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
1393TiP - A phase II/III study to evaluate the optimal dose, safety, and efficacy of livmoniplimab (Livmo) in combination with budigalimab (Budi) plus chemotherapy (CT) vs pembrolizumab (Pembro) plus CT in untreated metastatic non-small cell lung cancer (mNSCLC)
Presenter: Nicolas Girard
Session: Poster session 06
1394TiP - KRYSTAL-7: A phase III study of first-line adagrasib plus pembrolizumab versus pembrolizumab alone in patients with advanced NSCLC with KRASG12C mutation
Presenter: Marina Garassino
Session: Poster session 06
1395TiP - A randomized phase III trial evaluating oral BAY 2927088, compared with standard of care, as first-line treatment of locally advanced or metastatic NSCLC harboring HER2-activating mutations (SOHO-02)
Presenter: Antonio Passaro
Session: Poster session 06
1397TiP - Phase III trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapy
Presenter: Stephen Liu
Session: Poster session 06
Resources:
Abstract
1398TiP - Be6A Lung-01, a phase III study of sigvotatug vedotin (SV), an investigational antibody-drug conjugate (ADC) versus docetaxel in patients (pts) with previously treated non-small cell lung cancer (NSCLC)
Presenter: Solange Peters
Session: Poster session 06
1399TiP - Phase III, double-blind study of cannabis sativa extract in pain management and quality of life in patients with metastatic lung cancer: Protocol of a study (IPElife trial)
Presenter: Danielli Matias
Session: Poster session 06
1728P - Results of TNT: A phase II study using talimogene laherparepvec, nivolumab and trabectedin for advanced leiomyosarcoma and liposarcoma [NCT# 03886311]
Presenter: Sant Chawla
Session: Poster session 06
1729P - Update on SAINT: A phase II study using trabectedin (T) in combination with ipilimumab (I) and nivolumab (N) in previously treated soft tissue sarcoma
Presenter: Anmol Dia Agarwal
Session: Poster session 06
1730P - Preliminary results of phase II study on preoperative intensity-modulated radiotherapy with concurrent PARP inhibitor for patients with non-metastatic inoperable or borderline operable extremity and trunk soft tissue sarcoma
Presenter: NingNing Lu
Session: Poster session 06
Resources:
Abstract