The exploratory end point was duration of response (DOR).īaseline patient characteristics were comparable across treatment groups and PD-L1 populations. Secondary end points included objective response rate (ORR), and safety. The primary end points of the study were progression-free survival and OS. Patients 18 years and older with previously untreated recurrent or metastatic squamous cell carcinoma of the oropharynx with a known p16 expression, oral cavity, hypopharynx, or larynx that could not be cured with local therapy were eligible to enroll on the study. Patients continued treatment until disease progression, unacceptable toxicity, or withdrawal. Patients received 200 mg of intravenous pembrolizumab once every 3 weeks, with or without chemotherapy consisting of 100 mg/m 2 of cisplatin every 3 weeks or carboplatin and fluorouracil at 1000 mg/m 2 every 3 weeks or a 400 mg/m 2 loading dose of cetuximab followed by 250 mg/m 2 per week along with the same chemotherapy backbone. The KEYNOTE-048 study randomly assigned a total of 882 patients to receive either the pembrolizumab alone (n = 301), pembrolizumab plus chemotherapy (n = 281), or the cetuximab regimen (n = 300). 00994).Īdditionally, the median OS among those with a CPS of 20 or more who were treated with pembrolizumab/chemotherapy was 14.7 months (95% CI, 10.3-19.3) compared with 11.1 months (95% CI, 9.2-13.0) in the cetuximab arm (HR, 0.62 95% CI, 0.46-0.84 P =. Among patients with a CPS 1 or more, pembrolizumab alone produced a median OS of 12.3 months (95% CI, 10.8-14.8) compared with 10.4 months (95% CI, 9.0-11.7) among those in the cetuximab arm (HR, 0.74 95% CI, 0.61-0.8p P =. The median OS for those receiving pembrolizumab was 14.9 months (95% CI, 11.5-20.6) vs 10.8 months (95% CI, 8.8-12.8) for those receiving cetuximab/chemotherapy who had a CPS score of 20 or more (HR, 0.61 95% CI, 0.46-0.81 P =. First-line pembrolizumab (Keytruda) plus chemotherapy continued to demonstrate improved overall survival (OS) benefit compared with cetuximab (Erbitux) plus chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinomas, according to results from the phase 3 KEYNOTE-048 study (NCT02358031).Īt a median follow-up of 45.0 months, pembrolizumab demonstrated OS improvements in patients whose PD-L1 combined positive scores (CPS) were 20 or more and 1 or more.
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |