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

Mechanism of Action

Molecular Targets

pembrolizumab acts on 1 molecular target:

CD274CD274 molecule (B7H1, B7-H)
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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

PubMedMedicine2026-09-19

Durable disease control following multidisciplinary treatment including pembrolizumab in POLE-mutated dedifferentiated endometrial carcinoma with brain metastases: A case report.

Ito Takumi T, Yoshida Jumpei J, Iwakoshi Akari A, Sugiyama Keiji K et al.

Dedifferentiated endometrial carcinoma (DEC) is a rare and aggressive subtype of endometrial cancer comprising undifferentiated carcinoma and a low-grade endometrioid component. Although POLE-mutated tumors usually show favorable outcomes owing to their ultramutated and immunogenic nature, the clinical relevance of POLE mutations in DEC remains unclear. In particular, the therapeutic effects of immune checkpoint inhibitors in POLE-mutated DEC with brain metastases have not been well characterized. Here, we report the case of a 58-year-old woman with POLE-mutated DEC who presented with headache, dizziness, and generalized weakness due to multiple brain and pulmonary metastases. The clinical course, pathological and genomic findings, multidisciplinary treatment, and treatment outcomes were evaluated. Endometrial biopsy confirmed dedifferentiated carcinoma. Genomic profiling identified a pathogenic POLE exonuclease domain mutation (V411L) and a high tumor mutational burden (49.7 mutations/Mb). The patient underwent urgent cerebellar resection, followed by radiotherapy, during which a new intracranial lesion developed. Systemic therapy with carboplatin, paclitaxel, and pembrolizumab resulted in marked regression of uterine and pulmonary lesions. Her symptoms resolved completely, and the Eastern Cooperative Oncology Group performance status improved from 2 to 0. During maintenance pembrolizumab therapy, further tumor regression was observed, and durable disease control was maintained thereafter. At 14 months, the patient remained progression-free without significant adverse events. This case demonstrated a dramatic and sustained response following multidisciplinary treatment, including surgery, radiotherapy, chemotherapy, and immune checkpoint inhibitor therapy, in POLE-mutated DEC with brain metastases. This highlights the importance of molecular profiling in identifying patients who may benefit from immunotherapy, even in aggressive and widely metastatic disease.

PubMedFrontiers in oncology2026-09-19

Case Report: Neuroendocrine-low POU2F3-positive small cell lung cancer presenting as a diagnostically unstable thoracic malignancy.

Ma Ying Y, Chen Wenlong W, Guo Fangfei F, Han Songchen S

POU2F3-positive small cell lung cancer (SCLC) is a tuft-cell-like, neuroendocrine-low subtype that may be difficult to classify in small specimens. We report a 61-year-old man with a left-upper-lobe high-grade thoracic malignancy radiographically staged as cT2aN2bM0. The cN2b component was imaging-based, and inflammatory nodal uptake could not be fully excluded because of previous pulmonary tuberculosis. Bronchoscopic biopsy from the opening of the left-upper-lobe lingular bronchus and CT-guided core biopsy of the primary mass sampled anatomically distinct sites within the same tumor process. Both samples showed morphology favoring small cell carcinoma, but conventional neuroendocrine markers were absent, focal, or weak and the immunophenotype varied by specimen and review. Morphology and specimen-specific immunophenotyping, integrated with specialist consultation, supported small cell carcinoma; POU2F3 nuclear positivity supported subtype assignment and explained the neuroendocrine-low phenotype rather than establishing the diagnosis alone. Nab-paclitaxel, cisplatin, and pembrolizumab were used as an empiric bridge strategy while histologic classification remained unresolved. After four induction cycles and marked radiographic response, a highly selected multidisciplinary decision led to surgery for pathologic assessment. Resection showed pCR/ypT0N0M0, followed by four postoperative cycles of TP plus pembrolizumab. On May 26, 2026, surveillance imaging showed no recurrence or metastasis; no ctDNA was detected on subsequent plasma testing, which was interpreted as MRD-negative. This single case is illustrative and does not define a treatment standard, a POU2F3-specific response phenotype, or evidence of cure.

PubMedFrontiers in oncology2026-09-19

Immune checkpoint inhibitors plus chemotherapy for early-stage or locally -advanced triple-negative breast cancer: a systematic review and Bayesian network meta-analysis of randomized trials.

Leng Ying Y, Dan Jiaqiang J, Heng Qiuhan Q, Li Junyan J

Immune checkpoint inhibitors (ICIs) combined with chemotherapy have become a cornerstone in managing early and locally advanced triple-negative breast cancer (TNBC). Yet direct comparative evidence on the relative efficacy and safety of different PD-1/PD-L1 agents and treatment strategies-particularly neoadjuvant-only versus perioperative, "full-course" approaches-remains limited. To guide clinical decision-making, we performed a Bayesian network meta-analysis (NMA) comparing six specific ICI-based regimens and four overarching treatment strategies. We systematically searched PubMed, Embase, Cochrane Library, and Web of Science from database inception through February 25, 2026. Eligible randomized controlled trials (RCTs) enrolled patients with previously untreated early or locally advanced TNBC and compared ICI plus neoadjuvant chemotherapy with chemotherapy alone. The primary endpoint was pathological complete response (pCR); secondary endpoints included overall survival (OS) and grade ≥3 adverse events (AEs ≥3). We assessed risk of bias using the Cochrane RoB 2 tool. A Bayesian random-effects model was applied for the NMA; effects are reported as odds ratios (ORs) or hazard ratios (HRs) with 95% credible intervals (CrIs). Treatment rankings were derived from surface under the cumulative ranking curve (SUCRA) values. Certainty of evidence was evaluated using the GRADE framework, supplemented by the CINeMA tool. Eight RCTs involving 2,073 patients met the inclusion criteria, encompassing four strategic treatment categories and six specific ICI-containing regimens. For pCR, PD-1 (neoadjuvant) + CT (OR 2.56, 95% CrI 1.55-4.22), PD-L1 (perioperative) + CT (OR 2.00, 95% CrI 1.29-3.09), and PD-1 (perioperative) + CT (OR 1.71, 95% CrI 1.39-2.10) each significantly improved pCR rates versus chemotherapy alone, though certainty of evidence ranged from moderate to very low. PD-L1 (neoadjuvant) + CT showed a numerical trend toward higher pCR (OR 1.41, 95% CrI 0.98-2.01) without reaching statistical significance. Regarding OS, both PD-L1 (neoadjuvant) + CT (HR 0.24, 95% CrI 0.08-0.72) and PD-1 (perioperative) + CT (HR 0.63, 95% CrI 0.48-0.82) demonstrated significant survival benefits over chemotherapy. In sensitivity analyses, durvalumab (neoadjuvant) + CT and pembrolizumab (perioperative) + CT yielded identical HRs (0.24 and 0.63, respectively). Safety profiles varied: camrelizumab (perioperative) + CT (OR 0.60, 95% CrI 0.34-1.04) and pembrolizumab (neoadjuvant) + CT (OR 0.53, 95% CrI 0.28-1.01) suggested reduced risks of AEs ≥3, but these findings did not achieve statistical significance and were supported by low-to-very-low certainty evidence. ICI-chemotherapy combinations consistently improve pCR rates in early and locally advanced TNBC. Notably, while our analysis hints at potential survival advantages with neoadjuvant PD-L1 blockade and perioperative PD-1 inhibition, these signals derive from only three studies and remain hypothesis-generating rather than practice-changing. Future head-to-head RCTs are warranted to confirm these observations and to better define long-term safety profiles. https://www.crd.york.ac.uk/prospero/, identifier CRD420261385223.

PubMedMedicine2026-09-19

Development and validation of a blood-based diagnostic model for pulmonary tuberculosis combining GBP5 expression and routine laboratory indicators.

Zhao Miaomiao M, Hu Qiuxiang Q, Wang Qing Q, Cha Xinlang X et al.

WHO reports that only 54% of tuberculosis (TB) patients received rapid diagnostic tests at their initial presentation. Conventional laboratory methods in TB detection have high specificity (>90%) but low sensitivity (<50%). This means a large number of tuberculosis patients are missed. A better diagnostic approach is essential to decrease the TB burden. Studies on multi-indicator blood-based models for rapid TB diagnosis remain limited. We developed a rapid, non-sputum-based model to improve the efficiency of TB diagnosis. This was a retrospective case-control study including 301 patients with active tuberculosis (ATB) and 191 patients with other pulmonary diseases (OPD) who were evaluated at the Department of Pulmonary Medicine of the Affiliated Infectious Diseases Hospital of Soochow University between May 2023 and May 2024. A composite clinical diagnosis served as the gold standard for ATB diagnosis, including either a clinical diagnosis or bacteriological confirmation. The diagnostic outcome of ATB (ATB vs OPD) was defined as the dependent variable, while guanylate-binding protein 5 (GBP5) expression levels and routine laboratory indicators (including blood cell counts and plasma protein measurements) were defined as independent variables. Univariate and multivariate logistic regression analyses were performed to identify key predictors, and an AdaBoost algorithm was used to construct a TB diagnostic model. The performance of the model was compared with traditional laboratory-based TB tests. DeLong's Test was used to evaluate the statistical difference of AUC between AdaBoost and traditional methods. Through univariate and multivariate logistic regression analyses, the GBP5 gene, white blood cell (WBC) count, platelet (PLT) count, and prothrombin time (PT) were selected to construct an ATB diagnosis model using the AdaBoost algorithm. The AdaBoost model achieved an AUC of 0.808 in the training set and 0.805 in the test set, while the AUC of smear microscopy, MTB culture, Xpert MTB/RIF, and IGRA were 0.67, 0.59, 0.63 and 0.75 respectively. Therefore, our model demonstrated better diagnostic performance than conventional methods. This study preliminarily demonstrates that our AdaBoost diagnostic model based on GBP5 gene expression and routine blood indicators could serve as a potential tool for the clinical diagnosis of ATB. However, to be applied to the clinic, large samples are needed to validate the performance of the model.

PubMedJournal of the European Academy of Dermatology and Venereology : JEADV2026-09-19

From diagnostic accuracy to clinical utility in molecular dermatopathology.

Yılmaz Ercan E, Özer Nezihe Koker NK, Topal Erdem E

PubMedInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2026-09-19

Response: Diagnostic utility of APRI, FIB-4, and FIB-5 in intrahepatic cholestasis of pregnancy.

Cicek Sevil S, Kapudere Bilge B, Kaya Parspancı Yasemin Beyza YB, Tavukcuoglu Zehra Z et al.

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