Trial Outcomes & Findings for Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S. (NCT NCT04750824)
NCT ID: NCT04750824
Last Updated: 2024-09-19
Results Overview
ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response (response based on the scan where the patient showed the best response to treatment (not progression)). Charted/physician-reported (physician-provided information as recorded in patient's chart) ORR is reported.
Recruitment status
COMPLETED
Target enrollment
110 participants
Primary outcome timeframe
From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
Results posted on
2024-09-19
Participant Flow
This was a non-interventional, retrospective, United States (US), multi-site, cohort study based on existing data from medical records of patients with Neuregulin-1 (NRG1) gene fusion-positive solid tumors treated with afatinib or other systemic therapy.
Only subjects that met all inclusion and none of the exclusion criteria were included.
Participant milestones
| Measure |
All Afatinib Patients
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
38
|
|
Overall Study
First Line Therapy Patients
|
16
|
36
|
|
Overall Study
COMPLETED
|
10
|
14
|
|
Overall Study
NOT COMPLETED
|
62
|
24
|
Reasons for withdrawal
| Measure |
All Afatinib Patients
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|
|
Overall Study
Toxicity/intolerability
|
3
|
1
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Scheduled duration of therapy complete
|
1
|
9
|
|
Overall Study
Disease progression (confirmed with scan)
|
57
|
11
|
Baseline Characteristics
Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.
Baseline characteristics by cohort
| Measure |
All Afatinib Patients
n=72 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 Years
n=5 Participants
|
66 Years
n=7 Participants
|
62.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Geographic Region
Northeast
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Geographic Region
Midwest
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Geographic Region
South
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Geographic Region
West
|
26 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Line of therapy in which index therapy was received
First line therapy (1L)
|
16 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Line of therapy in which index therapy was received
Second line therapy (2L)
|
51 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Line of therapy in which index therapy was received
≥ third line therapy (3L+)
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
0,1
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
2+
|
50 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Smoking status at initiation of index therapy
Never smoked
|
32 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Smoking status at initiation of index therapy
Current smoker
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Smoking status at initiation of index therapy
Past history of smoking
|
38 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Tumor stage at initiation of index therapy
Stage I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Tumor stage at initiation of index therapy
Stage II
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Tumor stage at initiation of index therapy
Stage III
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Tumor stage at initiation of index therapy
Stage IV
|
65 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Comorbidities
Hypertension
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Comorbidities
Cardiovascular disease
|
0 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Comorbidities
Diabetes with chronic complications
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Comorbidities
Chronic pulmonary disease
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Comorbidities
Depression
|
17 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Comorbidities
None of the above
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
NRG1 testing characteristics: NRG1 testing location
Caris Life Sciences
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
NRG1 testing characteristics: NRG1 testing location
Foundation One
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
NRG1 testing characteristics: NRG1 testing location
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
NRG1 testing characteristics: NRG1 testing location
Specialty gene testing lab
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
NRG1 testing characteristics: NRG1 testing location
Tempus
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
NRG1 testing characteristics: NRG1 testing location
Unknown
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response (response based on the scan where the patient showed the best response to treatment (not progression)). Charted/physician-reported (physician-provided information as recorded in patient's chart) ORR is reported.
Outcome measures
| Measure |
All Afatinib Patients
n=72 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=16 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=36 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response
|
37.5 percentage of patients
|
76.3 percentage of patients
|
43.8 percentage of patients
|
77.8 percentage of patients
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
ORR based on lesion measurements and RECIST v1.1 criteria is reported. ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): CR: Disappearance of all target lesions or disappearance of all non-target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
All Afatinib Patients
n=72 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=16 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=36 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria
|
34.7 percentage of patients
|
71.1 percentage of patients
|
43.8 percentage of patients
|
72.2 percentage of patients
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020 and had a complete or partial response according to charted/physician-reported disease response.
DOR was defined as the time from initial response (for any patient with a complete or partial response initially) until the earliest of either disease progression or death. Duration of response is reported for those patients who had a complete or partial response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date.
Outcome measures
| Measure |
All Afatinib Patients
n=27 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=29 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=7 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=28 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Duration of Objective Response (DOR)
|
5.851 months
Interval 3.419 to 9.04
|
13.38 months
Interval 8.974 to 13.38
|
NA months
Median and 95% Confidence Interval could not be calculated due to insufficient number of participants with the event
|
13.38 months
Interval 8.98 to 13.38
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020 and had a complete, partial, or stable disease response according to charted/physician-reported disease response.
DOCB was defined as the time from initial response (for any patient with a complete, partial, or stable disease response initially) until the earliest of either disease progression or death. DOCB reported for those patients who had a complete, partial or response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date.
Outcome measures
| Measure |
All Afatinib Patients
n=35 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=32 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=8 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=31 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Duration of Clinical Benefit (DOCB)
|
5.85 months
Interval 2.99 to 9.04
|
13.38 months
Interval 8.97 to 13.38
|
NA months
Could not be calculated due to insufficient number of participants with events.
|
13.38 months
Interval 8.97 to 13.38
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
PFS was defined as time from initiation of a line of therapy until disease progression or death; patients on therapy at the time of data cut-off were censored on the last date of treatment. Patients who discontinued a line of therapy for a reason other than disease progression but who subsequently die prior to the receipt of any other therapy were considered an event on the date of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeter (mm).
Outcome measures
| Measure |
All Afatinib Patients
n=72 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=16 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=36 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.490 months
Interval 4.602 to 5.917
|
12.886 months
Interval 4.865 to
Upper Limit of 95% Confidence Interval could not be calculated due to insufficient number of participants with the event.
|
6.345 months
Interval 5.325 to
Upper Limit of 95% Confidence Interval could not be calculated due to insufficient number of participants with the event.
|
12.89 months
Interval 4.865 to
Upper Limit of 95% Confidence Interval could not be calculated due to insufficient number of participants with the event.
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
TOT was defined as time from initiation of a line of therapy until discontinuation for any reason. Patients on therapy at the time of data cut-off were censored on the last date of treatment.
Outcome measures
| Measure |
All Afatinib Patients
n=72 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=16 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=36 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Time on Treatment (TOT)
|
5.42 months
Interval 4.24 to 5.82
|
5.08 months
Interval 3.48 to 15.91
|
6.34 months
Interval 5.33 to
Upper Limit of 95% Confidence Interval could not be calculated due to insufficient number of participants with the event.
|
5.08 months
Interval 3.48 to 15.91
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
TTP was defined as time from initiation of a line of therapy until discontinuation due to disease progression. Patients on therapy or those who discontinued due to a reason other than disease progression were censored on the last date of treatment.
Outcome measures
| Measure |
All Afatinib Patients
n=72 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=16 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=36 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Time to Progression (TTP)
|
5.49 months
Interval 4.6 to 6.08
|
12.89 months
Interval 12.89 to
Upper Limit of 95% Confidence Interval could not be calculated due to insufficient number of participants with the event.
|
6.44 months
Interval 5.36 to
Upper Limit of 95% Confidence Interval could not be calculated due to insufficient number of participants with the event.
|
12.89 months
Interval 12.89 to
Upper Limit of 95% Confidence Interval could not be calculated due to insufficient number of participants with the event.
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
OS was defined as time from initiation of any therapy in the metastatic setting until death. Patients alive at the time of data cut-off were censored on the last date the patient was seen by the provider/clinic.
Outcome measures
| Measure |
All Afatinib Patients
n=72 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=16 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=36 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
7.166 months
Interval 6.246 to 9.04
|
22.551 months
Interval 10.815 to 29.848
|
9.928 months
Interval 7.002 to
Upper Limit of 95% Confidence Interval could not be calculated due to insufficient number of participants with the event.
|
22.55 months
Interval 10.82 to 29.85
|
PRIMARY outcome
Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.Population: All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
Number of patients who experienced any averse drug reactions (ADRs) during index treatment line is reported. An ADR was defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event (AE) is at least a reasonable possibility.
Outcome measures
| Measure |
All Afatinib Patients
n=72 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Afatinib Patients
n=16 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
First Line Non-afatinib Patients
n=36 Participants
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|---|---|
|
Number of Patients Who Experienced Any ADRs During Index Treatment Line
|
7 Participants
|
8 Participants
|
2 Participants
|
8 Participants
|
Adverse Events
All Afatinib Patients
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
All Non-afatinib (Other Systemic Therapies)
Serious events: 4 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
All Afatinib Patients
n=72 participants at risk
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 participants at risk
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/72 • From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e.11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
|
5.3%
2/38 • From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e.11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/72 • From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e.11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
|
5.3%
2/38 • From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e.11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
|
Other adverse events
| Measure |
All Afatinib Patients
n=72 participants at risk
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up).
|
All Non-afatinib (Other Systemic Therapies)
n=38 participants at risk
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
2/72 • From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e.11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
|
7.9%
3/38 • From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e.11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER