Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 20

1400P - Real-world effectiveness and safety of sotorasib in patients with KRAS G12C mutated metastatic non-small cell lung cancer (NSCLC): Results of the IFCT-2102 Lung KG12Ci study

Date

21 Oct 2023

Session

Poster session 20

Topics

Clinical Research;  Targeted Therapy

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Marie Wislez

Citation

Annals of Oncology (2023) 34 (suppl_2): S755-S851. 10.1016/S0923-7534(23)01943-9

Authors

M. Wislez1, C. Mascaux2, J. Cadranel3, Q. Thomas4, C. Ricordel5, A. Swalduz6, E. Pichon7, R. Veillon8, V. Gounant9, G. Rousseau Bussac10, A. Madroszyk Flandin11, C. Daniel12, M. RAVOIRE13, A. Métivier14, P. Fournel15, P. missy16, F. Morin17, F. Guisier18, V. Westeel19

Author affiliations

  • 1 Pneumologie, Hopital Tenon AP-HP, 75970 - Paris, Cedex/FR
  • 2 Pneumologie, Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil, 67091 - Strasbourg/FR
  • 3 Service De Pneumologie Et Oncologie Thoracique, Hopital Tenon AP-HP, 75970 - Paris, Cedex/FR
  • 4 Service D’oncologie Médicale, ICM - Institut du Cancer de Montpellier, 34298 - Montpellier, Cedex/FR
  • 5 Pulmonology, Hopital Pontchaillou, 35033 - Rennes/FR
  • 6 Rhône, Centre Léon Bérard, 69008 - Lyon/FR
  • 7 Service De Pneumologie, CHRU Hopitaux de Tours - Hopital Bretonneau, 37044 - Tours, cedex/FR
  • 8 Service Des Maladies Respiratoires, Hopital De Haut Leveque, 33604 - Pessac/FR
  • 9 Service D'oncologie Thoracique, Hopital Bichat Claude Bernard, 75018 - Paris/FR
  • 10 Service De Pneumologie, Centre hospitalier Intercommunal de Créteil, 94010 - Creteil/FR
  • 11 Service D'oncologie Médicale, IPC - Institut Paoli-Calmettes, 13273 - Marseille, Cedex/FR
  • 12 Service De Pneumologie, Institut Curie, 75005 - Paris/FR
  • 13 Service De Pneumologie, Institut du Cancer Avignon-Provence, Avignon/FR
  • 14 Service De Pneumologie, Hopital Foch, 92151 - Suresnes/FR
  • 15 Service De Pneumologie Et D'oncologie Thoracique, Centre Hospitalier Universitaire de Saint-Etienne, 42100 - Saint-Étienne/FR
  • 16 Clinical Research, French Cooperative Thoracic Intergroup, 75009 - Paris/FR
  • 17 Clinical Research Unit, French Cooperative Thoracic Intergroup, 75009 - Paris/FR
  • 18 Pneumologie, CHU de Rouen Normandie, 76000 - Rouen/FR
  • 19 Service De Pneumologie, CHRU Besancon - Hopital Jean Minjoz, 25030 - Besancon/FR

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 1400P

Background

Sotorasib has demonstrated robust activity in phase 3 trial in pretreated NSCLC patients (pts) with KRAS G12C mutation. However, its effectiveness and safety in a real-world (RW) setting, particularly when administered after treatment with immune checkpoint inhibitors (ICI), remains to be confirmed.

Methods

Multicenter retrospective study including NSCLC pts who received at least one dose of sotorasib as part of the French expanded access program between February 2021 and April 2022. The primary objective was to evaluate real-world progression-free survival (rwPFS), and the secondary objectives included overall survival (OS) and reporting of sotorasib-related hepatic toxicity.

Results

At time of intermediate database lock a total of 313 pts with data collection completed (out of 446 included) were considered in this analysis. At time of sotorasib initiation: median age 66 years (range [39-85]), males (56%), PS2+ (30%) and smokers (95%). Brain metastases (BM) were present in 116 (37%) pts, with 53% in progression. PD-L1 expression was < 1% in 33%, ≥ 1-49% in 35% and ≥ 50% in 23% of the pts. The median number of lines of treatment before sotorasib was 2.0, and the last treatment before sotorasib included ICI in 164 pts. The median follow-up time was 13.7 months (ms). Median rwPFS was 4.2 ms [95%CI 3.3;4.9], and median OS was 9.3 ms [95%CI 7.9 ;12.3]. Objective response rate (ORR) was 34.3% [95%CI 28.4; 40.1] and disease control rate (DCR) was 64.2%. Median duration of response was 3.9 ms [95%CI 2.9;5.6]. In BM, DCR was 65.9% with 18.7% of ORR. Hepatic grade 3 or 4 treatment-related adverse events (TRAEs) were reported in 7% pts, with ALAT elevation observed in 3.5% and ASAT elevation observed in 2.2% of pts. Among 263 pts who stopped treatment, 42 (16%) discontinued sotorasib due to toxicity, including hepatic toxicity (26 pts), diarrhea (14 pts) and other reasons (8 pts).

Conclusions

Our IFCT-2102 study confirms the effectiveness of sotorasib in pretreated KRAS G12C-NSCLC pts, and its safety profile is manageable with hepatic grade 3 or 4 TRAEs occurring in 7% of pts. Our findings support the use of sotorasib as a treatment option in this population.

Clinical trial identification

NCT05273047.

Editorial acknowledgement

Legal entity responsible for the study

IFCT.

Funding

Amgen.

Disclosure

M. Wislez: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, Roche, BMS, MSD, AstraZeneca, Sanofi, Novartis, Lilly; Financial Interests, Personal, Speaker’s Bureau: Amgen, MSD, BMS, AstraZeneca, Lilly, Sanofi; Non-Financial Interests, Personal, Non financial benefits, Support for attending meetings and/or travel: Roche, MSD. C. Mascaux: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK, Janssen, Amgen, Kephren, AstraZeneca, MSD, Bristol Myers Squibb, Pfizer, Takeda, Sanofi, Roche, Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: MSD; Financial Interests, Personal, Other, Uncompensated Relationships: Boehringer Ingelheim. J. Cadranel: Financial Interests, Personal, Advisory Board, Participation to boards: Amgen, Daiichi, Takeda, MSD, Jansen, AZ; Financial Interests, Institutional, Other, prospective: AbbVie; Non-Financial Interests, Principal Investigator, Trials: AZ, AbbVie, Takeda, BI, Daiichi, Pfizer, Novartis, Amgen, Sanofi, Janssen, BMS; Financial Interests, Institutional, Research Grant, Translational research: AbbVie; Financial Interests, Institutional, Research Grant, Preclinical research: Sanofi; Financial Interests, Institutional, Research Grant, Support to academic trial: Pfizer; Financial Interests, Personal, Advisory Board, Participation to Boards: Pfizer; Financial Interests, Institutional, Advisory Board, Participation to boards: Novartis, Sanofi; Financial Interests, Personal, Invited Speaker, Participation to boards: BI. Q. Thomas: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, Sanofi, AstraZeneca; Non-Financial Interests, Personal, Non financial benefits, Support for attending meetings and/or travel: Sanofi. A. Swalduz: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Janssen, Roche, Amgen, BMS, Pfizer, Lilly. E. Pichon: Non-Financial Interests, Personal, Non financial benefits, Attending meeting: Takeda; Financial Interests, Personal, Other, Personal payment for educational event: Takeda; Financial Interests, Institutional, Local PI, clinical trials: BeiGene, AstraZeneca, Bristol Myers Squib, Janssen. V. Gounant: Financial Interests, Personal, Advisory Board: BMS, AstraZeneca, Takeda; Non-Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Sanofi, Pfizer. G. Rousseau Bussac: Financial Interests, Institutional, Research Grant: Takeda, AstraZeneca, BMS; Financial Interests, Personal, Speaker’s Bureau: BMS, Takeda; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Sanofi, Boehringer, AstraZeneca. A. Madroszyk Flandin: Financial Interests, Institutional, Research Grant: AstraZeneca, Roche; Financial Interests, Personal, Expert Testimony: AstraZeneca, Roche; Non-Financial Interests, Personal, Non financial benefits, Support for attending meetings and/or travel: AstraZeneca, Pfizer. C. Daniel: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, MSD, Amgen, Sanofi. P. Fournel: Financial Interests, Personal, Advisory Board: BMS, Sanofi, Janssen; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Amgen; Financial Interests, Personal, Other, Congress invitation: Takeda; Financial Interests, Institutional, Local PI: BMS, Ipsen. F. Guisier: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, MSD, Roche, Sanofi, Janssen, Pfizer, Takeda; Financial Interests, Institutional, Research Grant: Pfizer, Roche, Takeda. V. Westeel: Financial Interests, Personal, Speaker, Consultant, Advisor, Consulting fees: Amgen; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Bristol Myers Squibb, MSD, Roche, Sanofi; Non-Financial Interests, Personal, Other, Support for attending meetings and/or travel: AstraZeneca, Bristol Myers Squibb, Janssen, MSD, Roche, Sanofi; Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Ipsen. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.