Therapy Detail

Therapy Name Neratinib
Synonym
Therapy Description

Nerlynx (neratinib) inhibits the ERBB2 (HER2) receptor as well as EGFR, resulting in decreased proliferation of HER2 and EGFR expressing tumor cells (PMID: 15173008). Nerlynx (neratinib) is FDA approved for breast cancer patients with ERBB2 (HER2) overexpression and/or amplification (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Neratinib Nerlynx HKI-272|PB272 HER2 Inhibitor 21 Nerlynx (neratinib) inhibits the ERBB2 (HER2) receptor as well as EGFR, resulting in decreased proliferation of HER2 and EGFR expressing tumor cells (PMID: 15173008). Nerlynx (neratinib) is FDA approved for breast cancer patients with ERBB2 (HER2) overexpression and/or amplification (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 S310F non-small cell lung carcinoma predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 L869R Her2-receptor negative breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 3.6 months in a patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) L869R (PMID: 29420467; NCT01953926). 29420467
ERBB2 G776delinsVC Advanced Solid Tumor sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G292R urinary bladder cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with bladder cancer harboring both ERBB2 (HER2) G292R (PMID: 29420467; NCT01953926). 29420467
ERBB2 V659E non-small cell lung carcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in two patients with non-small cell lung cancer harboring ERBB2 (HER2) V659E (PMID: 29420467; NCT01953926). 29420467
ERBB2 Y772_A775dup non-small cell lung carcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 5 patients and progressive disease in 4 patients with non-small cell lung cancer harboring ERBB2 (HER2) Y772_A775dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F cervical cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response in 1 patient, stable disease in 1 patient, and progressive disease in 1 patient with cervical cancer harboring ERBB2 (HER2) D769N (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755_T759del breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2 (HER2) L755_T759del were sensitive to treatment with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 mutant colorectal cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 8.3% (1/12), and a median progression-free survival of 1.8 months in patients with colorectal cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant endometrial cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 28.6% (2/7), and a median progression-free survival of 2.6 months in patients with endometrial cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 P761del endometrial cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with endometrial cancer harboring ERBB2 (HER2) P761del (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769H colorectal cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with colorectal cancer harboring ERBB2 (HER2) D769H (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F colorectal cancer conflicting Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) S310F in culture (PMID: 26243863). 26243863
ERBB2 S310F colorectal cancer conflicting Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with colorectal cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant Her2-receptor positive breast cancer sensitive Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) treatment resulted in complete response in 12.5% (3/24) and partial response in 20.8% (5/24) of ERBB2 (HER2) mutant but not amplified breast cancer patients (Cancer Res 2017;77(4 Suppl):Abstract nr PD2-08). detail...
ERBB2 G776_V777insVGC non-small cell lung carcinoma predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 1 patient and progressive disease in 2 patients with non-small cell lung cancer harboring ERBB2 (HER2) G776_V777insVGC (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F Advanced Solid Tumor sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) decreased cell survival of transformed human cells expressing ERBB2 (HER2) S310F (PMID: 22908275). 22908275
KRAS G12D colorectal cancer resistant Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) treatment resulted in continued tumor growth in xenograft models of patient derived colorectal cancer cells harboring KRAS G12D (PMID: 26243863). 26243863
ERBB2 L755A non-small cell lung carcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.6 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L755A (PMID: 29420467; NCT01953926). 29420467
ERBB2 amp ERBB2 L313I Her2-receptor positive breast cancer predicted - sensitive Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including partial response in a patient harboring ERBB2 (HER2) L313I (PMID: 30301790). 30301790
ERBB2 G309A breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) G309A demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 V777L urinary bladder cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 6.9 months in a patients with bladder cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F gastroesophageal junction adenocarcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.9 months in a patient with gastroesophageal cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755S non-small cell lung carcinoma predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 12.7 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L755S (PMID: 29420467; NCT01953926). 29420467
ERBB2 L841V colorectal cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.8 months in a patient with colorectal cancer harboring ERBB2 (HER2) L841V (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F colon cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) S310F in culture (PMID: 26243863). 26243863
ERBB2 V842I colon cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) V842I in culture (PMID: 26243863). 26243863
ERBB2 M774delinsWLV ERBB2 C805S Advanced Solid Tumor resistant Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells co-expressing ERBB2 (HER2) M774delinsWLV and ERBB2 (HER2) C805S demonstrated resistance to Nerlynx (neratinib) in culture (PMID: 28363995). 28363995
ERBB2 L663P Advanced Solid Tumor predicted - sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 amp ERBB2 Y772_A775dup Her2-receptor positive breast cancer predicted - sensitive Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including stable disease in a patient harboring ERBB2 (HER2) Y772_A775dup (PMID: 30301790). 30301790
ERBB2 mutant Her2-receptor negative breast cancer sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an object response rate of 24% (6/25), a clinical benefit rate of 40% (10/25), and a median progression-free survival of 3.5 months in patients with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F ERBB2 V842I breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) demonstrated activity in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, resulting in a clinical benefit rate of 31% (5/16), with 1 complete response, 1 partial response, and 3 patients achieving stable disease for 24 weeks or more, which included a patient harboring ERBB2 (HER2) S310F and V842I (PMID: 28679771). 28679771
ERBB2 D769Y gastroesophageal junction adenocarcinoma predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with gastroesophageal cancer harboring ERBB2 (HER2) D769Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) demonstrated activity in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, with treatment resulting in a clinical benefit rate of 31% (5/16; 1 complete response, 1 partial response, and 3 patients achieving stable disease for 24 weeks or more) and a median progression-free survival of 16 weeks (PMID: 28679771). 28679771
ERBB2 G778_P780dup breast cancer sensitive Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) demonstrated activity in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, resulting in a clinical benefit rate of 31% (5/16), which included patients with ERBB2 G778_P780dup (1 complete response (referred to as V777_G778insGSP) and 1 patient with stable disease for more than 24 weeks (referred to as P780_Y781insGSP) (PMID: 28679771). 28679771
ERBB2 G778_P780dup breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) P780_Y781insGSP reverted to normal morphology in culture upon Nerlynx (neratinib) treatment (PMID: 23220880). 23220880
ERBB2 mutant non-small cell lung carcinoma sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate of 3.8% (1/26), a clinical benefit rate of 42.3% (11/26), and a median progression-free survival of 5.5 months in patients with non-small cell lung cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant non-small cell lung carcinoma sensitive Neratinib Phase I Actionable In a Phase I study, Nerlynx (neratinib) administered with temsirolimus was tolerable and demonstrated antitumor activity in ERBB2-mutant non-small-cell lung cancer (PMID: 24323026). 24323026
ERBB2 V697L Advanced Solid Tumor predicted - sensitive Neratinib Phase II Actionable In a Phase II trial, a patient with cancer of unknown primary involving the head and neck that harbored ERBB2 (HER2) V697L demonstrated a response to treatment with Nerlynx (neratinib) that lasted 13 months (PMID: 29247016). 29247016
ERBB2 S310F biliary tract cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response in one and progressive disease in another patient with biliary tract cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant ovarian cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, no clinical benefit, and a median progression-free survival of 2.1 months in patients with ovarian cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L Her2-receptor negative breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response in one patient, and progressive disease in 4 patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 L786V non-small cell lung carcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.7 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L786V (PMID: 29420467; NCT01953926). 29420467
ERBB2 V773L breast cancer sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) V773L were sensitive to Nerlynx (nerlatinib) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 S310Y colorectal cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) delayed tumor growth in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y (PMID: 26243863). 26243863
ERBB2 V777L gastroesophageal junction adenocarcinoma predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.1 months in a patient with gastroesophageal cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 R678Q Advanced Solid Tumor predicted - sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 amp ERBB2 R456C Her2-receptor positive breast cancer predicted - sensitive Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including stable disease in a patient harboring ERBB2 (HER2) R456C (PMID: 30301790). 30301790
ERBB2 D277G ERBB2 S310F urinary bladder cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with bladder cancer harboring both ERBB2 (HER2) D277G and S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant biliary tract cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate at 8 weeks of 22.2% (2/9), a clinical benefit rate of 33.3% (3/9), and a median progression-free survival of 2.8 months in patients with biliary tract cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L colon cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) V777L in culture (PMID: 26243863). 26243863
ERBB2 G778_P780dup Advanced Solid Tumor conflicting Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P780_Y781insGSP demonstrated decreased response to Nerlynx (neratinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor conflicting Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 28363995). 28363995
ERBB2 L768S breast cancer sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) L768S were sensitive to Nerlynx (neratinib) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 S310F endometrial cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 2.6 months in a patient with endometrial cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778_P780dup non-small cell lung carcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival over 17 months in 2 patient with non-small cell lung cancer harboring ERBB2 (HER2) G778_P780dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769N cervical cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.5 months in a patient with cervical cancer harboring ERBB2 (HER2) D769N (PMID: 29420467; NCT01953926). 29420467
ERBB2 L841V Her2-receptor negative breast cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 2.8 months in a patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) L841V (PMID: 29420467; NCT01953926). 29420467
ERBB2 V842I breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) V842I demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 R678Q breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) R678Q demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 D769Y urinary bladder cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.4 months in a patient with bladder cancer harboring both ERBB2 (HER2) D769Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant urinary bladder cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 18.8% (3/16), and a median progression-free survival of 1.8 months in patients with bladder cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant lung cancer sensitive Neratinib Phase I Actionable In a Phase I clinical trial, Nerlynx (neratinib) administered with Torisel (temsirolimus) was tolerable and demonstrated antitumor activity in ERBB2 (HER2)-mutant non-small-cell lung cancer (PMID: 24323026). 24323026
ERBB2 act mut breast cancer sensitive Neratinib Phase II Actionable In a Phase II clinical trial, Nerlynx (neratinib) treatment resulted in clinical benefit in 36% (5/14) of metastatic breast cancer patients harboring ERBB2 (HER2) activating mutations, with 1 complete response, 1 partial response, and 2 patients achieving stable disease for greater than 6 months, and a median progression-free survival of 5 months (J Clin Oncol 34, 2016 (suppl; abstr 516)). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Neratinib Phase II Actionable In a Phase II clinical trial, Nerlynx (neratinib) demonstrated safety and efficacy as a monotherapy in patients with ERBB2 (HER2)-positive breast cancer (PMID: 23953056). 23953056
ERBB2 positive Her2-receptor positive breast cancer sensitive Neratinib FDA approved Actionable In a Phase III trial that supported FDA approval, ERBB2 (HER2)-positive breast cancer patients previously treated with Herceptin (trastuzumab) demonstrated a significantly greater two year invasive disease-free survival rate (93.9%) when treated with Nerlynx (neratinib) compared to the rate (91.6%) in those patients treated with placebo (PMID: 26874901; NCT00878709). 26874901
ERBB2 T733I biliary tract cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.7 months in a patient with biliary tract cancer harboring ERBB2 (HER2) T733I (PMID: 29420467; NCT01953926). 29420467
ERBB2 exon 20 ins Her2-receptor negative breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response in 1, partial response in 1, and stable disease in 3 of the 5 patients with Erbb2 (Her2)-receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) exon 20 insertion mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of ESR1-positive/ERBB2 (HER2)-positive breast cancer cell lines with ERBB2 amplification and harboring ERBB2 L755S in culture (PMID: 28487443). 28487443
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer sensitive Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including stable disease in a patient harboring ERBB2 (HER2) L755S, and breast cancer cell lines with ERBB2 (HER2) amplification and expressing ERBB2 (HER2) L755S demonstrated sensitivity to Nerlynx (neratinib) in culture (PMID: 30301790). 30301790
ERBB2 V777L breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) V777L demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 Y772_A775dup urinary bladder cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patients with bladder cancer harboring ERBB2 (HER2) Y722_A775dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 V842I endometrial cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.8 months in a patient with endometrial cancer harboring ERBB2 (HER2) V842I (PMID: 29420467; NCT01953926). 29420467
ERBB2 Y772_A775dup Her2-receptor negative breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response in one patient, and stable disease in 2 patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) Y772_A775dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769H Her2-receptor negative breast cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.5 months in a patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) D769H (PMID: 29420467; NCT01953926). 29420467
ERBB2 R678Q endometrial cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 5.5 months in a patient with endometrial cancer harboring ERBB2 (HER2) R678Q (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755S Her2-receptor negative breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response in 1 patient, partial response in 1 patient, stable disease in 2 patients, and progressive disease in 4 patients with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) L755S (PMID: 29420467; NCT01953926). 29420467
ERBB2 exon 20 ins non-small cell lung carcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 10 and progressive disease in 5 of the 15 patients with non-small cell lung cancer harboring ERBB2 (HER2) exon 20 insertion mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 V659E biliary tract cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 11.1 months in a patient with biliary tract cancer harboring ERBB2 (HER2) V659E (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755S colon cancer sensitive Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) demonstrated activity in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, resulting in a clinical benefit rate of 31% (5/16), with 1 complete response, 1 partial response in a patient with ERBB2 (HER2) L755S, and 3 patients achieving stable disease for 24 weeks or more (PMID: 28679771). 28679771
ERBB2 L755S colon cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) L755S in culture (PMID: 26243863). 26243863
ERBB2 S310F urinary bladder cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 4 patients and progressive disease in 1 patient with bladder cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778_P780dup Her2-receptor negative breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 3.5 months in one patient, and stable disease with a progression-free survival of 20.0 months in another patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) G778_P780dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 amp ERBB2 D769Y Her2-receptor positive breast cancer sensitive Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including stable disease in a patient harboring ERBB2 (HER2) D769Y, and Nerlynx (neratinib) inhibited tumor growth in a breast cancer patient-derived xenograft (PDX) model with ERBB2 (HER2) amplification and ERBB2 (HER2) D769Y (PMID: 30301790). 30301790
ERBB2 V777L biliary tract cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 3.6 months in one patient, and progressive disease with a progression-free survival of 0.8 months in another patient with biliary tract cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 K831N colorectal cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with colorectal cancer harboring ERBB2 (HER2) K831N (PMID: 29420467; NCT01953926). 29420467
ERBB2 amp uterine corpus serous adenocarcinoma sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, a uterine serous carcinoma cell line harboring ERBB2 (HER2) amplification demonstrated sensitivity to treatment with Nerlynx (neratinib) in culture, resulting in inhibition of cell growth (PMID: 26333383). 26333383
ERBB2 S310Y cervical cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 0.5 month in a patient with cervical cancer harboring ERBB2 (HER2) S310Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F Her2-receptor negative breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response with a progression-free survival of 14.6 months in one patient, and stable disease with a progression-free survival of 3.7 months in another patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 G660R Advanced Solid Tumor predicted - sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 S310Y urinary bladder cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 2 patients and progressive disease in 2 patients with bladder cancer harboring ERBB2 (HER2) S310Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 V697L triple-receptor negative breast cancer sensitive Neratinib Phase II Actionable In a Phase II trial, a triple-negative breast cancer patient harboring ERBB2 V697L demonstrated a response to treatment with Nerlynx (neratinib) (PMID: 29247016). 29247016
ERBB2 L755S colorectal cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) L755S in culture (PMID: 26243863). 26243863
ERBB2 V842I colorectal cancer conflicting Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 2 patients and progressive disease in 1 patient with colorectal cancer harboring ERBB2 (HER2) V842I (PMID: 29420467; NCT01953926). 29420467
ERBB2 V842I colorectal cancer conflicting Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cell lines over expressing ERBB2 (HER2) V842I in culture (PMID: 26243863). 26243863
ERBB2 V777L colorectal cancer conflicting Neratinib Preclinical - Cell line xenograft Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) V777L in culture and suppressed tumor growth in cell line xenograft models (PMID: 26243863). 26243863
ERBB2 V777L colorectal cancer conflicting Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.4 months in a patient with colorectal cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 R678Q gastroesophageal junction adenocarcinoma predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with gastroesophageal cancer harboring ERBB2 (HER2) R678Q (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755S ERBB2 R1153* ERBB2 V777L urinary bladder cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patients with bladder cancer harboring ERBB2 (HER2) L755S, R1153*, and V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 G776delinsVC non-small cell lung carcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 8.5 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) G776delinsVC (PMID: 29420467; NCT01953926). 29420467
ERBB2 amp ERBB2 V777L Her2-receptor positive breast cancer predicted - sensitive Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including partial response in a patient harboring ERBB2 (HER2) V777L (PMID: 30301790). 30301790
ERBB2 L755S breast cancer sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, treatment with Nerlynx (neratinib) resulted in growth inhibition in transformed human breast cell lines expressing ERBB2 (HER2) L755S in culture (PMID: 23220880). 23220880
ERBB2 L755S biliary tract cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease in one and stable disease in another patient with biliary tract cancer harboring ERBB2 (HER2) L755S (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L ERBB2 V842I colorectal cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.8 months in a patient with colorectal cancer harboring ERBB2 (HER2) V777L and V842I (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769Y breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) D769Y reverted to normal morphology in culture upon Nerlynx (neratinib) treatment (PMID: 23220880). 23220880
ERBB2 L866M colon cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) L866M in culture (PMID: 26243863). 26243863
ERBB2 amp ERBB2 L866M colorectal cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) treatment resulted in stable tumor size in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) L866M and ERBB2 (HER2) amplification (PMID: 26243863). 26243863
ERBB2 R896C breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) R896C reverted to normal morphology in culture upon Nerlynx (neratinib) treatment (PMID: 23220880). 23220880
ERBB2 V697L endometrial cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.6 months in a patient with endometrial cancer harboring ERBB2 (HER2) V697L (PMID: 29420467; NCT01953926). 29420467
ERBB2 G660D Advanced Solid Tumor predicted - sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 S310Y endometrial cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 9.6 months in a patient with endometrial cancer harboring ERBB2 (HER2) S310Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778A colorectal cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with colorectal cancer harboring ERBB2 (HER2) G778A (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755P non-small cell lung carcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 14.8 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L755P (PMID: 29420467; NCT01953926). 29420467
ERBB2 Y772_A775dup Advanced Solid Tumor sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) Y772_A775dup (also referred to as ERBB2 A775_G776insYVMA) in culture (PMID: 28363995). 28363995
ERBB2 K753E breast cancer sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) K753 were sensitive to Nerlynx (neratinib) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 mutant gastroesophageal junction adenocarcinoma no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 20% (1/5), and a median progression-free survival of 1.7 months in patients with gastroesophageal cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 V659E Advanced Solid Tumor predicted - sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 V777L endometrial cancer no benefit Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 6.9 months in a patient with endometrial cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 L866M colorectal cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) 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 Neratinib 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 Nerlynx (neratinib) in culture (PMID: 28363995). 28363995
ERBB2 S310Y gastroesophageal junction adenocarcinoma predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 0.8 month in a patient with gastroesophageal cancer harboring ERBB2 (HER2) S310Y (PMID: 29420467; NCT01953926). 29420467
KRAS G13D colorectal cancer decreased response Neratinib Preclinical Actionable In a preclinical study, colorectal cancer cells harboring KRAS G13D were less sensitive to Nerlynx (neratinib) induced growth inhibition in culture (PMID: 26243863). 26243863
ERBB2 L869R breast cancer sensitive Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) demonstrated activity in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, resulting in a clinical benefit rate of 31% (5/16), with 1 complete response, 1 partial response, and 3 patients achieving stable disease for 24 weeks or more, which included a patient harboring ERBB2 (HER2) L869R (PMID: 28679771). 28679771
ERBB2 L869R breast cancer sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited ERBB2 (HER2) phosphorylation and growth of transformed breast epithelial cells expressing ERBB2 (HER2) L869R in culture (PMID: 28274957). 28274957
ERBB2 R678Q colorectal cancer predicted - resistant Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.6 months in a patient with colorectal cancer harboring ERBB2 (HER2) R678Q (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769H breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) D769H demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 mutant cervical cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate of 20% (1/5), a clinical benefit rate of 60% (3/5), and a median progression-free survival of 20.1 months in patients with cervical cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
KRAS G12V colorectal cancer decreased response Neratinib Preclinical Actionable In a preclinical study, colorectal cancer cells harboring KRAS G12V were less sensitive to Nerlynx (neratinib) induced growth inhibition in culture (PMID: 26243863). 26243863
ERBB2 L755_E757delinsS Her2-receptor negative breast cancer predicted - sensitive Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 9.0 months in a patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) L755_E757delinsS (PMID: 29420467; NCT01953926). 29420467
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Nerlynx (neratinib) in culture (PMID: 30527195). 30527195
Clinical Trial Phase Therapies Title Recruitment Status
NCT03289039 Neratinib Fulvestrant + Neratinib A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer Recruiting
NCT01494662 Phase II Capecitabine + Neratinib Neratinib HKI-272 for HER2-Positive Breast Cancer and Brain Metastases Recruiting
NCT03812393 Phase II Carboplatin + Neratinib + Paclitaxel Neratinib Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast (FACT-2) Not yet recruiting
NCT01953926 Phase II Neratinib An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification Recruiting
NCT02400476 Phase II Neratinib A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide Recruiting
NCT02932280 Phase Ib/II Neratinib Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment Recruiting
NCT01670877 Phase II Neratinib Fulvestrant + Neratinib Neratinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer Recruiting
NCT02673398 Phase II Neratinib Neratinib in Treating Older Patients With Locally Advanced or Metastatic HER2-Positive Breast Cancer Recruiting
NCT03094052 Phase II Neratinib Loperamide Crofelemer Neratinib + Trastuzumab Diarrhea Prophylaxis in Patients With HER2+ Breast Cancer Treated With Trastuzumab and Neratinib, Followed by Neratinib Monotherapy Recruiting