Abstract 1387P
Background
KRAS G12C mutation is the second most prevalent oncogenic driver in non-squamous NSCLC. Sotorasib is a potent selective oral inhibitor for treating KRAS G12C mutation-in positive locally advanced or metastatic NSCLC patients whose disease has progressed on, or who cannot tolerate platinum-based chemotherapy or anti PD-1/PD-L1 immunotherapy. It has been approved to use in the second line by NHS England since late 2021. We aim to present real world data collected from 12 cancer centres across the UK exploring the clinical outcomes and tolerability of Sotorasib.
Methods
Retrospective data was collected from 12 hospitals across the UK for patients who received Sotorasib (n=125). We reviewed data including demographics, stage histopathology, PD-L1 status, metastatic disease including CNS, ECOG performance status and toxicity markers. Outcomes including PFS, OS and response rates were also calculated. Here, we report real-world data against the registry trial CodeBreak 100.
Results
Table: 1387P
Real-world CodeBreak 100 |
n=patients 125 126 |
Median age -Yr 68 (41-93) 63.5 (37-80) |
Female-no (%) 78 (62.4) 63 (50.0) |
ECOG performance status no. (%) 0 15 (12) 0-1 PS =100 |
1 80 (64) |
Brain mets no. (%) |
Yes 29 (23) 26 (20.6) |
No 96 (77) 100(79.4) |
Objective response rate % 36.8 37.1 |
Response -no.(%) out of 124 patients |
Complete response 3 (2.4) 4 (3.2) |
Partial response 43 (34.4) 42 (33.9) |
Progression free survival -months 6.5 6.8 |
Median Overall survival-months 10 12.5 |
Treatment related adverse events leading to discontinuation of therapy– any grade -no-(%) 19 (15.2) 9 (7.1) |
Treatment related adverse event leading to dose modification- any grade -no.(%)26 (20.8) 28 (22.2) |
Conclusions
Our outcome data closely aligns with those from Codebreak100. As expected mOS is lower, reflective of the overall frailer real world patient cohort in comparison to the trial group. Diarrhoea and elevated liver enzymes are the primary causes for stopping medication in real-world observations. Further real-world data is necessary to explore how efficacy varies based on PDL-1 status and other co-existing mutations.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1362P - Evaluation of imaging-based prognostication (IPRO) for advanced non-small cell lung cancer (aNSCLC) using deep learning applied to computed tomography (CT)
Presenter: Omar Khan
Session: Poster session 06
1363P - An AI-derived tool to pre-screen lung cancer candidates for clinical trials
Presenter: Mihaela Aldea
Session: Poster session 06
1364P - Federated analysis of overall survival (OS) by location of metastases (mets) in patients (pts) with metastatic NSCLC (mNSCLC) from the Digital Oncology Network for Europe (DigiONE)
Presenter: Åsa Öjlert
Session: Poster session 06
1365P - Does cancer care differ for older adults with lung cancer living with and without Alzheimer disease and related dementias (ADRD)?
Presenter: Lorinda Coombs
Session: Poster session 06
1366P - Natural Language Processing (NLP) as promising artificial intelligence (AI) tool to improve patients (pts) enrollment in clinical trials (CT): Analysis in real-world conditions on a lung cancer cohort
Presenter: Julien Mazieres
Session: Poster session 06
1367P - Sex disparities in patient and tumour characteristics, and overall survival in advanced non-small cell lung cancer (NSCLC) within the precision oncology era: A Danish nationwide observational study
Presenter: Matilde Frost
Session: Poster session 06
1368P - Correlation between depth of response at 6 months and survival in patients (pts) with metastatic non-small cell lung carcinoma (mNSCLC): SPORE trial
Presenter: Fabien Moinard-Butot
Session: Poster session 06
1369P - Trilaciclib combined with intraventricular injection chemotherapy in the treatment of advanced NSCLC with leptomeningeal metastasis: A prospective, single-arm, phase II clinical trial
Presenter: Shen Cun Fang
Session: Poster session 06
1370P - Survival of de novo metastatic non-small cell lung cancer according to biomarker status in Denmark and Norway: A register-based cohort study
Presenter: Johan Liseth Hansen
Session: Poster session 06