Merck Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations - Seite 2

osimertinib in epidermal growth factor receptor (EGFR) mutated, MET
amplified, locally advanced or metastatic NSCLC having acquired
resistance to prior EGFR TKI.

The Breakthrough Therapy Designation is based on data from the
ongoing VISION study (NCT02864992), showing preliminary clinical
evidence that tepotinib may offer an improvement over available
therapy in patients with metastatic NSCLC harboring MET exon 14
skipping alterations detected by liquid biopsy (LBx) or tissue biopsy
(TBx) across different lines of treatment.

Results from an interim analysis of the ongoing VISION study in 73
efficacy-evaluable patients with NSCLC with MET exon 14 skipping
alterations identified by LBx or TBx testing demonstrate overall
objective response rate (ORR) of 50.0% for LBx-identified patients as
assessed by Independent Review Committee (IRC), and 55.3% as assessed
by investigators. The ORR for TBx-identified patients was 45.1% and
54.9%, respectively. The overall median duration of response (DOR)
was 12.4 months and 17.1 months among LBx-identified patients, as
assessed by IRC and investigators, respectively, while among
TBx-identified patients, 15.7 and 14.3 months were observed,
respectively.

Most treatment-related adverse events (TRAEs) were Grade 1 and 2.
No Grade 4 or 5 TRAEs were observed. Any grade TRAEs reported by
>=10% of 87 patients evaluable for safety were peripheral edema
(48.3%), nausea (23.0%) diarrhea (20.7%) and increased blood
creatinine (12.6%). Other relevant TRAEs of any grade include
increased lipase (4.6%), fatigue (3.4%) and vomiting (3.4%). TRAEs
led to permanent discontinuation in four patients (two patients due
to peripheral edema, one due to interstitial lung disease, one due to
diarrhea and nausea).

Results from this study were presented in an oral presentation at
the 2019 American Society of Clinical Oncology (ASCO) Annual
Meeting.[6] The use of both LBx and TBx to identify patients for the
VISION study is intended to support improved patient selection and is
consistent with the company's focus on patient-centric drug
development.

*Tepotinib is the recommended International Nonproprietary Name
(INN) for the MET kinase inhibitor (MSC2156119J). Tepotinib is
currently under clinical investigation and not approved for any use
anywhere in the world.

About Breakthrough Therapy Designation

Breakthrough Therapy Designation is designed to expedite the
development and review of drugs which are intended to treat a serious
condition, and preliminary clinical evidence indicates that the drug
may demonstrate substantial improvement over available therapy on a