berahyaluronidase alfa (ALT-B4) / Alteogen - LARVOL DELTA

Berahyaluronidase Alfa Enables Subcutaneous Administration of Antibody–Drug Conjugates with Improved Local and Hematologic Tolerability (ESMO 2026) - No abstract available

ADC • Oncology

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

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

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

Effect of berahyaluronidase alfa on subcutaneous absorption and local tolerability of ALT-P7, an antibody-drug conjugate in preclinical studies. (PubMed, J Control Release) - "Together, this study quantitatively characterized how the dose and administration method of BHα modulate the SC absorption of ALT-P7. BHα-mediated acceleration of absorption was associated with attenuated local dermatologic toxicity and with model-predicted reductions in ADC residence and local exposure at the injection site."

Journal • Preclinical • Dermatology • HER-2

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

Alteogen…announced today that it has entered into an exclusive license agreement with a global pharmaceutical company for the development and commercialization of a subcutaneous (SC) biologic product utilizing ALT-B4 powered by Alteogen's Hybrozyme technology (PRNewswire) - "Under the terms of the agreement, the counterparty will acquire exclusive worldwide rights to develop and commercialize a subcutaneous formulation of a biologic product using Alteogen's ALT-B4 (berahyaluronidase alfa). Alteogen is eligible to receive up to US$365 million, including an upfront payment and development, regulatory and sales milestone payments. In addition, Alteogen will be entitled to receive royalties based on net sales of the product commercialized under the agreement."

Licensing / partnership • Oncology

Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed

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

Transitioning Therapeutic Antibodies in Oncology from Intravenous to Hyaluronidase-Facilitated Subcutaneous Administration. (PubMed, Clin Pharmacokinet) - "We conducted a narrative review of published clinical studies, major congress presentations, trial registries, and Food and Drug Administration (FDA)/European Medicines Agency (EMA) regulatory documents describing development of hyaluronidase-facilitated SC formulations for seven oncology antibodies (trastuzumab, rituximab, daratumumab, atezolizumab, nivolumab, pembrolizumab, and amivantamab)...Across programs, PH20-based recombinant hyaluronidases, including human hyaluronidase PH20 (rHuPH20) and berahyaluronidase alfa, transiently depolymerize SC hyaluronan, enabling delivery of multi-milliliter injections and high fixed doses...Hyaluronidase-facilitated IV→SC conversion has become a reproducible, model-informed, PK-driven development paradigm. By synthesizing study-design choices, formulation pathways, and extrapolation logic across seven approved antibodies-including the recent IO and targeted-therapy wave-this review builds upon a previously described clinical..."

Journal • Review • Oncology

ALT-TKA: Effect of Tergase Injection on Reducing Edema After Bilateral Total Knee Arthroplasty (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Man Soo Kim

New trial • Immunology • Orthopedics • Osteoarthritis • Rheumatology

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

PHARMACOKINETICS, EFFICACY, AND SAFETY OF SUBCUTANEOUS PEMBROLIZUMAB IN RELAPSED OR REFRACTORY CLASSIC HODGKIN LYMPHOMA (CHL) OR PRIMARY MEDIASTINAL LARGE B-CELL LYMPHOMA (PMBCL): A PHASE 2 STUDY (EHA 2026) - P2 | "MK-3475A is pembrolizumab with berahyaluronidase alfa (MK-5180) for subcutaneous administration (subcutaneous pembrolizumab)...Participants with cHL had received ≥1 multiagent regimen, and participants with PMBCL had received ≥2 prior therapies (including ≥1 rituximab-based regimen)...Summary/Conclusion The PK profile of subcutaneous pembrolizumab in participants with hematologic tumors was similar to that in solid tumors and was consistent with the typical PK profile for subcutaneous monoclonal antibodies (Figure). Subcutaneous pembrolizumab at a dose of 790 mg Q6W showed a manageable safety profile and efficacy consistent with intravenous pembrolizumab."

Clinical • P2 data • PK/PD data • B Cell Lymphoma • Classical Hodgkin Lymphoma • Endocrine Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Musculoskeletal Pain • Primary Mediastinal Large B-Cell Lymphoma • Pruritus • Solid Tumor

Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open

A clinical trial of V940 with or without MK-3475A in people with non-small cell lung cancer (V940-014) (clinicaltrialsregister.eu) - P2/3 | N=137 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

Monotherapy • New P2/3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Sanofi

New P1 trial

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=142 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed | N=72 ➔ 142

Enrollment change • Trial completion • Oncology • Solid Tumor

INTerpath-014: A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014) (clinicaltrials.gov) - P3 | N=876 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

KANDLELIT-013: MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=102 ➔ 400

Enrollment change • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

A clinical trial of MK-1084, pembrolizumab, and chemotherapy in people with nonsmall cell lung cancer (MK-1084-013) (clinicaltrialsregister.eu) - P2/3 | N=79 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

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

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

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11) (clinicaltrials.gov) - P2 | N=147 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Nov 2026 ➔ Feb 2027

Trial completion date • Cutaneous Melanoma • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • ALK • EGFR • ROS1

INTerpath-014: A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014) (clinicaltrials.gov) - P3 | N=876 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

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