Keytruda Qlex (pembrolizumab/berahyaluronidase alfa-pmph) / Merck (MSD) - LARVOL DELTA

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Central Nervous System Cancers, Version 3.2025. (NCCN)

NCCN guideline • Astrocytoma • CNS Lymphoma • Glioma • Oligodendroglioma

Halozyme Wins Preliminary Injunction Against Merck's Keytruda SC in Germany (PRNewswire) - "The Munich Regional Court's 7th Civil Division found that there is imminent infringement for Keytruda SC in Germany regarding one of Halozyme's MDASE patents in Europe, European Patent No. 2 797 622 (EP 622). As a consequence, Merck's launch activities for Keytruda SC in Germany that are within the scope of the order must be halted...Importantly, patients who want to use Keytruda will have access to the IV version of Keytruda, which is not covered by Halozyme's patent or the court's injunction order....The MDASE patents are not included in Halozyme's ENHANZE licensing program and are distinct from its ENHANZE patents. Therefore, the outcome of the infringement lawsuit against Merck will not impact ENHANZE..."

Patent • Biliary Tract Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hodgkin Lymphoma • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84) (clinicaltrials.gov) - P3 | N=160 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22) (clinicaltrials.gov) - P3 | N=1023 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

Alteogen Expects Multiple Tech Exports by Year-end (Business Korea) - "Alteogen recorded consolidated revenue of 49 billion won, operating profit of 26.7 billion won, and net profit of 22 billion won in the third quarter of this year...'As Keytruda SC launches in earnest simultaneously in the United States and Europe, there appears to be no risk of profit decrease with the operating profit margin falling below 50% as we continue to stably receive royalties in the next quarter and next year.'...Revenue through ALT-B4 is also expected to increase...'ALT-B4’s patent duration extends until 2039 (expected to reach early 2042 when all extension conditions including PTA and PTE are applied)'...""

Commercial • Breast Cancer • Cervical Cancer • Gastric Cancer • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Alteogen said on the 27th that it will receive about 21.9 billion won in stepwise technology fees (milestones) from Merck (MSD) within 30 days. (Chosun Biz) - "The proceeds are equivalent to 21.3% of the company’s last year sales of 102.9 billion won. That is because 'Keytruda SC,' to which Alteogen’s subcutaneous formulation conversion technology was applied, received marketing authorization in Europe....Earlier, Alteogen received a milestone of about 35.1 billion won ($25 million) from MSD in line with Keytruda SC’s U.S. Food and Drug Administration (FDA) marketing approval last month."

Commercial • Biliary Tract Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hodgkin Lymphoma • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer

The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin. (FDA) - "Efficacy was evaluated in KEYNOTE-905/EV-303 (NCT03924895)...The recommended pembrolizumab dose for neoadjuvant treatment is 200 mg IV every 3 weeks administered in combination with enfortumab vedotin-ejfv 1.25 mg/kg (up to a maximum of 125 mg for patients ≥ 100 kg) IV on Days 1 and 8 of a 21-day cycle for 3 cycles for a total duration of 9 weeks of neoadjuvant treatment...This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence."

FDA approval • Project Orbis • Bladder Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), NCCN Guidelines Navigator, and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Prostate Cancer, Version 3.2026. (NCCN)

NCCN guideline • Prostate Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium, the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Pediatric Central Nervous System Cancers, Version 1.2026. (NCCN)

NCCN guideline • Glioma • Medulloblastoma

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Penile Cancer, Version 1.2026. (NCCN)

NCCN guideline • Penile Cancer

Budget and Time Impact Analysis of Introducing Subcutaneous Pembrolizumab to Patients From Institution HCP and Patient Perspectives in the United States (US) (ISPOR-EU 2025) - "Pembrolizumab with berahyaluronidase alfa for subcutaneous (SC) administration demonstrated noninferior pharmacokinetics compared to pembrolizumab IV with consistent efficacy and safety results reported in the MK3475A-D77 trial. Pembrolizumab SC will enhance the drug administration of immunotherapy for healthcare providers, expecting to improve practice efficiency, mitigate capacity constraints, and save budget. It also provides benefits to patients in administration time saving and potential productivity gain."

Clinical

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Gestational Trophoblastic Neoplasia., Version 1.2026. (NCCN)

NCCN guideline • Gestational Trophoblastic Neoplasia

European Commission Approves Subcutaneous Administration of KEYTRUDA (pembrolizumab) for All Adult Indications Approved in the European Union (Merck (MSD) Press Release) - "The approval of KEYTRUDA SC is based on results from the pivotal 3475A-D77 trial...This decision authorizes the marketing of KEYTRUDA SC in all 27 EU member states, as well as Iceland, Liechtenstein and Norway."

dMMR • EMA approval • MSI-H • Biliary Tract Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hodgkin Lymphoma • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Vulvar Cancer, Version 1.2026. (NCCN)

NCCN guideline • Vulvar Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), NCCN Guidelines Navigator, the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Uterine Neoplasms, Version 1.2026. (NCCN)

dMMR • MSI-H • NCCN guideline • pMMR • Endometrial Cancer • Uterine Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), NCCN Guidelines Navigator, the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Non-Small Cell Lung Cancer, Version 1.2026. (NCCN)

NCCN guideline • Non Small Cell Lung Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Melanoma: Uveal, Version 2.2025. (NCCN)

NCCN guideline • Uveal Melanoma

In brief: Keytruda Qlex - a subcutaneous formulation of pembrolizumab. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Development of preclinical anti-PD-1 resistant models to uncover mechanisms of immune evasion (SITC 2025) - "(1) Drug induced model: BALB/c-hPD1 mice were subcutaneously transplanted with CT26 cells and treated with anti-PD-1 (KEYTRUDA®) twice weekly...Notably, CD8+ cytotoxic T lymphocyte infiltration decreased, and myeloid-derived suppressor cells (MDSCs) significantly accumulated in the tumor microenvironment. Additionally, Stk11 deletion was associated with reduced PD-L1 expression in tumor cells, suggesting that the immunosuppressive microenvironment contributed to the development of resistance.Conclusions These preclinical anti-PD-1 resistance models are valuable tools to dissect the complexity of anti-PD-1 resistance mechanisms, validate resistance-associated biomarkers and evaluate novel immunotherapeutic strategies."

IO biomarker • Preclinical • Oncology • B2M • CD8 • IFNG • STK11

Merck…announced new research from more than 100 abstracts across more than 20 types of cancer and multiple treatment settings from the company’s broad and differentiated portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 (Merck (MSD) Press Release) - "Presentations at the Congress will feature new or updated findings from Merck’s broad portfolio of cancer medicines, including data for KEYTRUDA (pembrolizumab); LENVIMA (lenvatinib), in collaboration with Eisai; WELIREG (belzutifan); and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)."

Clinical data • dMMR • MSI-H • Platinum resistant • pMMR • Bladder Cancer • Endometrial Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Paraganglioma • Pheochromocytoma

Merck…announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) (Merck (MSD) Press Release) - "The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 7, 2026, marking the first concurrent review of both KEYTRUDA and KEYTRUDA QLEX for the same novel indication...The sBLAs are based on data from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas."

FDA filing • PDUFA • Priority review • Bladder Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Occult Primary, Version 1.2026. (NCCN)

dMMR • MSI-H • NCCN guideline • Microsatellite Instability • Solid Tumor

Model-based dose selection and pharmacokinetic bridging of subcutaneous from intravenous pembrolizumab across indications. (PubMed, Eur J Cancer) - P1, P3 | "These findings confirm pembrolizumab SC 790 mg Q6W and 395 Q3W are appropriate to maintain efficacy and safety similar to pembrolizumab IV across approved indications."

Journal • PK/PD data • Oncology

A Clinical Study of MK-1084 and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) (clinicaltrials.gov) - P3 | N=675 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • PD-L1

A Time and Motion Study Comparing Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab in Combination with Chemotherapy for the Treatment of Metastatic Non-small Cell Lung Cancer. (PubMed, Adv Ther) - "Pembrolizumab SC substantially reduces active HCP time and patient chair time versus pembrolizumab IV. Time liberated for HCPs could be reallocated toward additional patient care activities, while optimized chair utilization could improve overall healthcare efficiency."

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