In 2L+ advanced/metastatic NSq NSCLC with high c-Met protein overexpression1*
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).
*High c-Met protein overexpression is defined as ≥50% of tumor cells with strong (3+) staining.1
†In addition to testing, physicians should evaluate their patient’s profile for informed treatment decisions.
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,* 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*
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 who received prior systemic therapy. Primary endpoint was confirmed ORR per BICR; secondary endpoints included DoR.1,2 View full study design.
Testing is essential to identify eligible patients
Approximately 1 in 8 patients with EGFR wt NSq NSCLC has high c-Met protein overexpression2*§
The VENTANA MET (SP44) RxDx Assay is a companion diagnostic to identify NSCLC patients with high c-Met protein overexpression1,3
- Like other protein biomarkers such as PD-L1, c-Met protein overexpression is not detectable by NGS or FISH4-6
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‡Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by BICR.1
§Prevalence of 13.5% from the multicenter, open-label, non-randomized, single-arm, multi-cohort phase 2 LUMINOSITY clinical trial in patients with locally advanced or metastatic NSq NSCLC with high c-Met protein overexpression who received prior systemic therapy.1,2
2L=second line; ADC=antibody-drug conjugate; BICR=blinded independent central review; CI=confidence interval; CR=complete response; DoR=duration of response; EGFR=epidermal growth factor receptor; FDA=Food and Drug Administration; FISH=fluorescence in situ hybridization; 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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