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Association details:
| Biomarker: | KRAS G12C |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | garsorasib (D-1553) (KRAS G12C inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors
Excerpt:
...Recommended phase II dose (RP2D) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation`Objective Response Rate (ORR) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation...
Trial ID:
Source:
Title:
Study to Evaluate D-1553 in Subjects With Lung Cancer
Excerpt:
...- Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA....
Trial ID:
More C2 evidence
Source:
Title:
A Study to Evaluate D-1553 in Combination Therapy in Non-Small Cell Lung Cancer
Excerpt:
...- Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA....
Trial ID:
Source:
Title:
Study to Evaluate D-1553 in Subjects With Solid Tumors
Excerpt:
...- Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA....
Trial ID:
Less C2 evidence
Source:
Title:
D-1553 (garsorasib), a Potent and Selective Inhibitor of KRASG12C in Patients with Non-Small Cell Lung Cancer: Phase I Study Results
Published date:
03/20/2023
Excerpt:
Patients with KRAS G12C-mutated NSCLC were administrated D-1553 600 mg orally once daily, 800 mg once daily, 1200 mg once daily, 400 mg twice a day, or 600 mg twice a day in dose escalation….Among 74 patients evaluable for efficacy analysis, 30 patients had partial response (PR) and 38 had stable disease (SD) with a confirmed ORR and DCR of 40.5% and 91.9%, respectively. The median PFS was 8.2 months, and the median DOR was 7.1 months. Among 62 patients evaluable for response at the recommended phase 2 dose (RP2D), PR occurred in 24 patients (ORR, 38.7%) and SD in 32 patients (DCR, 90.3%).
DOI:
https://doi.org/10.1016/j.jtho.2023.03.015
Source:
Title:
OA03.07 - Safety and Efficacy of D-1553 in Patients with KRAS G12C Mutated Non-Small Cell Lung Cancer: A Phase 1 Trial
Published date:
07/12/2022
Excerpt:
Among 73 patients at all dose levels evaluable for tumor response, 29 patients had partial response (PR) and 38 had stable disease (SD); ORR and DCR were 39.7% (29/73) and 91.8% (67/73), respectively. Among 3 patients with measurable CNS metastasis at baseline, one PR and two SD were achieved in brain lesions. Median DOR was not reached, but among 29 responders there were 25 (86.2%) patients still ongoing with 14 patients having DOR ≥ 12 weeks. For PFS, 57 (78.1%) subjects have not reached an event. D-1553 was well tolerated, with promising antitumor activity in heavily pretreated KRAS G12C mutant-NSCLC patients.
Trial ID:
