1404P - Clinical characteristics and therapeutics sequences of KRAS G12C metastatic non-small cell lung cancer (mNCSLC) patients treated by sotorasib in the French pre-marketing authorization (MA) early access program (cohort temporary authorization of use, cATU)

Background

Sotorasib is the first specific and irreversible KRAS G12C inhibitor that showed superiority vs docetaxel in CodeBreaK 200 phase 3 study, with a median PFS of 5.6 mos (HR: 0,66) and an acceptable safety profile for sotorasib. In France, sotorasib has been authorized before MA for patients with KRAS G12C mNSCLC who progressed after at least one treatment line. Here, we present the clinical characteristics of patients included in the cATU.

Methods

From 08/2021 to 06/2022, data from 1011 pts, of which 958 received sotorasib, were collected in 249 centers.

Results

Main characteristics of this population are presented below: Table: 1404P

*39 pts didn’t receive sotorasib at all 80% of patients were exposed to chemotherapy (CT) and immunotherapy (IO) before sotorasib: ∼50% simultaneously, ∼30% sequentially. 51% of patients received sotorasib directly after IO. With a median follow-up of 8.9 [0.2-17.5] mos, the median duration of treatment was 8.1 [0.1-17.5] mos. These data must be interpreted with caution because of the short follow-up period.

Conclusions

Nearly 1000 pts, ineligible to clinical trials, were treated by sotorasib through French cATU, highlighting the unmet therapeutic need. The main technique to retrieve KRASG12C was NGS. Clinical characteristics are consistent with those of CodeBreaK 200 trial pts, with a relatively lower proportion of patients with PD-L1≥50%. More than half of the patients received sotorasib in 2L, reflecting conditional marketing authorization granted in Europe. Real-life data on sotorasib efficacy, safety and QoL are currently studied by academic institutions.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Amgen SAS.

Funding

Amgen SAS.

Disclosure

H. Lena: Financial Interests, Personal, Advisory Board: MBS, Roche, MSD, Pfizer, AZ, Lilly, Takeda, Amgen. J. Cadranel: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, BMS, MSD, Novartis, Sanofi, Takeda, Pfizer, Amgen, Lilly; Financial Interests, Institutional, Funding: AbbVie, 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; Non-Financial Interests, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Family member is an employee: AstraZeneca. J. Mazieres: Financial Interests, Personal, Invited Speaker: AZ, Roche, BMS, MSD, daiichi, Novartis, Amgen; Financial Interests, Personal, Advisory Board: Roche, AZ, Pierre Fabre, Takeda, BMS, MSD, Jiangsu Hengruii, Blueprint, Daiichi, Novartis, Amgen, Lillly, Merck; Financial Interests, Institutional, Research Grant: Roche, AZ, PF, BMS; Non-Financial Interests, Institutional, Principal Investigator: Roche, AZ, PF, Takeda, BMS, MSD, Jiangsu Hengruii, Blueprint, Daiichi, Novartis, Amgen, Sanofi, Pfizer, Merck. H. Curcio: Financial Interests, Personal, Invited Speaker: Viatris. A. Madroszyk Flandin: Financial Interests, Personal and Institutional, Advisory Board: AZ, Roche. J.B. Auliac: Non-Financial Interests, Personal, Advisory Board: AZ, BI, BMS, Roche; Non-Financial Interests, Personal, Invited Speaker: Sanofi, Takeda. O. Bylicki: Financial Interests, Personal, Advisory Board: BMS, Roche, Takeda, MSD, AZ, Janssen. S. Couraud: Financial Interests, Personal, Advisory Board: Amgen, AZ, BMS, MSD, Roche, Takeda, Sanofi, Fabentech; Financial Interests, Institutional, Funding: Chugai, Novartis, Amgen, AZ, BMS, MSD, Roche, Takeda, Bayer, Sanofi, Janssen; Financial Interests, Personal, Invited Speaker: AZ, Pfizer; Financial Interests, Institutional, Research Grant: AZ, Chugai, Takeda; Financial Interests, Personal, Other: Laidet. F. Barlesi: Financial Interests, Institutional, Advisory Board: AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, Mirati, MSD, Pierre Fabre, Pfizer, Sanofi Aventis, Seattle Genetics, Takeda, AbbVie, Acea, Amgen, Eisai, Ignyta; Non-Financial Interests, Principal Investigator: AstraZeneca, BMS, Merck, Pierre Fabre, F. Hoffmann-La Roche Ltd., Innate Pharma, Mirati. E. Pichon: Financial Interests, Personal, Research Grant: Mirati, BMS, Janssen, AZ, BeiGene, GSK; Financial Interests, Personal, Advisory Board: Takeda. A. Métivier: Financial Interests, Personal, Training: BMS, MSD, Takeda; Financial Interests, Personal, Sponsor/Funding: Novartis, Pfizer. B. Duchemann: Financial Interests, Personal, Expert Testimony: AZ, BMS, Amgen, Lilly; Financial Interests, Personal, Invited Speaker: Roche, Chiesi; Financial Interests, Personal, Other: Oxyvie. L. De Gunten: Financial Interests, Personal, Full or part-time Employment: Amgen. All other authors have declared no conflicts of interest.