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

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

[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) - "In the first three months of 2025, Roche achieved sales growth of 6% (7% in CHF) to CHF 15.4 billion...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. This represents a plus of CHF 0.7 billion at CER compared to the first quarter of 2024...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,..."

Commercial • Ankylosing Spondylitis • Asthma • Breast Cancer • Chronic Obstructive Pulmonary Disease • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ophthalmology • Ovarian Cancer • Pruritus • 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

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) - No abstract available

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • 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

Socioeconomic Value of Targeted Therapies for HER2+ Breast Cancer in National Reimbursement Drug List of China (ISPOR 2025) - "However, few researches quantified the socioeconomic value of innovative medications in China. 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. We retrospectively analyzed data from adult women with HER2+ BC identified between 01/01/2021 and 12/31/2023 in the IQVIA PharMetricsⓇ Plus database. 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

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

ProHer: A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants with Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer (clinicaltrials.gov) - P3 | N=347 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Mar 2025 ➔ Nov 2024

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

GIM30-RAPID: An Observational, Multicenter Study Evaluating the Safety of ReAl-lifePertuzumab and Trastuzumab Fixed Dose Combination: the RAPID Study (clinicaltrials.gov) - P=N/A | N=80 | Completed | Sponsor: Fondazione Oncotech

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

HALOZYME REPORTS FULL YEAR 2024 RECORD REVENUE OF $1.015 BILLION AND EXCEEDS ITS FINANCIAL GUIDANCE FOR ROYALTY REVENUE, ADJUSTED EBITDA AND NON-GAAP DILUTED EPS (PRNewswire) - "Revenue was $298.0 million, compared to $230.0 million in the fourth quarter of 2023. The 30% year-over-year increase was primarily driven by royalty revenue growth and higher revenues under collaborative agreements mainly due to the timing of milestones achieved. Revenue for the quarter included $170.4 million in royalties, an increase of 40% compared to $122.1 million in the fourth quarter of 2023, primarily attributable to increases in revenue of DARZALEX SC...and Phesgo. Total revenue for the full year was $1,015.3 million, compared to $829.3 million in 2023, representing 22% year-over-year growth."

Sales • HER2 Positive Breast Cancer • Multiple Myeloma

INAVO122: A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=230 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jan 2028 ➔ Dec 2032

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

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 | Recruiting | Sponsor: Latin American Cooperative Oncology Group | Not yet recruiting ➔ Recruiting

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

Safety study on switching from intravenous to fixed‑dose subcutaneous formulation of pertuzumab and trastuzumab. (PubMed, Mol Clin Oncol) - "The study also examined patients who switched to an intravenous formulation after receiving PHESGO; skin and subcutaneous tissue disorders occurred in five patients, three of whom continued on a slower dose rate, and two of whom discontinued PHESGO and switched to pertuzumab and trastuzumab for intravenous infusion. With PHESGO, IRs are also more likely to occur the first time, and when skin and subcutaneous tissue disorders occur, there is a tendency to switch formulations in groups with a history of intravenous formulation use."

Journal • Breast Cancer • Colorectal Cancer • Oncology • Solid Tumor

Chugai Announces Consolidated 2024 Full Year Results and Forecasts for 2025 (Chugai Press Release) - "Domestic sales were ¥461.1 billion (- ¥96.9 billion, -17.4%, YoY). In the oncology field, although our new product Phesgo performed well, products including our mainstay product Avastin were affected by NHI drug price revisions and biosimilars. Also, sales of Perjeta and Herceptin fell along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients, resulting in a decrease by 4.8% compared to the previous year...Chugai reported that revenue for the fiscal year ended December 2024 totaled ¥1,170.6 billion (+ ¥59.2 billion, +5.3%, YoY)...Tecentriq filed an application for expanded indication...Overseas sales are expected to be ¥555.5 billion (+ ¥18.7 billion, +3.5%, YoY) due to growth in sales of Hemlibra, Alecensa and NEMLUVIO, despite decrease in Actemra."

Commercial • Breast Cancer • Gastrointestinal Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ovarian Cancer

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2024 results with 7% sales growth; fourth quarter marks third straight quarter of 9% growth (GlobeNewswire) - "The top four growth drivers – Vabysmo, Phesgo, Ocrevus and Hemlibra – achieved total sales of CHF 16.9 billion. This represents a plus of CHF 3.3 billion at CER compared to 2023."

Sales • Breast Cancer • Hemophilia • Hemophilia A • Multiple Sclerosis • Wet Age-related Macular Degeneration