MSD Korea said that it has won expanded indication for its cancer immunotherapy Keytruda as the first-line treatment for head and neck cancer.
The Ministry of Food and Drug Safety approved the combination treatment of Keytruda (ingredient: pembrolizumab) plus chemotherapy for metastatic and inoperable head and neck squamous cell carcinoma, and Keytruda’s monotherapy for programmed death-ligand 1 (PD-L1) positive patients, the company said.
|The Ministry of Food and Drug Safety has expanded indications for the combination and monotherapy of MSD Korea’s treatment for head and neck cancer, Keytruda. (MSD)|
With the lately approved indication, Keytruda can be used alone, or with platinum-based or fluorouracil (5-FU) chemotherapy as the first-line treatment for patients with metastatic or inoperable recurrent squamous cell carcinoma of head and neck, it added.
Keytruda is intravenously infused with 200 milligrams every three weeks for 30 minutes and administered until confirming cancer progression or unacceptable toxicity.
The ministry expanded the indication based on phase 3 clinical trial KEYNOTE-048, which compared the result of single and combination treatment of Keytruda with chemotherapy and the control group that received Cetuximab's combo therapy and platinum-based chemotherapy.
The study results showed that the median overall survival (OS) of single Keytruda treatment was 12.3 months, and combination with chemotherapy was 13.6 months. The survival period significantly increased compared to 10.3 and 10.4 months of median OS in monotherapy and combo treatment, respectively, in the control group.
The median progression-free survival was 3.2 months in the group that received Keytruda monotherapy and five months in the combination treatment group.
“We are pleased to provide a new first-line treatment that has confirmed high efficacy for patients in Korea who had a poor prognosis and limited treatment options,” said Choi Jae-yeon, director of MSD Korea’s oncology business unit. “The company is conducting clinical trials on more than 30 cancers worldwide to prolong and improve cancer patients' lives.”