publication date: Oct. 26, 2018

Clinical Roundup

Keytruda improved OS as monotherapy and in combination with chemo in first-line recurrent or metastatic head and neck cancer

Merck announced the first presentation of interim data from the pivotal phase III KEYNOTE-048 trial investigating Keytruda as both monotherapy and in combination with chemotherapy for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma.

Interim data from KEYNOTE-048 showed Keytruda monotherapy improved overall survival, a primary endpoint of the study, by 39 percent (HR 0.61 [95% CI, 0.45-0.83]; p=0.0007) in patients whose tumors expressed PD-L1 with Combined Positive Score≥20, and by 22 percent (HR 0.78 [95% CI, 0.64-0.96]; p=0.0086) in patients with CPS≥1, compared to the EXTREME regimen (cetuximab with carboplatin or cisplatin plus 5-fluorouracil), the current standard of care.

In addition, Keytruda in combination with chemotherapy (carboplatin or cisplatin plus 5-FU) (Keytruda combination) demonstrated improved OS compared to the EXTREME regimen by 23 percent (HR 0.77 [95% CI, 0.63-0.93]; p=0.0034), regardless of PD-L1 expression. At the final analysis, superiority for OS will be evaluated for Keytruda monotherapy in the total population and Keytruda combination in patients whose tumors express PD-L1 at CPS≥20 and CPS≥1; at this interim analysis, based upon the prespecified testing algorithm, non-inferiority for Keytruda monotherapy in the total population was demonstrated and statistical significance was not achieved for the Keytruda combination in the subset of patients whose tumors expressed PD-L1 at CPS ≥20 or ≥1.

At this time point there was no difference in progression-free-survival, a dual primary endpoint of the study, in any of the groups studied. There were no new safety concerns identified with the use of Keytruda in KEYNOTE-048, the company said.

Keytruda is approved in 61 … Continue reading Keytruda improved OS as monotherapy and in combination with chemo in first-line recurrent or metastatic head and neck cancer

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Copyright (c) 2018 The Cancer Letter Inc.