Abstract 1410P
Background
Around 15% of patients (pts) with NSCLC harbor the KRAS G12C mutation. In a changing landscape of KRAS G12C treatment (tx), there is a need for updated real-world evidence on characteristics and outcomes of routine clinical practice. Here we present characteristics, tx patterns, outcomes, and direct healthcare costs in pts with NSCLC and KRAS G12C in the Spanish clinical practice.
Methods
Observational, retrospective, multicenter study in pts with newly diagnosed locally advanced (not candidate for radical tx) or metastatic NSCLC and KRAS G12C. Pts participating in clinical trials with RAS inhibitors were excluded. The study collected clinical and economic data from medical records and administrative databases from 1st Jan 2016 to 9th Mar 2022 (diagnosis period: Jan 2016-Oct 2021).
Results
A total of 127 pts were included (median age 65 years, 71% male, 43%/54% current/former smokers, 82% ECOG≤2, 57% ≥2 metastatic site). PD-L1 expression was analysed in 104 pts at baseline: 19/104 (18%) pts had a PD-L1 expression <1%, 45/104 (43%) pts 1-50%, and 40/104 (39%) pts ≥50%. 94 pts (74%) received systemic tx. The most common first line tx was platinum-based chemotherapy alone (71%). Table shows progression free survival and overall survival. 124 and 103 pts had available global and disease-related (d-r) economic data, respectively. Total global cost over study period was €5,780,686 (total global mean cost per pt: €46,618) with a total pharmacological cost of €2,373,384 (mean cost per pt: €19,140). Total d-r cost was €4,245,504 (total d-r mean cost per pt: €41,218) with a d-r pharmacological cost of €2,177,712 (mean cost per pt: €21,142). Table: 1410P
PFS, median (95%CI), m | OS, median (95%CI), m | |
TL 1 | ||
CTx (n=60) | 2.8 (2.4-4.0) | 5.0 (3.3-7.4) |
IO (n=23) | 17.8 (3.7-NR) | 31.9 (7.4-NR) |
CTx + IO (n=10) | 13.2 (0.2-NR) | NR (0.5-NR) |
TL 2 | ||
CTx (n=9) | 1.6 (1.0-9.0) | 9.2 (1.5-14.3) |
IO (n=20) | 4.2 (1.4-12.5) | 10.4 (2.8-17.9) |
TL 3 | ||
CTx (n=7) | 2.1 (0.1-9.9) | 6.6 (0.1-25.8) |
Date of diagnosis * | ||
Jan 2016-Sep 2017 (n=24)‡ | NA | 6.8 (4.4-18.5) |
Oct 2017-Oct 2021 (n=66)§ | NA | 7.7 (4.0-20.5) |
CI, confidence interval; CTx, chemotherapy; FU, follow up; IO, immunotherapy; m, months; NA, not applicable; NR, not reached; OS, overall survival; PFS, progression free survival; TL, treatment line *Periods due to a major change in Spain: IO can be used as TL 1 from Oct 2017 ‡Median FU6.8 m §Median FU6.6 m
Conclusions
The real-world data confirm limited outcomes for most KRASG12C pts and emphasize the high clinical and economic burden of these pts’ care in an evolving tx landscape. Evaluating the impact of new and effective targeted therapies is warranted.
Clinical trial identification
Editorial acknowledgement
Medical writing support provided by Irene Mansilla from TFS HealthScience and funded by Amgen S.A.
Legal entity responsible for the study
Amgen S.A.
Funding
Amgen S.A.
Disclosure
N. Reguart Aransay: Financial Interests, Personal, Advisory Board: Roche, MSD, Takeda, Bayer, Novartis, Sanofi, Janssen, AstraZeneca, Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Boehringer, Guardant, BMS, Pfizer, Amgen, Novartis. O.J. Juan Vidal: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Merck Sharp & Dohme, Lilly, Takeda, AstraZeneca, Janssen; Financial Interests, Personal, Invited Speaker: Roche/Genentech; Financial Interests, Institutional, Funding: AstraZeneca. E. Arriola: Financial Interests, Personal, Advisory Board: Roche, Boehringer Ingelheim, Lilly; Financial Interests, Personal, Invited Speaker: Takeda, MSD, AstraZeneca, BMS, Thermo Fisher Scientific, Guardant Health, Pfizer; Financial Interests, Personal, Other, Co-founder: Trialing Health; Financial Interests, Institutional, Research Grant: AstraZeneca. S. Palanca: Financial Interests, Personal, Speaker, Consultant, Advisor: Roche Pharma, AstraZeneca, Lilly; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Research Funding: Roche Pharma, AstraZeneca; Financial Interests, Personal, Invited Speaker: Pfizer, Amgen, Takeda; Financial Interests, Personal, Research Grant: Roche Pharma, Amgen. L. Planellas, A. Lloansi Vila: Financial Interests, Personal, Full or part-time Employment: Amgen. All other authors have declared no conflicts of interest.
Resources from the same session
1368P - LUMINATE 102: A real-world study on biomarker testing rates among patients with non-small cell lung cancer (NSCLC) across lines of therapy
Presenter: Charu Aggarwal
Session: Poster session 20
1369P - BrigAlec study: Focus on alectinib efficacy after brigatinib exposure in BrigALK2 study (GFPC 02-2019)
Presenter: Renaud Descourt
Session: Poster session 20
1370P - Efficacy and safety of ensartinib in ALK-positive non-small cell lung cancer patients with brain metastases: A multicenter, open-label, single-arm, phase II study
Presenter: Jianhua Chang
Session: Poster session 20
1371P - First-line alectinib vs. brigatinib in advanced metastatic NSCLC with ALK rearrangement: Real-world data
Presenter: Young Kyung Jeon
Session: Poster session 20
1372P - Repotrectinib in patients (pts) with NTRK fusion-positive (NTRK+) advanced solid tumors, including NSCLC: Update from the phase I/II TRIDENT-1 trial
Presenter: Ben Solomon
Session: Poster session 20
1373P - Efficacy and safety of taletrectinib in patients (Pts) with ROS1+ non-small cell lung cancer (NSCLC): Interim analysis of global TRUST-II study
Presenter: Maurice Pérol
Session: Poster session 20
1374P - Survival and therapy analysis of small-scale ROS1-mutant non-small cell lung cancer (NSCLC) patients
Presenter: Moritz Glaser
Session: Poster session 20
1375P - Beamion Lung 1, an ongoing phase Ia/Ib trial of the HER2 TKI, BI 1810631 in patients (pts) with advanced solid tumors with HER2 aberrations: Latest data
Presenter: Frans Opdam
Session: Poster session 20
1377P - Differential impact of EGFR exon 20 insertion location on tyrosine kinase inhibitor sensitivity
Presenter: Xiuning Le
Session: Poster session 20
1378P - Efficacy and safety of tunlametinib (HL-085) combined with vemurafenib in patients with advanced BRAF V600-mutated solid tumors: A multicenter, phase I study
Presenter: Yuan-Kai Shi
Session: Poster session 20