FDA-Approved PI3K Inhibitors for CLL and FL

Slides:



Advertisements
Similar presentations
Final Results of a Phase 1 Study of Idelalisib (GS-1101), a Selective Inhibitor of Phosphatidylinositol 3-Kinase p110 Delta (PI3K), in Patients with Relapsed.
Advertisements

Rituximab plus Lenalidomide Improves the Complete Remission Rate in Comparison with Rituximab Monotherapy in Untreated Follicular Lymphoma Patients in.
A Phase 1 Study of the Selective Phosphatidylinositol 3-Kinase-Delta (PI3Kδ) Inhibitor, Idelalisib (GS- 1101) in Combination with Rituximab and/or Bendamustine.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib and Rituximab for Previously Treated Patients.
Phase II Multicenter Study of Single-Agent Lenalidomide in Subjects with Mantle Cell Lymphoma Who Relapsed or Progressed After or Were Refractory to Bortezomib:
CDK 4 and 6 Inhibitors in HR-Positive Advanced Breast Cancer: Assessing New Data.
Campos M et al. Proc EHA 2013;Abstract B2009.
Campos M et al. Proc EHA 2013;Abstract B2009.
Idelalisib plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a.
Shustov AR et al. Proc ASH 2010;Abstract 961.
Nivolumab in Patients (Pts) with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL): Clinical Outcomes from Extended Follow-up of a Phase 1 Study.
Ibrutinib plus Rituximab in Treatment-Naive Patients with Follicular Lymphoma: Results from a Multicenter, Phase 2 Study1 Phase I Study of Rituximab,
New Findings in Hematology: Independent Conference Coverage
Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia
Figure 1. Progression-free survival and overall survival for FL/DLBCL patients. From: Clinicobiological features and prognostic impact of diffuse large.
The Use of PARP Inhibitors in Breast Cancer: Challenges and Opportunities.
Evolving Paradigms in the Management of HR-Positive Breast Cancer
CDK 4 and 6 Inhibitors in HR-Positive Breast Cancer: Implementing Paradigms in Clinical Practice.
Relapsed/Refractory Follicular Lymphoma Conundrums
Case Studies.
Peripheral T-Cell Lymphoma in 2013
Overall Program Goals. Overall Program Goals Current Approaches.
Metastatic Renal Cell Carcinoma
Prolonging Progression-Free Survival in Follicular Lymphoma
Continuing the Advances in Relapsed/Refractory CLL: New Data, New Paradigms.
Current and Future Goals in the Treatment of Relapsed CLL
PARP Inhibitors and Cancer: What Do You Need to Know?
BTK Inhibitors in Relapsed/Refractory Mantle Cell Lymphoma
CDK4/6 Inhibitors in Breast Cancer:
Updates in Follicular Lymphoma
Emerging Targeted Agents for Relapsed/Refractory Non-Hodgkin Lymphoma
CDK 4 and 6 Inhibitors in HR-Positive Advanced Breast Cancer: Assessing New Data.
Novel and Emerging Approaches to Treating CLL
The Nurse View.
Activity Goals. Activity Goals Case Presentation.
Managing gBRCA-Positive Metastatic Breast Cancer
Treatment Decisions in Chemorefractory Follicular Lymphoma
Coiffier B et al. Proc ASH 2010;Abstract 857.
Updates in Lymphoma From Recent Congresses
Practical Guidance on Using New Therapies for Relapsed/ Refractory Follicular Lymphoma and Chronic Lymphocytic Leukemia.
Evaluating Next-Generation BTK Inhibitors
A Spotlight on PI3K Inhibition in Relapsed/Refractory B-Cell Lymphoma
Targeting BTK Signaling in B-Cell Malignancies
Managing Adverse Events With New Oral Therapies in CLL
Emerging Frontline Treatments for Patients With Hodgkin Lymphoma
New Horizons in Adjunctive Type 1 Diabetes Management With SGLT Inhibitors.
Personalized Therapy in Relapsed or Refractory CLL
How to Select Therapy In Newly Diagnosed CLL
Myeloid Updates From the Summer Congresses
PARP Inhibitors.
This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the US, and data that were.
Managing Patients with Relapsed CLL who Discontinue BCR Signaling Inhibitors.
This program will include a discussion of off-label treatment and investigational agents not approved by the FDA for use in the US, and data that were.
Individualizing Therapy for Patients With CLL in the Community Practice Setting: Focus on Age and Comorbidities.
VOD/SOS: Aligned Education for Patients and the Interprofessional Team
Emerging Regimens in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Ahmadi T et al. Proc ASH 2011;Abstract 266.
New Paradigms in M0 CRPC.
Checkpoint Inhibitors in First-Line Advanced NSCLC
How to Select Therapy in Relapsed/Refractory CLL
CDK4/6 Inhibitors.
Presented By Caroline Dartigeas at 2016 ASCO Annual Meeting
A Closer Look.
Clinical Focus.
Mitigating Side Effects and Optimizing Compliance With Oral Therapies in CLL.
Changing Paradigms in Relapsed/Refractory Indolent NHL
Care Team Collaboration for CAR T-Cell Therapy: Real-World Advice
PCSK9 Inhibitors and Real-World Evidence
Interprofessional Approach to Managing Adverse Events of PI3K Inhibitors.
Presentation transcript:

Using PI3K Inhibitors for Relapsed/Refractory CLL and Follicular Lymphoma

FDA-Approved PI3K Inhibitors for CLL and FL

Idelalisib Registration Trial for R/R FL (101-09)

101-09: Best Overall Response

101-09: Other Key Efficacy Endpoints

101-09: Efficacy in Early Relapsed FL Subset

101-09: Most Common Grade 3/4 AEs

Idelalisib Registration Trial for R/R CLL (116)

Study 116: Overall Response Rate

Study 116: Progression-Free Survival

Study 116: Overall Survival

Common Toxicities Associated With Idelalisib

Copanlisib Registration Trial for R/R FL: CHRONOS-1

CHRONOS-1: ORR

CHRONOS-1: Other Key Efficacy Endpoints

CHRONOS-1: Most Common Grade > 3 AEs

Duvelisib Registration Trial for R/R CLL: DUO

DUO: PFS

DUO: PFS in Patients with ≥ 2 Prior Therapies

DUO: Lymph Node Responses

Duvelisib Registration Trial for R/R FL: DYNAMO

DYNAMO: Efficacy Results

Common Toxicities Associated With Duvelisib

AE Management Strategies

AE Management Strategies (cont)

Current Challenges/Unanswered Questions

Goals and Future Directions

Conclusions

Abbreviations