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

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

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

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

Real-World Outcomes of Subcutaneous PHESGO in HER2-Positive Breast Cancer: Pathological Response, Sequencing, and Safety (Multidisciplinary Digital Publishing Institute) - "In the neoadjuvant cohort (n = 26), pCR was 65% (17/26). PHESGO-first regimens achieved higher pCR than anthracycline-first regimens (85.7% vs. 41.7%; p = 0.038). Treatment was generally well tolerated: the most frequent events were dysgeusia (57%), diarrhea (38%), and rash (34%), mostly grade 1–2; one grade ≥3 event (thrombocytopenia) occurred, and no symptomatic cardiac dysfunction was observed."

Retrospective data • HER2 Positive Breast Cancer

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=346 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

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

Pharmac’s decision to fund access...from 1 December 2025. (NZ Doctor) - "Subcutaneous pertuzumab with trastuzumab (Phesgo) for HER2-positive metastatic breast cancer....Entrectinib (Rozlytrek) for ROS1-positive non-small cell lung cancer."

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

Hypoalbuminemia and Nutritional Status in Docetaxel-Induced Erythema Multiforme: A Case Report. (PubMed, Cureus) - "We present a case of a patient with breast cancer developing an erythematous rash covering 20% of her total body surface area where malnutrition and severe hypoalbuminemia of 17g/L were present. This occurred 17 days post cycle five administration of her chemotherapy - docetaxel and Phesgo (pertuzumab, trastuzumab and hyaluronidase). The pharmacokinetics of docetaxel are discussed, and we conclude that due to its extensive protein binding, hypoalbuminemia and malnutrition may contribute to the risk of docetaxel-induced toxicities. This case highlights the potential need to monitor albumin and nutritional status in patients receiving docetaxel to mitigate toxicities."

Journal • Breast Cancer • Dermatology • Oncology • Solid Tumor • Steven-Johnson Syndrome

Third Quarter 2025 Financial Highlights (PRNewswire) - "Revenue was $354.3 million, compared to $290.1 million in the third quarter of 2024....Revenue included $236.0 million in royalties, an increase of 52% compared to $155.1 million in the third quarter of 2024, primarily driven by continued sales uptake of ENHANZE partner products that have launched since 2020, predominantly by VYVGART Hytrulo by argenx, DARZALEX SC by Janssen and Phesgo by Roche in all geographies."

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

Prospective, multicenter study of neoadjuvant Phesgo with chemotherapy de-escalation for HER2-positive FUSCC HER2-CLA early breast cancer (ChiCTR) - P4 | N=31 | Not yet recruiting | Sponsor: The affiliated hospital of southwest medical university; The affiliated hospital of southwest medical university

New P4 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

An exploratory study of neoadjuvant therapy with toripalimab combined with Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection and nab-paclitaxel in patients with HER2-positive stage II–III breast cancer. (ChiCTR) - P2 | N=112 | Recruiting | Sponsor: The First Affiliated Hospital of Army Medical University; The First Affiliated Hospital of Army Medical University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong sales growth momentum of 7% (CER) in the first nine months of 2025; full-year earnings outlook raised (Roche Press Release) - "In the United States, sales rose by 8% due to growth in sales of Xolair, Phesgo, Ocrevus, Hemlibra, Polivy (blood cancer) and Vabysmo. Sales in Europe grew 5% as strong demand for Ocrevus and Vabysmo and the continuing uptake of Polivy, Phesgo and Hemlibra more than compensated for the lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo and the impact of biosimilar competition on Actemra/RoActemra sales. In Japan, sales increased by 5%, mainly due to the strong uptake of Phesgo, Hemlibra, Vabysmo....Sales in the International region grew by 13%, led by Phesgo, Hemlibra, Vabysmo....and Kadcyla (breast cancer)."

Commercial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Colorectal Cancer • Diabetic Macular Edema • Diffuse Large B Cell Lymphoma • Hemophilia A • HER2 Positive Breast Cancer • Multiple Sclerosis • Wet Age-related Macular Degeneration

Other declines were seen for Perjeta (-21% to CHF 703 million) — as patients switch to the newer breast cancer drug Phesgo — as well as for Avastin (-17% to CHF 241 million) and Herceptin (-20% to CHF 257 million) due to continued biosimilar erosion. (Firstwordpharma Press Release)

Sales • Colorectal Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Glioblastoma • Hepatocellular Cancer • HER2 Positive Breast Cancer • Lung Non-Squamous Non-Small Cell Cancer • Renal Cell Carcinoma

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 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Consolidated financial highlights (Core results) (Chugai Press Release) - "Of revenue, sales were ¥794.6 billion (an increase of 5.9% year on year). Domestic sales exceeded the levels of the same period of the previous fiscal year due to the increase in the sales of new products Phesgo and PiaSky, and the mainstay products Vabysmo, Hemlibra, and Enspryng, despite the effects of the NHI drug price revisions and the market penetration of generic drugs."

Commercial • Breast Cancer • CNS Disorders • Colorectal Cancer • Hemophilia A • Inflammation • Lupus • Ophthalmology • Paroxysmal Nocturnal Hemoglobinuria • Rheumatoid Arthritis

Letter to the Editor Regarding the Article "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) - No abstract available

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

Comment on "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) - No abstract available

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • 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: Feb 2026 ➔ Sep 2025

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

HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG SECOND QUARTER 2025 RESULTS (PRNewswire) - "Revenue was $325.7 million, compared to $231.4 million in the second quarter of 2024. The 41% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenues. Revenue included $205.6 million in royalties, an increase of 65% compared to $124.9 million in the second quarter of 2024, primarily attributable to increases in revenue of DARZALEX SC...and Phesgo."

Sales • HER2 Positive Breast Cancer • Multiple Myeloma

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

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

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 | Recruiting ➔ Active, not recruiting | Phase classification: P1 ➔ P1/2

Enrollment closed • Phase classification • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Omission of surgery and sentinel lymph node dissection in clinically low-risk HER2positive breast cancer with high HER2 addiction and a complete response following standard anti- HER2-based neoadjuvant therapy (ELPIS trial) (clinicaltrialsregister.eu) - P2 | N=27 | Ongoing | Sponsor: Fundació Clínic per a la Recerca Biomèdica

New P2 trial • Breast Cancer • CNS Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Psychiatry • Solid Tumor • HER-2

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

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