Therapy Detail
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| Therapy Name | Afatinib |
| Synonyms | |
| Therapy Description |
Gilotrif (afatinib) is a second-generation pan-Egfr inhibitor with activity against EGFR T790M and EGFR exon 19 and 21 deletions, and also inhibits ERBB2 (HER2), ERBB3 (HER3), ERBB4 (HER4) (PMID: 24435321, PMID: 25505694). Gilotrif (afatinib) is FDA approved for use in non-small cell lung cancer patients harboring non-resistant EGFR mutations, including exon 19 deletions, L858R, S768I, G719X, and L861Q, and for patients with metastatic squamous NSCLC (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Afatinib | Gilotrif | BIBW 2992 | EGFR Inhibitor (Pan) 46 EGFR Inhibitor 2nd gen 3 HER inhibitor (Pan) 5 HER3 Inhibitor 2 | Gilotrif (afatinib) is a second-generation pan-Egfr inhibitor with activity against EGFR T790M and EGFR exon 19 and 21 deletions, and also inhibits ERBB2 (HER2), ERBB3 (HER3), ERBB4 (HER4) (PMID: 24435321, PMID: 25505694). Gilotrif (afatinib) is FDA approved for use in non-small cell lung cancer patients harboring non-resistant EGFR mutations, including exon 19 deletions, L858R, S768I, G719X, and L861Q, and for patients with metastatic squamous NSCLC (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ERBB2 L755S | colorectal cancer | conflicting | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) L755S in culture (PMID: 26243863). | 26243863 |
| ERBB2 L755S | colorectal cancer | conflicting | Afatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Gilotrif (afatinib) did not significantly inhibit tumor growth compared to vehicle control in cell line xenograft models of colorectal cancer harboring ERBB2 (HER2) L755S (PMID: 31588020). | 31588020 |
| ERBB2 positive | gastroesophageal junction adenocarcinoma | predicted - sensitive | Afatinib | Phase II | Actionable | In a Phase II clinical trial, monotherapy with Gilotrif (afatinib) resulted in a moderate clinical benefit in ERBB2 (HER2)-positive patients with either gastroesophageal junction adenocarcinoma, metastatic esophageal cancer, or gastric adenocarcinoma, demonstrating a tumor reduction in 25% (5/20) according to RECIST, an objective partial response in 10% (2/20), a median progression-free survival of 2 months, and a median overall survival of 7 months (PMID: 30463996; NCT01522768). | 30463996 |
| ERBB2 D769Y | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). | 31588020 |
| ROS1 rearrange | lung non-small cell carcinoma | no benefit | Afatinib | Guideline | Actionable | EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). | detail... |
| ERBB2 Y772_A775dup | Advanced Solid Tumor | resistant | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). | 31588020 |
| ERBB2 Y772_A775dup | Advanced Solid Tumor | resistant | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) demonstrated decreased response to Gilotrif (afatinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). | 30527195 |
| ERBB2 L869R | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) L869R in culture (PMID: 31588020). | 31588020 |
| ERBB2 M774delinsWLV ERBB2 C805S | Advanced Solid Tumor | resistant | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells co-expressing ERBB2 (HER2) M774delinsWLV and ERBB2 (HER2) C805S demonstrated resistance to Gilotrif (afatinib) in culture (PMID: 28363995). | 28363995 |
| ERBB2 P489L | cancer | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) P489L in culture (PMID: 32366937). | 32366937 |
| ERBB2 V777L | lung adenocarcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a retrospective study, Gilotrif (afatinib) treatment resulted in a partial response in a patient with lung adenocarcinoma harboring ERBB2 (HER2) V777L (PMID: 32162827). | 32162827 |
| ERBB2 amp | lung non-small cell carcinoma | sensitive | Afatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited proliferation and induced cell-cycle arrest and apoptosis of non-small cell lung cancer (NSCLC) cell lines with ERBB2 (HER2) amplification in culture, and inhibited tumor growth in ERBB2 (HER2)-amplified NSCLC cell line xenograft models (PMID: 26545934). | 26545934 |
| ERBB2 Y772_A775dup | lung cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) in culture (PMID: 26545934). | 26545934 |
| ERBB2 T798M | breast cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, breast cancer cells expressing ERBB2(HER2) T798M were sensitive to Gilotrif (afatinib) (PMID: 23948973). | 23948973 |
| ERBB2 exon 20 ins | lung non-small cell carcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical study, targeted therapy with Gilotrif (afatinib) or Herceptin (trastuzumab) resulted in an objective response rate of 44% (4/9) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies, all four responders harbored ERBB2 (HER2) exon 20 insertions (PMID: 28167203). | 28167203 |
| ERBB2 S310Y | lung squamous cell carcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical case study, Gilotrif (afatinib) treatment resulted in stable disease over 8-months in a patient with advanced squamous cell lung carcinoma harboring ERBB2 (HER2) S310Y (PMID: 30584328). | 30584328 |
| ERBB2 L786V | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) L786V in culture (PMID: 31588020). | 31588020 |
| ERBB4 G1109C | head and neck squamous cell carcinoma | sensitive | Afatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Gilotrif (afatinib) treatment induced apoptosis in head and neck squamous cell carcinoma cells harboring ERBB4 (HER4) G1109C in culture and inhibited tumor growth in cell line xenograft models (PMID: 27207775). | 27207775 |
| ERBB2 V659E | lung non-small cell carcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical case study, Gilotrif (afatinib) treatment resulted in eight months of progression-free survival followed by disease progression in a non-small cell lung cancer patient harboring ERBB2 (HER2) V659E previously treated with the combination of Tykerb (lapatinib) and Xeloda (capecitabine) (PMID: 32478891). | 32478891 |
| ERBB2 G776delinsVC ERBB2 C805S | Advanced Solid Tumor | resistant | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Gilotrif (afatinib) in culture (PMID: 30527195). | 30527195 |
| ERBB2 S310F | urinary bladder cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited foci formation of bladder cancer cells over expressing ERBB2 (HER2) S310F in culture (PMID: 24971884). | 24971884 |
| ERBB2 Y772_A775dup | lung non-small cell carcinoma | predicted - sensitive | Afatinib | Clinical Study | Actionable | In a retrospective analysis, Gilotrif (afatinib) treatment resulted in an objective response rate of 16% (5/31) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). | 30527195 |
| ERBB2 positive | inflammatory breast carcinoma | predicted - sensitive | Afatinib | Phase II | Actionable | In a Phase II clinical trial, treatment with Gilotrif (afatinib) resulted in a clinical benefit rate of 35% (9/26) in patients with ERBB2 (HER2)-positive inflammatory breast cancer, with 8 confirmed partial responses and 1 patient achieving stable disease for greater than 6 months (PMID: 27923043). | 27923043 |
| ERBB2 G778_P780dup | Advanced Solid Tumor | resistant | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) demonstrated decreased response to Gilotrif (afatinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). | 30527195 |
| ERBB2 G778_P780dup | Advanced Solid Tumor | resistant | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsVV | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsLC | lung cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G776delinsLC in culture (PMID: 26545934). | 26545934 |
| ERBB2 A775_G776insYVMA | lung non-small cell carcinoma | sensitive | Afatinib | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, treatment with Gilotrif (afatinib) resulted in decreased cell viability of patient-derived non-small cell lung cancer organoids harboring ERBB2 A775_G776insYVMA and tumor growth inhibition and tumor regression in patient derived xenograft (PDX) models, but to a lesser degree than treatment with Pyrotinib (PMID: 30596880; NCT02535507). | 30596880 |
| ERBB2 G776delinsVC | lung non-small cell carcinoma | conflicting | Afatinib | Clinical Study | Actionable | In a retrospective analysis, Gilotrif (afatinib) treatment resulted in an objective response rate of 0% (0/3) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). | 30527195 |
| ERBB2 G776delinsVC | lung non-small cell carcinoma | conflicting | Afatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited proliferation and induced cell-cycle arrest and apoptosis of a non-small cell lung cancer (NSCLC) cell line harboring ERBB2 (HER2) G776delinsVC in culture and inhibited tumor growth in NSCLC cell line xenografts carrying ERBB2 (HER2) G776delinsVC (PMID: 26545934). | 26545934 |
| ERBB2 D277H ERBB2 S310F | urinary bladder cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited foci formation of bladder cancer cells over expressing both ERBB2 (HER2) D277H and S310F in culture (PMID: 24971884). | 24971884 |
| ERBB2 L869R | breast cancer | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited ERBB2 (HER2) phosphorylation and growth of transformed breast epithelial cells expressing ERBB2 (HER2) L869R in culture (PMID: 28274957). | 28274957 |
| ERBB2 S310F ERBB2 G660D | ampulla of Vater carcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical case study, Gilotrif (afatinib) treatment resulted in stable disease with slight lymph node metastasis reduction in a patient with ampulla of Vater carcinoma harboring ERBB2 S310F and G660D, but the disease eventually progressed after 4 months (PMID: 29146616). | 29146616 |
| ERBB2 mutant | lung adenocarcinoma | sensitive | Afatinib | Phase II | Actionable | In a Phase II trial, treatment with Gilotrif (afatinib) resulted in objective response in 3 lung adenocarcinoma patients harboring ERBB2 (HER2) mutations (PMID: 22325357). | 22325357 |
| ERBB2 G660D | lung cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G660D in culture (PMID: 26545934). | 26545934 |
| ERBB2 G660D | lung cancer | sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical case study, Gilotrif (afatinib) treatment resulted in partial response in the lung lesion and stable bone metastasis for over 16 months in a patient with familial lung cancer harboring germline ERBB2 G660D mutation (PMID: 29146616). | 29146616 |
| ERBB2 G660D | lung cancer | sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical study, a patient with lung cancer harboring a germline mutation, ERBB2 (HER2) G660D, demonstrated improved symptoms within 30 days of Gilotrif (afatinib) treatment, as well as a 21% reduction in tumor volume in 12 weeks and a durable response that lasted for more than 15 weeks (PMID: 30449325). | 30449325 |
| ERBB2 G660D | Advanced Solid Tumor | predicted - sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). | 30449325 |
| ERBB2 mutant | lung non-small cell carcinoma | no benefit | Afatinib | Guideline | Actionable | Gilotrif (afatinib) is not recommended as a monotherapy in guidelines for non-small cell lung cancer patients with ERBB2 mutations (NCCN.org). | detail... |
| ERBB2 D769N | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). | 31588020 |
| ERBB2 positive | gastric adenocarcinoma | predicted - sensitive | Afatinib | Phase II | Actionable | In a Phase II clinical trial, monotherapy with Gilotrif (afatinib) resulted in a moderate clinical benefit in ERBB2 (HER2)-positive patients with either gastroesophageal junction adenocarcinoma, metastatic esophageal cancer, or gastric adenocarcinoma, demonstrating a tumor reduction in 25% (5/20) according to RECIST, an objective partial response in 10% (2/20), a median progression-free survival of 2 months, and a median overall survival of 7 months (PMID: 30463996; NCT01522768). | 30463996 |
| ERBB2 V777L | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). | 31588020 |
| ERBB2 V842I | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V842I in culture (PMID: 31588020). | 31588020 |
| ERBB2 L1157R | cancer | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) L1157R in culture (PMID: 32366937). | 32366937 |
| ERBB2 D769H | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). | 31588020 |
| ERBB2 G778_S779insLPS | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsVC | lung cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 26545934). | 26545934 |
| ERBB2 N813D | lung adenocarcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a Phase II trial, Gilotrif (afatinib) treatment resulted in partial response in a patient with lung adenocarcinoma harboring ERBB2 (HER2) N813D (PMID: 30149884; NCT02979821). | 30149884 |
| ERBB2 L755S | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) L755S in culture (PMID: 31588020). | 31588020 |
| ERBB2 R678Q | Advanced Solid Tumor | predicted - sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). | 30449325 |
| ERBB2 S653C | urinary bladder cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited foci formation of bladder cancer cells over expressing ERBB2 (HER2) S653C in culture (PMID: 24971884). | 24971884 |
| ERBB2 V659E | Advanced Solid Tumor | predicted - sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). | 30449325 |
| ERBB2 G776delinsVC | Advanced Solid Tumor | conflicting | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). | 31588020 |
| ERBB2 G776delinsVC | Advanced Solid Tumor | conflicting | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). | 30527195 |
| ERBB2 Q709L | Advanced Solid Tumor | predicted - sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). | 30449325 |
| ERBB2 G778_P780dup | lung non-small cell carcinoma | predicted - sensitive | Afatinib | Clinical Study | Actionable | In a retrospective analysis, Gilotrif (afatinib) treatment resulted in an objective response rate of 25% (1/4) in non-small cell lung cancer patients harboring ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) (PMID: 30527195). | 30527195 |
| ERBB2 Y772_A775dup | lung adenocarcinoma | no benefit | Afatinib | Clinical Study - Cohort | Actionable | In a retrospective study, Gilotrif (afatinib) treatment resulted in an objective response rate (ORR) of 15.6% (5/32) and a disease control rate of 68.8% (22/32) in patients with lung adenocarcinoma harboring ERBB2 (HER2) mutations, ORR (0%, 0/14), DCR (35.7%, 5/14), and median progression-free survival (1.2 mo) were significantly lower in patients with Y772_A775dup than those with other exon 20 insertions (40%, 4/10; 100%, 10/10; 7.6 mo) or missense mutations (13%, 1/8; 75%, 6/8; 3.6 mo) (PMID: 32162827). | 32162827 |
| ERBB2 Y772_A775dup | lung adenocarcinoma | no benefit | Afatinib | Case Reports/Case Series | Actionable | In a clinical study, a lung adenocarcinoma patient harboring ERBB2 Y772_A775dup (also referred to as A775_G776insYVMA and E740_A741insAYVM) achieved a partial response for 5 months following treatment with pulse Gilotrif (afatinib), however, a second patient harboring ERBB2 Y772_A775dup treated with pulse Gilotrif (afatinib) demonstrated progressive disease (PMID: 26964772). | 26964772 |
| ERBB2 V777L | colorectal cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) V777L in culture (PMID: 26243863). | 26243863 |
| Unknown unknown | colorectal cancer | not applicable | 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 |
| ERBB2 amp | urinary bladder cancer | sensitive | Afatinib | Phase II | Actionable | In a Phase II clinical trial, patients with ERBB2 (HER2) amplified urothelial carcinoma had improved progression free survival when treated with Gilotrif (afatinib), and median PFS was 6.6 months for patients with ERBB2 or ERBB3 alterations relative to 1.4 months for patients lacking alterations (PMID: 27044931). | 27044931 |
| ERBB2 L866M | colorectal cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) L866M in culture (PMID: 26243863). | 26243863 |
| ERBB2 Y772_A775dup ERBB2 C805S | Advanced Solid Tumor | resistant | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells co-expressing ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) and ERBB2 (HER2) C805S demonstrated resistance to Gilotrif (afatinib) in culture (PMID: 28363995). | 28363995 |
| ERBB2 L755P | Advanced Solid Tumor | resistant | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). | 31588020 |
| ERBB2 G778_P780dup | lung cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 26545934). | 26545934 |
| ERBB2 L663P | Advanced Solid Tumor | predicted - sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). | 30449325 |
| ERBB2 V659E | lung cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) V659E in culture (PMID: 26545934). | 26545934 |
| ERBB2 amp | Advanced Solid Tumor | sensitive | Afatinib | Phase II | Actionable | In a Phase II trial, Gilotrif (afatinib), demonstrated safety and efficacy in various advanced solid tumor patients with ERBB2 (HER2) amplification (PMID: 23775486). | 23775486 |
| ALK rearrange | lung non-small cell carcinoma | no benefit | Afatinib | Guideline | Actionable | EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ALK rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). | detail... |
| ERBB2 exon 20 ins | lung adenocarcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical study, treatment with pulse Gilotrif (afatinib) resulted in an objective response rate of 33.3% (1/3) in lung adenocarcinoma patients with ERBB2 (HER2) exon 20 insertion mutations (PMID: 26964772). | 26964772 |
| ERBB2 G776delinsLC | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsLC in culture (PMID: 31588020). | 31588020 |
| ERBB2 S310F | colorectal cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) S310F in culture (PMID: 26243863). | 26243863 |
| ERBB2 mutant | lung squamous cell carcinoma | predicted - sensitive | Afatinib | Phase III | Actionable | In a Phase III trial (LUX-Lung 8), secondary analysis demonstrated favorable outcomes with Gilotrif (afatinib) treatment compared to Tarceva (erlotinib) in lung squamous cell carcinoma patients with ERBB (HER) family mutations, and ERBB2 (HER2) mutations predicted an OS (HR=0.06, p=0.02) and PFS (HR=0.06, p=0.02) benefit for Gilotrif (afatinib) over Tarceva (erlotinib) treatment (PMID: 29902295; NCT01523587). | 29902295 |
| ERBB2 R188C | cancer | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) R188C in culture (PMID: 32366937). | 32366937 |
| ERBB2 G778_P780dup | lung adenocarcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical case study, a patient with metastatic lung adenocarcinoma harboring ERBB2 (HER2) G778_P780dup (also referred to as V777_G778insGSP) demonstrated tumor shrinkage and clinical response for 7 months following treatment with Gilotrif (afatinib) (PMID: 28363995). | 28363995 |
| ERBB2 G778_P780dup | lung adenocarcinoma | predicted - sensitive | Afatinib | Clinical Study - Cohort | Actionable | In a retrospective study, Gilotrif (afatinib) treatment resulted in an objective response rate (ORR) of 15.6% (5/32) and a disease control rate of 68.8% (22/32) in patients with lung adenocarcinoma harboring ERBB2 (HER2) mutations, patients harboring G776delinsVC (n=5) or G778_P780dup (n=5) achieved longer median progression-free survival (7.6 mo) than those with Y772_A775dup (n=14, 1.2 mo) or missense mutations (n=8, 3.6 mo), with an ORR of 40% (4/10) and a DCR of 100% (10/10) (PMID: 32162827). | 32162827 |
| ERBB2 G778_P780dup | lung adenocarcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical study, five lung adenocarcinoma patients each harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) demonstrated a clinical benefit from treatment with Gilotrif (afatinib), including one patient with a partial response lasting nine months, a second patient demonstrating a 51% reduction in primary tumor size after one month with a partial response lasting eight months, and three patients with stable disease ranging from 6 to 9 months (PMID: 32036069). | 32036069 |
| ERBB2 G778_P780dup | lung adenocarcinoma | predicted - sensitive | Afatinib | Case Reports/Case Series | Actionable | In a clinical study, a lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also referred to as V747_G748insGSP and G748_P750dup), demonstrated a 13% regression of target lesions and stable disease for 11 months following treatment with pulse Gilotrif (afatinib) (PMID: 26964772). | 26964772 |
| ERBB2 G776delinsVC | lung adenocarcinoma | predicted - sensitive | Afatinib | Clinical Study - Cohort | Actionable | In a retrospective study, Gilotrif (afatinib) treatment resulted in an objective response rate (ORR) of 15.6% (5/32) and a disease control rate of 68.8% (22/32) in patients with lung adenocarcinoma harboring ERBB2 (HER2) mutations, patients harboring G776delinsVC (n=5) or G778_P780dup (n=5) achieved longer median progression-free survival (7.6 mo) than those with Y772_A775dup (n=14, 1.2 mo) or missense mutations (n=8, 3.6 mo), with an ORR of 40% (4/10) and a DCR of 100% (10/10) (PMID: 32162827). | 32162827 |
| ERBB2 amp | breast cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited proliferation of breast cancer cell lines with ERBB2 (HER2) amplification in culture (PMID: 26545934). | 26545934 |
| ERBB2 V773M | Advanced Solid Tumor | sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). | 31588020 |
| ERBB2 positive | esophageal cancer | predicted - sensitive | Afatinib | Phase II | Actionable | In a Phase II clinical trial, monotherapy with Gilotrif (afatinib) resulted in a moderate clinical benefit in ERBB2 (HER2)-positive patients with either gastroesophageal junction adenocarcinoma, metastatic esophageal cancer, or gastric adenocarcinoma, demonstrating a tumor reduction in 25% (5/20) according to RECIST, an objective partial response in 10% (2/20), a median progression-free survival of 2 months, and a median overall survival of 7 months (PMID: 30463996; NCT01522768). | 30463996 |
| ERBB4 mutant | lung squamous cell carcinoma | predicted - sensitive | Afatinib | Phase III | Actionable | In a Phase III trial (LUX-Lung 8), secondary analysis demonstrated favorable outcomes with Gilotrif (afatinib) treatment compared to Tarceva (erlotinib) in lung squamous cell carcinoma patients with ERBB (HER) family mutations, and ERBB4 (HER4) mutations predicted an OS (HR=0.22) and PFS (HR=0.21) benefit for Gilotrif (afatinib) over Tarceva (erlotinib) treatment (PMID: 29902295; NCT01523587). | 29902295 |
| ERBB2 V842I | colorectal cancer | sensitive | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cell lines over expressing ERBB2 (HER2) V842I in culture (PMID: 26243863). | 26243863 |
| ERBB2 G660R | Advanced Solid Tumor | predicted - sensitive | Afatinib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). | 30449325 |
| ERBB2 amp ERBB2 over exp | stomach cancer | sensitive | Afatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Gilotrif (afatinib) induced tumor regression in a gastric cancer cell line xenograft model with HER2 (ERBB2) amplification and over expression (PMID: 23578997). | 23578997 |
| ERBB2 L755S ERBB2 amp | Her2-receptor positive breast cancer | sensitive | Afatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited growth of ESR1-positive/ERBB2 (HER2)-positive breast cancer cell lines with ERBB2 amplification and harboring ERBB2 L755S in culture, and inhibited tumor growth in xenograft models (PMID: 28487443). | 28487443 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT02491099 | Phase II | Afatinib | A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma (Afatinib) | Active, not recruiting |
| NCT01783587 | Phase I | Afatinib Docetaxel | Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer | Active, not recruiting |
| NCT02122172 | Phase II | Afatinib | Afatinib in Advanced Refractory Urothelial Cancer | Recruiting |
| NCT02372006 | Phase Ib/II | Afatinib | Trial of Afatinib in Pediatric Tumours | Active, not recruiting |
| NCT02506517 | Phase II | Afatinib | A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene | Active, not recruiting |
| NCT01553942 | Phase II | Afatinib Cisplatin Pemetrexed Disodium | Afatinib With CT and RT for EGFR-Mutant NSCLC | Recruiting |
| NCT01824823 | Phase II | Afatinib | Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence | Active, not recruiting |
| NCT02551718 | Phase I | Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate | High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia | Recruiting |
| NCT02438722 | Phase II | Afatinib Afatinib + Cetuximab | S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer | Active, not recruiting |
| NCT01746251 | Phase II | Afatinib | Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation | Active, not recruiting |
| NCT02465060 | Phase II | Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | Recruiting |
| NCT02695290 | Phase III | Afatinib | Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3) | Terminated |
| NCT02514174 | FDA approved | Afatinib | Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older | Completed |
| NCT02693535 | Phase II | Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Crizotinib Abemaciclib Sunitinib Olaparib | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer | Recruiting |
| NCT02115048 | Phase II | Afatinib Letrozole | Clinical Study for the Treatment of Breast Cancer the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone | Terminated |
| NCT02541903 | Phase II | Afatinib | Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma | Terminated |
| NCT01647711 | Phase I | Afatinib | A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations | Completed |
| NCT02423525 | Phase I | Afatinib | Safety Study of Afatinib for Brain Cancer | Active, not recruiting |
| NCT02795156 | Phase II | Cabozantinib Afatinib Regorafenib | Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations | Recruiting |
| NCT01649284 | Phase I | Afatinib | Afatinib Expanded Access Program | Approved for marketing |
| NCT01345669 | Phase III | Afatinib | LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy | Terminated |
| NCT02271906 | Phase II | Afatinib | The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting | Terminated |
| NCT03297606 | Phase II | Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) | Recruiting |
| NCT03878524 | Phase I | Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab | A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) | Recruiting |
| NCT02451553 | Phase I | Afatinib Capecitabine | Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer | Recruiting |
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