Abstract 1307P
Background
Sotorasib is the first KRAS G12C inhibitor that significantly improved PFS vs docetaxel in CodeBreaK 200 phase 3 study, with a median PFS of 5.6 months (mos) (HR: 0,66) and an acceptable safety profile. In France, sotorasib has been authorized from 12/2020 to 06/2023 through several programs of early access. Here, we present clinical characteristics of pts with KRAS G12C aNSCLC at progression after at least one previous line of treatment newly included in the post-marketing authorization early access (post-MA EA) from 06/2022 to 06/2023.
Methods
From 06/2022 to 10/2023, data from 1,121 pts newly treated by sotorasib in post-MA EA were collected in 272 centers.
Results
Main characteristics of this population are presented below: Table: 1307P
| Variable | Results |
| Median age, years [Q1-Q3] n=1,121 | 66.0 [30.2-91.3] |
| Male, % n=1,121 | 57.2 |
| Smoking status Non / former / regular or occasional, % n=1,118 | 3.2 / 80.2 / 16.5 |
| Adenocarcinoma, % n=1,120 | 95.6 |
| ECOG PS, % n=1,121 01≥2 | 20.260.219.6 |
PD-L1, % n=1,117 ConclusionsBetween 06/2022 and 10/2023, more than 1,600 pts were treated by sotorasib through French post-MA EA, highlighting the unmet therapeutic need. Clinical characteristics are consistent with those of CodeBreaK 200 trial pts. Interestingly, in post-MA EA, more pts received sotorasib in 2L, reflecting conditional marketing authorization granted in Europe, mostly after CT+IO in 1L. Clinical trial identificationEditorial acknowledgementLegal entity responsible for the studyAmgen. FundingAmgen. DisclosureJ. Cadranel: Financial Interests, Personal, Advisory Board, Participation to boards: AMGEN, Jansen, AZ, MSD, Takeda, Daichi; Financial Interests, Institutional, Other, prospective: AbbVie; Financial Interests, Institutional, Advisory Board, Participation to boards: Sanofi, Novartis; Financial Interests, Personal, Invited Speaker, Participation to boards: BI; Financial Interests, Personal, Advisory Board, Participation to Boards: Pfizer; Financial Interests, Institutional, Research Grant, Support to academic trial: Pfizer; Financial Interests, Institutional, Research Grant, Preclinical research: Sanofi; Financial Interests, Institutional, Research Grant, Translational research: AbbVie; Non-Financial Interests, Principal Investigator, Trials: BMS, Jansen, Sanofi, AMGEN, Novartis, Pfizer, Daichi, BI, Takeda, AbbVie, AZ. H. Curcio: Financial Interests, Personal, Speaker, Consultant, Advisor: Viatris. Y. Oulkhouir: Financial Interests, Personal, Invited Speaker: Amgen. S. Couraud: Financial Interests, Personal and Institutional, Member of Board of Directors: Adene; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor: Amgen, Boehringer; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, BMS, Takeda; Financial Interests, Institutional, Funding: BD, Celgene, Chugai, Lilly; Financial Interests, Personal, Speaker, Consultant, Advisor: Health Event; Financial Interests, Personal and Institutional, Sponsor/Funding: Janssen, MSD, Novartis, Pfizer, Sanofi; Financial Interests, Personal, Sponsor/Funding: MaaT Pharma, Pierre Fabre, SNCF; Financial Interests, Institutional, Sponsor/Funding: Roche, Transdiag, Volition. J. Mazieres: Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, AstraZeneca, Pierre Fabre, Takeda, BMS, MSD, Pfizer, Jiangsu Hengruii, Blueprint, Daiichi Sankyo, Novartis, Amgen; Financial Interests, Personal and Institutional, Research Grant: Roche, AstraZeneca, Pierre Fabre, BMS, Illumina. A. Métivier: Financial Interests, Personal, Speaker, Consultant, Advisor: Takeda, MSD, BMS, Novartis, Pfizer. N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi, Gilead; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Other, Family member is an employee: AstraZeneca. M. Wislez: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AstraZeneca, BMS, F. Hoffman La Roche, Janssen, MSD Oncology, Lilly, Merck Serono, Novartis, Pfizer, Takeda, Sanofi, Leopharma; Non-Financial Interests, Personal, Other: Transgene. F. Guisier: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, MSD, Roche, Sanofi, Janssen, Pfizer, Takeda; Financial Interests, Institutional, Research Grant: Pfizer, Roche, Takeda. X. Quantin: Financial Interests, Institutional, Invited Speaker: Sanofi; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Institutional, Other, Educational support: AstraZeneca. C. Naltet: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, MSD, Pfizer, BMS, Sanofi, Janssen, Amgen, Takeda; Non-Financial Interests, Personal, Sponsor/Funding: Roche. B. Roch: Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, AstraZeneca, Amgen, Roche, Chugai, Lilly, Takeda; Non-Financial Interests, Personal, Non remunerated activity: MSD; Non-Financial Interests, Non remunerated activity: Novartis. L. Greillier: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BMS, MSD, Novartis, Sanofi, Takeda, Roche; Financial Interests, Personal, Invited Speaker: Lilly, Pfizer; Financial Interests, Institutional, Local PI: AstraZeneca, AbbVie, BMS, MSD, Novartis, Takeda, Pfizer, PharmaMar; Financial Interests, Institutional, Coordinating PI: Sanofi; Financial Interests, Personal, Local PI: Roche. C. Clément: Financial Interests, Personal, Full or part-time Employment: Amgen. L. De Gunten: Financial Interests, Personal, Full or part-time Employment: Amgen. V. Gounant: Financial Interests, Personal, Advisory Role: Janssen, Sanofi, Takeda, Roche; Financial Interests, Personal, Advisory Board: AstraZeneca Pharmaceuticals LP; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb Co. All other authors have declared no conflicts of interest. 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