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

OPTIMAL-BC: Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer (clinicaltrials.gov) - P=N/A | N=112 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Swiss Roche cancer drugs will be packaged in Ukraine (LIGA.net) - "Ukraine has signed an agreement with the Swiss pharmaceutical giant Roche (F. Hoffmann-La Roche) on the localization of production of drugs for lung and breast cancer. The document was signed during the Ukraine Recovery Conference 2025 in Rome, the press service of the state-owned enterprise Medical Procurement of Ukraine (MPU) reported. The investment agreement provides for the supply of medicines in bulk, i.e. in a ready-to-package form, and their packaging, final packaging and labeling will be carried out directly in Ukraine....Under the agreement, F. Hoffmann-La Roche will supply two drugs to Ukraine: (i) atezolizumab (trade name Tecentriq) - used, in particular, to treat the most common type of lung cancer; (ii) pertuzumab in combination with trastuzumab (trade name Fesgo) - used to treat HER2-positive breast cancer. The final implementation of the project is scheduled for 2027."

Commercial • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong momentum with 7% growth (CER) in the first half of 2025 (Roche Press Release) - "Group sales grew by 7% at constant exchange rates (CER; 4% in CHF), driven by strong demand for medicines. Pharmaceuticals Division sales rose by 10% (6% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Hemlibra (haemophilia A), Vabysmo (severe eye diseases) and Ocrevus (multiple sclerosis) being the top growth drivers...The top five growth drivers – Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus – achieved total sales of CHF 10.6 billion. This represents an increase of CHF 1.7 billion at CER compared to the first half of 2024...Highlights: EU approval for Itovebi for a type of advanced breast cancer and Evrysdi tablet for spinal muscular atrophy"

Commercial • Allergy • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Multiple Sclerosis • Muscular Dystrophy • Ophthalmology

Pharmacokinetic bioequivalence of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using a handheld syringe or an on-body delivery system. (PubMed, J Cancer Res Clin Oncol) - P1 | "This study demonstrated the feasibility of a hands-free device approach to deliver pertuzumab and trastuzumab in one fixed-dose combination for subcutaneous injection without compromising pharmacokinetics and safety."

Clinical • Journal • PK/PD data

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

HER2CLIMB-05: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer (clinicaltrials.gov) - P3 | N=654 | Active, not recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial primary completion date: May 2025 ➔ Feb 2026

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

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (clinicaltrials.gov) - P2 | N=4200 | Recruiting | Sponsor: American Society of Clinical Oncology | Trial completion date: Jun 2027 ➔ Dec 2028 | Trial primary completion date: Jun 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Tumor mutational burden • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • BRAF

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues good momentum into 2025 with 6% (CER) sales growth in the first quarter (Roche Press Release) - "Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the impact from the loss of exclusivity on Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis, COVID-19), totalling CHF 0.2 billion, and the impact of the recent healthcare pricing reforms in China...The top five growth drivers – Phesgo, Vabysmo, Xolair, Hemlibra and Xofluza (influenza) – achieved total sales of CHF 3.6 billion; Sales in Europe grew by 5% as the strong uptake of Vabysmo, Polivy, Ocrevus, Phesgo and Hemlibra; In Japan, sales increased by 3% due to growth in sales of Phesgo, Vabysmo...Diagnostics: key developments - Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU"

Commercial • Ankylosing Spondylitis • Asthma • HER2 Breast Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ophthalmology • Ovarian Cancer • Pruritus • Schizophrenia

Socioeconomic Value of Targeted Therapies for HER2+ Breast Cancer in National Reimbursement Drug List of China (ISPOR 2025) - " Socioeconomic values of 7 targeted therapies in National Reimbursement Drug list (NRDL) from 2023 to 2032 were estimated, covering Trastuzumab, Pertuzumab, Ado-trastuzumab Emtansine , pertuzumab + trastuzumab + hyaluronidase-zzxf (Subcutaneous Injection) , Neratinib, Pyrotinib and Fam-trastuzumab Deruxtecan . Targeted therapies for HER2+ in breast cancer significantly improve patients’ quality of life and create great socioeconomic values. It implies that NRDL inclusion of these innovative medication not only provides reimbursement but also yields great socioeconomic impacts in China."

Reimbursement • US reimbursement • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Evaluation of Real-World Total Healthcare Costs Difference Between Subcutaneous and Intravenous Formulations of Pertuzumab and Trastuzumab in HER2+ Breast Cancer Patients (ISPOR 2025) - "This study compares the average monthly THCC of SQ fixed-dose combination [FDC] Pertuzumab and Trastuzumab (PH) with intravenous (IV) PH among patients with breast cancer (BC) over a one-year period or a maximum of 18 cycles. PH FDC (SQ) is associated with significantly lower average monthly THCC compared to PH IV across different BC cohorts, with projected potential annual savings ranging from $59,637 in eBC (4 NEO + 14 ADJ cycles) to $62,724 in mBC (18 cycles)"

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

Cost-Effectiveness of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in HER2-Positive Early Breast Cancer in China: A Post-Hoc Analysis of the FeDeriCa Trial (ISPOR 2025) - "PH FDC SC simplifies administration and represents a cost-effective alternative to IV infusion for HER2-positive early breast cancer in China, combining economic savings with improved health outcomes."

Cost effectiveness • HEOR • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Anaphylaxis/hypersensitivity with the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in HER2-positive breast cancer (HER2+ BC) (ESMO-BC 2025) - "This analysis shows a low PH FDC SC anaphylaxis/hypersensitivity risk, particularly when tolerability is established and CT completed; most AEs were mild to moderate and responsive to tx. This supports PH FDC SC outside the hospital setting as a reasonable approach after pts complete initial tx cycles."

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

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings (Roche Press Release) - "Roche...announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo, a subcutaneous (SC) fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab), for human epidermal growth factor receptor 2 (HER2)-positive breast cancer....A final decision regarding the approval is expected from the European Commission in the near future....The CHMP positive opinion is supported by results from clinical, real-world and bioequivalence data, drug safety reports and the United States expanded access study, AL42478, in people with early-stage and metastatic HER2-positive breast cancer..."

CHMP • HER2 Positive Breast Cancer

Chugai Announces 2025 1st Quarter Results (Chugai Press Release) - "Core revenue, core operating profit, and core net income at ¥288.5 billion (+21.8%), ¥139.5 billion (+36.6%), and ¥99.2 billion (+30.5%), respectively (all changes year-on-year)...Regarding revenue, domestic sales remained nearly flat with a slight decrease of 0.2% year-on-year. In the oncology field, sales decreased by 5.3% compared to the previous year. While our new product Phesgo performed well, this was offset by the decline in Perjeta and Herceptin along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients. Additionally, products including our mainstay product Avastin were affected by NHI drug price revisions and biosimilars...Overseas sales increased significantly by 54.7% year-on-year, driven by a substantial increase in exports of Hemlibra and Actemra to Roche."

Commercial • Ankylosing Spondylitis • Hemophilia • HER2 Breast Cancer • Lupus • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Ovarian Cancer • Rheumatoid Arthritis • Schizophrenia

Time is Treatment: How PHESGO is Reshaping the HER2+ Breast Cancer Care (GBCC 2025) - "Sponsored by Roche Korea co.,Ltd PHESGO® is a novel subcutaneous (SC) formulation combining pertuzumab and trastuzumab with recombinant human hyaluronidase (rHuPH20). This formulation offers comparable efficacy and safety to IV administration while enhancing patient convenience and quality of life. The adoption of PHESGO® may Satellite streamline treatment protocols and optimize resource utilization in oncology care settings."

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

TBCRC065: The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

NRG-GY026: Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: National Cancer Institute (NCI) | Phase classification: P2/3 ➔ P3 | N=525 ➔ 360

Enrollment change • Phase classification • Breast Cancer • Carcinosarcoma • Endometrial Adenocarcinoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Endometrial Serous Carcinoma • HER2 Breast Cancer • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • HER-2 • TP53

MORPHEUS BC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov) - P1/2 | N=510 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Apr 2026 ➔ Nov 2027

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

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 | N=510 ➔ 316

Enrollment change • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER

PRIOR-HER2 - Pathologic Response Investigation of Oncologic Regions in HER2 Positive Breast Cancer : PHESGO in Indian setting (SG-BCC 2025) - "Goals: Primary: To segregate pCR into Total, Breast and Nodal pCR in Her-2 positive patients with Subcutaneous Dual Agent (PHESGO) vs IV Single Agent (Trastuzumab) in Indian Population.Secondary: To evaluate various clinic-pathological parameters associated with pCR with use of PHESGO in Indian patients. Post NeoAdjuvant Response in Her-2 Positive Invasive Breast Carcinoma should be evaluated on Concept of Oncologic Regions (Breast and Nodal). The need of the hour is to weigh in the benefits of NAT separately for Breast primary and Nodal Disease. The superior nodal pCR rates associated with dual HER2 blockade suggest a pivotal role in optimizing treatment for patients with node-positivity."

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

Treatment outcome of neoadjuvant subcutaneous Trastuzumab and Pertuzumab (Phesgo) with chemotherapy in Her2 positive breast cancer – A real-world experience from South India, a LMIC from Asia (SG-BCC 2025) - "The median Ki 67 was 40 (range-18-80%) The most used NACT regimen was TCHP (Docetaxel Carboplatin with Phesgo) in 46 patients (74.2%) followed by AC-THP (Anthracycline Cyclophosphamide followed by Docetaxel Phesgo) in 16 (25.8%). In our real-world study, NACT with Phesgo demonstrated 67.7% pCR rate which is superior than most of the clinical trial results. pCR is more likely associated with early clinical stage and HR negative status . Phesgo is a safe and convenient option in Her2 + BC without new added saftey signals."

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

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

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

A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) (clinicaltrials.gov) - P3 | N=922 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Mar 2027 ➔ Dec 2027

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

Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=8 | Recruiting | Sponsor: Mayo Clinic | N=25 ➔ 8

Enrollment change • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • NRG1

Clinical Experience of Phesgo® Administration Using a Syringe Pump (JSMO 2025) - No abstract available

Clinical • Oncology