![]() ![]() Demonstrates adequate organ function, within 10 days prior to the start of study drug. Has a life expectancy ≥12 weeks from randomization. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, asĪssessed within 10 days prior to the start of study drug. Status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or Recurrent inoperable or metastatic tumor lesion for central determination of TNBC Has provided recently or newly obtained core or excisional biopsy from a locally Has measurable disease based on Response Evaluation Criteria in Solid Tumors versionġ.1 (RECIST 1.1) as determined by local radiology review. In the (neo)adjuvant setting, unless anthracycline was contraindicated or notĬonsidered the best treatment option for the participant in the opinion of the Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment Whichever occurred last) and first documented local or distant disease recurrence. Primary breast tumor surgery or date of last adjuvant chemotherapy administration, Has completed treatment for Stage I-III breast cancer, if indicated, and ≥6 monthsĮlapsed between the completion of treatment with curative intent (e.g., date of Has centrally confirmed TNBC, as defined by the most recent American Society ofĬlinical Oncology/college of American Pathologists (ASCO/CAP) guidelines. Inclusion Criteria: - Has locally recurrent inoperable breast cancer not previously treated withĬhemotherapy and which cannot be treated with curative intent OR has metastatic breastĬancer not previously treated with chemotherapy. participants with PD-L1 CPS ≥10 tumors. participants with PD-L1 CPS ≥1 tumors, and the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) participants with PD-L1 CPS ≥10 tumors, andĢ. participants with programmed cell death-ligand 1 (PD-L1) combined positive score (PFS) compared to placebo and chemotherapy in: the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival Treatment of locally recurrent inoperable or metastatic TNBC, which has not been previouslyġ. In Part 2, the safety and efficacy of pembrolizumab plus background chemotherapy will beĪssessed compared to the safety and efficacy of placebo plus background chemotherapy in the Metastatic triple negative breast cancer (TNBC), which has not been previously treated with In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three differentĬhemotherapies will be assessed in the treatment of locally recurrent inoperable or Refer to Triple Negative Breast Cancer Market report for detailed Insights.A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355) Pembro + chemo was generally well tolerated, with no new safety concerns.Įnough evidence to support the addition of pembrolizumab to standard chemotherapy for the first line treatment of mTNBC as per KEYNOTE-355 trial. Pembro combined with several chemo partners showed a statistically significant and clinically meaningful improvement in PFS vs chemo alone in pts with previously untreated locally recurrent inoperable or metastatic TNBC whose tumors expressed PD-L1 (CPS >=10). One pt in the chemo arm died due to a treatment-related AE. Grade 3-5 treatment related adverse event (AE) rates were 22% vs 66% for pembro vs chemo. Confirmed ORR was 43.8% vs 33.1% median (range) duration of response was not reached (2.3+ to 41.4+) with pembro vs 10.6 mo (2.8 to 37.5+) with chemo. The 12- and 24-mo PFS rates were 55.3% and 48.3% with pembro vs 37.3% and 18.6% with chemo. Intervention : pembrolizumab + chemotherapyĪt data cutoff, 153 pts were randomized to pembro and 154 to chemo. Indication : Triple Negative Breast Cancer ![]()
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