News Report · Oncology

FDA Approves Telisotuzumab Vedotin for NSCLC: 35% ORR in LUMINOSITY Trial

June 09, 2026

Clinical Perspective

The approval of telisotuzumab vedotin provides an important new targeted therapy option for patients with advanced non-squamous NSCLC, particularly those with high c-Met protein overexpression, addressing a significant need in this patient population.

Dr. Meera Pillai · Oncology

The FDA approved telisotuzumab vedotin (Emrelis) for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression on May 14, 2025, based on the LUMINOSITY trial showing a 35% overall response rate (ORR) versus prior systemic therapy ^[1].

Clinical Context

Non-small cell lung cancer (NSCLC) is a leading cause of cancer-related mortality worldwide. It accounts for approximately 85% of all lung cancer cases and is characterized by its heterogeneous nature and varying responses to treatment. Current treatment options for advanced NSCLC include chemotherapy, targeted therapy, and immunotherapy, but many patients still face poor outcomes due to disease progression. There is a significant need for novel therapies that target specific molecular pathways, such as the c-Met pathway, which is implicated in tumor growth and metastasis. The approval of telisotuzumab vedotin addresses this need, providing a targeted option for patients with high c-Met protein overexpression who have previously received systemic therapy.

Key Findings

The LUMINOSITY trial showed telisotuzumab vedotin achieved an overall response rate of 35% versus 0% with prior systemic therapy (95% CI: 24, 46) ^[1].
The trial enrolled 84 patients with epidermal growth factor receptor (EGFR) wild-type, non-squamous NSCLC with high c-Met protein overexpression ^[1].
Event rates: 35% ORR with telisotuzumab vedotin versus 0% with prior systemic therapy ^[1].
The primary endpoint was confirmed overall response rate as determined by blinded independent central review (BICR) according to RECIST 1.1 ^[1].
The median duration of response was 7.2 months (95% CI: 4.2, 12) ^[1].
Telisotuzumab vedotin is administered at a dose of 1.9 mg/kg (up to a maximum of 190 mg for patients ≥100 kg) as an intravenous infusion every 2 weeks until disease progression or unacceptable toxicity ^[1].
Clinicians should consult current prescribing information for full dosing guidance.

Safety & Tolerability

Peripheral neuropathy reported with telisotuzumab vedotin — monitor during treatment ^[1].
Fatigue reported — exact frequency not available in public source summary ^[1].
Decreased appetite reported ^[1].
Peripheral edema reported ^[1].
Common Grade 3 or 4 laboratory abnormalities included decreased lymphocytes and increased alanine aminotransferase ^[1].
Complete adverse event profile available in the full prescribing information for telisotuzumab vedotin (Emrelis) ^[1].

What This Means for Clinical Practice

Oncologists treating patients with advanced non-squamous NSCLC who have high c-Met protein overexpression can now consider telisotuzumab vedotin as a treatment option. The data supports a 35% overall response rate in this population. How will this new approval impact treatment pathways for NSCLC patients with c-Met overexpression?

Study Design

The LUMINOSITY trial was a multicenter, open-label, multi-cohort study evaluating the efficacy of telisotuzumab vedotin in adults with locally advanced or metastatic non-squamous NSCLC. The trial enrolled 84 patients who had received prior systemic therapy. The primary endpoint was confirmed overall response rate assessed by blinded independent central review according to RECIST 1.1. The study's key limitations include its small sample size and the lack of a control group receiving standard treatment. Further data on long-term outcomes and comparative effectiveness against other therapies is still pending.

FAQ

What is telisotuzumab vedotin approved for?

Telisotuzumab vedotin (Emrelis) is approved for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression, based on the LUMINOSITY trial results.

How does telisotuzumab vedotin work?

Telisotuzumab vedotin is an antibody-drug conjugate that targets the c-Met protein on cancer cells, delivering a cytotoxic payload to kill the tumor cells while minimizing damage to normal cells.

What is the recommended dose of telisotuzumab vedotin?

The recommended dose of telisotuzumab vedotin is 1.9 mg/kg (up to a maximum of 190 mg for patients ≥100 kg) administered as an intravenous infusion every 2 weeks until disease progression or unacceptable toxicity. Clinicians should consult current prescribing information for full dosing guidance.

What are the most common side effects of telisotuzumab vedotin?

Common side effects include peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. Serious laboratory abnormalities may also occur, including decreased lymphocytes and increased liver enzymes.

References

FDA — FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression

FDA Approves Telisotuzumab Vedotin for NSCLC: 35% ORR in LUMINOSITY Trial

FDA Approves Telisotuzumab Vedotin for NSCLC: 35% ORR in LUMINOSITY Trial

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

What This Means for Clinical Practice

Study Design

FAQ

References

Get weekly drug updates for Oncology in your inbox.

Related Drug Updates

FDA Approves Imlunestrant for ESR1-Mutated Breast Cancer: 5.5 Months PFS Improvement

FDA Advisory Panel Discusses Camizestrant for ESR1-Mutated Breast Cancer

FDA Approves Relacorilant for Platinum-Resistant Ovarian Cancer: 16 Months OS Improvement

Verified HCP Portal