Antibody Drug Conjugate

bispecific

First Line treatment

First Line maintenance treatment

Second Line treatment

Study in combination with avelumab.

Includes study in combination with bintrafusp alfa.

Includes studies (phase I/II) in collaboration with/ sponsored by external partners, e.g. NCI.

In combination with cetuximab.

In combination with osimertinib.

On March 01, Merck announced a worldwide in-licensing agreement with Debiopharm, Switzerland, for the development and commercialization of xevinapant (Debio 1143).

As announced on February 03, 2021, the US Food and Drug Administration (FDA) has approved tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

As announced on November 26, 2020, the European Medicines Agency (EMA) has validated for review the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer.

As announced on January 25, 2021, the European Commission (EC) has approved avelumab as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

As announced on February 24, 2021, Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved a new indication for avelumab as a first-line maintenance treatment for advanced bladder cancer.

Additional information: Several combination studies (phase II) of avelumab with talazoparib, axitinib, ALK inhibitors or chemotherapy ongoing under sponsorship of Pfizer.

Unless noted otherwise, clinical programs conducted in collaboration with external partners are not shown unless Merck has co-ownership of data. In such case the indication is shown in Italics.