Abstract 1116P
Background
Sotorasib has recently been licensed in Europe and USA for locally advanced and metastatic KRAS G12C mutant non-small cell lung cancer (NSCLC), following platinum chemotherapy and/or immunotherapy, based on the CodeBreaK 100 phase I/II trial. Given the small sample size and that patients in clinical trials are rarely representative of those in routine practice, it is vital to compare clinical trial data with real world experience.
Methods
Under the auspices of the British Thoracic Oncology Group, retrospective data was collected on patients prescribed sotorasib as per license, including those on compassionate access schemes. Data included patient demographics, diagnostic and prior treatment information, as well as outcomes of therapy.
Results
89 patients were treated from 22 sites across the UK. Objective response rate was 34.8% with a median progression-free survival of 185 days. The most common adverse event was diarrhoea (34%). One patient had a grade 4 event: thrombocytopenia. Comparison of efficacy and toxicity to the CodeBreak 100 trial is shown in the table. Table: 1116P
| CodeBreaK 100 | Real World Data | |
| Baseline Data | ||
| N. of Patient | 126 | 89 |
| Female (%) | 63 | 66.1 |
| Median Age (Yrs; Range) | 63.5 (37 – 80) | 66 (42 – 88) |
| Performance Score 0-1 (%) | 100 | 71.9 |
| Median (range) previous therapies | 2 (1 – 3) | 2 (1-5) |
| Brain Metastases (%) | 20.6 | 13.4 |
| Sotorasib Efficacy Data | ||
| Disease Control Rate (%) | 80.6 | 62.9 |
| Objective Response Rate (%) | 37.1 | 34.8 |
| Overall Survival (Days) | 380 (95% CI 304 – NA) | 262 (95% CI 210 - NA) |
| Progression Free Survival (days) | 206 (95% CI 155 – 249) | 185 (95% CI 171 – NA) |
| Grade 3 and above adverse events (%) | 20.6 | 9 |
| Dose Reductions (%) | 22.2 | 19.1 |
Conclusions
Although immature, real world data matches that of the CodeBreaK 100 study, confirming sotorasib as an effective treatment for relapsed KRAS G12C mutant NSCLC. Updated response and survival data will be presented.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
C. Lindsay: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Institutional, Sponsor/Funding: Mirati, Roche, Apollomics, Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: cbpartners. A. Georgiou: Financial Interests, Personal, Invited Speaker: Amgen, Merck; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other, Conference Attendance: Sanofi. D. Farrugia: Financial Interests, Personal, Advisory Board: BMS, MSD, Ipsen, Amgen, Roche. R. Shah: Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, Astra Zenenca, Roche, BMS, MSD, Pfizer, Lilly, Novartis, Takeda, Bayer, BeiGene, Guardant. S. Baijal: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Chugai, Daiichi Sankyo, FoundationOne, Gilead, GSK, Janssen, Lilly, Merck Serono, Novartis, Pierre Fabre, Pfizer, Roche, Servier, Sanofi, Takeda. A. Greystoke: Financial Interests, Personal, Advisory Board: BMS, AstraZeneca, Boehringer Ingelheim, Takeda, Roche, Novartis; Financial Interests, Personal, Invited Speaker: Merck, MSD, Pfizer, Janssen; Financial Interests, Institutional, Invited Speaker: MSD, Pfizer, AstraZeneca, Novartis, Achilles; Non-Financial Interests, Advisory Role: National Institute for Health and Clinical Excellence; Other, Clinical Lead for Cancer (paid position): North East England and Yorkshire Genomic Laboratory Hub. T. Newsom-Davis: Financial Interests, Personal, Invited Speaker: Amgen, Bayer, Boehringer Ingelheim, Lilly, Janssen, Merck Serono, MSD, Otsuka, Takeda, Roche, AstraZeneca, Guardant, BMS; Financial Interests, Personal, Advisory Board: Pfizer, Novartis. All other authors have declared no conflicts of interest.