Drug Database
PE

pembrolizumab

✓ Approved

Dako · CD274 · Companion diagnostic

What is pembrolizumab?

pembrolizumab is a companion diagnostic developed by Dako. It is approved for therapeutic indications via others.

Drug Profile

CompanyDako
Drug ClassCompanion diagnostic
Molecular TargetCD274
RouteOthers
StatusApproved
Sources: ClinicalTrials.gov, Dako

Mechanism of Action

Molecular Targets

pembrolizumab acts on 1 molecular target:

CD274CD274 molecule (B7H1, B7-H)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

pembrolizumab is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Uterine cancer✓ Approved

Related Research Articles

PubMedBreast cancer (Tokyo, Japan)2026-05-24

Real-world uptake of gBRCA testing as a companion diagnostic for olaparib in patients with high-risk HER2-negative early breast cancer in Japan: a cross-sectional multicenter study (BRCAwareness).

Taji Tomoe T, Uemura Yukari Y, Kimura Yuri Y, Maeda Noriko N et al.

Adjuvant olaparib significantly improves invasive disease-free and overall survival in high-risk human epidermal growth factor receptor 2 (HER2)-negative, early breast cancer patients carrying germline breast cancer susceptibility gene 1/2 (gBRCA) pathogenic variants (PVs). Timely gBRCA testing as a companion diagnostic for adjuvant olaparib is essential. However, its real-world uptake remains unclear. We enrolled patients with invasive HER2-negative early breast cancer who underwent curative surgery during 2023 in Japan. Eligibility was based on the OlympiA trial criteria. Estrogen receptor (ER)-positive patients required ≥ 4 positive nodes after surgery or non-pathological complete response (non-pCR) with clinical and pathologic stage (CPS) and estrogen receptor status and histologic grade (EG) score ≥ 3 following neoadjuvant chemotherapy (NAC). ER-negative patients required invasive tumor > 2 cm or ≥ 1 nodal metastasis after surgery, or non-pCR after NAC. The primary outcome was gBRCA testing rate; secondary outcomes included a proportion of patients with gBRCA PVs and a proportion of patients starting adjuvant olaparib. We also explored factors associated with not undergoing testing. Of 824 patients enrolled from 46 facilities, 691 were analyzed after random sampling and exclusions. The testing rate was 63.2% (95% confidence interval 59.5-66.9). Among 254 untested patients, 168 (66%) were not informed-mainly due to physician oversight in recognizing eligibility (57%) or physician-perceived patient ineligibility (40%). Of 69 informed but untested patients, reasons included psychological distress (46%), testing cost (35%), and familial concerns (12%). Of 42 patients (9.6%) with gBRCA PVs, 32 received olaparib. Multivariable analysis (female only) showed that age ≥ 65 years, postmenopausal status, major comorbidities, upfront surgery, absence of family history of hereditary breast and ovarian cancer-related cancers, and absence of bilateral or multiple primary breast cancers were associated with lower testing rates. Greater physician awareness of companion diagnostic is needed to ensure timely gBRCA testing and equitable access to adjuvant olaparib.

PMID 42176176
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PubMedAdvances in therapy2026-05-24

First-Line Pembrolizumab Plus Chemotherapy for Advanced Biliary Tract Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-966 Study.

Ren Zhenggang Z, Liang Tingbo T, Gu Shanzhi S, Gou Hongfeng H et al.

In the global phase 3 KEYNOTE-966 study (NCT04003636), pembrolizumab plus gemcitabine and cisplatin (pembrolizumab group) showed a statistically significant, clinically meaningful improvement in overall survival (OS) versus placebo plus gemcitabine and cisplatin (placebo group) without any new safety signals in participants with advanced biliary tract cancer (BTC). This analysis focused on the subgroup of participants from KEYNOTE-966 enrolled in China. Adults with previously untreated advanced BTC were randomly assigned (1:1) to receive pembrolizumab 200 mg or placebo intravenously every 3 weeks plus gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 intravenously on days 1 and 8 of every 3-week cycle. Primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR), all per RECIST v1.1 by blinded independent central review, and safety. One hundred fifty-eight participants were enrolled in China (75, pembrolizumab group; 83, placebo group). Median time from randomization to data cutoff (December 15, 2022) was 20.5 (range, 15.0-28.8) months. Median OS was 14.1 (95% CI, 10.4-17.7) months in the pembrolizumab group versus 9.9 (95% CI, 8.6-13.0) months in the placebo group (HR, 0.74; 95% CI, 0.51-1.08); median PFS was 5.6 (95% CI, 3.2-7.4) months versus 5.7 (95% CI, 4.4-6.9; HR, 0.83 [95% CI, 0.58-1.19]) months; ORR was 36.0% (95% CI, 25.2-47.9) versus 28.9% (95% CI, 19.5-39.9); median DOR was 10.2 (range, 1.2+ to 20.6) months versus 5.7 (range, 1.4+ to 18.2) months. Grade 3 or 4 treatment-related adverse events occurred in 53 participants (71.6%) in the pembrolizumab group versus 58 (70.7%) in the placebo group; no treatment-related grade 5 events occurred. Consistent with the KEYNOTE-966 global population, first-line pembrolizumab plus gemcitabine and cisplatin provided a numeric improvement in OS versus placebo plus gemcitabine and cisplatin and no new safety signals in participants enrolled in China. ClinicalTrials.gov identifier-NCT04003636.

PMID 42176183
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PubMedVeterinary research communications2026-05-24

Diagnosis of acetaminophen and codeine poisoning in a dog using earwax analysis by headspace gas chromatography-mass spectrometry (HS/GC-MS).

de Vicente Monica Chacon MC, Barros Alexandre Có Mangoni ACM, de Souza Gabriela Scarpin GS, di Pauli Taborda Prado Lais L et al.

Poisoning of companion animals resulting from exposure to analgesics intended for human use is a frequent and clinically relevant problem in veterinary practice, usually associated with administration without professional supervision. This can induce severe systemic toxicity. Diagnostic confirmation can be particularly challenging in cases presenting with nonspecific clinical signs or when conventional biological samples are unavailable. This case report describes the innovative use of earwax as a non-invasive biological matrix for toxicological confirmation in veterinary medicine. A 9-year-old male mixed-breed dog was admitted following a traumatic accident and subsequent administration by its owner of a human medication containing acetaminophen and codeine. Clinical evaluation revealed lethargy, hypersalivation, hyporexia, dehydration, and neurological abnormalities. Laboratory findings demonstrated neutrophilic leukocytosis and marked increases in hepatic enzyme activities, consistent with acute hepatocellular injury. Toxicological investigation using headspace gas chromatography-mass spectrometry detected acetaminophen-related signatures in an earwax sample, supporting suspected exposure to the drug. Intensive treatment was promptly initiated and included fluid therapy, antidotal treatment with N-acetylcysteine, opioid antagonism, analgesia, and supportive care. The patient showed progressive clinical improvement, with complete resolution of clinical signs and full recovery. This case highlights the significant risks of administering human medications to companion animals and underscores the need to improve owner awareness of self-medication practices. Furthermore, it demonstrates the diagnostic potential of earwax as a non-invasive biological matrix for toxicological confirmation, expanding the range of complementary diagnostic tools available for veterinary toxicology and supporting improved clinical decision-making in cases of suspected pharmaceutical intoxication.

PMID 42176063
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PubMedTranslational oncology2026-05-24

Integrated histopathology-transcriptomic biomarker enhances survival prediction in HNSCC patients treated with immunotherapy.

Belete Merzu M, Thakkar Nitya N, Khatri Indu I, Guan Meijian M et al.

Recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) remains a challenging disease with modest response to immune checkpoint inhibitors and a need for more robust predictive biomarkers. In a real-world (RW) cohort of patients treated with pembrolizumab alone or in combination with chemotherapy, we evaluated transcriptomic and histopathologic features associated with therapeutic benefit. PD-L1 expression, measured by combined positive score (CPS), was not significantly associated with progression-free survival (PFS). In contrast, immune-related gene signatures, particularly those linked to T cells and tertiary lymphoid structures (TLS), were predictive of improved outcomes. TLS presence identified from Hematoxylin and Eosin-stained (H&E) whole slide images correlated with favorable survival and showed association with RNA-derived TLS signatures. TLS-associated features demonstrated treatment-specific prognostic patterns, with stronger predictive power in pembrolizumab monotherapy versus combination therapy. We developed multimodal risk prediction models integrating molecular features with imaging data which better associated with RW outcomes. Evaluation using concordance index analysis revealed that traditional pathological markers and individual molecular signatures had modest predictive capability. Digital pathology features achieved better performance than clinical or molecular features alone, but the combination of imaging and molecular features yielded the highest predictive accuracy with concordance index values of 0.86 and 0.81 in pembrolizumab and combination therapy cohorts, respectively. Kaplan-Meier analysis confirmed that our multimodal risk signature achieved significant separation between high- and low-risk groups in both treatment arms, substantially outperforming molecular features alone. These findings highlight that integrating transcriptomic and histopathological data enables precise patient stratification for immunotherapy in R/M HNSCC.

PMID 42176558
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PubMedRheumatology international2026-05-24

Dermatomyositis predominates among checkpoint inhibitor-associated inflammatory myositis phenotypes: a pharmacovigilance disproportionality analysis identifies a class-wide signal.

Frey Connor C

ICI-induced inflammatory myositis (IIM) is a recognized irAE with significant morbidity and potential for life-threatening overlap syndromes. Whether polymyositis (PM) and dermatomyositis (DM) carry differential pharmacovigilance signals across ICI drug classes has not been systematically examined. A disproportionality analysis of FAERS was conducted to quantify reporting odds ratios across twelve approved ICI agents. Adverse event reports were extracted from FAERS through March 2026 using OpenVigil 2.1. RORs with 95% CIs were calculated for twelve ICI agents spanning PD-1, PD-L1, CTLA-4, and LAG-3 classes. Primary MedDRA endpoints were myositis, immune-mediated myositis, polymyositis, and dermatomyositis. Significant disproportionality for broad myositis was identified across all adequately powered ICI agents (PD-1, PD-L1, CTLA-4, LAG-3 classes), with RORs ranging 12- to 47-fold above background. The largest adequately powered signals were observed for pembrolizumab (ROR 18.34, n = 258), nivolumab (ROR 18.65, n = 256), atezolizumab (ROR 22.22, n = 132), and ipilimumab (ROR 15.11, n = 73); cemiplimab (ROR 46.89), relatlimab (ROR 44.68), and dostarlimab (ROR 33.48) produced high-magnitude estimates with smaller case counts. The immune-mediated myositis Preferred Term generated the largest estimates: pembrolizumab (ROR 45.64, n = 187), nivolumab (ROR 33.11, n = 137), and ipilimumab (ROR 25.40, n = 38). Significant dermatomyositis signals were identified in five agents, with atezolizumab producing the largest powered estimate (ROR 15.53, n = 29); DM RORs consistently exceeded PM RORs across agents, though ascertainment and coding bias likely contribute to this pattern. IIM is a pharmacovigilance signal of substantial magnitude across all ICI drug classes. The DM phenotype is more consistently disproportionate than PM across classes, with mechanistic plausibility given PD-L1's role in restraining interferon-producing plasmacytoid dendritic cells. The immune-mediated myositis MedDRA term captures the most statistically robust signal, reflecting a distinct ICI-associated coding pattern in spontaneous reporting.

PMID 42176033
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PubMedJournal of vascular and interventional radiology : JVIR2026-05-24

Diagnostic Performance of Ultrasound-Guided Omental Core Needle Biopsy: Impact of Coaxial Technique and Complementary Role of Ascitic Fluid Cytology in 463 Patients.

Kahriman Guven G, Onem Muhammed Musa MM, Karabiyik Ozgur O, Herdem Nevzat N et al.

To evaluate the safety and diagnostic performance of ultrasound (US)-guided omental core needle biopsy (CNB) using a composite reference standard, compare conventional and coaxial techniques, and assess the complementary role of ascitic fluid cytology. In this single-center retrospective cohort study, 463 patients (354 female, 109 male; median age, 64 years) with suspected omental disease who underwent US-guided omental CNB between January 2010 and December 2025 were included. Standard contraindications (eg, uncorrected coagulopathy) were respected. No additional exclusion criteria were applied. Biopsy results were correlated with surgical pathology or clinical-radiologic follow-up. Primary endpoints were diagnostic performance metrics and procedure-related adverse events. Subgroup comparisons were performed using Fisher's exact test, with p < 0.05 considered statistically significant. Technical success was achieved in 98.7% (457/463) of procedures, with no procedure-related adverse events. Overall, CNB demonstrated a sensitivity of 90.3%, specificity of 100%, and diagnostic accuracy of 93.3%. After repeat CNB in discordant cases, sensitivity increased to 95.0% and diagnostic accuracy to 96.5%. Coaxial CNB demonstrated higher sensitivity (92.7% vs 85.3%, p = 0.043) and diagnostic accuracy (95.0% vs 89.4%, p = 0.041) compared with conventional CNB. Ascitic fluid cytology showed sensitivity ranging from 65.1% to 76.7% depending on the interpretative threshold. US-guided omental CNB is a safe, minimally invasive approach, achieving high diagnostic accuracy with an excellent safety profile in an outpatient setting. The coaxial technique demonstrated higher diagnostic accuracy and sensitivity. Ascitic fluid cytology provided complementary diagnostic information, particularly in cases with false-negative biopsy results.

PMID 42177021
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