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

Perioperative Enfortumab Vedotin and Pembrolizumab in Bladder Cancer. (PubMed, N Engl J Med) - P3 | "Perioperative enfortumab vedotin plus pembrolizumab and surgery led to significantly better event-free and overall survival outcomes and a greater percentage of participants with pathological complete response than surgery alone in a predominantly cisplatin-ineligible population with muscle-invasive bladder cancer. Safety was also assessed. (Funded by Merck Sharp and Dohme, a subsidiary of Merck [Rahway, NJ]; KEYNOTE-905 ClinicalTrials.gov number, NCT03924895.)."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • NECTIN4

Updated results for MK-1084 + pembrolizumab in KRAS G12C-mutated (mut) metastatic non-small cell lung cancer (mNSCLC) enrolled in KANDLELIT-001 (ELCC 2026) - P1 | "Pts in arm 4 had untreated nonsquamous mNSCLC and received MK-1084 50-200 mg/d + pembro 200 mg, carboplatin, and pemetrexed Q3W. Legal entity responsible for the study Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Funding Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA."

IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Exploratory analysis of participants without pathological complete response (pCR) in the KEYNOTE-671 study of perioperative pembrolizumab (pembro) in early-stage NSCLC after 5 years of follow-up (ELCC 2026) - P3 | "Legal entity responsible for the study Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Funding Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Five-year outcomes of participants with pathological complete response (pCR) enrolled in the KEYNOTE-671 trial of perioperative pembrolizumab (pembro) in early-stage NSCLC (ELCC 2026) - P3 | "Legal entity responsible for the study Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Funding Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Recruiting ➔ Active, not recruiting | N=30 ➔ 10 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment change • Enrollment closed • Trial primary completion date • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

FLAGSHP-1: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Erasca, Inc. | N=200 ➔ 90 | Trial completion date: Feb 2026 ➔ Jun 2026 | Trial primary completion date: Nov 2025 ➔ Feb 2026

Enrollment change • First-in-human • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

TRAP-BTCnEfficacy and safety of GemCis plus Trastuzumab plus Pembrolizumab in previously untreated HER2-positive biliary tract cancer (clinicaltrialsregister.eu) - P1/2 | N=24 | Active, not recruiting | Sponsor: Institut fuer Klinische Krebsforschung IKF GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor • HER-2

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) (clinicaltrials.gov) - P3 | N=895 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

Efficacy of PErioperative PEmbrolizumab treatment in patients with resectable metastases from kidney cancer. The PE-PE study (clinicaltrialsregister.eu) - P1/2 | N=81 | Active, not recruiting | Sponsor: Consorzio Oncotech | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Agilent Technologies Inc…announced that it has received U.S. Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA (Businesswire) - "PD-L1 IHC 22C3 pharmDx, Code SK006, is the only FDA-approved companion diagnostic indicated to identify patients with esophageal or GEJ carcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) ≥ 1) who may be eligible for treatment with KEYTRUDA."

Diagnostic • FDA approval • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma

TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC). (ASCO 2025) - P1 | " Pts across 6 cohorts were dosed with Dato-DXd (4 or 6 mg/kg) plus pembro 200 mg alone (doublet) or with pembro plus Pt-CT (triplet; cisplatin 75 mg/m2 or carboplatin AUC 5) Q3W. In this largest data set to date evaluating an ADC combined with an anti-PD-1/L1 agent in the 1L setting, the combination of Dato-DXd plus pembro treatment both with and without Pt-CT elicited durable antitumor activity in pts with aNSCLC. Tolerability of the combinations was as expected, based on known profiles of the individual agents. aProportion of pts with confirmed CR + PR + SD at 12 wks."

Clinical • IO biomarker • Metastases • Dental Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • PD-L1

TROPION-Breast04: a randomized phase III study of neoadjuvant datopotamab deruxtecan (Dato-DXd) plus durvalumab followed by adjuvant durvalumab versus standard of care in patients with treatment-naïve early-stage triple negative or HR-low/HER2- breast cancer. (PubMed, Ther Adv Med Oncol) - P3 | "Approximately 1728 patients (aged ⩾18 years) will be randomized 1:1 to eight cycles of neoadjuvant Dato-DXd (6 mg/kg intravenously (IV) every 3 weeks (Q3W)) plus durvalumab (1120 mg IV Q3W) followed by nine cycles of adjuvant durvalumab (1120 mg IV Q3W) with or without chemotherapy versus eight cycles of pembrolizumab (200 mg IV Q3W) plus chemotherapy followed by nine cycles of adjuvant pembrolizumab (200 mg IV Q3W) with or without chemotherapy. The findings of this trial could lead to promising treatment options for these patients. ClinicalTrials.gov identifier: NCT06112379."

Journal • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Datopotamab Deruxtecan Plus Pembrolizumab With or Without Platinum-Based Chemotherapy for Advanced or Metastatic NSCLC: The Phase Ib TROPION-Lung02 Trial. (PubMed, J Thorac Oncol) - P1 | "Dato-DXd plus pembrolizumab therapy (with and without Pt-CT) exhibited appreciable safety and durable antitumor activity across PD-L1 expression levels in patients with amNSCLC."

IO biomarker • Journal • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TACSTD2

Plinabulin boosts antitumor efficacy of topoisomerase inhibitor-based antibody-drug conjugates without or with immune checkpoint inhibitor (AACR 2026) - "Preclinically, Plin boosts irinotecan activity in human colon cancer models and reduces topotecan-induced neutropenia. Here we investigated Plin synergy with TOP1-ADC in-vitro, and with or without PD-1/L1 inhibitor pembrolizumab (Pembro) or atezolizumab (Atezo) in-vivo. For combinations in-vitro, HER2+ KPL-4 breast cancer cells were treated with Plin (1.46 - 46.8 nM), T-DXd (0.105 - 3.37 μM) or both. For combinations in-vivo, MC38 mouse colon adenocarcinoma cells overexpressing hTROP2 (hTROP2-MC38) or hHER2 (hHER2-MC38), were inoculated in B-hPD-1 or B-hPD-1/hPD-L1/hHER2 mice respectively, and antitumor activities of Plin (7.5 mg/kg) plus Dato-DXd (5 mg/kg) ± Pembro (0.3 mg/kg) or T-DXd (3 mg/kg) ± Atezo (8 mg/kg) were evaluated. On HER2+ KPL-4 cells, Plin showed synergistic activity with T-DXd with median CI <1 at 1:1, 2:1 and 4:1 ratios (T-DXd:Plin)... Plinabulin is a Phase 3 novel agent clinically validated to promote DC maturation and T-cell activation,..."

ADC • Checkpoint inhibition • Clinical • Breast Cancer • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1 • TACSTD2 • TOP1

What can we expect from a combination of datopotamab deruxtecan, carboplatin, and pembrolizumab for brain metastases from non-small cell lung cancer? (PubMed, Expert Opin Emerg Drugs) - No abstract available

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

SHEDDING LIGHT ON PATIENT-REPORTED OUTCOME MEASURE UTILIZATION ACROSS NSCLC THERAPIES (ISPOR 2026) - "Within monotherapies, disease-specific quality-of-life (QOL) measures, particularly EORTC QLQ-C30 (n=11) and EORTC QLQ-LC13 (n=8), were frequently used in trials of ALK inhibitors (e.g., alectinib), PD-L1 inhibitors (e.g., atezolizumab, durvalumab), and PD-1 inhibitors (e.g., nivolumab, and pembrolizumab). Tyrosine kinase inhibitors (e.g., zongertinib, entrectinib) combined disease-specific EORTC QLQ-C30 and generic QOL instruments, such as EQ-5D (n= 4). In contrast, TIGIT inhibitors (e.g. rilvegostomig) and antibody-drug conjugates (e.g. dato-DXd) predominantly utilize PROMIS, which assesses general health and physical and mental functioning rather than QOL (n= 4). PRO measures remain underutilized in NSCLC monotherapy trials and are primarily positioned as supportive endpoints. PRO measures remain underutilized in NSCLC monotherapy trials and are primarily positioned as supportive endpoints. Substantial heterogeneity in PRO instrument selection suggests a lack of..."

Clinical • Patient reported outcomes • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • TIGIT

TROPION-Urothelial03: A phase 2/3 study of datopotamab deruxtecan (Dato-DXd) + platinum chemotherapy (CT) vs gemcitabine + platinum CT in participants with locally advanced or metastatic urothelial carcinoma (la/mUC) with progression on or after enfortumab vedotin (EV) + pembrolizumab (pembro). (ASCO-GU 2026) - P1, P2, P2/3 | "We describe a phase 2/3 trial comparing the efficacy and safety of Dato-DXd + platinum CT (carboplatin or cisplatin) vs gemcitabine + platinum CT in participants with la/mUC with disease progression on or after EV + pembrolizumab. In part A, ORR will be summarized with 2-sided 95% exact confidence intervals using the Clopper–Pearson method by trial group. In part B, PFS and OS will be compared between trial groups using a log-rank test stratified by randomization stratification factors, with hazard ratios from the stratified Cox regression model."

Metastases • P2/3 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

TROP2 expression predicts sensitivity to datopotamab deruxtecan (Dato-DXd) in patient-derived breast cancer organoids (AACR 2026) - "Importantly, Dato-DXd showed potent antitumor activity in three treatment-refractory TNBC PDOs, including models derived from tumors progressing after pembrolizumab plus chemotherapy combination (IC₅₀: OSV-001, 0.82 nM; SBO-105, 0.27 nM) and sacituzumab govitecan (IC₅₀: OSV-011, 0.55nM), whereas T-DXd showed lower activity compared to Dato-DXd in these organoids (IC₅₀: OSV-001, 200 nM; SBO-105 = 160 nM; OSV-011, not reached). These findings demonstrate that TROP2 expression is a key determinant of Dato-DXd sensitivity and provide mechanistic insights into ADC resistance. These findings demonstrate that TROP2 expression is a key determinant of Dato-DXd sensitivity and provide mechanistic insights into ADC resistance. Our results support the potential of TROP2-guided patient stratification to enhance therapeutic outcomes with Dato-DXd in breast cancer. Dato-DXd showed significant antitumor activity in PDOs from tumors resistant to anti-PD-1 and ADC treatment."

Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • TACSTD2

TROPION-Lung10: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (clinicaltrials.gov) - P3 | N=675 | Recruiting | Sponsor: AstraZeneca | Trial completion date: May 2030 ➔ Dec 2029 | Trial primary completion date: Apr 2028 ➔ Dec 2029

IO biomarker • Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

SHEDDING LIGHT ON PATIENT-REPORTED OUTCOME MEASURE UTILIZATION ACROSS NSCLC THERAPIES (ISPOR 2026) - "Within monotherapies, disease-specific quality-of-life (QOL) measures, particularly EORTC QLQ-C30 (n=11) and EORTC QLQ-LC13 (n=8), were frequently used in trials of ALK inhibitors (e.g., alectinib), PD-L1 inhibitors (e.g., atezolizumab, durvalumab), and PD-1 inhibitors (e.g., nivolumab, and pembrolizumab). Tyrosine kinase inhibitors (e.g., zongertinib, entrectinib) combined disease-specific EORTC QLQ-C30 and generic QOL instruments, such as EQ-5D (n= 4). In contrast, TIGIT inhibitors (e.g. rilvegostomig) and antibody-drug conjugates (e.g. dato-DXd) predominantly utilize PROMIS, which assesses general health and physical and mental functioning rather than QOL (n= 4). PRO measures remain underutilized in NSCLC monotherapy trials and are primarily positioned as supportive endpoints. PRO measures remain underutilized in NSCLC monotherapy trials and are primarily positioned as supportive endpoints. Substantial heterogeneity in PRO instrument selection suggests a lack of..."

Clinical • Patient reported outcomes • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • TIGIT

REAL-TIME AI-ASSISTED LIVING SYSTEMATIC LITERATURE REVIEW (REAL-SLR) CAPTURES A 2025 STANDARD-OF-CARE (SOC) SHIFT DRIVEN BY ANTIBODY-DRUG CONJUGATES (ADCS) IN UROTHELIAL CARCINOMA (UC): IMPLICATIONS FOR HEALTH TECHNOLOGY ASSESSMENTS (HTAS) (ISPOR 2026) - "Among 31 ADC studies identified, 14 were published in 2025, including pivotal evidence supporting enfortumab-vedotin+pembrolizumab in first-line metastatic UC, marking a clear SOC transition. The REAL-SLR also captured evolving guideline-recommended ADCs (e.g., trastuzumab-deruxtecan) and changing regulatory status (e.g., sacituzumab-govitecan), as well as emerging agents in development such as disitamab-vedotin and datopotamab-deruxtecan. REAL-SLR enables HTA stakeholders to detect and contextualize SOC changes as they occur, rather than retrospectively. In UC, where ADC-driven innovation altered first-line treatment in 2025, REAL-SLR provides HTA-ready evidence foundation that reduces rework, improves transparency, and supports timely reimbursement and access decisions in rapidly evolving oncology landscapes."

Review • Oncology • Solid Tumor • Urothelial Cancer

DS1062-328: Dato-DXd plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Previously Treated la/mUC. (clinicaltrialsregister.eu) - P2/3 | N=341 | Recruiting | Sponsor: Daiichi Sankyo Inc.

New P2/3 trial • Oncology • Solid Tumor • Urothelial Cancer

C6461001: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrialsregister.eu) - P2/3 | N=203 | Not yet recruiting | Sponsor: Pfizer Inc.

New P2/3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A clinical study of V940 in people with non-small cell lung cancer (V940-013) (clinicaltrialsregister.eu) - P1/2 | N=15 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BECOME-MB: Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: UNICANCER | Trial completion date: Apr 2029 ➔ Mar 2026 | Trial primary completion date: Apr 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF