In 2L+ advanced/metastatic NSq NSCLC with high c-Met protein overexpression (3+, ≥50%)1
EMRELIS is the first and only c-Met targeted ADC
Granted accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
*In addition to testing, physicians should evaluate their patient’s profile for informed treatment decisions.
NCCN Category 2A Recommended
Telisotuzumab vedotin-tllv (EMRELIS) is the only Category 2A recommended option for patients with 2L+ advanced/metastatic NSq EGFR wt NSCLC who have high c-Met protein overexpression/HGF receptor (c-Met) ≥50% IHC3+2†
EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining] as determined by an FDA-approved test, who have received a prior systemic therapy.1
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
EMRELIS is a c-Met targeted treatment for 2L+ NSCLC with high c-Met protein overexpression (3+, ≥50%)
ORR per BICR‡ of 35% (29/84) (95% CI: 24-46) [CR=0, PR=35%] and median DOR of 7.2 months (n=29; 95% CI: 4.2-12)1
From a multicenter, open-label, non-randomized, single-arm, multi-cohort phase 2 study that evaluated EMRELIS monotherapy in 84 patients with locally advanced or metastatic EGFR wt NSq NSCLC with high c-Met protein overexpression (3+, ≥50%) who received prior systemic therapy. Primary endpoint was confirmed ORR per BICR; secondary endpoints included DoR.1 View full study design.
Testing is essential to identify eligible patients
Approximately 1 in 6 patients with EGFR wt NSq NSCLC has high c-Met protein overexpression (3+, ≥50%)3,4§
The VENTANA MET (SP44) RxDx Assay is a companion diagnostic to identify NSCLC patients with high c-Met protein overexpression (3+, ≥50%)1,5
- Like other protein biomarkers such as PD-L1, c-Met protein overexpression is detected only by IHC, and not by NGS or FISH.6-8
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†Hepatocyte growth factor (HGF) receptor is also known as c-Met/MET.
‡Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by BICR.1
§High c-Met protein overexpression is defined as ≥50% of tumor cells with strong (3+) staining.1
2L=second line; ADC=antibody-drug conjugate; CI=confidence interval; CR=complete response; DoR=duration of response; FDA=Food and Drug Administration; FISH=fluorescence in situ hybridization; ICR=independent central review; IHC=immunohistochemistry; NGS=next-generation sequencing; NSq=non-squamous; ORR=overall response rate; PD-L1=programmed death-ligand 1; PR=partial response; wt=wild-type.
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