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D-1553 (Garsorasib), a Potent and Selective Inhibitor of KRASG12C in Patients With NSCLC: Phase 1 Study Results

Ziming Li1, Zhengbo Song2, Yanqiu Zhao3

  • 1Shanghai Lung Cancer Center, Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, People's Republic of China.

Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer
|March 22, 2023
PubMed
Abstract

Insights

D-1553 (garsorasib) shows promise for KRAS G12C-mutated non-small cell lung cancer (NSCLC). This phase I study found D-1553 to be well-tolerated with encouraging antitumor activity, including a 40.5% objective response rate.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Non-small cell lung cancer (NSCLC) remains a leading cause of cancer mortality worldwide.
  • KRAS G12C mutations are present in approximately 13% of NSCLC patients, representing an unmet medical need.
  • Targeted therapies inhibiting KRAS G12C are emerging as a promising treatment strategy.

Purpose of the Study:

  • To evaluate the safety, pharmacokinetics, and efficacy of D-1553 (garsorasib), a potent and selective oral KRAS G12C inhibitor.
  • To determine the recommended Phase 2 dose for D-1553 in patients with KRAS G12C-mutated NSCLC.
  • To assess the antitumor activity of D-1553 in a Chinese patient population.

Main Methods:

  • A Phase I, dose-escalation and dose-expansion study was conducted in multiple sites in China.
  • Patients with KRAS G12C-mutated NSCLC received D-1553 at various oral doses (600 mg QD to 600 mg BID).
  • Safety, pharmacokinetics, and efficacy (including objective response rate and progression-free survival) were evaluated.

Main Results:

  • A total of 79 patients were treated. Most treatment-related adverse events were manageable.
  • The confirmed objective response rate (ORR) was 40.5% and the disease control rate (DCR) was 91.9% among 74 assessable patients.
  • Median progression-free survival was 8.2 months and median duration of response was 7.1 months.

Conclusions:

  • D-1553 (garsorasib) demonstrates a favorable safety profile and encouraging antitumor activity in patients with KRAS G12C-mutated NSCLC.
  • The study supports D-1553 as a promising therapeutic option for this patient population.
  • Further investigation in larger trials is warranted to confirm these findings.
Keywords:
KRAS G12C mutationNon–small cell lung cancerPhase 1 clinical trialSmall molecule agent

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