Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) / Roche, Halozyme - LARVOL DELTA

A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial

Phase III study of paclitaxel/carboplatin alone or combined with either trastuzumab and hyaluronidase-oysk or pertuzumab, trastuzumab, and hyaluronidase-zzxf in HER2 positive, stage I-IV endometrial carcinoma (NRG-GY026) (SGO 2026) - No abstract available

P3 data • Endometrial Cancer • Oncology • Solid Tumor • HER-2

HCB-ONC002: HER2DX-guided diagnostic treatment For patients with HER2-positive early-stage breast cancer (clinicaltrialsregister.eu) - P2/3 | N=224 | Recruiting | Sponsor: Fundacio De Recerca Clinic Barcelona-Institut DInvestigacions Biomediques August Pi I Sunyer

New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • HER-2

Safety and preliminary efficacy of giredestrant (GIRE) + the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) + palbociclib (PALBO) in MORPHEUS Breast Cancer (BC): A Phase Ib/II trial in patients (pts) with oestrogen receptor-positive, HER2-positive (ER+, HER2+) metastatic (m)BC (ESMO-BC 2026) - No abstract available

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=210 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jul 2026 ➔ Jul 2027 | Trial primary completion date: Jul 2026 ➔ Jul 2027

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant Intravenous Biosimilar Pertuzumab and Trastuzumab Versus Subcutaneous Pertuzumab/Trastuzumab/Hyaluronidase(Phesgo) in HER2- PositiveBreast Cancer: A Real-World Comparative Study (ESMO-BC 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer (clinicaltrials.gov) - P3 | N=200 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • PIK3CA

Halozyme Reports Full Year 2025 Record Revenue of $1.4 Billion… (PRNewswire) - "Three ENHANZE‑enabled blockbusters, DARZALEX SC, Phesgo and VYVGART Hytrulo, drove royalty revenue growth of 52%, reaching a record $868 million in 2025....The 38% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $867.8 million in royalties, an increase of 52% compared to $571.0 million in 2024, primarily driven by continued sales uptake of ENHANZE partner products..."

Sales • HER2 Positive Breast Cancer • Multiple Myeloma • Myasthenia Gravis

DEMETHER: A single-arm phase II trial to evaluate the efficacy & safety of subcutaneous pertuzumab & trastuzumab maintenance after induction treatment w/ trastuzumab deruxtecan (T-DXd) for previously untreated HER2-positive advanced breast cancer (SABCS 2024) - P2 | "Taking this into consideration, the rationale of the DEMETHER study is to find the right balance between T-DXd shorter treatment duration and subcutaneous fixed-dose combination of pertuzumab and trastuzumab maintenance therapy to ensure efficacy and tolerance in previously untreated HER2-positive ABC pts. Date of registration: May (Europe), July-August (FDA-IRB, US), December (Brazil), 2024. First patient enrolled: June (Europe), September (US), December (Brazil), 2024."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Symposium 27: Subcutaneous injection in cancer chemotherapy - Learning from the past (JSMO 2026) - "Hyaluronidase-containing preparations (e.g., Phesgo and Dalacuro) have also appeared, and similar drugs are expected to increase in number...We will look back at the history of subcutaneous injections. Furthermore, we will discuss new knowledge and know-how on administering hyaluronidase-containing anticancer drugs and issues related to outpatient chemotherapy surcharges."

Oncology

CHERRY-PICK: Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade (clinicaltrials.gov) - P2 | N=63 | Active, not recruiting | Sponsor: Latin American Cooperative Oncology Group | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2031 ➔ Apr 2032 | Trial primary completion date: Oct 2026 ➔ Apr 2026

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer (clinicaltrials.gov) - P3 | N=246 | Active, not recruiting | Sponsor: R-Pharm

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

CONSOLIDATED FINANCIAL STATEMENTS (IFRS) (Non-Audited) (for the year ended December 31, 2025) (Chugai Press Release) - "Oncology products sales were ¥246.5 billion (a decrease of 0.5% year on year). Sales of the mainstay product Avastin...decreased due to the market penetration of generic drugs and the effects of the NHI drug price revisions. In addition, sales of Perjeta (an anti-HER2 humanized monoclonal antibody, anti-cancer agent) decreased significantly, mainly due to the ongoing replacement of Perjeta with the new product Phesgo...a subcutaneous combination drug containing Perjeta. Meanwhile, in addition to the significant increase in sales of Phesgo, the market penetration of Lunsumio (antineoplastic agent/anti-CD20/CD3 humanized bispecific monoclonal antibody), launched in March 2025, was also favorable, and the mainstay product Polivy (an antimicrotubule binding anti-CD79b monoclonal antibody, anti-cancer agent) performed strongly."

Commercial • Cervical Cancer • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Fallopian Tube Cancer • Follicular Lymphoma • Glioblastoma • Hepatocellular Cancer • HER2 Positive Breast Cancer • Indolent Lymphoma • Lung Non-Squamous Non-Small Cell Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma

Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=7 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed | Trial completion date: Oct 2027 ➔ Apr 2025 | Trial primary completion date: Oct 2027 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • NRG1

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2025 results with 7% sales growth (Roche Press Release) - "Pharmaceuticals Division sales increased by 9% (3% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Vabysmo (severe eye diseases) being the top growth drivers."

Commercial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Diabetic Macular Edema • Diabetic Retinopathy • Hemophilia A • HER2 Positive Breast Cancer • Multiple Sclerosis • Wet Age-related Macular Degeneration

Long-Term Safety and Efficacy of the Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-Positive Early Breast Cancer in PHranceSCa, a Randomized, Open-Label Phase II Study. (PubMed, Clin Breast Cancer) - P2 | "PH FDC SC was well tolerated, with safety consistent with that of P + H IV (except local injection-site reactions) and no grade ≥ 3 anaphylaxis/hypersensitivity or new safety signals in the continuation period. Immature efficacy data showed high event-free rates, consistent with the known clinical benefit of pertuzumab and trastuzumab (although follow-up was relatively short at 3 years). PHranceSCa adds to the totality of evidence reinforcing the long-term clinical benefit and safety of pertuzumab and trastuzumab."

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Oncology • Solid Tumor • HER-2

KORU Medical Systems, Inc…announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical’s FreedomEDGE infusion system to subcutaneously administer PHESGO (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer (Businesswire) - "The submission represents a key milestone in KORU Medical’s strategy to expand the use of the FreedomEDGE system beyond its current immunoglobulin (Ig) indications and into the broader oncology infusion center market."

FDA filing • HER2 Positive Breast Cancer

Efficacy and Safety of Subcutaneous Pertuzumab-Trastuzumab (Phesgo) in Neoadjuvant Treatment of HER2-positive Breast Cancer: Real-world Data from Japan. (PubMed, Anticancer Res) - "Phesgo demonstrated comparable or superior efficacy and favorable safety with markedly improved treatment efficiency in real-world Japanese practice. Phesgo represents a promising alternative to intravenous administration, reducing patient burden and optimizing healthcare resource utilization."

Journal • Real-world evidence • Retrospective data • Breast Cancer • Dermatology • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Musculoskeletal Pain • Oncology • Pruritus • Solid Tumor • HER-2

MORPHEUS BC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov) - P1/2 | N=316 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2027 ➔ May 2029 | Trial primary completion date: Nov 2027 ➔ May 2029

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER

Real-World Outcomes of Subcutaneous PHESGO® in HER2-Positive Breast Cancer: Pathological Response, Sequencing, and Safety. (PubMed, Curr Oncol) - "In routine practice, PHESGO® showed substantial neoadjuvant activity, acceptable toxicity, and workflow advantages. Early use of subcutaneous dual HER2 blockade with taxane may enhance pCR and facilitate delivery; prospective validation is warranted."

Journal • Real-world evidence • Retrospective data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Thrombocytopenia • HER-2

Subcutaneous pertuzumab and trastuzumab fixed-dose combination versus dual intravenous pertuzumab and trastuzumab or subcutaneous trastuzumab plus intravenous pertuzumab in HER2-positive breast cancer adjuvant therapy: A time and motion study in a lean operating day care oncology unit in China (SABCS 2025) - "This real-world time-motion study demonstrates that PH FDC SC significantly reduces pt treatment burden and healthcare resource utilization in HER2+ BC adjuvant therapy. Pt preference data strongly favored PH FDC SC across convenience dimensions. These findings support PH FDC SC implementation as a favorable option in day-care settings."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=210 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Oct 2026 ➔ Jul 2026 | Trial primary completion date: Oct 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Multidimensional impact of fixed-dose subcutaneous trastuzumab-pertuzumab on oncology workflow and patient time burden in a real-world study. (PubMed, Breast Cancer) - “Phesgo improves both patient time burden and staff workflow efficiency, supporting more sustainable and patient-centered delivery of HER2-targeted therapy. These findings highlight the broader system-level value of fixed-dose SC regimens in high-volume oncology settings under real-world conditions.”

Journal • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

PHERGAIN-2: Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer (clinicaltrials.gov) - P2 | N=393 | Active, not recruiting | Sponsor: MedSIR | Trial primary completion date: Sep 2025 ➔ Mar 2027

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC (clinicaltrials.gov) - P2 | N=164 | Not yet recruiting | Sponsor: Zhimin Shao

New P2 trial • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor