Merck grows Keytruda indications with head and neck cancer approval
Merck’s checkpoint star is shining a little brighter today with two new approvals in head and neck squamous cell carcinoma.
The pharma giant first clinched an accelerated approval to use Keytruda in recurrent or metastatic cases in 2016, targeting patients whose disease progressed on or after platinum-based chemotherapy.
On Tuesday the FDA converted it into a full approval right at the end of a priority review period, and additionally stamped its OK on Keytruda as a frontline treatment for head and neck cancer. That covers both monotherapy (in patients whose tumor express PD-L1) and a combination with platinum and fluorouracil, or FU (whole population).
In the Phase III KEYNOTE-048, Keytruda improved overall survival over the standard regimen comprising cetuximab and carboplatin or cisplatin plus FU. The hazard ratio was 0.78 (p=0.0171) for PD-L1 positive patients in the monotherapy group and 0.77 (p=0.0067) for the entire combo cohort.
“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,” said Jonathan Cheng, Merck’s VP of clinical research, said in a statement.
AstraZeneca mounted its own effort in this disease with the prized Imfinzi/tremelimumab combo, only to weaken the outlook on the combo of PD-L1 and CTLA-4.
Meanwhile as Keytruda settles into its market-leading place, bolstered by a dominant position in frontline lung cancer, Merck is busy pushing earlier uses of the PD-1 in other indications, including kidney cancer and esophageal carcinoma.
The drug brought in $2.27 billion in the first quarter, a 55% increase from the same quarter in 2018 — which ended with more than $7 billion in sales.