Therapy Detail
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| Therapy Name | Temsirolimus |
| Synonyms | |
| Therapy Description |
Torisel (temsirolimus) binds to FKBP-12 and allosterically inhibits mTOR (PMID: 16883305). Torisel (temsirolimus) is FDA approved for advanced renal cell carcinoma (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Temsirolimus | Torisel | CCI-779 | mTORC1 Inhibitor 9 | Torisel (temsirolimus) binds to FKBP-12 and allosterically inhibits mTOR (PMID: 16883305). Torisel (temsirolimus) is FDA approved for advanced renal cell carcinoma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PTEN loss | clear cell renal cell carcinoma | sensitive | Temsirolimus | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Torisel (temsirolimus) inhibited cell proliferation and induced cell cycle arrest in PTEN-deficient clear cell renal carcinoma cell lines in culture and inhibited tumor growth in a cell line xenograft model (PMID: 35165399). | 35165399 |
| 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 |
| TSC1 mutant | renal cell carcinoma | predicted - sensitive | Temsirolimus | Case Reports/Case Series | Actionable | In a clinical study, treatment with Afinitor (everolimus) or Torisel (temsirolimus) resulted in more partial responses (odds ratio = 0.08, p=0.030) in patients with renal cell carcinoma harboring mTOR pathway mutations, including MTOR (n=8), TSC1 (n=1), and TSC2 (n=2), than those without mutations (n=76) (PMID: 31335987). | 31335987 |
| TSC2 mutant | osteosarcoma | no benefit | Temsirolimus | Preclinical - Pdx | Actionable | In a preclinical study, Torisel (temsirolimus) treatment did not improve event-free survival in an osteosarcoma patient-derived xenograft (PDX) model harboring a TSC2 mutation (PMID: 37523146). | 37523146 |
| CTNNB1 mutant | endometrial cancer | predicted - sensitive | Temsirolimus | Phase II | Actionable | In a retrospective study of a Phase II trial, Torisel (temsirolimus) treatment resulted in an increased progression-free survival (HR 0.46) but not response rate (response difference 0.00) in advanced endometrial cancer patients harboring CTNNB1 mutations (PMID: 27016228). | 27016228 |
| TSC2 inact mut | renal cell carcinoma | predicted - sensitive | Temsirolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, 28% (12/43) of metastatic renal cell carcinoma patients who responded to rapalogs, Afinitor (everolimus) or Torisel (temsirolimus), harbored inactivating TSC1, TSC2 mutations and/or activating MTOR mutations, compared to 11% (4/36) in patients who did not respond to therapy (PMID: 26831717). | 26831717 |
| PIK3CA H1047R | ovarian cancer | predicted - sensitive | Temsirolimus | Case Reports/Case Series | Actionable | In a Phase II trial (TAPUR), Torisel (temsirolimus) treatment resulted in a partial response ongoing at 86 weeks in a patient with ovarian cancer harboring PIK3CA H1047R (J Clin Oncol 41, 2023 (suppl 16; abstr 3117); NCT02693535). | detail... |
| PIK3CA mutant | breast cancer | no benefit | Temsirolimus | Phase II | Actionable | In a Phase II trial, Torisel (temsirolimus) treatment resulted in stable disease in 9.7% (3/31) of breast cancer patients positive for ER, PR or ERBB2 (HER2), however there was no association between PIK3CA mutational status and clinical benefits (PMID: 22245973). | 22245973 |
| PIK3CA mutant | breast cancer | no benefit | Temsirolimus | Phase II | Actionable | In a Phase II trial (TAPUR), Torisel (temsirolimus) treatment demonstrated limited efficacy in patients with breast cancer harboring PIK3CA mutations, resulting in an objective response rate of 9% (1/12, 1 partial response) and a disease control rate of 9%, which let to the closing of the cohort due to futility (p=0.83) (J Clin Oncol 41, 2023 (suppl 16; abstr 3117); NCT02693535). | detail... |
| PTEN mutant | endometrial cancer | no benefit | Temsirolimus | Phase II | Actionable | In a retrospective study of a Phase II trial, mutation status of PTEN was not associated with progression-free survival or response rate in advanced endometrial cancer patients treated with Torisel (temsirolimus) (PMID: 27016228). | 27016228 |
| PIK3CA H1047X | endometrial adenocarcinoma | predicted - sensitive | Temsirolimus | Case Reports/Case Series | Actionable | In a clinical study, a patient with endometrial adenocarcinoma harboring a PIK3CA H1047 mutation demonstrated a partial response when treated with Torisel (temsirolimus) (PMID: 21216929). | 21216929 |
| PIK3CA mutant | ovarian cancer | sensitive | Temsirolimus | Case Reports/Case Series | Actionable | In a clinical study, an ovarian cancer patient harboring a PIK3CA E542 mutation demonstrated stable disease when treated with Torisel (temsirolimus) (PMID: 21216929). | 21216929 |
| PIK3CA mutant | ovarian cancer | sensitive | Temsirolimus | Phase I | Actionable | In a Phase I clinical trial, Torisel (temsirolimus) demonstrated limited efficacy in ovarian cancer patients with PIK3CA mutations (PMID: 22271473). | 22271473 |
| TSC1 inact mut | renal cell carcinoma | predicted - sensitive | Temsirolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, 28% (12/43) of metastatic renal cell carcinoma patients who responded to rapalogs, Afinitor (everolimus) or Torisel (temsirolimus), harbored inactivating TSC1, TSC2 mutations and/or activating MTOR mutations, compared to 11% (4/36) in patients who did not respond to therapy (PMID: 26831717). | 26831717 |
| PIK3CA act mut | Advanced Solid Tumor | predicted - sensitive | Temsirolimus | Phase II | Actionable | In a Phase II trial (TAPUR), Torisel (temsirolimus) treatment resulted in an objective response rate of 11% (3/28, 3 partial responses) and a disease control rate of 29% in patients with advanced solid tumors other than breast cancer harboring PIK3CA mutations, with PIK3CA H1047R/L (n=3), E545K (n=2), and E542K (n=2) as the most common mutation in patients achieved disease control (J Clin Oncol 41, 2023 (suppl 16; abstr 3117); NCT02693535). | detail... |
| PIK3CA mutant | Ewing sarcoma | predicted - sensitive | Temsirolimus | Preclinical - Pdx | Actionable | In a preclinical study, Torisel (temsirolimus) treatment increased event-free survival in a Ewing sarcoma patient-derived xenograft (PDX) model harboring a PIK3CA mutation (PMID: 37523146). | 37523146 |
| TSC2 V1067E | chromophobe renal cell carcinoma | predicted - sensitive | Temsirolimus | Case Reports/Case Series | Actionable | In a clinical case study, Torisel (temsirolimus) treatment led to a complete response in metastatic sites and an 80% decrease in primary tumor size in a patient with chromophobe renal cell carcinoma harboring biallelic mutations, TSC2 splice site mutation and TSC2 V1067E (PMID: 29632054). | 29632054 |
| TSC2 mutant | renal cell carcinoma | predicted - sensitive | Temsirolimus | Case Reports/Case Series | Actionable | In a clinical study, treatment with Afinitor (everolimus) or Torisel (temsirolimus) resulted in more partial responses (odds ratio = 0.08, p=0.030) in patients with renal cell carcinoma harboring mTOR pathway mutations, including MTOR (n=8), TSC1 (n=1), and TSC2 (n=2), than those without mutations (n=76) (PMID: 31335987). | 31335987 |
| FBXW7 R465H | lung adenocarcinoma | sensitive | Temsirolimus | Case Reports/Case Series | Actionable | In a clinical case study, a patient with lung adenocarcinoma harboring FBXW7 R465H demonstrated tumor shrinkage when treated with Torisel (temsirolimus) (PMID: 24360397). | 24360397 |
| PIK3CA mutant | endometrial cancer | no benefit | Temsirolimus | Phase II | Actionable | In a retrospective study of a Phase II trial, mutation status of PIK3CA was not associated with progression-free survival or response rate in advanced endometrial cancer patients treated with Torisel (temsirolimus) (PMID: 27016228). | 27016228 |
| PTEN inact mut | Advanced Solid Tumor | predicted - sensitive | Temsirolimus | Phase II | Actionable | In a Phase II trial (TAPUR), Torisel (temsirolimus) treatment resulted in a disease control rate of 26% (7/27, 2 partial responses and 5 with stable disease >=16 weeks) and an objective response rate of 7% (2/27) in patients with advanced solid tumors harboring inactivating PTEN mutations, with a median progression-free survival of 10 weeks and a median overall survival of 32 weeks (Cancer Res (2023) 83 (8_Supplement): CT231; NCT02693535). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05773326 | Phase I | Temsirolimus | Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG | Recruiting | USA | 0 |
| NCT01567930 | Phase II | Temsirolimus | Temsirolimus as Second-line Therapy in HCC | Unknown status | USA | 0 |
| NCT02567435 | Phase III | Cyclophosphamide + Dactinomycin + Vincristine Sulfate Temsirolimus Irinotecan | Combination Chemotherapy and Irinotecan Hydrochloride or Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma | Active, not recruiting | USA | NZL | CAN | AUS | 1 |
| NCT01767194 | Phase II | Dinutuximab Temsirolimus Irinotecan + Temozolomide | Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients With Refractory or Relapsed Neuroblastoma | Completed | USA | NZL | CAN | AUS | 1 |
| NCT02423954 | Phase Ib/II | Temsirolimus Nivolumab Capecitabine Irinotecan | Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus) | Terminated | USA | 0 |
| NCT01517243 | Phase II | Temsirolimus Sunitinib | Phase II Study of Alternating Sunitinib and Temsirolimus | Completed | USA | 0 |
| NCT03158389 | Phase Ib/II | Vismodegib Alectinib Idasanutlin Temsirolimus Atezolizumab Palbociclib APG101 | NCT Neuro Master Match - N²M² (NOA-20) (N²M²) | Completed | DEU | 0 |
| NCT01087554 | Phase I | Temsirolimus Everolimus Sirolimus Vorinostat | Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer | Active, not recruiting | USA | 0 |
| NCT01180049 | FDA approved | Temsirolimus | Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma | Completed | USA | ROU | POL | ITA | FRA | DEU | CZE | AUS | 3 |
| NCT03297606 | Phase II | Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) | Recruiting | CAN | 0 |
| NCT00838955 | Phase II | Temsirolimus | Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma | Terminated | USA | 0 |
| NCT02420613 | Phase I | Vorinostat Temsirolimus | Study of Suberoylanilide Hydroxamic Acid (SAHA) With Temsirolimus in Children With Diffuse Intrinsic Pontine Glioma (DIPG) | Active, not recruiting | USA | 0 |
| NCT02560012 | Phase II | Everolimus Sorafenib Temsirolimus Axitinib Sunitinib Pazopanib | Personalized Targeted Inhibitors Treatment in Renal Cell Cancer | Terminated | USA | 0 |
| NCT02693535 | Phase II | Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) | Recruiting | USA | 0 |
| NCT01392183 | Phase II | Diphenhydramine Temsirolimus Pazopanib | Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC) | Completed | USA | 0 |
| NCT02788201 | Phase II | Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Sulfate Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane | Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma | Completed | USA | 0 |
| NCT02551718 | Phase I | Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate | High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia | Completed | USA | 0 |
| NCT01187199 | Phase I | Bevacizumab Paclitaxel Carboplatin Sorafenib Temsirolimus | Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer | Active, not recruiting | USA | 0 |
| NCT02446431 | Phase I | Cyclophosphamide Bevacizumab Temsirolimus Valproic acid | Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence | Recruiting | USA | 0 |
| NCT01614197 | Phase I | Etoposide Cyclophosphamide Prednisone Cytarabine Temsirolimus Methotrexate | A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma | Completed | USA | CAN | AUS | 0 |
| NCT04199026 | Phase I | Irinotecan Doxorubicin Ifosfamide Temozolomide Temsirolimus Ganitumab Pazopanib Everolimus Vincristine Sulfate | Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma | Not yet recruiting | USA | 0 |
| NCT01396408 | Phase II | Temsirolimus Sunitinib | A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours | Active, not recruiting | CAN | 0 |
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