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Association details:
| Biomarker: | KRAS mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Verzenio (abemaciclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A randomized phase 3 study of abemaciclib versus erlotinib in previously treated patients with stage IV NSCLC with KRAS mutation: JUNIPER.
Published date:
05/16/2018
Excerpt:
Median OS was 7.4 months with abemaciclib and 7.8 months with erlotinib...Median PFS was 3.6 months with abemaciclib and 1.9 months with erlotinib...The ORR was 8.9% (95% CI: 5.5, 12.3%) with abemaciclib and 2.7% (0.4, 5.1%) with erlotinib (p = 0.01). The disease control rate was 54.4% (95% CI: 48.5, 60.4%) with abemaciclib and 31.7% (25.0, 38.4%) with erlotinib...In previously treated patients with stage IV NSCLC harboring KRAS mutations, abemaciclib did not improve OS but demonstrated improvement in PFS and ORR compared with erlotinib.
DOI:
10.1200/JCO.2018.36.15_suppl.9025
Trial ID:
Source:
Title:
Results From the Phase III JUNIPER Trial Evaluating Abemaciclib in KRAS-Mutated, Advanced NSCLC
Excerpt:
“While the outcome is unfortunate for patients with KRAS-mutated, advanced lung cancer, we remain encouraged by the antitumor activity observed with abemaciclib in this form of lung cancer where few clinical advances have been achieved,”...
Source:
Title:
A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
Excerpt:
...- Have a Stage IV diagnosis of 1 of the following: Part A: NSCLC (Kirsten rat sarcoma mutant [KRAS mt], PD-L1+); Part B: NSCLC (squamous histology); Part C: metastatic breast cancer (HR+, HER2-); or Part D: locally advanced or metastatic breast cancer (HR+, HER2-)...
Trial ID:
Source:
Title:
A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer
Excerpt:
...- Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma (KRAS) oncogene by an investigational assay at the study central laboratory....
Trial ID:
Less C2 evidence
Source:
Title:
Efficacy and Safety of Abemaciclib, an Inhibitor of CDK4 and CDK6, for Patients with Breast Cancer, Non–Small Cell Lung Cancer, and Other Solid Tumors
Excerpt:
...we evaluated the clinical activity of abemaciclib in a cohort of 68 patients with NSCLC who had received a median of 4 (range, 1–10) prior systemic therapies, including 29 patients who had tumors harboring KRAS mutations….The 6-month PFS rate was 26% (95% CI, 16%–38%), with 4 patients receiving single-agent abemaciclib without progression for ≥12 months (Supplementary Table S6). Partial response was achieved for 1 patient with KRAS-mutant NSCLC...
DOI:
10.1158/2159-8290.CD-16-0095
