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

B-NDG hIL15, FcγR KO mice: An optimized humanized model for evaluating T cell-modulating antibodies (AACR 2026) - "The huPBMC-B-NDG hIL15, FcγR KO mice provide a superior platform for evaluating the efficacy of therapeutic antibodies that modulate human T-cell functions, including immune checkpoint inhibitors."

Preclinical • Oncology • IL15 • PTPRC

KEYMAKER-U06 substudy 06B: A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B) (clinicaltrials.gov) - P1/2 | N=230 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Nov 2026 ➔ Jun 2027

Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Pancreatic Adenocarcinoma, Version 1.2026 (NCCN)

NCCN guideline • Pancreatic Adenocarcinoma

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

KANDLELIT-007: Phase III, open-label study of first-line calderasib with subcutaneous pembrolizumab (pembro SC) vs pembro SC plus chemotherapy (chemo) for KRAS G12C– mutant advanced/metastatic nonsquamous NSCLC (ELCC 2026) - P3 | "MK-3475A is pembro and berahyaluronidase alfa (MK-5180), a variant of human hyaluronidase developed and manufactured by Alteogen Inc (Daejeon, South Korea) for SC administration...Approximately 675 pts will be randomized 1:1 to calderasib 100 mg QD orally + pembro SC 790 mg Q6W for ≤18 cycles (arm A) or pembro SC 790 mg Q6W + cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min and pemetrexed 500 mg/m2 Q3W for 2 cycles (4 doses) followed by pembro SC 790 mg Q6W for ≤16 cycles and pemetrexed Q3W until discontinuation criteria are met (arm B)...Secondary endpoints are PFS (all pts), ORR (all pts and pts with PD-L1 TPS ≥1%), and duration of response (all pts) per RECIST v1.1 by BICR, as well as OS (all pts and pts with PD-L1 TPS ≥1%), safety, and patient-reported outcomes. Enrollment began in October 2025 and is ongoing across 219 global sites."

Clinical • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • KRAS

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

Trial initiation date • Cervical Cancer • Oncology • Solid Tumor • PD-L1

A clinical study of MK-1084 and other treatments for lung cancer (MK-1084-007) (clinicaltrialsregister.eu) - P2/3 | N=211 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

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

NCI-2019-08626: BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=49 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Tumor mutational burden • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Based on data from the LITESPARK-022 trial, the…FDA has accepted for priority review supplemental applications seeking approval of WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for the adjuvant treatment of adult patients with RCC with a clear cell component with increased risk of recurrence following nephrectomy (Merck (MSD) Press Release) - "The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 19, 2026 for the WELIREG sNDA and the KEYTRUDA and KEYTRUDA QLEX sBLAs."

FDA filing • PDUFA • Clear Cell Renal Cell Carcinoma

A Clinical Study of Calderasib (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 | N=218 ➔ 675

Enrollment change • Trial initiation date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • PD-L1

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) (clinicaltrials.gov) - P3 | N=3500 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=1343 ➔ 3500

Enrollment change • Hematological Malignancies • Oncology • Solid Tumor

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) (clinicaltrials.gov) - P3 | N=3500 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=1342 ➔ 3500

Enrollment change • Oncology

PRAC adopted extensions of indication for subcutaneous KEYTRUDA to include treatment of melanoma and classical Hodgkin lymphoma in adolescents aged 12 years and older. The updates are based on an extrapolation approach from adults to adolescents supported by pharmacokinetic modelling and simulation. Consequently, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC have been updated. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 9 – 12 Mar 2026: [AI generated summary]

PRAC • Melanoma • Oncology

Alteogen secures 17-year U.S. patent protection for Keytruda SC through early 2043 (BioNews) - "Intellectual property protection is secured for the ALT-B4 and pembrolizumab combination...Accordingly, the SC formulation of Keytruda (marketed as Keytruda Qlex), utilizing ALT-B4, will be protected by this patent for approximately 17 years, until early 2043."

Patent • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Hematological Malignancies • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer

KANDLELIT-013: MK-3475A±MK-1084 in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Health Canada Approves KEYTRUDA SC, a subcutaneous formulation of pembrolizumab across multiple cancer indications (Canada Newswire) - "The approval is based on results from pivotal trial 3475A-D77, which compared pembrolizumab administered subcutaneously with pembrolizumab administered intravenously, both in combination with chemotherapy, in patients with treatment-naïve metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 genomic tumor aberrations....Timing for commercial availability will depend on multiple factors, including provincial and territorial reimbursement processes."

Canada approval • dMMR • MSI-H • Biliary Tract Cancer • Bladder Cancer • Cervical Cancer • Classical Hodgkin Lymphoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Microsatellite Instability • Primary Mediastinal Large B-Cell Lymphoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39) (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

...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

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