Officials with the FDA today approved 2 new indications for pembrolizumab (Keytruda, Merck) in patients with head and neck squamous cell carcinoma (HNSCC), according to a press release.
Pembrolizumab is now indicated for use as a first-line monotherapy treatment for metastatic or unresectable recurrent HNSCC in patients whose tumors express PD-L1 (Combined Positive Score [CPS] 1) or in combination with platinum and fluorouracil (FU) regardless of PD-L1 expression.
The phase 3 KEYNOTE-048 trial included 882 patients with metastatic HNSCC who had not previously received systemic therapy and who were considered incurable by local therapies.
Compared with the EXTREME regimen (cetuximab with carboplatin or cisplatin plus FU), pembrolizumab demonstrated a statistically significant improvement in overall survival (OS) as a monotherapy in patients whose tumors expressed PD-L1 and in combination with chemotherapy in the total study population.
Pembrolizumab is the first anti-PD-1 therapy to demonstrate a statistically significant improvement in OS in this patient population, according to Merck.
The median duration of exposure to pembrolizumab 200 mg every 3 weeks was 3.5 months in the pembrolizumab single agent arm and 5.8 months in the combination arm.
“Head and neck squamous cell carcinoma has historically presented many challenges to physicians and patients, including limited treatment options and physical and functional issues caused by the disease and its treatment,” Jonathan Cheng, MD, vice president of clinical research, Merck Research Laboratories, said in a statement. “This approval is an important advance in the management of this devastating cancer. The results of KEYNOTE-048, which support this approval, demonstrated that Keytruda monotherapy for patients whose tumors expressed PD-L1 CPS greater than or equal to 1 and Keytruda in combination with chemotherapy regardless of PD-L1 expression significantly prolonged survival for patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma in the first-line setting.”
Adverse effects (AEs) leading to treatment interruption for pembrolizumab occurred in 31% of patients. The most common AEs that lead to interruption were pneumonia, pneumonitis, and hyponatremia. The most common AEs for pembrolizumab monotherapy were fatigue, constipation, and rash. In patients treated with the combination therapy, the most common AEs included nausea, fatigue, constipation, vomiting, mucosal inflammation, diarrhea, decreased appetite, stomatitis, and cough.
Pembrolizumab was initially approved for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy in 2016.
FDA Approves Two New Indications for Merck’s Keytruda (pembrolizumab) [news release]. Merck. Accessed June 11, 2019.