Therapy Detail
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| Therapy Name | Inavolisib + Trastuzumab deruxtecan |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Inavolisib | Itovebi | GDC-0077|RO7113755|RG6114|GDC0077|GDC 0077 | PIK3CA inhibitor 27 | Itovebi (inavolisib) inhibits PIK3CA, with selectivity for mutant PIK3CA over wild-type PIK3CA, potentially resulting in increased apoptosis and decreased growth of PIK3CA-mutant tumors (PMID: 36455032). Itovebi (inavolisib) in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) is FDA-approved for use in patients with endocrine-resistant, hormone receptor (HR)-positive, ERBB2 (HER2)-negative, locally advanced or metastatic breast cancer harboring PIK3CA mutations (FDA.gov). |
| Trastuzumab deruxtecan | Enhertu | DS-8201|DS8201a|T-DXd|DS-8201|fam-trastuzumab deruxtecan-nxki|DS-8201a | HER2 (ERBB2) Antibody 79 HER2 (ERBB2) Antibody-Drug Conjugate 35 | Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) comprising an anti-ERBB2 (HER2) antibody linked to a derivative of the topoisomerase inhibitor DX-8951, which delivers the cytotoxic agent to ERBB2 (HER2)-expressing tumor cells, potentially resulting in decreased growth of tumors, including tumors with low ERBB2 (HER2) expression (PMID: 27026201). Enhertu (fam-trastuzumab deruxtecan-nxki) is FDA approved for use in patients with ERBB2 (HER2)-positive breast cancer who have received two or more anti-HER2 therapies previously, in patients with ERBB2 (HER2)-low (IHC 1+ or IHC 2+/ISH -) breast cancer received prior chemotherapy, in patients with ERBB2 (HER2)-low or untra-low (IHC 0 with membrane staining) hormone receptor-positive breast cancer who had received endocrine therapy, in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy, and in patients with ERBB2 (HER2)-positive (IHC 3+) solid tumors who have received prior systemic therapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03424005 | Phase Ib/II | Fulvestrant + Inavolisib + PF-07220060 Fulvestrant + Inavolisib + Metformin Fulvestrant + Inavolisib + Metformin + Palbociclib Empagliflozin + Fulvestrant + Inavolisib Empagliflozin + Fulvestrant + Inavolisib + Palbociclib Inavolisib + Trastuzumab deruxtecan Abemaciclib + Inavolisib + Letrozole Fulvestrant + Inavolisib + Ribociclib Abemaciclib + Fulvestrant + Inavolisib Inavolisib + Letrozole + Ribociclib | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (Morpheus-panBC) | Recruiting | USA | ISR | GBR | FRA | ESP | DEU | AUS | 2 |
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