Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Conditions
Keywords
Neratinib, Nerlynx, Breast, Solid Tumors, Cancer, HER2 mutations, EGFR mutations, Fulvestrant, Trastuzumab, Cervical, Salivary, ERBB2, Exon 18, Metastatic, HR Positive, Lung, Non-Small Cell Lung Cancer (NSCLC)
Brief summary
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.
Detailed description
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology, including HER2 mutant breast, HER2 mutant cervical, HER2 mutant salivary gland, and EGFR Exon 18 mutant Non-small cell lung cancers. The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period.
Interventions
DRUGNeratinib
240 mg administered orally, once daily with food, continuously in 28 day cycles
DRUGFulvestrant
500 mg administered as two 5 mL injections on Days 1, 15, and 29; then once every 4 weeks thereafter month, then Day 1 of every 4 week cycle
DRUGTrastuzumab
Initial dose of 8 mg/kg of trastuzumab administered IV on Day 1, followed by 6 mg/kg IV once every 3 weeks thereafter
DRUGPaclitaxel
80mg/m\^2 administered IV on Days 1, 8, and 15 of every 4 week cycle
Sponsors
Puma Biotechnology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent * Histologically confirmed cancers for which no curative therapy exists * Documented HER2 or EGFR exon 18 mutation * Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol * At least one measurable lesion, defined by RECIST v1.1
Exclusion criteria
* Participants harboring ineligible somatic HER2 mutations * Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible * Participants who are receiving any other anticancer agents * Symptomatic or unstable brain metastases * Women who are pregnant or breast-feeding There are additional inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months | Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort) | From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months | Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (cervical cancer cohort). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | From first treatment date to first Complete or Partial Response, whichever came earlier, assessed up to 8 or 9 weeks | Percentage of participants who achieve CR or PR per Response Evaluation Criteria in Sold Tumors Criteria (RECIST) v1.1, or other defined response criteria, at the first scheduled tumor assessment (all other cohorts), per RECIST (if assessed) or PERCIST. RECISTv1.1 for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR PERCISTv1.0: Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions. Positive Metabolic Response - Participants having either Complete Metabolic Response or Part |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) by Investigator Review (All Cohorts) | From first response to first disease progression or death, assessed up to 58 months | Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed. |
| Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months | Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment. |
| Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months | Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment. |
| Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort) | From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months | Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months | Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants. |
| Number of Participants With Treatment-Emergent Adverse Events | From first dose through 28 days after the last dose, assessed up to 75 months. | The safety of neratinib in patients as measured by the incidence of treatment-emergent adverse events (TEAE), including serious adverse events (SAEs), in study participants. TEAEs are any adverse event that occurred on or after first dose of investigational product and up to 28 days after the last dose |
| Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months | Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants. |
| Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | From first treatment date to confirmed Complete or Partial Response, assessed up to 58 months. | Percentage of participants who achieve CR or PR per RECIST v1.1, or metabolic complete response via PERCIST v1.0. For RECIST, A complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met. PERCIST criteria were used for patients without RECIST assessments. |
| Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | From first response to first disease progression or death, assessed up to 58 months | Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed. |
Countries
Australia, Belgium, Canada, Denmark, France, Ireland, Israel, Italy, Serbia, South Korea, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neratinib Neratinib Monotherapy (Neratinib 240 mg PO daily) | 317 |
| Neratinib + Fulvestrant Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle) | 45 |
| Neratinib + Paclitaxel Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle) | 22 |
| Neratinib + Trastuzumab Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks) | 92 |
| Neratinib + Fulvestrant + Trastuzumab Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks) | 90 |
| Fulvestrant Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter) | 7 |
| Fulvestrant + Trastuzumab Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks) | 7 |
| Total | 580 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Discontinuation of study by sponsor | 41 | 7 | 5 | 12 | 46 | 5 | 6 |
| Overall Study | Lost to Follow-up | 18 | 3 | 0 | 5 | 3 | 0 | 0 |
| Overall Study | Not Treated | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Other, Disease progression | 2 | 1 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 23 | 3 | 3 | 5 | 6 | 0 | 1 |
Baseline characteristics
| Characteristic | Neratinib | Neratinib + Fulvestrant | Neratinib + Paclitaxel | Neratinib + Trastuzumab | Neratinib + Fulvestrant + Trastuzumab | Fulvestrant | Fulvestrant + Trastuzumab | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 116 Participants | 17 Participants | 18 Participants | 35 Participants | 31 Participants | 1 Participants | 4 Participants | 222 Participants |
| Age, Categorical Between 18 and 65 years | 201 Participants | 28 Participants | 4 Participants | 57 Participants | 59 Participants | 6 Participants | 3 Participants | 358 Participants |
| Age, Continuous | 59.4 years STANDARD_DEVIATION 13.1 | 60.6 years STANDARD_DEVIATION 11.5 | 69.4 years STANDARD_DEVIATION 9.4 | 60.4 years STANDARD_DEVIATION 11.1 | 59.2 years STANDARD_DEVIATION 11.6 | 58.3 years STANDARD_DEVIATION 11.2 | 62.0 years STANDARD_DEVIATION 12.4 | 60.0 years STANDARD_DEVIATION 12.4 |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 18 Participants | 2 Participants | 0 Participants | 7 Participants | 1 Participants | 0 Participants | 0 Participants | 28 Participants |
| Race/Ethnicity, Customized Race Black or African American | 16 Participants | 1 Participants | 0 Participants | 4 Participants | 4 Participants | 0 Participants | 1 Participants | 26 Participants |
| Race/Ethnicity, Customized Race Not Reported | 13 Participants | 2 Participants | 1 Participants | 5 Participants | 7 Participants | 0 Participants | 0 Participants | 28 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Unknown | 7 Participants | 1 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 13 Participants |
| Race/Ethnicity, Customized Race White | 255 Participants | 38 Participants | 21 Participants | 70 Participants | 77 Participants | 7 Participants | 5 Participants | 473 Participants |
| Sex: Female, Male Female | 188 Participants | 45 Participants | 5 Participants | 58 Participants | 89 Participants | 7 Participants | 7 Participants | 399 Participants |
| Sex: Female, Male Male | 129 Participants | 0 Participants | 17 Participants | 34 Participants | 1 Participants | 0 Participants | 0 Participants | 181 Participants |
| Tumor type Biliary tract cancer | 25 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 25 Participants |
| Tumor type Bladder/Urinary Tract cancer | 16 Participants | 0 Participants | 22 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 38 Participants |
| Tumor type Brain EGFR mutant cancer | 38 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 38 Participants |
| Tumor type Breast cancer HR- | 0 Participants | 0 Participants | 0 Participants | 21 Participants | 0 Participants | 0 Participants | 0 Participants | 21 Participants |
| Tumor type Breast cancer HR+ | 0 Participants | 45 Participants | 0 Participants | 0 Participants | 31 Participants | 0 Participants | 0 Participants | 76 Participants |
| Tumor type Breast cancer HR+ or HR- | 36 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 36 Participants |
| Tumor type Breast cancer HR+, prior CDK46 inhibitors | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 59 Participants | 7 Participants | 7 Participants | 73 Participants |
| Tumor type Cervical cancer | 22 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 22 Participants |
| Tumor type Colorectal cancer | 12 Participants | 0 Participants | 0 Participants | 19 Participants | 0 Participants | 0 Participants | 0 Participants | 31 Participants |
| Tumor type Endometrial cancer | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Tumor type Fibrolamellar carcinoma (FLC) | 15 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 15 Participants |
| Tumor type Gastroesophageal cancer | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Tumor type HER2 NOS cancer | 42 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 42 Participants |
| Tumor type HER3 NOS cancer | 16 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 16 Participants |
| Tumor type HER4 NOS cancer | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Tumor type Lung EGFR mutant exon 18 cancer | 31 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 31 Participants |
| Tumor type Lung Her2 mutant cancer | 26 Participants | 0 Participants | 0 Participants | 52 Participants | 0 Participants | 0 Participants | 0 Participants | 78 Participants |
| Tumor type Ovarian cancer | 10 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants |
| Tumor type Salivary gland cancer | 11 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 231 / 317 | 31 / 45 | 14 / 22 | 71 / 92 | 32 / 90 | 2 / 7 | 0 / 7 |
| other Total, other adverse events | 304 / 317 | 45 / 45 | 20 / 22 | 92 / 92 | 89 / 90 | 7 / 7 | 7 / 7 |
| serious Total, serious adverse events | 144 / 317 | 12 / 45 | 13 / 22 | 45 / 92 | 28 / 90 | 5 / 7 | 0 / 7 |
Outcome results
Primary
Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Population: Cohort of cancer type and treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 40.7 percentage of participants |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 0 percentage of participants |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 14.3 percentage of participants |
Primary
Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort)
Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (cervical cancer cohort). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Population: Cohort of cancer type and treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort) | 18.2 percentage of participants |
Primary
Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts)
Percentage of participants who achieve CR or PR per Response Evaluation Criteria in Sold Tumors Criteria (RECIST) v1.1, or other defined response criteria, at the first scheduled tumor assessment (all other cohorts), per RECIST (if assessed) or PERCIST. RECISTv1.1 for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR PERCISTv1.0: Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions. Positive Metabolic Response - Participants having either Complete Metabolic Response or Part
Time frame: From first treatment date to first Complete or Partial Response, whichever came earlier, assessed up to 8 or 9 weeks
Population: Cohort of cancer type and treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 36.1 percentage of participant |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 42.2 percentage of participant |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 48.4 percentage of participant |
| Breast Cancer HR- (Neratinib + Trastuzumab) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 33.3 percentage of participant |
| Lung Cancer HER2 Mutant (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 3.8 percentage of participant |
| Lung Cancer HER2 Mutant (Neratinib + Trastuzumab) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 15.4 percentage of participant |
| Lung Cancer EGFR Mutant Exon 18 (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 19.4 percentage of participant |
| Biliary Tract Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 12.0 percentage of participant |
| Bladder/Urinary Tract Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 13.6 percentage of participant |
| Brain Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Colorectal Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Colorectal Cancer (Neratinib + Trastuzumab) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 5.3 percentage of participant |
| Endometrial Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Ovarian Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Salivary Gland Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 36.4 percentage of participant |
| Gastroesophageal Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Fibrolamellar Carcinoma (FLC) (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| HER2 NOS Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 4.8 percentage of participant |
| HER3 NOS Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| HER4 NOS Cancer (Neratinib) | Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts) | 0 percentage of participant |
Secondary
Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.
Time frame: From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 49.2 percentage of participant |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 0 percentage of participant |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 14.3 percentage of participant |
Secondary
Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts)
Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.
Time frame: From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 54.2 percentage of participant |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 0 percentage of participant |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 0 percentage of participant |
| Breast Cancer HR- (Neratinib + Trastuzumab) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 33.3 percentage of participant |
| Lung Cancer HER2 Mutant (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 42.2 percentage of participant |
| Lung Cancer HER2 Mutant (Neratinib + Trastuzumab) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 54.8 percentage of participant |
| Lung Cancer EGFR Mutant Exon 18 (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 42.9 percentage of participant |
| Biliary Tract Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 45.5 percentage of participant |
| Bladder/Urinary Tract Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 38.5 percentage of participant |
| Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 30.8 percentage of participant |
| Brain Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 48.4 percentage of participant |
| Colorectal Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 24.0 percentage of participant |
| Colorectal Cancer (Neratinib + Trastuzumab) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 18.8 percentage of participant |
| Endometrial Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 31.8 percentage of participant |
| Ovarian Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 10.5 percentage of participant |
| Salivary Gland Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 8.3 percentage of participant |
| Gastroesophageal Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 21.1 percentage of participant |
| Fibrolamellar Carcinoma (FLC) (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 14.3 percentage of participant |
| HER2 NOS Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 20.0 percentage of participant |
| HER3 NOS Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 54.5 percentage of participant |
| HER4 NOS Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 0 percentage of participant |
| Fibrolamellar Carcinoma (FLC) (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 13.3 percentage of participant |
| HER2 NOS Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 19.0 percentage of participant |
| HER3 NOS Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 6.3 percentage of participant |
| HER4 NOS Cancer (Neratinib) | Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts) | 0 percentage of participant |
Secondary
Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts)
Percentage of participants who achieve CR or PR per RECIST v1.1, or metabolic complete response via PERCIST v1.0. For RECIST, A complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met. PERCIST criteria were used for patients without RECIST assessments.
Time frame: From first treatment date to confirmed Complete or Partial Response, assessed up to 58 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 25.0 percentage of participant |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 28.9 percentage of participant |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 35.5 percentage of participant |
| Breast Cancer HR- (Neratinib + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 33.3 percentage of participant |
| Lung Cancer HER2 Mutant (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 3.8 percentage of participant |
| Lung Cancer HER2 Mutant (Neratinib + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 9.6 percentage of participant |
| Lung Cancer EGFR Mutant Exon 18 (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 32.3 percentage of participant |
| Biliary Tract Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 16.0 percentage of participant |
| Bladder/Urinary Tract Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 13.6 percentage of participant |
| Brain Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 2.6 percentage of participant |
| Colorectal Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Colorectal Cancer (Neratinib + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 5.3 percentage of participant |
| Endometrial Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Ovarian Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Salivary Gland Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 9.1 percentage of participant |
| Gastroesophageal Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| Fibrolamellar Carcinoma (FLC) (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| HER2 NOS Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 2.4 percentage of participant |
| HER3 NOS Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 0 percentage of participant |
| HER4 NOS Cancer (Neratinib) | Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts) | 0 percentage of participant |
Secondary
Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Population: Cohort of cancer type and treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort) | 30.5 percentage of participants |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort) | 0 percentage of participants |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort) | 0 percentage of participants |
Secondary
Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
Time frame: From first response to first disease progression or death, assessed up to 58 months
Population: Number of confirmed responders
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 13.14 month |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | NA month |
Secondary
Duration of Response (DOR) by Investigator Review (All Cohorts)
Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
Time frame: From first response to first disease progression or death, assessed up to 58 months
Population: Number of confirmed responders
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 14.4 month |
| Breast Cancer HR- (Neratinib + Trastuzumab) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 4.76 month |
| Lung Cancer HER2 Mutant (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 9.23 month |
| Lung Cancer HER2 Mutant (Neratinib + Trastuzumab) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 9.17 month |
| Lung Cancer EGFR Mutant Exon 18 (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 7.28 month |
| Biliary Tract Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 7.62 month |
| Bladder/Urinary Tract Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 9.23 month |
| Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 6.80 month |
| Brain Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 22.24 month |
| Colorectal Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 3.75 month |
| Endometrial Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 7.20 month |
| Ovarian Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 19.94 month |
| Gastroesophageal Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 12.19 month |
| HER3 NOS Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | NA month |
| HER2 NOS Cancer (Neratinib) | Duration of Response (DOR) by Investigator Review (All Cohorts) | 3.71 month |
Secondary
Number of Participants With Treatment-Emergent Adverse Events
The safety of neratinib in patients as measured by the incidence of treatment-emergent adverse events (TEAE), including serious adverse events (SAEs), in study participants. TEAEs are any adverse event that occurred on or after first dose of investigational product and up to 28 days after the last dose
Time frame: From first dose through 28 days after the last dose, assessed up to 75 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent adverse event | 313 Participants |
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent serious adverse event | 144 Participants |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent adverse event | 45 Participants |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent serious adverse event | 12 Participants |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent adverse event | 21 Participants |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent serious adverse event | 13 Participants |
| Breast Cancer HR- (Neratinib + Trastuzumab) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent adverse event | 92 Participants |
| Breast Cancer HR- (Neratinib + Trastuzumab) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent serious adverse event | 45 Participants |
| Lung Cancer HER2 Mutant (Neratinib) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent adverse event | 89 Participants |
| Lung Cancer HER2 Mutant (Neratinib) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent serious adverse event | 28 Participants |
| Lung Cancer HER2 Mutant (Neratinib + Trastuzumab) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent adverse event | 7 Participants |
| Lung Cancer HER2 Mutant (Neratinib + Trastuzumab) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent serious adverse event | 5 Participants |
| Lung Cancer EGFR Mutant Exon 18 (Neratinib) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent adverse event | 7 Participants |
| Lung Cancer EGFR Mutant Exon 18 (Neratinib) | Number of Participants With Treatment-Emergent Adverse Events | Any treatment-emergent serious adverse event | 0 Participants |
Secondary
Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
Time frame: From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 8.11 month |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 2.27 month |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort) | 4.11 month |
Secondary
Progression-Free Survival (PFS) by Investigator Review (All Cohorts)
Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
Time frame: From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 8.3 month |
| Breast HR+ w. Prior CDK4/6i (Fulvestrant) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 4.1 month |
| Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 3.9 month |
| Breast Cancer HR- (Neratinib + Trastuzumab) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 3.48 month |
| Lung Cancer HER2 Mutant (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 5.36 month |
| Lung Cancer HER2 Mutant (Neratinib + Trastuzumab) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 8.21 month |
| Lung Cancer EGFR Mutant Exon 18 (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 6.24 month |
| Biliary Tract Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 5.09 month |
| Bladder/Urinary Tract Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 4.17 month |
| Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 4.01 month |
| Brain Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 5.75 month |
| Colorectal Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 2.76 month |
| Colorectal Cancer (Neratinib + Trastuzumab) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 1.77 month |
| Endometrial Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 3.75 month |
| Ovarian Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 1.81 month |
| Salivary Gland Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 1.71 month |
| Gastroesophageal Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 2.04 month |
| Fibrolamellar Carcinoma (FLC) (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 1.87 month |
| HER2 NOS Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 2.37 month |
| HER3 NOS Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 5.32 month |
| HER4 NOS Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 1.74 month |
| Fibrolamellar Carcinoma (FLC) (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 3.58 month |
| HER2 NOS Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 1.84 month |
| HER3 NOS Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 1.69 month |
| HER4 NOS Cancer (Neratinib) | Progression-Free Survival (PFS) by Investigator Review (All Cohorts) | 1.71 month |