Merck KGaA's c-Met inhibitor Tepmetko receives final EMA approval as a treatment for MET‑mutated non‑small cell lung cancer
Background and Clinical Significance of the EMA Approval
On 16 February 2022, the European Medicines Agency (EMA) granted final approval for Tepmetko, a c-Met receptor tyrosine kinase inhibitor developed by Merck KGaA (ticker: MRK.DE), for the treatment of non‑small cell lung cancer (NSCLC). The approval targets adult patients with advanced NSCLC harboring MET exon 14 skipping mutations who require systemic therapy after prior treatment with immunotherapy or platinum‑based chemotherapy. MET alterations occur in approximately 3–4 % of all NSCLC cases and are associated with a very poor prognosis, representing a substantial unmet medical need. This approval provides European lung‑cancer patients with a new targeted therapeutic option for MET‑mutated disease.
Key Data and Efficacy from the Phase 2 VISION Trial
The European approval was based on the results of the VISION trial (NCT02864992), a multicenter, single‑arm, open‑label Phase 2 study. An independent central review committee (BIRC) evaluated 313 patients, reporting an overall objective response rate (ORR) of 51.4 % across the entire cohort, with 57.3 % in treatment‑naïve patients and 45.0 % in previously treated patients. The median duration of response (mDoR) for the overall population was 18.0 months, indicating a durable and sustained antitumor effect. Median progression‑free survival (mPFS) in the previously treated subgroup was approximately 11 months, demonstrating superior clinical utility compared with standard chemotherapy.
Intense Market Competition with the Rival Drug Tabrecta
In the European market, the direct competitor in the c-Met inhibitor class is Tabrecta (capmatinib) from Novartis (ticker: NVS). Tabrecta received its first FDA approval in May 2020, securing a first‑in‑class designation in the United States, but Tepmetko obtained EMA approval in February 2022, four months earlier than Tabrecta’s EMA approval in June 2022. Tepmetko’s once‑daily dosing regimen offers a clear adherence advantage over Tabrecta’s twice‑daily schedule. By securing an early foothold in Europe, Merck can capture a larger share of initial prescriptions and position itself to shape the regional treatment paradigm.
Global MET Inhibitor Market Size and Financial Growth Drivers
The global c-Met and HGF inhibitor market is projected to grow from approximately USD 3.48 billion in 2024 to about USD 10.71 billion by 2031, representing a compound annual growth rate (CAGR) of 17.5 %. Within the seven major markets (the United States, the four largest European countries, the United Kingdom, and Japan), the MET‑mutated NSCLC segment alone was valued at roughly USD 0.59 billion in 2023. The European approval substantially expands Merck’s oncology portfolio and adds a new cash‑cow to its revenue pipeline. Rapid adoption of companion diagnostic testing for patient selection is expected to further accelerate sales growth.
The EMA approval carries significant commercial implications, as it positions Merck (MRK.DE) four months ahead of Novartis’ Tabrecta in the rapidly expanding global c-Met inhibitor market, projected to reach USD 10.71 billion by 2031. From an investor perspective, the robust efficacy demonstrated in the Phase 2 VISION study—an ORR of 51.4 % and a median duration of response of 18.0 months—should translate into increased prescriptions and become a key driver of Merck’s oncology revenue growth. For clinicians and industry stakeholders, the introduction of a once‑daily, precision‑targeted therapy for MET‑mutated NSCLC enhances market adoption, supports the expansion of companion‑diagnostic testing, and broadens therapeutic options. In the medium to long term, the European approval of Tepmetko, followed by an anticipated FDA registration in 2024, is expected to serve as a benchmark that accelerates further c‑Met‑targeted drug development and combination‑therapy clinical trials.
Source: EMA (ema)