Sotorasib in KRAS G12C-mutated non-small cell lung cancer: a multicenter real-world experience from the compassionate use program in Germany
Background - Sotorasib is a first-in-class KRAS p.G12C-inhibitor that has entered clinical trials in pretreated patients with non-small cell lung cancer (NSCLC) in 2018. First response rates were promising in the CodeBreaK trials. It remains unclear whether response to sotorasib and outcomes differ...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
April 2024
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| In: |
European journal of cancer
Year: 2024, Jahrgang: 201, Pages: 113911 |
| ISSN: | 1879-0852 |
| DOI: | 10.1016/j.ejca.2024.113911 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ejca.2024.113911 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S095980492400087X 
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| Verfasserangaben: | Jan A. Stratmann, Friederike C. Althoff, Paula Doebel, Jacqueline Rauh, Arne Trummer, Ali Nuri Hünerlitürkoglu, Nikolaj Frost, Hüsameddin Yildirim, Petros Christopoulos, Oswald Burkhard, Christian Meyer zum Büschenfelde, Aaron Becker von Rose, Jürgen Alt, Sven P. Aries, Maximilian Webendörfer, Stefan Kaldune, Mark Uhlenbruch, Guergana Tritchkova, Cornelius F. Waller, Achim Rittmeyer, Petra Hoffknecht, Jan Braess, Hans-Georg Kopp, Christian Grohé, Monica Schäfer, Christian Schumann, Frank Griesinger, Jonas Kuon, Martin Sebastian, Niels Reinmuth |
MARC
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| 245 | 1 | 0 | |a Sotorasib in KRAS G12C-mutated non-small cell lung cancer |b a multicenter real-world experience from the compassionate use program in Germany |c Jan A. Stratmann, Friederike C. Althoff, Paula Doebel, Jacqueline Rauh, Arne Trummer, Ali Nuri Hünerlitürkoglu, Nikolaj Frost, Hüsameddin Yildirim, Petros Christopoulos, Oswald Burkhard, Christian Meyer zum Büschenfelde, Aaron Becker von Rose, Jürgen Alt, Sven P. Aries, Maximilian Webendörfer, Stefan Kaldune, Mark Uhlenbruch, Guergana Tritchkova, Cornelius F. Waller, Achim Rittmeyer, Petra Hoffknecht, Jan Braess, Hans-Georg Kopp, Christian Grohé, Monica Schäfer, Christian Schumann, Frank Griesinger, Jonas Kuon, Martin Sebastian, Niels Reinmuth |
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| 520 | |a Background - Sotorasib is a first-in-class KRAS p.G12C-inhibitor that has entered clinical trials in pretreated patients with non-small cell lung cancer (NSCLC) in 2018. First response rates were promising in the CodeBreaK trials. It remains unclear whether response to sotorasib and outcomes differ in a real-world setting when including patients underrepresented in clinical trials. - Methods - Patients with KRAS p.G12C-mutated advanced or metastatic NSCLC received sotorasib within the German multicenter sotorasib compassionate use program between 2020 to 2022. Data on efficacy, tolerability, and survival were analyzed in the full cohort and in subgroups of special interest such as co-occurring mutations and across PD-L1 expression levels. - Results - We analyzed 163 patients who received sotorasib after a median of two treatment lines (range, 0 to 7). Every fourth patient had a poor performance status and 38% had brain metastases (BM). The objective response rate was 38.7%. The median overall survival was 9.8 months (95% CI, 6.5 to not reached). Median real-world (rw) progression-free survival was 4.8 months (9% CI, 3.9 to 5.9). Dose reductions and permanent discontinuation were necessary in 35 (21.5%) and 7 (4.3%) patients, respectively. Efficacy seems to be influenced by PD-L1 expression and a co-occurring KEAP1 mutation. KEAP1 was associated with an inferior survival. Other factors such as BM, STK11, and TP53 mutations had no impact on response and survival. - Conclusion - First results from a real-world population confirm promising efficacy of sotorasib for the treatment of advanced KRAS p.G12C-mutated NSCLC. Patients with co-occurring KEAP1 mutations seem to derive less benefit. | ||
| 650 | 4 | |a Further-line treatment | |
| 650 | 4 | |a KRAS G12C | |
| 650 | 4 | |a NSCLC | |
| 650 | 4 | |a Sotorasib | |
| 650 | 4 | |a Targeted therapy | |
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