 @default.
- W2604824031 hasRelatedWork W2941778812 @default.
- W2604824031 hasRelatedWork W3152481161 @default.
- W2604824031 hasRelatedWork W3152840861 @default.
- W2604824031 isParatext "false" @default.