Therapy Detail
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| Therapy Name | Atezolizumab + Ipatasertib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Atezolizumab | Tecentriq | RG7446|MPDL3280A | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Tecentriq (atezolizumab) is a monoclonal antibody against PD-L1 (CD274), preventing activation of its receptor, potentially enhancing T-cell-mediated immune response to neoplasms and inhibiting T-cell inactivation (PMID: 29449897). Tecentriq (atezolizumab) is FDA approved for use in PD-L1 positive (IC >/= 5%) advanced or metastatic urothelial carcinoma not eligible for cisplatin-containing chemotherapy, in advanced or metastatic urothelial carcinoma not eligible for chemotherapy, in metastatic non-small cell lung cancer (NSCLC) progressed on platinum-containing therapy, as first-line therapy in metastatic NSCLC with high PD-L1 expression (TC>/=50% or IC>/=10%) and without EGFR or ALK alterations, for adjuvant treatment in patients with PD-L1-positive (>=1% tumor cell expression) NSCLC, in combination with bevacizumab, paclitaxel, and carboplatin as first-line therapy for non-squamous NSCLC with no EGFR or ALK aberrations, in combination with paclitaxel protein-bound and carboplatin in metastatic non-squamous NSCLC with no EGFR or ALK aberrations, in combination with carboplatin and etoposide in extensive-stage small cell lung cancer, in combination with bevacizumab in hepatocellular carcinoma without prior systemic therapy, in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) in unresectable or metastatic BRAF V600-mutated melanoma, and in pediatric and adult patients with unresectable or metastatic alveolar soft part sarcoma (FDA.gov). |
| Ipatasertib | GDC-0068|RG-7440 | Akt Inhibitor (Pan) 21 | Ipatasertib (GDC-0068) binds to and inhibits the activity of AKT in an ATP-competitive manner, which may result in the inhibition of the PI3K-AKT signaling pathway and tumor cell proliferation (PMID: 22934575, PMID: 32205017). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PTEN inact mut | Advanced Solid Tumor | no benefit | Atezolizumab + Ipatasertib | Phase II | Actionable | In a Phase II trial (CRAFT), treatment with Ipatasertib (GDC-0068) plus Tecentriq (atezolizumab) demonstrated safety but limited clinical benefit in advanced solid tumor patients harboring PI3K-AKT pathway mutations (n=13), including PTEN deletion/inactivating mutations or activating mutations in PIK3CA or AKT1, with a partial response in a breast cancer patient with AKT1 E17K and stable disease in a prostate cancer patient with PTEN loss (Ann Oncol (2023) 34 (suppl_2): S256-S257;NCT04551521). | detail... |
| PTEN del | Advanced Solid Tumor | no benefit | Atezolizumab + Ipatasertib | Phase II | Actionable | In a Phase II trial (CRAFT), treatment with Ipatasertib (GDC-0068) plus Tecentriq (atezolizumab) demonstrated safety but limited clinical benefit in advanced solid tumor patients harboring PI3K-AKT pathway mutations (n=13), including PTEN deletion/inactivating mutations or activating mutations in PIK3CA or AKT1, with a partial response in a breast cancer patient with AKT1 E17K and stable disease in a prostate cancer patient with PTEN loss (Ann Oncol (2023) 34 (suppl_2): S256-S257;NCT04551521). | detail... |
| PIK3CA act mut | Advanced Solid Tumor | no benefit | Atezolizumab + Ipatasertib | Phase II | Actionable | In a Phase II trial (CRAFT), treatment with Ipatasertib (GDC-0068) plus Tecentriq (atezolizumab) demonstrated safety but limited clinical benefit in advanced solid tumor patients harboring PI3K-AKT pathway mutations (n=13), including PTEN deletion/inactivating mutations or activating mutations in PIK3CA or AKT1, with a partial response in a breast cancer patient with AKT1 E17K and stable disease in a prostate cancer patient with PTEN loss (Ann Oncol (2023) 34 (suppl_2): S256-S257;NCT04551521). | detail... |
| PTEN inact mut | glioblastoma | predicted - sensitive | Atezolizumab + Ipatasertib | Phase I | Actionable | In a Phase I trial (Ice-CAP), combination treatment with Ipatasertib (GDC-0068) and Tecentriq (atezolizumab) demonstrated safety and tolerability in glioblastoma patients harboring PTEN loss or PTEN mutations, and led to a clinical benefit rate of 29% (2/7), with 1 pathological complete response, and stable disease in 1 patient of 7 patients (Cancer Res 2021;81(13_Suppl):Abstract nr CT120; NCT03673787). | detail... |
| PTEN loss | glioblastoma | predicted - sensitive | Atezolizumab + Ipatasertib | Phase I | Actionable | In a Phase I trial (Ice-CAP), the combination of Ipatasertib (GDC-0068) and Tecentriq (atezolizumab) resulted in a clinical benefit rate (CBR) of 32% (6/19) in patients with glioblastoma, and CBR was 28.6% (4/14) in patients with PTEN loss as determined by IHC (H<30) (Cancer Res (2023) 83 (8_Supplement): CT093; NCT03673787). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04486352 | Phase Ib/II | Atezolizumab + Talazoparib Atezolizumab + Ipatasertib Atezolizumab + Bevacizumab | A Study of Targeted Agents With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer (EndoMAP) | Recruiting | USA | 0 |
| NCT04551521 | Phase II | Atezolizumab Atezolizumab + Ipatasertib Atezolizumab + Pertuzumab + Trastuzumab Atezolizumab + Cobimetinib Alectinib Atezolizumab + Cobimetinib + Vemurafenib | CRAFT: The NCT-PMO-1602 Phase II Trial | Recruiting | DEU | 0 |
| NCT05180006 | Phase II | Atezolizumab Atezolizumab + Pertuzumab + Trastuzumab Atezolizumab + Ipatasertib Atezolizumab + Bevacizumab | Impact of Neoadjuvant Immunotherapy in Early Stage Breast Cancer Before Standard Therapy (BIS-Program) | Recruiting | FRA | 0 |
| NCT04739202 | Phase II | Atezolizumab + Bevacizumab Atezolizumab + Ipatasertib | Personalized Targeted IMMUNOtherapy-based Regimens in Recurrent GASTric Adenocarcinoma (IMMUNOGAST) (IMMUNOGAST) | Unknown status | FRA | 0 |
| NCT03424005 | Phase Ib/II | Atezolizumab + Bevacizumab + Selicrelumab Atezolizumab + RO6874281 Atezolizumab + Bevacizumab Atezolizumab + Carboplatin + Gemcitabine Atezolizumab + Eribulin Capecitabine Atezolizumab Atezolizumab + Bevacizumab + Cobimetinib Atezolizumab + Capecitabine Atezolizumab + Ipatasertib Atezolizumab + Ladiratuzumab vedotin | A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer (Morpheus-TNBC) (Morpheus-TNBC) | Recruiting | USA | ISR | GBR | FRA | ESP | DEU | AUS | 1 |
| NCT03280563 | Phase Ib/II | Atezolizumab + Ipatasertib Atezolizumab + Bevacizumab + Exemestane Atezolizumab + Cobimetinib Atezolizumab + Bevacizumab + Fulvestrant Atezolizumab + Bevacizumab + Tamoxifen Atezolizumab + Fulvestrant + Ipatasertib Fulvestrant Atezolizumab + Fulvestrant | A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (MORPHEUS HR+BC) | Completed | USA | ISR | 1 |
| NCT03673787 | Phase Ib/II | Atezolizumab + Ipatasertib | A Trial of Ipatasertib in Combination With Atezolizumab (IceCAP) | Unknown status | GBR | 0 |
| NCT04434040 | Phase II | Atezolizumab + Ipatasertib | Ipatasertib + Atezolizumab to Prevent Recurrence in TNBC | Active, not recruiting | USA | 0 |
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