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

Improving public cancer care by implementing precision medicine in Norway (clinicaltrialsregister.eu) - P1/2 | N=1000 | Recruiting | Sponsor: Oslo University Hospital HF | N=6000 ➔ 1000

Enrollment change • Oncology

Efficacy of anthracycline-taxane based chemotherapy with Pertuzumab/Trastuzumab (Phesgo) in neoadjuvant HER2-positive early breast cancer (ESMO 2026) - No abstract available

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

Safety, social costs and quality of life (QOL) in HER2-positive (HER2+) breast cancer (BC) patients (pts) treated with Pertuzumab (P) and Trastuzumab (T) Fixed Dose combination (FDC): results from the prospective, observational, multicenter GIM30-RAPID study (ESMO 2026) - No abstract available

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

Safety and efficacy of ZN-A-1041, a highly blood-brain barrier (BBB)–permeable HER2 tyrosine kinase inhibitor (TKI), + trastuzumab deruxtecan (T-DXd) or pertuzumab-trastuzumab (PH) in HER2-positive metastatic breast cancer (HER2+ mBC): Phase Ic expansion results from the ZN-A-1041-101-US trial. (ASCO 2026) - P1/2 | "ZN-A-1041 showed manageable safety profiles and promising clinical activity when combined with standard anti-HER2 therapies in pts with HER2+ mBC, both with or without CNS metastases. High disease control in pts pretreated with T-DXd and notable continued responses in the PH maintenance setting support further clinical evaluation of these combinations. *Efficacy reported for 13 pts with measurable disease receiving maintenance therapy with ZN-A-1041 + PH after taxane + H ± P induction."

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

GeparPiPPa: Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: GBG Forschungs GmbH | Trial primary completion date: Oct 2026 ➔ Jan 2027

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

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

Satellite Symposium 4 (SL04) Efficiency, and beyond: Driving HER2 care transformation with Phesgo SC (KSMO 2026) - "Sponsored by Roche"

HER-2

Efficiency, and beyond: Driving HER2 care transformation with Phesgo SC (KSMO 2026) - "Sponsored by Roche"

HER-2

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

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 | Trial completion date: Apr 2032 ➔ Nov 2032 | Trial primary completion date: Apr 2026 ➔ Apr 2027

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

Cytokine-Release Syndrome Due to Intravenous Trastuzumab With Good Tolerance to Subcutaneous Administration. (PubMed, J Investig Allergol Clin Immunol) - No abstract available

Journal • Inflammation

Final analysis of the FeDeriCa phase III study: long-term efficacy, safety and pharmacokinetics of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection, plus chemotherapy, in HER2-positive early breast cancer. (PubMed, ESMO Open) - P3 | "Long-term efficacy of PH FDC SC and P + H IV was comparable. Safety remained similar and consistent with P + H + chemotherapy. PH FDC SC is established as a faster, more convenient, less invasive patient- and health care professional-preferred alternative to P + H IV for HER2-positive BC."

Journal • P3 data • PK/PD data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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) | Suspended ➔ Recruiting

Enrollment open • Carcinosarcoma • Endometrial Adenocarcinoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Endometrial Serous Carcinoma • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • HER-2

FINPROVE - The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs (clinicaltrialsregister.eu) - P1/2 | N=250 | Recruiting | Sponsor: HUS-Yhtymae | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Oncology

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc (Roche Press Release) - "Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (hemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers."

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

A case of HER2-positive right breast cancer recurrence in the axilla 17 years post-surgery, difficult to differentiate from accessory breast cancer. (JBCS 2026) - "Postoperative chemotherapy consisted of TC therapy, followed by 10 years of tamoxifen and 3 years of LHRHa hormone therapy. The previous breast cancer was HER2-negative, but this lesion was HER2-positive. Therefore, the possibility of newly developed HER2-positive accessory breast cancer cannot be ruled out, but in either case, since curative resection was achieved, postoperative treatment consisted of EC → PHESGO + docetaxel therapy and hormone therapy."

Clinical • Post-surgery • Surgery • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

A retrospective observational study on changes in outpatient stay time before and after PHESGO in HER2-positive breast cancer patients. (JBCS 2026) - "This was a single-center retrospective study, and confounding due to timing cannot be ruled out, so a prospective study is a future challenge. [Conclusion] The introduction of PHESGO was considered a useful option that can reduce chronotoxicity in HER2-positive breast cancer patients while improving the operational efficiency of the outpatient chemotherapy unit and the time workload of nurses."

Observational data • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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 | Suspended | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Suspended

Trial suspension • Breast Cancer • Carcinosarcoma • Endometrial Adenocarcinoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Endometrial Serous Carcinoma • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • HER-2

Global longitudinal strain (GLS) assessment of cardiac function was useful in perioperative chemotherapy for HER2 breast cancer. (JBCS 2026) - "[Case 1] A woman in her 40s was treated with EC-DTX/Phesgo as neoadjuvant chemotherapy (NAC) for cStage IIA Luminal-HER2 breast cancer...Postoperatively, T-DM1 was administered, and after 6 courses, LVEF remained similar, but ΔGLS decreased to -20.6%, so ARBs were added...However, based on the decrease in GLS, cardiological intervention was initiated more quickly than previously based on LVEF criteria, preventing symptomatic development and interruption/discontinuation of perioperative drug therapy. We report on the usefulness of GLS in assessing cardiac function during breast cancer chemotherapy, along with a literature review."

Clinical • Breast Cancer • Congestive Heart Failure • Diabetes • Heart Failure • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hypertension • Metabolic Disorders • Oncology • Solid Tumor • HER-2

Chronotoxicity reduction effect of PHESGO in HER2-positive breast cancer: A comparative study with conventional trastuzumab-pertuzumab combination therapy. (JBCS 2026) - "However, in this study as well, the required time from arrival at the hospital to completion of administration, and from the start of consultation to completion of administration, was shortened in the PHESGO group, suggesting, as previously reported, that there may be low chronotoxicity in real clinical practice. This study presents real-world clinical data from a single domestic institution after implementation, and is considered significant as a document demonstrating the chronotoxicity reduction effect of PHESGO."

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

A case of HER2-positive male breast cancer with sentinel lymph node biopsy site metastasis. (JBCS 2026) - "[Histopathological Examination] Metastatic adenocarcinoma ER>95 PgR>50 Her2 3+ MIB1 24.6% [Clinical Course] For metastatic left breast cancer, DTX+PHESGO was administered 6 times with a partial response (PR)...Left Ax+Sc irradiation was performed, and treatment is ongoing with high-dose TOR and denosumab administration...However, in this case, the metastasis was in the soft tissue of the SLNB area, not in the lymph nodes or accessory breast tissue. While the reported frequency of dissemination to the needle biopsy insertion site in lung cancer is low (0.012-0.18%), and not as frequent as biopsy, considering the pathology and surgical procedure in this case, although non-touch isolation was performed, there is a possibility of dissemination during wound closure, and although rare, caution is required."

Biopsy • Clinical • Breast Cancer • CNS Disorders • Colorectal Cancer • Depression • Endocrine Disorders • Genito-urinary Cancer • Grave’s Disease • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Male Breast Cancer • Oncology • Solid Tumor • Testicular Cancer • BRCA • HER-2

Clinical utility of neoadjuvant chemotherapy with fesgo for HER2-positive breast cancer (JBCS 2026) - "In recent years, the combination drug Fesgo (subcutaneous fixed-dose combination of trastuzumab and pertuzumab), which allows simultaneous subcutaneous injection of both drugs at fixed doses, has been introduced, and is expected to improve treatment efficiency and patient convenience. Adverse events were observed in 10 patients (34%) in the fesgo group, mainly mild events such as injection site reactions (4 patients, 40.0%) and muscle pain (5 patients, 50.0%), with no serious cardiac dysfunction or hypersensitivity reactions. Treatment room stay time was significantly shorter in the fesgo group (42 minutes) compared to the average of 108 minutes in the intravenous injection group (p < 0.001) [Conclusion] Fesgo demonstrated favorable therapeutic efficacy and safety in neoadjuvant chemotherapy for HER2-positive breast cancer, significantly shortening treatment time and suggesting potential contributions to reducing patient burden and improving the efficiency of..."

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

Atezolizumab (A) plus pertuzumab/trastuzumab/hyaluronidase (PHESGO) in patients (pts) with solid tumors with ERBB2 alterations (alt): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study. (ASCO 2026) - P2 | "A+PHESGO did not demonstrate sufficient antitumor activity in pts with ERBB2-altered solid tumors to warrant further study. However, the cohort did not reach its planned accrual, limiting statistical power for demonstrating efficacy. Other tx should be considered for these pts, including tx offered in clinical trials."

Clinical • Acute Kidney Injury • Colorectal Cancer • Infectious Disease • Nephrology • Oncology • Pneumonia • Renal Disease • Septic Shock • Solid Tumor • HER-2

Neoadjuvant intravenous biosimilar pertuzumab and trastuzumab versus subcutaneous pertuzumab/trastuzumab/hyaluronidase (Phesgo) in HER2-positive breast cancer: A real-world comparative study. (ASCO 2026) - "Neoadjuvant chemotherapy combined with biosimilar intravenous pertuzumab and trastuzumab achieved pathological response and surgical outcomes comparable to Phesgo in patients with HER2-positive breast cancer. Clinical implications: These findings support biosimilar-based dual HER2 blockade as an effective and affordable neoadjuvant strategy, particularly relevant for improving access to standard-of-care therapy in resource-constrained settings."

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

The value of time savings in breast cancer therapy for patients and healthcare providers: the subcutaneous injection of pertuzumab and trastuzumab fixed-dose combination at a tertiary care center in the UAE. (PubMed, J Comp Eff Res) - " PH FDC SC was associated with significant time savings for both patients and healthcare providers. The transition to SC administration unlocked 2468.25 clinical hours annually, translating into notable indirect cost reductions through optimized resource utilization and improved operational efficiency compared with IV administration."

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