Keytruda (pembrolizumab) / Merck (MSD) - LARVOL DELTA

Pembrolizumab-related toxicity in patients with advanced melanoma. (PubMed, N Z Med J) - "Pembrolizumab-related toxicities are common and mostly mild but can require protracted courses of steroids and specialty referrals. Prospective data on toxicity and the management of toxicities from ICIs are needed."

Journal • Retrospective data • Hematological Disorders • Melanoma • Musculoskeletal Diseases • Oncology • Solid Tumor

Patient-Reported Outcomes From LIBRETTO-431: First-Line Selpercatinib Versus Chemotherapy With Pembrolizumab in RET Fusion-Positive NSCLC. (PubMed, JTO Clin Res Rep) - "The selpercatinib group reported better tolerability, as measured by GP5, with a lower proportion bothered by side effects compared with control (22.6% versus 39.7%, OR = 0.58, 95% CI: 0.33-0.99). These PROs, combined with the established efficacy and safety profile of selpercatinib, further support the use of first-line selpercatinib as a standard of care and highlight the importance of early and comprehensive genomic testing in patients with RET fusion-positive NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

The Role of Immunotherapy and Immune Modulators in Hormone-Positive Breast Cancer: Implications for Localized and Metastatic Disease. (PubMed, J Clin Med) - "Key Findings: While immune checkpoint inhibitors like pembrolizumab and atezolizumab have shown promising results in combination with chemotherapy for triple negative breast cancer, their efficacy in HR+ breast cancer has generally been modest. Immunotherapy holds potential for improving outcomes in HR+ breast cancer, particularly in metastatic settings where treatment options are limited. The integration of immune modulators to enhance therapeutic efficacy in HR+ breast cancer, along with ongoing research into biomarkers, promises to refine patient selection and improve clinical outcomes."

IO biomarker • Journal • Review • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Periodic Boosters of COVID-19 Vaccines Do Not Affect the Safety and Efficacy of Immune Checkpoint Inhibitors for Advanced Non-Small Cell Lung Cancer: A Longitudinal Analysis of the Vax-On-Third Study. (PubMed, Cancers (Basel)) - "After optimally balancing prognostic factors, regular mRNA vaccine boosters at the onset of ICIs did not impact the safety and survival of patients with advanced NSCLC. The improved outcome observed in patients with high PD-L1 expression levels aligns with previous findings and warrants further investigation."

Checkpoint inhibition • IO biomarker • Journal • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor

Immune Checkpoint Inhibitors in Clear Cell Renal Cell Carcinoma (ccRCC). (PubMed, Int J Mol Sci) - "Agents such as nivolumab, pembrolizumab, and ipilimumab have demonstrated the ability to restore T-cell activity and mitigate immune suppression, offering clinical benefit in metastatic ccRCC. This review synthesizes current advances in immunotherapy for ccRCC, with a focus on mechanisms of resistance and innovative strategies to enhance immune responsiveness. A deeper understanding of TME modulation and strategic combination approaches is essential to improve survival and quality of life for patients with advanced ccRCC."

Checkpoint inhibition • IO biomarker • Journal • Review • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • VHL

Vancomycin-Induced Linear IgA Bullous Dermatosis Mimicking Stevens-Johnson Syndrome Associated With Anticancer Therapy. (PubMed, Am J Dermatopathol) - "Herein, we document the rare case of a 41-year-old woman with a history of invasive ductal breast carcinoma, receiving an anticancer regimen of pembrolizumab, cyclophosphamide, and doxorubicin, who developed erythema, tense bullae, and extensive sloughing of skin after vancomycin therapy. Presented is a rare case of vancomycin-induced LABD in a patient receiving concurrent chemotherapy and immunotherapy. Clinician awareness of the increased susceptibility of vancomycin-induced LABD in this population subset can improve clinical outcomes and decrease morbidity/mortality."

Journal • Breast Cancer • Dermatology • Oncology • Solid Tumor • Steven-Johnson Syndrome

Biosimilarity and advanced structural characterization of monoclonal antibodies charge variants using capillary zone electrophoresis and mass spectrometry. (PubMed, Talanta) - "CZE-UV analysis of pembrolizumab showed that none of the five charge variants separated were originating from C-terminal lysine residues and/or N-glycans...Thus, the CZE-UV separation resulted from the synergistic effect of several simultaneous PTMs affecting the apparent mobilities of the charge variants. As a consequence, experiments illustrated the relevance and potential of intact mAbs analysis using CZE-UV to provide an overview of the structural diversity of therapeutic mAbs."

Journal

Exploring the Potential of a Novel Oil Blend Therapy for Immunity Enhancement and Cervical Carcinoma Treatment. (PubMed, Asian Pac J Cancer Prev) - "Natural compounds derived from a novel vegetable oil blend demonstrate promising molecular interactions with key biomarkers of cervical carcinoma. These findings support their potential role as effective therapeutic agents and warrant further in vitro and in vivo validation."

Journal • Cervical Cancer • Oncology • Solid Tumor • CDKN2A • MMP9 • TP53

Neoadjuvant immunotherapy is associated with a recurrence free survival benefit versus active surveillance in patients with resected hepatocellular cancer (ESMO-GI 2025) - "In the NeoHCC cohort, nICIs regimens included single-agent nivolumab (18%), cemiplimab (15.6%), cabozantinib–nivolumab (9.4%), pembrolizumab (0.8%), atezolizumab–bevacizumab (5.6%), and nivolumab–ipilimumab (50.6%), with 30 (23%) patients also receiving postoperative ICI... nICI exposure is associated with improved RFS compared to active surveillance post resection. While limited by treatment heterogeneity and indirect reconstruction of RFS curves, our data warrant prospective testing of nICI in randomized trials to confirm RFS benefit."

Clinical • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Transarterial chemoembolization (TACE) with or without anti-PD1/PD-L1 systemic therapy in unresectable hepatocellular carcinoma: A meta-analysis of randomized clinical trials (ESMO-GI 2025) - "PD1/PD-L1 agents (camrelizumab, durvalumab, or pembrolizumab) arms included anti-angiogenic agents (TKIs or bevacizumab) in combination with immunotherapy. This meta-analysis demonstrates the significant efficacy of TACE combined with immunotherapy in patients with unresectable HCC. Further data from ongoing studies with extended follow-up are necessary to assess the long-term benefits and safety of this combination approach."

Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

BXCL701 plus pembrolizumab in second-line advanced pancreatic ductal adenocarcinoma (ESMO-GI 2025) - P2 | "This study will determine the efficacy of '701 + pembrolizumab in second-line advanced PDAC. Preliminary findings suggest efficacy in a historically immunotherapy-resistant population."

Clinical • IO biomarker • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CD8 • CXCL9 • CXCR3 • MSI

Deep learning-based CT segmentation methods for radiomics in pembrolizumab-treated gastric cancer (ESMO-GI 2025) - "Deep learning–based automated segmentation yielded results comparable to manual methods without significant differences among segmentation methods. Therefore, automated DL segmentation provides advantages in efficiency and reproducibility without compromising predictive performance compared to manual methods."

Gastric Cancer • Oncology • Solid Tumor

Comprehensive molecular and immunological characterization of CLDN18.2 in esophageal and esophagogastric junction carcinoma (EEJC) (ESMO-GI 2025) - "CLDN18.2 is associated with increased PD-L1 and HER2 expression, a differentially modulated immune microenvironment, and longer pembrolizumab time on treatment."

IO biomarker • Esophageal Cancer • Gastric Cancer • Oncology • ARID1A • BTLA • CD276 • CDH1 • CLDN18 • GNAS • HER-2 • KRAS • LAG3 • PD-L1 • PD-L2 • PIK3CA • SMAD4 • TMB • TP53

First-line therapy (1L) of cisplatin/gemcitabine (CisGem) with pembrolizumab (pembro) in patients with advanced biliary tract cancer (aBTC): Open-label, single-arm phase II EORTC-1607-GITCG/ABC-09 intergroup study with translational research (TR) (ESMO-GI 2025) - P2 | "CisGem plus Durvalumab or Pembro has been recently approved. Despite our single-arm aBTC phase II trial was negative for pE 6mPFS, 1L CisGem-pembro had ORR >40%, med. PFS >8m, and manageable Grade 3/4 events. Pat with higher CPS had better outcome."

Clinical • IO biomarker • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Gallbladder Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

First-line treatment in MSI-H/dMMR metastatic colorectal cancer across Europe, Canada and the United States: A real-world survey of patients and clinicians (ESMO-GI 2025) - "The most prescribed tx was pembrolizumab (83%)... Despite guideline recommendations of single-agent IO for 1L MSI-H/dMMR mCRC pts, some are not receiving the standard of care. There remains unmet need, with clinicians reporting a desire to further improve tx outcomes, and preference for txs with greater response rates, PFS and OS benefits."

Clinical • dMMR • Metastases • MSI-H • Real-world • Real-world evidence • Colorectal Cancer • Oncology • Solid Tumor • MSI

Comparative efficacy and safety of tislelizumab (TIS) vs other anti–PD-1 treatments in first-line (1L) gastric or gastroesophageal junction cancer (GC/GEJC): A network meta-analysis (NMA) (ESMO-GI 2025) - P3 | "Background: Anti–PD-1 treatments such as nivolumab (NIV) or pembrolizumab (PEM) given 1L in combination with chemotherapy (CT) have been found to extend overall survival (OS) and improve response in unresectable, locally advanced, or metastatic GC/GEJC. Compared to the currently recommended anti–PD-1 therapies, TIS+CT is similarly efficacious while maintaining a similar or more favorable safety profile in the 1L treatment of GC/GEJC."

Retrospective data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

Real-world study of immunotherapy and trastuzumab for HER2-positive biliary tract cancers (ESMO-GI 2025) - "Role of antiHer2 therapy has not been established in the first line, though zanidatamab has been approved in second line...34 patients received Durvalumab at standard doses and 2 received pembrolizumab. Chemotherapy backbone was Gemcitabine cisplatin in 34 patients and Gemcitabine oxaliplatin in 2 patients, with median 5 cycles (3-12)... Combination of immunotherapy and Trastuzumab appears to be safe & well tolerated with good response rates. The PFS is inferior and the overall survival appears to be longer, perhaps due to long term responders. The present study suggests that a combination of Trastuzumab and immunotherapy is a valid option for HER2-positive aBTC."

Clinical • IO biomarker • Real-world • Real-world evidence • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor • HER-2

Microsatellite-instability-high/mismatch-repair-deficient (MSI-H/dMMR) and BRAFV600E mutant (BRAFm) advanced colorectal cancers (CRC) treated with immune checkpoint inhibitors (ICI): Real-world data from the Royal Marsden Hospital (ESMO-GI 2025) - "In the BRAFm group, 40% were treated with pembrolizumab and 43.3% with nivolumab, as opposed to 42.9% and 25.7% respectively in the BRAFwt group. There was no statistically significant difference in PFS or OS between BRAFm and BRAFwt MSI-H/dMMR ICI-treated advanced CRC pts in this real-world dataset, despite a significantly higher proportion of PS≥2 in the BRAFm group. Trial results exploring first-line combination ICI plus BRAF-targeted therapy (SEAMARK) are awaited."

Checkpoint inhibition • Clinical • dMMR • IO biomarker • Metastases • Mismatch repair • MSI-H • Real-world • Real-world evidence • Colorectal Cancer • Oncology • Solid Tumor • BRAF • MLH1 • MSI • PMS2

Immunotherapy in dMMR/MSI locally advanced rectal cancer: A real-world retrospective study from an Argentine center (ESMO-GI 2025) - "Despite growing off-label use in this setting, real-world evidence remains limited. We conducted a retrospective cohort study of dMMR/MSI LARC patients treated with immunotherapy anti-PD-1 (Pembrolizumab - Nivolumab) at a leading public referral center for digestive oncology in Buenos Aires (Hospital Udaondo) between March 2021 and April 2025. This real-world analysis confirms the transformative potential of ICIs in dMMR/MSI LARC, underscores the need for universal MMR/MSI testing, and challenges current radiographic response assessment paradigms."

dMMR • IO biomarker • Metastases • Real-world • Real-world evidence • Retrospective data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • MSH2 • MSI • PMS2

Phase II trial of low dose neoadjuvant immunotherapy in locally advanced MSI/dMMR colorectal cancer: First safety and efficacy outcomes (ESMO-GI 2025) - "Pts were treated with nivolumab (100 mg) every 2 weeks, or pembrolizumab 100 mg every 4 weeks and underwent surgery after 6 months of immunotherapy. First data show similar results in safety and efficacy of LD-ICIs compared to standard-dose preoperative ICIs."

Clinical • dMMR • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor • MSI

Prognostic impact of secondary actionable alterations in dMMR/MSI-H digestive tumors (ESMO-GI 2025) - "The overall response rate to pembrolizumab was 84.2%, with a disease control rate of 89.5%... Digestive tumors with dMMR/MSI-H, MLH1 loss, and wild-type MAPK are enriched for secondary actionable alterations, with 44.4% of CRC patients harboring these alterations. NTRK fusions were associated with poorer long-term outcomes, raising the hypothesis that these alterations may contribute to primary resistance to ICI in CRC. Further studies are needed to explore their potential role in the prognosis of dMMR/MSI-H tumors."

dMMR • IO biomarker • MSI-H • Colorectal Cancer • Gastrointestinal Cancer • Oncology • BRAF • KRAS • MLH1 • MSH2 • MSH6 • MSI • NRAS • NTRK • NTRK1 • RET

Uncharted territory: Efficacy and safety of lower dose intensity immunotherapy in mismatch-repair-deficient and microsatellite instability-high gastrointestinal cancers: Real world data (ESMO-GI 2025) - "Twenty-five received pembrolizumab, three received ipilimumab/nivolumab, and one received nivolumab. Lower doses of ICI are safe and effective in treatment of MSI-H/dMMR GI malignancies. Prospective trials are needed to confirm our results."

Clinical • dMMR • Mismatch repair • MSI-H • Real-world • Real-world evidence • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

Pembrolizumab real-world data, including inflammatory indices in dMMR/MSI-H mCRC from a tertiary cancer centre (ESMO-GI 2025) - "Our data reflects that Pembrolizumab is an effective treatment for dMMR/MSI-H mCRC with an acceptable toxicity profile. NLR, MLR, PLR and SIRI were shown to be predictive markers for toxicity. However, larger studies are required to confirm this finding."

Clinical • dMMR • IO biomarker • MSI-H • Real-world • Real-world evidence • Colorectal Cancer • Oncology • MSI

Pembrolizumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An initial analysis of real-world experience (ESMO-GI 2025) - "Our results were comparable to those of the KEYNOTE-966 trial; GCP in patients with advanced BTC was feasible and effective in a real-world setting. Regarding efficacy, the duration of follow-up is still limited, and further evaluation is needed."

Clinical • Metastases • Real-world • Real-world evidence • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Efficacy of pembrolizumab and feasibility of organ preservation in non-metastatic, unresectable dMMR CRC (ESMO-GI 2025) - P2 | "Neoadjuvant pembrolizumab resulted in a 48% cCR/pCR rate in pts with unresectable dMMR CRC. Endoscopic (near)CR plus tumor negative biopsies were predictive of ypT0. We show that organ preservation seems feasible in a selected population, warranting further investigation."

Clinical • dMMR • Metastases • Colorectal Cancer • Gastrointestinal Cancer