Study Design

EMRELIS was studied in the LUMINOSITY trial1,2

A multicenter, open-label, non-randomized, single-arm, multi-cohort phase 2 study evaluated EMRELIS monotherapy in 84 patients with locally advanced or metastatic EGFR wt NSq NSCLC with high c-Met protein overexpression who received prior systemic therapy.

Flow chart of the EMRELIS study results in the luminosity trial

Select inclusion criteria:

  • Patients with locally advanced or metastatic NSCLC with high c-Met protein expression defined as ≥50% TC with strong (3+) staining with the MET (SP44) IHC assay
  • Patients have received ≤2 prior lines of systemic therapy
  • ECOG performance status of 0 or 1
  • Patients with CNS metastasis if they have received definitive therapy and:
    • There is no evidence of progression ≥2 weeks after definitive therapy
    • They are asymptomatic and off systemic steroids and anticonvulsants for at least 2 weeks before the first dose of EMRELIS

Select exclusion criteria:

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
  • ILD/pneumonitis within 3 months of the first dose
  • Radiation therapy to the lungs less than 6 months prior
  • Patients who have tested positive for EGFR-mutant NSCLC

Baseline patient characteristics

Illustration of two patients

Patient demographics1

  • Median patient age was 64 years (range: 38-83 years) and 75% were male
  • 61% were white, 38% were Asian, 1.2% were Black or African American, and 0% were Hispanic or Latino 
  • Patients had an ECOG performance status of 0 (25%), 1 (74%)
  • 19% never smoked, 68% were former smokers, 13% were current smokers
Icon of a clipboard with three checkmarks and one incomplete task

Majority had metastases1,2

  • 99% had Stage IV disease
  • 19% had pretreated and stable brain metastases
IV bag icon

Prior exposure to a range of systemic therapies1

  • 73% 1 line of prior systemic therapy
  • 24% 2 lines of prior systemic therapy
  • 3.6% 3 lines of prior systemic therapy

Previous therapy experience:

  • 96% platinum therapy
  • 82% immunotherapy
  • 6% targeted therapy
  • 3.6% MET tyrosine kinase inhibitor therapy

*Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as confirmed by BICR.1

For the complete inclusion/exclusion criteria for the LUMINOSITY phase 2 study, please refer to doi.org/10.1200/JCO.24.00720.2

Of the 84 patients with high c-Met protein overexpression identified by the MET (SP44) clinical trial assay in a central lab prior to enrollment, tissue samples were tested retrospectively using the VENTANA MET (SP44) RxDx Assay. Of the 37 samples retested and evaluable, 32 (87%) samples were confirmed to have high c-Met protein overexpression, defined as ≥50% of tumor cells with strong (3+) membrane and/or cytoplasmic staining.1

CNS=central nervous system; ECOG=Eastern Cooperative Oncology Group.

Next: