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

...The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1)... (FDA) - "FDA also approved the PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Inc) as a companion diagnostic device to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) for treatment with pembrolizumab....Efficacy was evaluated in KEYNOTE-B96 (NCT05116189), a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 643 patients with platinum-resistant, epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who received one or two prior lines of systemic therapy for ovarian carcinoma....This review was conducted under Project Orbis..."

Diagnostic • FDA approval • Platinum resistant • Project Orbis • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

Subcutaneous (SC) versus intravenous (IV) pembrolizumab (Pembro) plus chemotherapy (CT) in metastatic non-small cell lung cancer (mNSCLC): Phase III MK-3475A-D77 trial (ELCC 2025) - P3 | "Pembro SC 790 Q6W resulted in pembro exposure and trough concentrations that were noninferior to those of pembro IV 400 mg Q6W, in combination with CT, in pts with mNSCLC. Efficacy was similar in the SC and IV arms. The safety profile of pembro SC plus CT was manageable and consistent with that of pembro IV plus CT."

Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Alteogen recorded its highest performance ever as the commercialization of the Keytruda Subcutaneous Injection (SC) formulation applying its own technology began in earnest. (Maeil Business Newpaper) - "Compared to the previous year, sales and operating profit rose 117 percent and 275 percent. Sales and operating profit are both the highest ever, and operating profit margin has also improved significantly from 33% to 57%."

Commercial • Colorectal Cancer • Endometrial Cancer • Hematological Malignancies • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Solid Tumor

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=67 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | N=160 ➔ 67 | Trial primary completion date: Jun 2026 ➔ Mar 2026

Enrollment change • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Merck & Co., Inc., Rahway, N.J., USA Announces Fourth-Quarter and Full-Year 2025 Financial Results… (Merck (MSD) Press Release) - "Full-Year Worldwide Sales Were $65.0 Billion (1% Growth; 2% Growth ex-FX): KEYTRUDA/KEYTRUDA QLEX Sales Were $31.7 Billion (7% Growth Both Nominally and ex-FX); Includes KEYTRUDA QLEX Sales of $40 Million; WINREVAIR Sales Were $1.4 Billion; CAPVAXIVE Sales Were $759 Million; GARDASIL/GARDASIL 9 Sales Were $5.2 Billion (39% Decline Both Nominally and ex-FX)."

Sales • Anal Carcinoma • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Endometrial Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Negative Breast Cancer • Hormone Receptor Negative Breast Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Carcinoma • Oropharyngeal Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Vaginal Cancer

A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65) (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

KEYMAKER-06C: Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2029 ➔ Sep 2029 | Trial primary completion date: Jan 2027 ➔ Sep 2029

Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • ERBB3 • HER-2

FDA accepted two supplemental Biologics License Applications (sBLAs) for KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of certain patients with PD-L1+ inoperable (unresectable) locally advanced or metastatic TNBC based on Phase 3 KEYNOTE-D19/ASCENT-04 trial. (Merck (MSD) Press Release) - "FDA set Prescription Drug User Fee Act (PDUFA) dates in the second half of 2026 for these applications."

FDA approval • FDA filing • Triple Negative Breast Cancer

Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Andrew Hantel, MD

New P1 trial • Breast Cancer • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Phase 3 Trial of First-Line MK-3475A (Subcutaneous Pembrolizumab) for Stage IV NSCLC With PD-L1 TPS ≥ 50% (IASLC-WCLC 2025) - P3 | "Introduction : First-line treatment for patients with stage IV non-small-cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) ≥50% and no targetable genetic alterations includes intravenous (IV) administration of the anti-PD-1 monoclonal antibody (mAb) pembrolizumab. Secondary objectives include exposure (cycle 1 maximum concentration [C max ] and C trough , and steady state [cycle 3] C max and AUC 0-6wk ) of pembrolizumab SC vs pembrolizumab IV Q6W, anti-pembrolizumab antibody levels, cycle 1 and steady-state (cycle 3) C trough of pembrolizumab SC vs pembrolizumab IV Q3W, ORR, PFS, and duration of response (each per RECIST v1.1 by blinded independent central review), OS, safety, and pt-reported outcomes. Recruitment is ongoing."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • ROS1

A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18) (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2026 ➔ May 2026 | Trial primary completion date: Sep 2026 ➔ May 2026

Trial completion date • Trial primary completion date • Solid Tumor

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), NCCN Guidelines Navigator, the NCCN Drugs & Biologics Compendium (NCCN Compendium), and the NCCN Radiation Therapy Compendium for Head and Neck Cancers, Version 1.2026. (NCCN)

NCCN guideline • Head and Neck Cancer • Oropharyngeal Cancer • Squamous Cell Carcinoma of Head and Neck

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Bone Cancer, Version 2.2026. (NCCN)

NCCN guideline • Bone Cancer

KEYNOTE-C62: Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers (clinicaltrials.gov) - P1/2 | N=36 | Terminated | Sponsor: SignalChem Lifesciences Corporation | N=92 ➔ 36 | Trial completion date: Sep 2028 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2026 ➔ Dec 2025; Lack of efficacy and enrollment challenges

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • KRAS • PD-L1 • ROS1

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