publication date: Jan. 10, 2020

Clinical Roundup

Keytruda shows mixed results in late-stage lung cancer study

The phase III KEYNOTE-604 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy, met one of its dual primary endpoints of progression-free survival in the first-line treatment of patients with extensive stage small cell lung cancer.

The primary endpoint overall survival favored the Keytruda combination, but the separation from chemotherapy was not statistically valid.

In the study, treatment with Keytruda in combination with chemotherapy (etoposide plus cisplatin or carboplatin) resulted in a statistically significant improvement in PFS compared to chemotherapy alone (HR=0.75 [95% CI, 0.61-0.91]), which was observed at a prior interim analysis.

At the final analysis of the study, there was also an improvement in overall survival for patients treated with Keytruda in combination with chemotherapy compared to chemotherapy alone; however, these OS results did not meet statistical significance per the pre-specified statistical plan (HR=0.80 [95% CI, 0.64-0.98]). Results will be presented at an upcoming medical meeting and discussed with regulatory authorities.


Breast density notification laws not effective for all women

Researchers at Yale and New York University found that state-mandated notifications on mammogram reports intended to inform women of the health risks related to breast density are not worded effectively.

The study, conducted by researchers at Yale and New York University, found that although dense breast notification laws did help some women understand they had increased breast density, those women were not more likely to know that breast density is associated with a higher risk of breast cancer or that dense breasts limit the ability of mammograms to detect cancer. The finding was particularly pronounced for women with a … Continue reading Keytruda shows mixed results in late-stage lung cancer study

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