Molecular Profile Detail

Profile Name ERBB2 T798M
Gene Variant Detail

ERBB2 T798M (gain of function)

Relevant Treatment Approaches HER inhibitor (Pan) HER2 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown colorectal cancer not applicable HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited proliferation and increased apoptosis in several human colorectal tumor cell lines in culture (PMID: 21617858). 21617858
Unknown unknown lung non-small cell carcinoma not applicable HER inhibitor (Pan) Afatinib + Nimotuzumab Phase Ib/II Actionable In a Phase I/II trial, Gilotrif (afatinib) and Nimotuzumab combination treatment resulted in a median progression-free survival of 4.0 months, an overall survival of 11.7 months, and overall response rate of 23% (10/44) in non-small cell lung cancer patients with acquired resistance to Iressa (gefitinib) or Tarceva (erlotinib) (PMID: 26667485). 26667485
Unknown unknown Advanced Solid Tumor not applicable HER inhibitor (Pan) Afatinib + Vinorelbine Phase I Actionable In a Phase I trial, the combination of Gilotrif (afatinib) and Navelbine (vinorelbine) resulted in clinical efficacy, including two breast cancer patients with a partial response and stable disease in eight patients with advanced solid tumors (PMID: 26254023). 26254023
Unknown unknown breast cancer not applicable HER inhibitor (Pan) Afatinib + Vinorelbine Phase I Actionable In a Phase I trial, the combination of Gilotrif (afatinib) and Navelbine (vinorelbine) resulted in clinical efficacy, including two breast cancer patients with a partial response and stable disease in eight patients with advanced solid tumors (PMID: 26254023). 26254023
Unknown unknown Advanced Solid Tumor not applicable HER inhibitor (Pan) Poziotinib Phase I Actionable In a Phase I trial, Poziotinib (HM781-36B) displayed favorable pharmacokinetics in patients with advanced solid tumors (PMID: 25377158). 25377158
Unknown unknown mantle cell lymphoma not applicable HER2 Inhibitor Buparlisib + Ibrutinib Phase Ib/II Actionable In a Phase I/II trial, Buparlisib (BKM120) and Imbruvica (ibrutinib) combination treatment resulted in a best overall response rate of 88% (15/17, 11 complete response, 4 partial response) in patients with relapsed/refractory mantle cell lymphoma (J Clin Oncol 36, 2018 (suppl; abstr 7520); NCT02756247). detail...
Unknown unknown follicular lymphoma not applicable HER2 Inhibitor Buparlisib + Ibrutinib Phase Ib/II Actionable In a Phase I/II trial, Buparlisib (BKM120) and Imbruvica (ibrutinib) combination treatment resulted in a best overall response rate of 20% (1/5, 1 complete response) in patients with relapsed/refractory follicular lymphoma (J Clin Oncol 36, 2018 (suppl; abstr 7520); NCT02756247). detail...
Unknown unknown diffuse large B-cell lymphoma not applicable HER2 Inhibitor Buparlisib + Ibrutinib Phase Ib/II Actionable In a Phase I/II trial, Buparlisib (BKM120) and Imbruvica (ibrutinib) combination treatment resulted in a best overall response rate of 31% (4/13, 3 complete response, 1 partial response) in patients with relapsed/refractory diffuse large B-cell lymphoma (J Clin Oncol 36, 2018 (suppl; abstr 7520); NCT02756247). detail...
Unknown unknown chronic lymphocytic leukemia not applicable HER2 Inhibitor Ibrutinib Phase III Actionable In a Phase III clinical trial, Imbruvica (ibrutinib) treatment resulted in a greater progression-free survival, overall survival, and response rate when compared to chlorambucil treatment in chronic lymphocytic leukemia patients aged 65 or older (PMID: 26639149). 26639149
Unknown unknown chronic lymphocytic leukemia not applicable HER2 Inhibitor Ibrutinib FDA approved Actionable In a Phase III trial that supported FDA approval, treatment with Imbruvica (ibrutinib) in chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) patients resulted in improved progression-free survival compared to treatment with Arzerra (ofatumumab) (median duration not reached vs. 8.1 months), and an overall response rate of 43% (83/195) versus 4% (8/196) with Arzerra (ofatumumab) (PMID: 24881631). detail... 24881631
Unknown unknown chronic lymphocytic leukemia not applicable HER2 Inhibitor Ibrutinib Clinical Study Actionable In a clinical study, treatment with Imbruvica (ibrutinib) resulted in a discontinuation-free survival rate at 1 year of 73.7% (232/315) and an absolute 1 year survival rate of 83.3% (264/315) in patients with relapsed or refractory chronic lymphocytic leukemia (PMID: 27756834). 27756834
Unknown unknown hairy cell leukemia not applicable HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited Btk activity and B-cell receptor signaling, thereby resulting in inhibition of cell proliferation and decreased survival of human hairy cell leukemia cells in culture (PMID: 24697238). 24697238
Unknown unknown central nervous system lymphoma not applicable HER2 Inhibitor Ibrutinib Phase I Actionable In a Phase I trial, Imbruvica (ibrutinib) treatment resulted in antitumor efficacy in 77% (10/13) of patients with primary central nervous system lymphoma, demonstrating a complete response in five patients and a partial response in five patients (PMID: 28619981). 28619981
Unknown unknown mantle cell lymphoma not applicable HER2 Inhibitor Ibrutinib Phase II Actionable In a Phase II trial, Imbruvica (ibrutinib) treatment resulted in a response rate of 68% (75/111, complete response 21%, partial response 47%), with an estimated median progression-free survival of 13.9 months in patients with relapsed or refractory mantle-cell lymphoma (PMID: 23782157, NCT01236391). 23782157
Unknown unknown diffuse large B-cell lymphoma not applicable HER2 Inhibitor Ibrutinib Phase II Actionable In a Phase II trial, Imbruvica (ibrutinib) treatment demonstrated preferential efficacy in the ABC subtype of diffuse large B-cell lymphoma (DLBCL) compared to the GCB subtype, resulted in complete response in 8% (2/25) and partial response in 32% (8/25) of ABC DLBCL patients, but only partial response in 5.3% (1/19) of GCB DLBCL patients (Blood 2012, 120 (21): 686). detail...
Unknown unknown mantle cell lymphoma not applicable HER2 Inhibitor Ibrutinib + ONC201 Preclinical - Patient cell culture Actionable In a preclinical study, the combination of ONC201 and Imbruvica (ibrutinib) induced apoptosis in primary mantle cell lymphoma samples in culture, including Imbruvica (ibrutinib)-resistant samples, with greater efficacy than either agent alone (PMID: 26884599). 26884599
Unknown unknown mantle cell lymphoma not applicable HER2 Inhibitor Ibrutinib + Palbociclib Phase I Actionable In a Phase I trial, Imbruvica (ibrutinib) and Ibrance (palbociclib) combination treatment resulted in an overall response rate of 67%, a complete response rate of 37%, and a two year progression-free survival in 59.4% of patients with previously treated mantle cell lymphoma, with a median follow up of 25.6 months (PMID: 30692121; NCT02159755). detail... 30692121
Unknown unknown diffuse large B-cell lymphoma not applicable HER2 Inhibitor Ibrutinib + PQR309 Preclinical - Cell line xenograft Actionable In a preclinical study, the combination therapy of PQR309 and Imbruvica (ibrutinib) led to a synergistic effect in 6/7 diffuse large B-cell lymphoma (DLBCL) cell lines in culture, and the effect was confirmed in a DLBCL cell line xenograft model (PMID: 29066507). 29066507
Unknown unknown diffuse large B-cell lymphoma not applicable HER2 Inhibitor Ibrutinib + SEL24-B489 Preclinical Actionable In a preclinical study, SEL24-B489 demonstrated a synergistic effect when combined with Ibruvica (ibrutinib) in diffuse large B-cell lymphoma cells in culture, resulting in cell growth inhibition ((Blood 126 (23):706.December 2015). detail...
Unknown unknown diffuse large B-cell lymphoma not applicable HER2 Inhibitor Ibrutinib + Silmitasertib Preclinical - Cell culture Actionable In a preclinical study, the combination of Silmitasertib (CX-4945) and Imbruvica (ibrutinib) worked synergistically to decrease cell viability and resulted in increased apoptosis and decreased AKT phosphorylation in ABC and GCB-type diffuse large B-cell lymphoma cell lines in culture (PMID: 28460620). 28460620
Unknown unknown B-cell lymphoma not applicable HER2 Inhibitor Ibrutinib + Ublituximab + Umbralisib Phase I Actionable In a Phase I trial, Imbruvica (Ibrutinib), TGR01201, and Ublituximab combination treatment resulted in complete response in 14% (1/7) and partial response in 71% of patients with relapsed B-cell lymphoas within 8 weeks of treatment (J Clin Oncol 33, 2015 (suppl; abstr 8501)). detail...
Unknown unknown colorectal cancer not applicable HER2 Inhibitor Ibrutinib + unspecified CTLA4 antibody Preclinical Actionable In a preclinical study, the combination of Imbruvica (ibrutinib) and an anti-CTLA4 antibody resulted in complete tumor regression in colorectal cancer mouse models (Cancer Res 2016;76(14 Suppl):Abstract nr 2321). detail...
Unknown unknown Advanced Solid Tumor not applicable HER2 Inhibitor Ibrutinib + unspecified PD-L1 antibody Preclinical Actionable In a preclinical study, the combination treatment of Imbruvica (ibrutinib) and an anti-PD-L1 antibody in mouse models with advanced solid tumors resulted in antitumor efficacy, including decreased tumor size, minimized metastasis, and improved survival in triple-receptor negative breast cancer mouse models, and a 30% cure rate and improved survival in colon cancer mouse models (PMID: 25730880). 25730880
Unknown unknown diffuse large B-cell lymphoma not applicable HER2 Inhibitor Ibrutinib + Venetoclax Preclinical - Cell culture Actionable In a preclinical study, the combination of Imbruvica (ibrutinib) and Venclexta (venetoclax) resulted in a synergistic effect, demonstrating growth suppression in germinal center B-cell diffuse large B-cell lymphoma (DLBCL) cell lines in culture, increased apoptotic activity and inhibition of colony formation in activated B-cell (ABC) DLBCL cell lines, and complete tumor growth inhibition in ABC-DLBCL cell line xenograft models (PMID: 28428442). 28428442
Unknown unknown follicular lymphoma not applicable HER2 Inhibitor Ibrutinib + Venetoclax Preclinical - Cell culture Actionable In a preclinical study, the combination of Imbruvica (ibrutinib) and Venclexta (venetoclax) resulted in a synergistic effect, demonstrating growth suppression in follicular lymphoma cell lines in culture (PMID: 28428442). 28428442
Unknown unknown chronic lymphocytic leukemia not applicable HER2 Inhibitor Ibrutinib + Venetoclax Phase II Actionable In a Phase II trial, Imbruvica (ibrutinib) and Venclexta (venetoclax) combination therapy resulted in a response rate of 100% (14/14, 9 complete response, 5 partial response) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients, and a response rate of 100% (16/16, 9 complete response, 7 partial response) in untreated patients with high-risk features including del 17p, TP53 mutations, and del 11q (ASH, 59th Annual Meeting and Exposition, Dec 2017, Abstract 429; NCT02756897). detail...
Unknown unknown lymphoblastic lymphoma not applicable HER2 Inhibitor Ibrutinib + VLX1570 Preclinical - Cell culture Actionable In a preclinical study, the combination of Imbruvica (ibrutinib) and VLX1570 worked synergistically to reduce viability of an Imbruvica (ibrutinib)-resistant Waldenstrom macroglobulinemia cell line in culture (PMID: 27813535). 27813535
Unknown unknown Advanced Solid Tumor not applicable HER2 Inhibitor Neratinib + Temsirolimus Phase I Actionable In a Phase I study, Nerlynx (neratinib) administered with Torisel (temsirolimus) was tolerable and demonstrated antitumor activity in multiple solid tumor types, including breast cancer and NSCLC (PMID: 24323026). 24323026
Unknown unknown Advanced Solid Tumor not applicable HER2 Inhibitor BMS-690514 Phase Ib/II Actionable In a Phase Ib/II trial, BMS-690514 demonstrated safety and preliminary efficacy in patients with advanced solid tumors (PMID: 23490650). 23490650
Unknown unknown lung non-small cell carcinoma not applicable HER2 Inhibitor BMS-690514 Phase Ib/II Actionable In a Phase 1b/II trial, BMS-690514 was demonstrated to be safe and efficacious in patients with NSCLC (PMID: 23490650). 23490650
Unknown unknown Advanced Solid Tumor not applicable HER2 Inhibitor AC480 Phase I Actionable In a Phase I trial, AC480 demonstrated safety and potential efficacy in patients with several solid tumor types (PMID: 21576284). 21576284
Unknown unknown stomach cancer not applicable HER2 Inhibitor CUDC-101 Phase I Actionable In a Phase I trial, a gastric cancer patient treated with CUDC-101 demonstrated a partial response for 57 days, in which the tumor regressed by 56% (PMID: 25107918). 25107918
Unknown unknown Advanced Solid Tumor not applicable HER2 Inhibitor PR610 Preclinical Actionable In a preclinical study, PR610 inhibited EGFR auto-phosphorylation and downstream signaling, and induced cell-cycle arrest and an anti-proliferative response in human cancer cell lines in culture (Mol Cancer Ther 2013;12(11 Suppl):B278). detail...
Unknown unknown stomach cancer not applicable HER2 Inhibitor JNJ-26483327 Preclinical Actionable In a preclinical study, human gastric cancer cells demonstrated sensitivity to JNJ-26483327 (PMID: 19584230). 19584230
Unknown unknown Advanced Solid Tumor not applicable HER2 Inhibitor JNJ-26483327 Phase I Actionable In a Phase I clinical trial, JNJ-26483327 was well-tolerated in patients with a range of advanced solid tumors, and demonstrated preliminary anti-tumor activity with 32% (6/19) of patients achieving stable disease for greater than 2 cycles (PMID: 20823884). 20823884
Unknown unknown Advanced Solid Tumor not applicable HER2 Inhibitor Varlitinib Phase I Actionable In a Phase I clinical trial, Varlitinib (ARRY-334543) demonstrated safety and some preliminary anti-tumor activity in patients with advanced solid tumors (Mol Cancer Ther 2009;8(12 Suppl):B54). detail...
Unknown unknown stomach cancer not applicable HER2 Inhibitor Cisplatin + Fluorouracil + Sapitinib Preclinical - Pdx Actionable In a preclinical study, Sapitinib (AZD8931), in combination with Platinol (cisplatin) and Adrucil (fluorouracil), demonstrated safety and an additive effect in a primary gastric cancer xenograft model (Cancer Res April 15, 2013 73; 2090). detail...
Unknown unknown Advanced Solid Tumor not applicable HER2 Inhibitor Sapitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Sapitinib (AZD8931) inhibited EGFR, ERBB2 (HER2), and ERBB3 (HER3) kinase activity, and inhibited tumor growth in several cell line xenograft models, including breast, NSCLC, colorectal, and head and neck squamous cell carcinoma xenograft models (PMID: 20145185). 20145185
Clinical Trial Phase Therapies Title Recruitment Status