Abstract 1956P
Background
Afatinib has shown durable responses in patients (pts) with solid tumours harbouring NRG1 gene fusions. The key objectives of this feasibility assessment were to determine the number of patients with NRG1 gene fusion-positive solid tumours available for analyses, characterise their treatment with afatinib and other systemic therapies, and gain insights into treatment patterns and testing for a larger, retrospective, real-world study.
Methods
US physicians in the Cardinal Health Oncology Provider Extended Network retrospectively abstracted data from medical records on adult pts with any solid tumour carrying a NRG1 gene fusion. Eligible pts had been treated with either afatinib or another systemic therapy (no prior afatinib) in any treatment line between Jan 2017 and Mar 2020 and had been followed up for ≥8 weeks. The target sample size was up to 120 pts. Data were reviewed by Cardinal Health and summarised using descriptive statistics for each treatment group.
Results
Twelve physicians participated (community practices n=9; academic settings n=3). A total of 108 pts with NRG1 gene fusion-positive tumours were identified; 67 pts received afatinib and 41 pts received other therapies. Pt and tumour characteristics and treatment patterns are shown in the table. The most common testing methodologies for NRG1 gene fusions were via mRNA (n=54; 50%) and DNA sequencing (n=28; 26%). Methodology was documented as other for 1 (<1%) pt and unknown for 25 (23%) pts. Testing was performed most frequently prior to first-line therapy (n=64; 59%). The most common fusion partners were CD74 (n=19; 18%) and SDC4 (n=14; 13%). Fusion partners were unknown for 22 (20%) pts. Table: 1956P
| Afatinib (n=67) | Other (n=41) | |
| Median age, yrs | 60 | 59 |
| Primary tumour type (≥10%*), n (%) | ||
| NSCLC | 27 (40) | 23 (56) |
| Pancreatic | 11 (16) | 3 (7) |
| Colorectal | 7 (10) | 3 (7) |
| Cholangiocarcinoma | 7 (10) | 3 (7) |
| Breast | 3 (4) | 4 (10) |
| Line in which treatment was received†, n (%) | ||
| 1 | 17 (25) | 41 (100) |
| 2 | 35 (52) | 14 (34) |
| 3 | 14 (21) | 3 (7) |
| 4 | 4 (6) | 0 |
| Median treatment duration by line, wks (min–max) | ||
| 1 | 36 (20–63) | 32 (12–52) |
| 2 | 30 (10–40) | 34 (12–60) |
| 3 | 18.5 (8–38) | 12 (12–12) |
| 4 | 16 (16–16) | n/a |
| Pts still receiving active therapy, n (%) | 31 (46) | 13 (32) |
| Reasons for treatment discontinuation (≥20%*), n (%) | ||
| Disease progression | 18 (27) | 9 (22) |
| Scheduled therapy completed | 2 (3) | 15 (37) |
*In either group; †n=3 pts received afatinib in two lines; pts reported in each line received.
Conclusions
These data support previous findings that NRG1 gene fusions are detected across multiple tumour types, most commonly in lung and gastrointestinal malignancies. Furthermore, these findings provide a rationale to perform a larger, retrospective, chart-based cohort study assessing treatment outcomes in pts with NRG1-positive tumours.
Clinical trial identification
n/a
Editorial acknowledgement
Writing, editorial support, and formatting assistance was provided by Laura Winton of GeoMed, an Ashfield company, part of UDG Healthcare PLC, which was contracted and funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI).
Legal entity responsible for the study
Boehringer Ingelheim Pharmaceuticals, Inc.
Funding
Boehringer Ingelheim Pharmaceuticals, Inc.
Disclosure
A. Gajra, J. Kaufman, J. Laney: Full/Part-time employment: Cardinal Health. A.J. Klink: Shareholder/Stockholder/Stock options, Full/Part-time employment: Cardinal Health. A. Cseh, K. Fernamberg, B. Moehring: Full/Part-time employment: Boehringer Ingelheim. All other authors have declared no conflicts of interest.