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pembrolizumab

✓ Approved

Dako · CD274 · 辅助诊断

什么是 pembrolizumab？

pembrolizumab 是一种辅助诊断，由Dako研发。该药已获批，用于治疗相关适应症，给药途径：Others。

药物档案

公司Dako
药物类别辅助诊断
分子靶点CD274
给药途径Others
状态Approved
来源： ClinicalTrials.gov, Dako

作用机制

分子靶点

pembrolizumab 作用于 1 个分子靶点：

CD274CD274 molecule (B7H1, B7-H)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

pembrolizumab 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Uterine cancer✓ Approved

相关研究文献

PubMedAnnals of thoracic surgery short reports2026-09-10

Study Designs for INTerpath-002 and INTerpath-009 of Adjuvant Intismeran Autogene Plus Pembrolizumab for Non-Small Cell Lung Cancer.

Spicer Jonathan D JD, Peters Solange S, Gainor Justin F JF, Chaft Jamie E JE et al.

Neoantigens are immunogenic molecules arising from patient-specific tumor mutations. Intismeran autogene (intismeran; formerly V940, mRNA-4157), an mRNA-based individualized neoantigen therapy (INT) encoding ≤34 neoantigens unique to each patient's tumor, is designed to promote an antitumor immune response. In early-phase studies, adjuvant intismeran plus pembrolizumab showed antitumor activity with solid tumors. Standard-of-care therapy for non-small cell lung cancer (NSCLC) tumors ≥4 cm includes platinum-based chemotherapy and pembrolizumab given after (adjuvant) or both before and after (perioperative) surgical resection. We describe study designs for the INTerpath-002 and INTerpath-009 studies evaluating the addition of intismeran to adjuvant pembrolizumab-based therapy in stage II-IIIB (N2) NSCLC. INTerpath-002 and INTerpath-009 are randomized, double-blind, phase 3 trials. Eligible participants for INTerpath-002 have completely resected, margin-negative, stage II-IIIB (N2) NSCLC (American Joint Committee on Cancer staging manual, eighth edition) and have received 1 to 4 cycles of adjuvant platinum-based chemotherapy. Eligible participants for INTerpath-009 have resectable stage II-IIIB (N2) NSCLC and have received ≤4 cycles of neoadjuvant pembrolizumab plus chemotherapy every 3 weeks. Participants with tumors that do not achieve a pathologic complete response, per pathologic examination of the resected tumor specimen, and have R0-R1 resection are eligible for randomized treatment. In both studies, participants are randomized 1:1 to receive pembrolizumab intravenously every 6 weeks plus either intismeran intramuscularly every 3 weeks or placebo. The primary endpoint in both studies is disease-free survival per investigator. Recruitment is ongoing for both studies. Results from these studies will provide insight into the potential role of INT in NSCLC.

PMID 42719123
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PubMedClinical pharmacology and therapeutics2026-09-10

Exposure-Response Analysis of Enfortumab Vedotin Plus Pembrolizumab as First-Line Therapy for Locally Advanced or Metastatic Urothelial Cancer.

Chudasama Vaishali L VL, Kastrissios Helen H, Kadry Hossam H, Zhang Daping D et al.

Enfortumab vedotin is a nectin-4-directed antibody-drug conjugate currently approved in combination with pembrolizumab for the first-line treatment of locally advanced or metastatic urothelial cancer. Here we describe the exposure-response relationship between enfortumab vedotin exposures and efficacy/safety endpoints in patients who received ≥1 dose of enfortumab vedotin 1.25 mg/kg (on days 1 and 8 of a 21-day dosing cycle) plus pembrolizumab (recommended dosage) and had evaluable pharmacokinetics in the EV-103 (N = 121) and EV-302 (N = 432) studies. Overall, most patients were older (median age of 69 years), White (74%), and male (77%), with median body weight in EV-103 (79 kg) trending higher than that in EV-302 (75 kg). Higher exposures of enfortumab vedotin were associated with consistently higher objective response rates across all exposure quartiles in both studies, and longer survival than chemotherapy in EV-302. Increased and faster incidence of treatment-related adverse events (Grade ≥ 3 hyperglycemia, Grade ≥ 3 skin reactions, and Grade ≥ 2 peripheral neuropathy) was also observed with increased exposures. However, dose modifications were effective in managing most adverse events, with most patients having at least partial resolution (hyperglycemia, >75%; skin reactions, >85%; and peripheral neuropathy, >50%). Responses attained with higher early cycle exposure were not impacted by subsequent dose modifications. Overall, exposure-response analysis supports the use of enfortumab vedotin at a starting dose of 1.25 mg/kg and in combination with pembrolizumab for first-line treatment of locally advanced or metastatic urothelial cancer.

PMID 42717277
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PubMedAnnals of translational medicine2026-09-10

Individualized pharmacotherapy: background and development.

Jørgensen Jan Trøst JT, Westergaard Niels N

Most drug prescriptions are still based on empiricism and not on solid biological data, which often results in considerable patient variability and, sometimes, low patient benefits. Although variability in patient response to pharmacotherapy has long been recognized, only in recent decades have new molecule analytical methods provided insight into some of the causes, which are often related to somatic or germline genetic variations. Based on this insight, different predictive biomarker tests have been developed to optimize and individualize pharmacotherapy. These biomarker tests are classified as companion diagnostic (CDx) or pharmacogenetic (PGx) tests. In both the United States and Europe, CDx and PGx information is part of the regulatory drug labeling and is included in the Prescribing Information for the individual drugs and biologics. In the United States, this type of information is found in the labeling of more than 400 regulatory-approved drugs and biological products. Despite these measures and the documented clinical utility of CDx and PGx testing, clinical implementation is lagging, especially with regard to PGx. There are various reasons for the lack of testing, such as insufficient education and awareness among healthcare professionals, inadequate access to biomarker testing, regulatory hurdles, and insufficient reimbursements. Although progress has been made in recent years, further efforts are needed to fully realize the potential of individualized pharmacotherapy by integrating the use of predictive biomarkers into routine clinical practice.

PMID 42718847
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PubMedFuture oncology (London, England)2026-09-10

A phase II study assessing the feasibility and clinical efficacy of adaptive immunotherapy combination with VEGFR-TKI in patients with advanced renal cell carcinoma.

Hatoum Firas F, Dyer Brandon B, Heiligh Jazlyn J, Poehlman Trey T et al.

Kidney cancer is one of the 10 most common cancers affecting both men and women in the United States, accounting for 4% to 5% of all cancers. Most recent estimates have shown that about 81,610 new cases of kidney cancer will be diagnosed in 2024, with renal cell carcinoma (RCC). The treatment landscape of metastatic or unresectable locally advanced clear cell renal cell carcinoma (ccRCC) has changed over the past years with the approval of multiple combination regimens using immune checkpoint inhibitors (ICI) and vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKI). However, this first‑line approach is associated with immense drug-related toxicity and financial burden. Recent research suggests that unlike traditional intermittent therapy, adaptive therapy modulates drug administration based on real-time tumor metrics to maintain a stable population of sensitive cells that suppress the growth of resistant clones. This phase II trial will assess the feasibility, patient acceptability, safety, and preliminary efficacy signals of a response-based multi-drug adaptive therapy approach with pembrolizumab-axitinib (pembro-axi) in patients with metastatic or unresectable locally advanced ccRCC.Clinical trial registration www.clinicaltrials.gov identifier is NCT06860386.

PMID 42719952
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PubMedAlimentary pharmacology & therapeutics2026-09-10

Risk of Coeliac Disease After Immune Checkpoint Inhibitor Exposure in Patients With Cancer.

Aburumman Razan R, Alsakarneh Saqr S, Choung Rok Seon RS, Murray Joseph A JA et al.

Immune checkpoint inhibitors (ICIs) enhance anti-tumour immunity by modulating immune pathways but can also trigger immune-related adverse events. We aimed to evaluate the risk of developing coeliac disease (CeD) among patients with malignancy treated with ICIs. Using the TriNetX US Collaborative Network, we identified adults (≥ 18 years) diagnosed with malignancies for which ICIs are routinely used between January 2010 and December 2024 and stratified them by exposure to immune checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab, atezolizumab, durvalumab, tremelimumab, or avelumab). Patients with pre-existing celiac disease (CeD) were excluded. Cohorts were propensity score matched for demographics and autoimmune comorbidities. The primary outcome was incident CeD occurring ≥ 90 days after the index event. Adjusted hazard ratios (aHRs) were calculated, with subgroup analyses by age and sex. Statistical significance was defined as p < 0.05. After propensity score matching, 158,208 patients were included in each cohort. CeD was diagnosed more frequently among patients exposed to ICIs than among matched controls (0.152% vs. 0.071%; aHR 3.95, 95% CI 3.11-5.03; p < 0.001), corresponding to a number needed to harm (NNH) of 1235. The increased risk persisted across sex and age subgroups, including females (aHR 3.43, 95% CI 2.55-4.62), males (aHR 5.36, 95% CI 3.53-8.12), with the risk being highest among patients older than 60 years (0.14% vs. 0.06%; aHR 4.24, 95% CI 3.17-5.67; p < 0.001). In this large real-world cohort, ICI exposure was associated with nearly a fourfold increase in the risk of being diagnosed with CeD compared with matched controls.

PMID 42717304
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PubMedAnnals of thoracic surgery short reports2026-09-10

Diagnostic Dilemmas and The Benefit of Robotic-Assisted Surgery in the Management of Neurogenic Thoracic Outlet Syndrome in Complex Patients.

Federico Emma M EM, Pohlman Alexander A, Lozanoski Madison M, Abdelsattar Zaid M ZM et al.

A 64-year-old male patient presented with progressive, debilitating bilateral arm pain for 2 years following traumatic cervical spine injuries requiring multiple operations. Despite extensive diagnostic workup by several specialists, he was left without a diagnosis, treatment plan, or ability to perform his job. He was diagnosed with bilateral neurogenic thoracic outlet syndrome, based on clinical diagnostic criteria. A 2-staged bilateral robotic first rib resection resulted in complete resolution of his symptoms.

PMID 42719030
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