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Related Experiment Video

Updated: Mar 27, 2026

Establishment and Characterization of Three Afatinib-resistant Lung Adenocarcinoma PC-9 Cell Lines Developed with Increasing Doses of Afatinib
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Setidegrasib in Advanced Non-Small-Cell Lung Cancer and Pancreatic Cancer.

Wungki Park1,2, Anup Kasi3, Alexander I Spira4

  • 1Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York.

The New England Journal of Medicine
|March 25, 2026
PubMed
Summary
This summary is machine-generated.

Setidegrasib shows antitumor activity in patients with KRAS G12D-mutated cancers. This targeted therapy demonstrated promising results in non-small-cell lung cancer and pancreatic cancer with manageable side effects.

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Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • The KRAS p.G12D variant is prevalent in non-small-cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC).
  • Currently, no targeted therapies are approved for KRAS p.G12D-mutated cancers.
  • Setidegrasib is a novel KRAS G12D-targeted protein degrader.

Purpose of the Study:

  • To evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of setidegrasib.
  • To determine the recommended phase 2 dose of setidegrasib.
  • To assess setidegrasib's efficacy in patients with advanced solid tumors harboring KRAS p.G12D variants.

Main Methods:

  • A phase 1 study was conducted with setidegrasib administered intravenously weekly at doses ranging from 10 to 800 mg.
  • Safety was assessed by dose-limiting toxicities and adverse events.
  • Antitumor activity was evaluated in patients with NSCLC and PDAC.

Main Results:

  • Among 76 patients receiving 600 mg of setidegrasib, all experienced adverse events, with 42% being grade 3 or higher.
  • In NSCLC patients (n=45), 36% showed a partial response, with a median progression-free survival of 8.3 months.
  • In PDAC patients (n=21), 24% responded, with a median overall survival of 10.3 months.

Conclusions:

  • Setidegrasib demonstrated antitumor activity in patients with previously treated advanced KRAS p.G12D-mutated NSCLC and PDAC.
  • Treatment discontinuation due to adverse events was infrequent.
  • Setidegrasib represents a potential therapeutic option for KRAS G12D-driven malignancies.