EFFICACY AND EFFECTIVENESS OF IMMUNE CHECKPOINT INHIBITORS IN TRIPLE-NEGATIVE BREAST CANCER: A SYSTEMATIC LITERATURE REVIEW
Author(s)
Mahima Saini, B. Pharm, Efrata A. Shegena, M. Pharm, Jacob T. Painter, MBA, PharmD, PhD;
University of Arkansas for Medical Sciences (UAMS), Little rock, AR, USA
University of Arkansas for Medical Sciences (UAMS), Little rock, AR, USA
OBJECTIVES: Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer, with a median overall survival (OS) of just 12-18 months. Addition of the FDA-approved Immune Checkpoint Inhibitor (ICI), Pembrolizumab, has shown improved outcomes in both early and metastatic TNBC. The objective of this review was to compare and evaluate the clinical efficacy and real-world effectiveness of Pembrolizumab across early-stage and metastatic TNBC settings using Nested Knowledge (NK), an AI assisted platform for structured evidence synthesis.
METHODS: A systematic search was executed via NK which identified Phase III Randomized Controlled Trials (RCTs) and Real-World Evidence (RWE) studies of Pembrolizumab in TNBC. Two independent researchers screened and tagged studies, supported by NK’s Inclusion Rate Modeling, which predicted inclusion likelihood based on abstract content. Outcomes extracted during tagging included pathological complete response (pCR), progression-free survival (PFS), and OS. Synthesized data was exported to Excel and compared across RCT and RWE studies to evaluate findings among diverse global populations.
RESULTS: The review included 11 studies (4 RCTs and 7 RWEs). All reviewer-included studies carried an NK-assigned inclusion probability exceeding 0.9. In early-stage TNBC, clinical trial outcomes aligned closely with real-world practice; the KEYNOTE-522 trial’s 64.8% pCR rate was mirrored by RWE in Turkey (63.9%) and the USA (57%). Conversely, a significant efficacy gap emerged in the metastatic TNBC setting. While KEYNOTE-355 reported a median PFS of 9.7 months in high PD-L1 expressing patients, real-world PFS consistently ranged from 5.9 to 6.6 months.
CONCLUSIONS: Pembrolizumab provides robust, generalizable benefits for early-stage TNBC. However, in metastatic TNBC, effectiveness appears diminished in real-world populations, likely due to poorer performance status and higher comorbidity burdens among included patients. Using the NK-assigned inclusion probability as a screening aid enhanced the efficiency and robustness of our inclusion decisions, demonstrating that AI-assisted screening can be useful tool for systematic literature reviews.
METHODS: A systematic search was executed via NK which identified Phase III Randomized Controlled Trials (RCTs) and Real-World Evidence (RWE) studies of Pembrolizumab in TNBC. Two independent researchers screened and tagged studies, supported by NK’s Inclusion Rate Modeling, which predicted inclusion likelihood based on abstract content. Outcomes extracted during tagging included pathological complete response (pCR), progression-free survival (PFS), and OS. Synthesized data was exported to Excel and compared across RCT and RWE studies to evaluate findings among diverse global populations.
RESULTS: The review included 11 studies (4 RCTs and 7 RWEs). All reviewer-included studies carried an NK-assigned inclusion probability exceeding 0.9. In early-stage TNBC, clinical trial outcomes aligned closely with real-world practice; the KEYNOTE-522 trial’s 64.8% pCR rate was mirrored by RWE in Turkey (63.9%) and the USA (57%). Conversely, a significant efficacy gap emerged in the metastatic TNBC setting. While KEYNOTE-355 reported a median PFS of 9.7 months in high PD-L1 expressing patients, real-world PFS consistently ranged from 5.9 to 6.6 months.
CONCLUSIONS: Pembrolizumab provides robust, generalizable benefits for early-stage TNBC. However, in metastatic TNBC, effectiveness appears diminished in real-world populations, likely due to poorer performance status and higher comorbidity burdens among included patients. Using the NK-assigned inclusion probability as a screening aid enhanced the efficiency and robustness of our inclusion decisions, demonstrating that AI-assisted screening can be useful tool for systematic literature reviews.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO145
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Oncology