FDA Approves Keytruda for Head and Neck Cancer

An accelerated FDA approval has been granted to the immunotherapy Keytruda for patients with recurrent or metastatic head and neck squamous cell carcinoma following progression on a platinum-containing chemotherapy.
SILAS INMAN @silasinman
PUBLISHED: AUGUST 05, 2016
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An accelerated FDA approval has been granted to the immunotherapy Keytruda (pembrolizumab) for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) following progression on a platinum-containing chemotherapy. Merck, the developer of pembrolizumab, announced the approval.
 
In supporting evidence for the new indication, which was from the phase 1b KEYNOTE-012 study, Keytruda showed an objective response rate (ORR) of 16 percent, which included a complete response (CR) rate of 5 percent. Responses lasted for ≥6 months for 82 percent of patients. Keytruda was approved regardless of PD-L1 expression at a fixed dose of 200 mg every 3 weeks. 
 
“Head and neck squamous cell carcinoma presents unique challenges including limited treatment options, especially for patients with recurrent or metastatic disease,” Holly Boykin, executive director, Head and Neck Cancer Alliance, said in a statement. “We welcome the approval of Keytruda as a new treatment option for people whose lives are impacted by this devastating disease.”

In the KEYNOTE-012 trial, 192 total patients with recurrent/metastatic HNSCC received two doses of Keytruda. In the first arm, patients with PD-L1-postive HNSCC received the PD-1 inhibitor at 10-mg/kg (n = 60). In the second group, patients received Keytruda at 200 mg every 3 weeks regardless of PD-L1 status (n = 132).
 
The approval was based solely on an assessment of 174 patients treated with a prior platinum-based regimen. In this group, 53 patients received the 10 mg/kg dose and 121 got the 200 mg dose of Keytruda.
 
The median age of patients across the full study was 60 years (range, 20-84), and the majority were males (83 percent). Overall, the median number of prior therapies was 2, with 45 percent having received ≥3 lines of systemic therapy. Fifty-seven percent of patients had received prior platinum therapy and cetuximab. The ECOG performance status was primarily 1 (70 percent) and most patients had metastatic disease (88 percent).
 
In patients treated with a prior platinum-based agent (n = 174), the ORR was 17 percent, with a CR rate of 5 percent in the data presented at ASCO. The median duration of response had not yet been reached and was similar across both doses of Keytruda.



Talk about this article with other patients, caregivers, and advocates in the Head & Neck Cancer CURE discussion group.
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