Molecular Profile Detail

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
PTEN negative lung squamous cell carcinoma sensitive PI3K Inhibitor (Pan) Buparlisib Phase II Actionable In a Phase II trial, one patient with Pten negative squamous NSCLC had a partial response to Buparlisib (BKM120) however, stage 2 of the study was not initiated due to failure of meeting overall stage 1 response endpoints (PMID: 26098748). 26098748
PTEN negative Advanced Solid Tumor conflicting Talazoparib Preclinical - Cell culture Actionable In a preclinical study, PTEN-deficient cancer cell lines with DNA repair deficiency demonstrated high sensitivity to the PARP inhibitor, Talazoparib (BMN-673) (PMID: 23881923). 23881923
PTEN negative Advanced Solid Tumor conflicting Talazoparib Phase II Actionable In a Phase II trial, Talzenna (talazoparib) treatment did not result in significant clinical benefit in patients with advanced solid tumors harboring PTEN mutation or loss (by IHC), with one patient harboring a PTEN mutation achieved a prolonged stable disease as best response in a cohort of 13 patients (Mol Cancer Ther 2018;17(1 Suppl):Abstract nr A096; NCT02286687). detail...
PTEN negative prostate cancer not predictive Niraparib Phase I Actionable In a Phase I trial, negative PTEN IHC staining was not associated with response to Zejula (niraparib) treatment in patients with castration-resistant prostate cancer (PMID: 23810788; NCT00749502). 23810788
PTEN negative renal cell carcinoma predicted - sensitive Temsirolimus Clinical Study - Cohort Actionable In a clinical study, negative PTEN IHC staining were detected more frequently in patients with renal cell carcinoma who responded to treatment with Afinitor (everolimus) or Torisel (temsirolimus) (odds ratio = 0.24, p=0.029) than those who did not respond (PMID: 31335987). 31335987
PTEN negative glioblastoma no benefit PI3K Inhibitor (Pan) Buparlisib + Capmatinib Phase Ib/II Actionable In a Phase Ib/II trial, combination of Buparlisib (BKM120) and Tabrecta (capmatinib) did not reach target exposure due to potential drug-drug interaction, and demonstrated minimal activity in patients with glioblastoma harboring PTEN alterations including deletion, mutation, or negative protein expression, therefore, Phase II of the trial was not initiated (PMID: 31776899; NCT01870726). 31776899
PTEN negative glioblastoma no benefit Temozolomide + Vandetanib Phase II Actionable In a Phase II trial, Caprelsa (vandetinib), in combination with radiation therapy and Temodar (temozolomide), demonstrated no difference in PFS and OS when compared between glioblastoma patients negative for PTEN versus those positive for PTEN (PMID: 25910950). 25910950
PTEN negative renal cell carcinoma predicted - sensitive Everolimus Clinical Study - Cohort Actionable In a clinical study, negative PTEN IHC staining were detected more frequently in patients with renal cell carcinoma who responded to treatment with Afinitor (everolimus) or Torisel (temsirolimus) (odds ratio = 0.24, p=0.029) than those who did not respond (PMID: 31335987). 31335987
PTEN negative endometrial carcinoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment did not significantly increase DNA damage or inhibit growth of PTEN-deficient endometrial carcinoma cell lines in culture (PMID: 28945226). 28945226
PTEN negative endometrial carcinoma sensitive PI3K Inhibitor (Pan) Buparlisib + Olaparib Preclinical - Cell culture Actionable In a preclinical study, the combination of Buparlisib (BKM120) and Lynparza (olaparib) resulted in enhanced DNA damage and growth inhibition in PTEN-deficient endometrial carcinoma cell lines in culture (PMID: 28945226). 28945226
PTEN negative endometrial carcinoma sensitive PI3K Inhibitor (Pan) Buparlisib Preclinical - Cell culture Actionable In a preclinical study, Buparlisib (BKM120) inhibited Akt signaling, induced DNA damage, and inhibited the growth of PTEN-deficient endometrial carcinoma cell lines in culture (PMID: 28945226). 28945226
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05038839 Phase I Cabozantinib + Pamiparib Cabozantinib and Pamiparib for the Treatment of Advanced of Refractory Solid Tumors Not yet recruiting USA 0
NCT04493853 Phase III Abiraterone + Capivasertib Abiraterone Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency (CAPItello-281) Recruiting USA | CAN 31
NCT01870726 Phase Ib/II Buparlisib + Capmatinib Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Gliobastoma Terminated USA 4
NCT04592237 Phase II Niraparib Cabazitaxel + Carboplatin + JNJ-63723283 JNJ-63723283 + Niraparib Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer Recruiting USA 0