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	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
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
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
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
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	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 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
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

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
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)	Active, not recruiting	USA \| CAN \| AUS	1
NCT02632994	Expanded access	LY3023414 LY2503029	Master Rollover Protocol for Continued Safety Assessment of Study Drug	Available	USA	0
NCT01655225	Phase I	LY3023414 + Midazolam Letrozole + LY3023414 LY3023414	A Study of LY3023414 in Participants With Advanced Cancer	Completed	USA \| ITA	1
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
NCT02407054	Phase II	Enzalutamide LY3023414	A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer	Completed	USA	0
NCT02549989	Phase II	LY3023414	Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer	Completed	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
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)	Completed	USA	1
NCT04032080	Phase II	Prexasertib LY3023414	Treatment With Oral LY3023414 To Inhibit Homologous Recombination Followed By Prexasertib (ExIST)	Completed	USA	0
NCT02443337	Phase II	Necitumumab LY3023414	A Study of LY3023414 and Necitumumab in Squamous Lung Cancer	Terminated	USA	0

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