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

Keytruda SC, Merck’s (MSD) immuno-oncology drug incorporating Alteogen’s subcutaneous (SC) formulation technology ALT-B4, has received manufacturing and marketing approval in Japan (BigGo) - "Marketed as Keyject in Japan, it is the first SC-formulation immune checkpoint inhibitor approved in the country. The approval was based on a Phase 3 trial in advanced or recurrent non-small cell lung cancer, which demonstrated that SC administration cuts dosing time from 30 minutes to just 1–2 minutes compared with intravenous infusion."

Japan approval • Biliary Tract Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

Alteogen disclosed on the 31st that it is set to receive a $25 million milestone (about 34.4 billion won) from MSD tied to sales of Keytruda SC (brand name Keytruda Qlex) (Keytruda Qlex). (Chosun Biz) - "This milestone is the first achieved among the $1 billion in sales milestones included in the license agreement between Alteogen and MSD....Quarterly sales surged to $128 million in the first quarter this year and $463 million in the second quarter. First-half sales this year reached $590 million (about 812.1 billion won)."

Commercial • Sales • Bladder Cancer • Cervical Cancer • Classical Hodgkin Lymphoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Hepatocellular Cancer • Lung Non-Small Cell Squamous Cancer • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Neuroendocrine Carcinoma • Peritoneal Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer

Merck Receives Positive EU CHMP Opinion for KEYTRUDA (pembrolizumab) Plus Padcev (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Resectable Muscle-Invasive Bladder Cancer (MIBC) (Businesswire) - "This recommendation, which also includes KEYTRUDA SC [known as KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway. A final decision is expected by the fourth quarter of 2026....The recommendation is based on results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas."

CHMP • EMA approval • Bladder Cancer

KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J) (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2033 ➔ May 2032 | Trial primary completion date: Jan 2033 ➔ Nov 2029

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • KRAS

Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study. (PubMed, JCO Oncol Pract) - P2 | "More participants preferred pembrolizumab SC over pembrolizumab IV and chose to continue with pembrolizumab SC. The results of this study suggest that pembrolizumab SC improves convenience compared with pembrolizumab IV in cancer treatment."

Journal • P2 data • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

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

Phase 3 Study of Adjuvant Subcutaneous MK-3475A Plus Calderasib or Placebo in Resected Stage IIA-IIIB (N2), KRAS G12Cm NSCLC (IASLC-WCLC 2026) - P3 | "MK-3475A is pembrolizumab with berahyaluronidase alfa (MK-5180), a variant of human hyaluronidase developed and manufactured by Alteogen Inc (Daejeon, South Korea) for subcutaneous (SC) administration. The phase 3 KANDLELIT-013 study (NCT07431827) evaluates adjuvant calderasib in combination with pembrolizumab SC in participants with completely resected, stage IIA-IIIB (N2), KRAS G12C-mutated NSCLC following receipt of neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy...Secondary endpoints include OS, distant metastasis-free survival per investigator, lung cancer-specific survival, patient reported outcomes, and safety. Enrollment is projected to start in April 2026 at 210 global sites."

Clinical • IO biomarker • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • KRAS • PD-L1

TroFuse-055: A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055) (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

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

STELLAR-316: Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Exelixis | Not yet recruiting ➔ Recruiting

Enrollment open • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Alteogen…said on the 23rd that a composition patent for a subcutaneous (SC) formulation combining the "Hybrozyme" platform-based "ALT-B4" and "Keytruda (ingredient name pembrolizumab)" was registered with the European Patent Office (EPO). (Chosun Biz) - "The term of the new European patent runs through 2040. Considering the time taken for marketing authorization, applying for a supplementary protection certificate (SPC) can extend the patent term by up to five years."

Patent • Oncology

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

Enrollment open • Breast Cancer • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2026 Financial Results (Businesswire) - "Total Worldwide Sales Were $16.6 Billion (5% Growth; 4% Growth ex-FX): KEYTRUDA/KEYTRUDA QLEX Sales Were $8.4 Billion (5% Growth; 4% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $463 Million"

dMMR • MSI-H • Sales • Breast Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Glioblastoma • HER2 Negative Breast Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Prostate Cancer • Small Cell Lung Cancer

STELLAR-316: Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Exelixis

New P3 trial • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

“Keytruda continues to benefit patients and drive growth” (Merck (MSD)) - Q2 2026 Results

Sales • Biliary Tract Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Hormone Receptor Positive Breast Cancer • Liver Cancer • Lung Non-Small Cell Squamous Cancer • Oncology • Triple Negative Breast Cancer • Urothelial Cancer

Risk-Adapted Pembrolizumab Dosing Schedule to Mitigate Financial and Time Toxicity in Adjuvant Clear Cell Renal Cell Carcinoma (KCRS 2026) - "FDA-approved alternatives now include 400 mg IV Q6W (pharmacokinetically equivalent per KEYNOTE-555) and subcutaneous (SC) formulations (395 mg Q3W, 790 mg Q6W; KEYTRUDA QLEX). This pragmatic strategy addresses both financial and time toxicity without compromising safety monitoring, and warrants prospective validation in the adjuvant ccRCC population. Keywords Adjuvant pembrolizumab, Clear cell renal cell carcinoma, Risk-adapted dosing, Financial toxicity, Time toxicity"

Clinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • 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 | Trial completion date: Feb 2030 ➔ Apr 2027

Trial 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

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 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • PD-L1

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 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

FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer (FDA) - "Efficacy was evaluated in KEYNOTE-B15/EV-304 (NCT04700124), an open-label, randomized, active-controlled, multicenter trial in 808 patients with previously untreated MIBC who were candidates for radical cystectomy with pelvic lymph node dissection and were eligible for cisplatin-based chemotherapy....For patients who are cisplatin-eligible, the recommended pembrolizumab dose for neoadjuvant treatment is 200 mg IV every 3 weeks or 400 mg IV every 6 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 4 cycles for a total duration of 12 weeks of neoadjuvant treatment."

FDA approval • Project Orbis • Bladder Cancer

PRAC adopted an extension of indication for subcutaneous KEYTRUDA to include the treatment of melanoma and classical Hodgkin lymphoma in adolescents aged 12 years and older, based on pharmacokinetic modelling and simulation with extrapolation from adult data. Consequently, sections 4.1, 4.2, 4.8, 5.1, and 5.2 of the SmPC were updated, and the Package Leaflet was revised accordingly. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 4 – 7 May 2026: [AI generated summary]

PRAC • Classical Hodgkin Lymphoma • Melanoma • Oncology • Skin Cancer • 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=0 | Sponsor: Merck Sharp & Dohme LLC | N=24 ➔ 0

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

European Commission Approves KEYTRUDA (pembrolizumab) Plus Padcev (enfortumab vedotin-ejfv) as First PD-1 Inhibitor Plus Antibody-Drug Conjugate Regimen for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer (Businesswire) - "This approval, which also covers KEYTRUDA SC [known as KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this combination the first and only PD-1 inhibitor plus ADC regimen available for these patients in the EU...This approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas."

EMA approval • Bladder Cancer

Merck…announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (Merck (MSD) Press Release) - ".....each in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorized test...These approvals are based on data from the Phase 3 KEYNOTE-D19/ASCENT-04 trial...for the first-line treatment of adult patients with PD-L1+ (CPS ≥10) unresectable locally advanced or metastatic TNBC."

FDA approval • Triple Negative Breast Cancer