FDA Approves New ORAL Tx for NSCLC – Tepmetko


Earlier this month the FDA approved a new ORAL therapy, Tepmetko (tepotinib) from EMD Serono, for the treatment of naïve and previously treated patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations.

Tepmetko is the only FDA approved MET inhibitor that offers once-daily oral dosing and is administered as two 225 mg tablets (450 mg).

Tepmetko is a precision medicine that advances patient access to a targeted treatment highlighted by routine comprehensive biomarker testing. It works as a tyrosine kinase inhibitor that targets the tyrosine kinase MET. MET is an enzyme, a type of protein, that is involved in various cellular processes. Its activity is abnormal or increased in cancer, which may lead to the uncontrollable growth of cells and tumor development.

Patients with this aggressive lung cancer are often elderly and face a poor clinical prognosis.

Tepmetko is the second drug with the same indication. In May of 2020, the FDA approved Tabrecta (capmatinib) from Novartis. Merck hasn’t confirmed the cost of therapy for Tepmetko, however, the list price for Tabrecta is $17,950 for a 28-day supply. Analysts believe that the two therapies will compete on price in this small patient population.

Merck did not indicate if Tepmetko will launch through limited distribution. By way of reference, the competing Novartis product (Tabrecta) launched through LD last year. We expect that Tepmetko will follow suit.

FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer

On February 3, 2021, the Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Efficacy was demonstrated in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations. Patients received tepotinib 450 mg orally once daily until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate (ORR) determined by a blinded independent review committee using RECIST 1.1 and response duration. Among the 69 treatment naïve patients, the ORR was 43% (95% CI: 32%, 56%) with a median response duration of 10.8 months (95% CI: 6.9, not estimable). Among the 83 previously treated patients, the ORR was 43% (95% CI: 33%, 55%) with a median response duration of 11.1 months (95% CI: 9.5, 18.5).

The most common adverse reactions (≥ 20% of patients) were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. Tepotinib can also cause interstitial lung disease, hepatotoxicity, and embryo-fetal toxicity.

The recommended tepotinib dose is 450 mg orally once daily with food.

This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

This review used the Real-Time Oncology Review, which streamlined data submission prior to the filing of the entire clinical application. The review also used the Oncology Center of Excellence Assessment Aid and the Product Quality Assessment Aid (PQAA), voluntary submissions from the applicant to facilitate the FDA’s assessment.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this application, a modified Project Orbis was undertaken because of the timing of submission to other regulatory agencies. FDA collaborated with Health Canada, Therapeutic Goods Administration (Australia), and Swissmedic on this review.


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