Therapy Detail

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Therapy Name Idelalisib
Synonyms
Therapy Description

Zydelig (idelalisib) inhibits PI3K-delta, preventing the activation of the PI3K signaling pathway and inhibiting tumor cell proliferation, motility, and survival (PMID: 24450857). Zydelig (idelalisib) is FDA approved for follicular B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lymphoma, and in combination with Rituxan (rituximab) for relapsed chronic lymphocytic leukemia (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Idelalisib Zydelig CAL-101|GS-1101 PIK3CD inhibitor 25 Zydelig (idelalisib) inhibits PI3K-delta, preventing the activation of the PI3K signaling pathway and inhibiting tumor cell proliferation, motility, and survival (PMID: 24450857). Zydelig (idelalisib) is FDA approved for follicular B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lymphoma, and in combination with Rituxan (rituximab) for relapsed chronic lymphocytic leukemia (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown Hodgkin's lymphoma not applicable Idelalisib Phase II Actionable In a Phase II trial, Idelalisib treatment resulted in an overall response rate of 20% (5/25) in Hodgkin's lymphoma patients, with one patient experiencing a complete response and four patients experiencing a partial response (PMID: 28327905). 28327905
Unknown unknown lymphoplasmacytic lymphoma not applicable Idelalisib Phase II Actionable In a Phase II trial, Zydelig (idelalisib) treatment resulted in an overall response rate of 80% (8/10) in patients with lymphoplasmacytic lymphoma (PMID: 24450858; NCT01282424). 24450858
Unknown unknown marginal zone B-cell lymphoma not applicable Idelalisib Phase II Actionable In a Phase II trial, Zydelig (idelalisib) treatment resulted in an overall response rate of 47% (7/15) in patients with marginal zone B-cell lymphoma (PMID: 24450858; NCT01282424). 24450858
Unknown unknown follicular lymphoma not applicable Idelalisib FDA approved Actionable In a Phase II trial that supported FDA approval, Zydelig (idelalisib) treatment resulted in an overall response rate of 54% (39/72, 6 complete response, 33 partial response) in patients with relapsed follicular lymphoma (PMID: 24450858; NCT01282424). 24450858 detail...
Unknown unknown chronic lymphocytic leukemia not applicable Idelalisib Preclinical - Cell culture Actionable In a preclinical study, Zydelig (idelalisib) inhibited proliferation, however, also resulted in increased activation-induced cytidine deaminase (AID) expression and genomic instability in a chronic lymphocytic leukemia cell line in culture (PMID: 28199309). 28199309
BRAF V600E/K PIK3CA wild-type melanoma no benefit Idelalisib Preclinical Actionable In a preclinical study, Zydelig (idelalisib) did not inhibit proliferation of melanoma cell lines harboring BRAF V600E/K and wild-type PIK3CA in culture (PMID: 26137449). 26137449
PIK3CA Q1033R PIK3CA H1047R Burkitt lymphoma predicted - sensitive Idelalisib Case Reports/Case Series Actionable In a clinical case study, Zydelig (idelalisib) treatment resulted in tumor shrinkage and decreased plasma LDH that continued for 10 months before recurrence in a patient with relapsed Burkitt lymphoma harboring PIK3CA H1047R and PIK3CA Q1033R (PMID: 32193631). 32193631
Unknown unknown hematologic cancer not applicable Idelalisib Phase I Actionable In a Phase I trial, Zydelig (idelalisib) treatment of patients with hematological malignancies produced an overall response rate of 72% (39/54) (PMID: 24615777). 24615777
Unknown unknown CLL/SLL not applicable Idelalisib FDA approved Actionable In a Phase II trial that supported FDA approval, Zydelig (idelalisib) treatment resulted in an overall response rate of 58% (15/26, all partial response) in patients with relapsed small lymphocytic lymphoma, with a median duration of response of 11.9 months (PMID: 24450858; NCT01282424). 24450858 detail...

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Clinical Trial Phase Therapies Title Recruitment Status
NCT01306643 Phase Ib/II Idelalisib Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma Completed
NCT03133221 Phase II Idelalisib 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation Recruiting
NCT02536300 Phase III Idelalisib Dose Optimization Study of Idelalisib in Follicular Lymphoma Recruiting
NCT03126019 Phase II Parsaclisib Idelalisib An Open-Label, Randomized Study Comparing INCB050465 to Idelalisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203) Recruiting
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Recruiting
NCT01732926 Phase III Idelalisib Bendamustine + Rituximab Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Terminated
NCT02662296 Phase II Idelalisib Ibrutinib Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant Withdrawn
NCT03151057 Phase I Idelalisib Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies Active, not recruiting
NCT01732913 Phase III Idelalisib Rituximab Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Terminated


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