The two-part KEYNOTE-355 trial examined pembrolizumab in combination with investigator's choice of either nab-paclitaxel (Abraxane), paclitaxel, or gemcitabine/carboplatin vs placebo plus 1 of the 3 chemotherapy agents in patients with previously untreated locally recurrent inoperable or metastatic TNBC.
We thank the patients and investigators who have allowed us to evaluate innovative treatment approaches, anchored by, across multiple settings and stages of TNBC.” “These new OS results confirm that in combination with chemotherapy represents an important treatment option for certain patients with metastatic TNBC. “In the fight against TNBC, the subtype with the worst survival prognosis, new options that can extend the lives of patients are urgently needed,” Vicki Goodman, MD, vice president of clinical research at Merck Research Laboratories, stated in a press release. Merck shared plans to present the OS data at an upcoming medical meeting and to submit to regulatory authorities. No new safety signals were reported with the regimen. The addition of pembrolizumab (Keytruda) to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival (OS) vs chemotherapy alone in patients with metastatic triple-negative breast cancer (TNBC) whose tumors had a PD-L1 expression of a combined positive score of 10 or higher, meeting the primary end point of the phase 3 KEYNOTE-355 trial (NCT02819518).
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