Merck’s anti-PD-1 therapy Keytruda has been granted priority review designation by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma.
Merkel cell carcinoma is a rare form of skin cancer caused by a Merkel cell associated polyomavirus.
The company’s supplemental biologics license application (sBLA), which has been accepted by the regulator, is seeking accelerated approval for Keytruda to treat adult and pediatric patients with recurrent locally advanced or metastatic MCC.
The acceptance of sBLA is based on data from the phase 2 Keynote-017 study, comprising overall response rate (ORR) and duration of response (DOR).
In July 2017, the company secured breakthrough therapy designation from the FDA for same indication.
Keytruda is a humanized monoclonal antibody, which inhibits the interaction between PD-1 and its ligands, PD-L1 and PD-L2, enabling to activate T lymphocytes that are expected to affect both tumor cells and healthy cells.
Merck Research Laboratories clinical research vice president Dr Scot Ebbinghaus said: “KEYNOTE-017 represents the longest observation to date of patients with advanced Merkel cell carcinoma receiving anti-PD-1 therapy in the first-line setting, and demonstrated durable tumor control in these patients.
“We look forward to working closely with the FDA throughout the review process and to bringing KEYTRUDA to patients with Merkel cell carcinoma.”
Merck has a wide clinical development program for Keytruda as monotherapy and in combination with other novel mechanisms.
The program included over 4,500 patients across more than 10 Merck-sponsored clinical studies, and assessing Keytruda across most settings and stages and different subtypes of the disease.
At present, Keytruda is being studied in over 800 trials across a range of cancers and treatment settings.
Keytruda, in combination with pemetrexed and platinum chemotherapy, can be used as a first-line treatment for patients with metastatic nonsquamous NSCLC, with
Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer NSCLC, with no EGFR or ALK genomic tumor aberrations.
Keytruda can also be used to treat patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.