Therapy Detail
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| Therapy Name | LY3023414 |
| Synonyms | |
| Therapy Description |
Samotolisib (LY3023414) is an ATP competitive inhibitor of PI3K/mTOR, inhibits signaling of the PI3K/mTOR pathway, and has demonstrated antiproliferative activity against tumor cells (PMID: 24387334, PMID: 31880826). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| LY3023414 | Samotolisib|LY-3023414|LY 3023414 | mTOR Inhibitor 51 PI3K Inhibitor (Pan) 42 | Samotolisib (LY3023414) is an ATP competitive inhibitor of PI3K/mTOR, inhibits signaling of the PI3K/mTOR pathway, and has demonstrated antiproliferative activity against tumor cells (PMID: 24387334, PMID: 31880826). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA act mut | Advanced Solid Tumor | no benefit | LY3023414 | Case Reports/Case Series | Actionable | In a Phase II trial (NCI-COG Pediatric MATCH), Samotolisib (LY3023414) treatment resulted in no objective responses in pediatric patients with advanced solid tumors harboring PI3K/mTOR pathway mutations, including PTEN (n=6), PIK3CA (n=5), TSC1 (n=2), TSC2 (n=3), and PIK3R1 (n=1), and resulted in a 3-month progression-free survival of 12%, a 6-month overall survival of 44%, and a 12-month overall survival of 15% (PMID: 39298693; NCT03155620). | 39298693 |
| PIK3CA act mut | endometrial cancer | no benefit | LY3023414 | Phase II | Actionable | In a Phase II trial, patients with advanced endometrial cancer harboring a PI3K pathway mutation, including PIK3CA activating mutations, demonstrated only a modest clinical benefit with an overall response rate of 16% (4/25), a clinical benefit rate of 28% (7/25) at 12 weeks, a progression-free survival of 2.5 months, and overall survival of 9.2 months when treated with LY3023414 (PMID: 31880826; NCT01775072). | 31880826 |
| TSC2 inact mut | Advanced Solid Tumor | no benefit | LY3023414 | Case Reports/Case Series | Actionable | In a Phase II trial (NCI-COG Pediatric MATCH), Samotolisib (LY3023414) treatment resulted in no objective responses in pediatric patients with advanced solid tumors harboring PI3K/mTOR pathway mutations, including PTEN (n=6), PIK3CA (n=5), TSC1 (n=2), TSC2 (n=3), and PIK3R1 (n=1), and resulted in a 3-month progression-free survival of 12%, a 6-month overall survival of 44%, and a 12-month overall survival of 15% (PMID: 39298693; NCT03155620). | 39298693 |
| PIK3CA E545K | leukemia | sensitive | LY3023414 | Preclinical | Actionable | In a preclinical study, LY3023414 inhibited tumor growth in a transgenic animal model of leukemia driven by PIK3CA E545K (PMID: 27439478). | 27439478 |
| PIK3CA G118D | lung non-small cell carcinoma | sensitive | LY3023414 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, LY3023414 inhibited proliferation of non-small cell lung cancer cells harboring PIK3CA G118D in culture, resulted in tumor growth inhibition in cell line xenograft models (PMID: 27439478). | 27439478 |
| PTEN inact mut | Advanced Solid Tumor | no benefit | LY3023414 | Case Reports/Case Series | Actionable | In a Phase II trial (NCI-COG Pediatric MATCH), Samotolisib (LY3023414) treatment resulted in no objective responses in pediatric patients with advanced solid tumors harboring PI3K/mTOR pathway mutations, including PTEN (n=6), PIK3CA (n=5), TSC1 (n=2), TSC2 (n=3), and PIK3R1 (n=1), and resulted in a 3-month progression-free survival of 12%, a 6-month overall survival of 44%, and a 12-month overall survival of 15% (PMID: 39298693; NCT03155620). | 39298693 |
| PTEN inact mut | kidney cancer | sensitive | LY3023414 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, LY3023414 inhibited proliferation of renal cancer cells harboring PTEN inactivating mutation in culture, resulted in tumor growth inhibition in cell line xenograft models (PMID: 27439478). | 27439478 |
| PTEN inact mut | endometrial cancer | no benefit | LY3023414 | Phase II | Actionable | In a Phase II trial, patients with advanced endometrial cancer harboring a PI3K pathway mutation, including PTEN inactivating mutations, demonstrated only a modest clinical benefit with an overall response rate of 16% (4/25), a clinical benefit rate of 28% (7/25) at 12 weeks, a progression-free survival of 2.5 months, and overall survival of 9.2 months when treated with LY3023414 (PMID: 31880826; NCT01775072). | 31880826 |
| PTEN loss | glioblastoma | sensitive | LY3023414 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, LY3023414 inhibited Pi3k/mTor signaling and proliferation in PTEN deficient glioblastoma cells in culture, and resulted in tumor growth inhibition in cell line xenograft models (PMID: 27439478). | 27439478 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02549989 | Phase II | LY3023414 | Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer | Completed | USA | 0 |
| NCT03213678 | Phase II | LY3023414 | Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial) | Active, not recruiting | USA | 1 |
| NCT01655225 | Phase I | LY3023414 + Midazolam Letrozole + LY3023414 LY3023414 | A Study of LY3023414 in Participants With Advanced Cancer | Completed | USA | ITA | 1 |
| NCT02632994 | Expanded access | LY3023414 LY2503029 | Master Rollover Protocol for Continued Safety Assessment of Study Drug | Available | USA | 0 |
| NCT02784795 | Phase I | Cisplatin + Gemcitabine + LY3039478 Carboplatin + Gemcitabine + LY3039478 LY3023414 + LY3039478 Abemaciclib + LY3039478 LY3039478 + Taladegib LY3039478 LY3023414 | A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors | Completed | USA | FRA | ESP | DNK | 0 |
| NCT04032080 | Phase II | Prexasertib LY3023414 | Treatment With Oral LY3023414 To Inhibit Homologous Recombination Followed By Prexasertib (ExIST) | Completed | USA | 0 |
| NCT02079636 | Phase I | LY3023414 Abemaciclib Gemcitabine Pemetrexed Disodium Ramucirumab | A Study of LY2835219 in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC) | Completed | USA | ESP | 0 |
| NCT02443337 | Phase II | Necitumumab LY3023414 | A Study of LY3023414 and Necitumumab in Squamous Lung Cancer | Terminated | USA | 0 |
| NCT02407054 | Phase II | Enzalutamide LY3023414 | A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer | Completed | USA | 0 |
| NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Recruiting | USA | CAN | AUS | 1 |
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