Perjeta (pertuzumab) / Roche - LARVOL DELTA

HER2 Vaccine for Locally Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Pravin T.P Kaumaya

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Real-World Subcutaneous Monoclonal Antibody Use Trends for Oncology in the US (ISPOR 2025) - "Our aim was to characterize their annual use trends in the US over a five-year period (2019-2023). We analyzed de-identified data from Trisus Medication Compare (The Craneware Group, Edinburgh, UK) between 1/1/2019-12/31/2023 to identify patient encounters containing a dispensation for subcutaneous formulations of hyaluronidase with rituximab, trastuzumab, daratumumab, and combination pertuzumab and trastuzumab...The most used product was daratumumab with hyaluronidase (82.7% of dispensations), which correlates with the high rate of multiple myeloma in the sample. From 2019-2022, national data show increased use of subcutaneous monoclonal antibodies for oncology, an advantageous alternative offering opportunities to enhance patient care and improve cost and resource efficiency."

Clinical • Real-world • Real-world evidence • Amyloidosis • B Cell Lymphoma • Breast Cancer • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Solid Tumor

Economic Burden of HER2+ Breast Cancer and the Targeted Therapies Epidemiological & Economic Impact in Trinidad and Tobago (ISPOR 2025) - "A population estimation model was performed to determine the impact of targeted HER2+ therapies in early BC avoided relapses, prevented metastases, life-years gained, quality-adjusted life-years , and metastatic BC cost reduction, comparing a base scenario (chemotherapy alone) vs actual scenario (Chemotherapy and Trastuzumab) vs ideal (Chemotherapy, Trastuzumab, Pertuzumab & Trastuzumab+Emtansine). The average-annual-cost of healthcare for a patient with HER2+ BC (actual-scenario) in neoadjuvant, adjuvant, in first and second line metastatic disease are noted as follows USD42,480.14; USD42,715.22, USD62,769.26, USD35,349.80; respectively. Metastatic HER2+ BC management incurs higher costs than neoadjuvant or adjuvant stages. Targeted therapies improve patient outcomes by preventing metastases, increasing LY's and QALY's, and reducing costs associated with advanced disease."

Clinical • HEOR • 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

Comparison of Pertuzumab Plus Trastuzumab Versus Trastuzumab Alone As Adjuvant Treatment for Chinese High-Risk HER2-Positive Early Breast Cancer: An Analysis of Long-Term Patient Benefits (ISPOR 2025) - "Breast cancer is a curable disease, and early standard treatment can significantly reduce the probability of disease progression, maximizing patients' health benefits. Moreover, early standard treatment can effectively reduce the direct medical costs and indirect costs caused by disease recurrence. The better the effectiveness of early-stage treatment regimens, the greater the long-term health benefits and cost savings for patients."

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

Comparison of Central Venous Access Device Insertion Proportions, Costs and Removal Time Between Subcutaneous and Intravenous Formulations of Pertuzumab and Trastuzumab in HER2+ Early Breast Cancer Patients (ISPOR 2025) - "PH FDC (SQ) is associated with a lower CVAD insertion proportions, and shorter time to removal compared to PH IV, which may enhance patients' experience, improve their QoL and reduce healthcare costs."

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

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

Association of statin use on survival outcomes of patients with early-stage HER2-positive breast cancer in the APHINITY trial. (PubMed, Breast Cancer Res Treat) - "In APHINITY, statin use was not associated with improved survival outcomes. These results must be interpreted with caution due to the exploratory nature of the analysis and the associated limitations."

Journal • Breast Cancer • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Heart Failure • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hypertension • Metabolic Disorders • Oncology • Solid Tumor • HER-2

ZMYND8 drives HER2 antibody resistance in breast cancer via lipid control of IL-27. (PubMed, Nat Commun) - "Histone reader ZMYND8 specifically confers resistance to cancer cells against trastuzumab and/or pertuzumab. Targeting c-Myc or cPLA2α effectively overcomes anti-HER2 therapy resistance in patient-derived xenografts. Collectively, this study uncovers a druggable signaling cascade that drives resistance to HER2-targeted therapies in HER2+ breast cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Metabolic Disorders • Oncology • Solid Tumor • MYC • ZMYND8

HER2DX ERBB2 mRNA score in first-line advanced HER2-positive breast cancer treated with chemotherapy, trastuzumab, and pertuzumab. (PubMed, NPJ Breast Cancer) - "In advanced HER2-positive breast cancer, the standard taxane-trastuzumab-pertuzumab (THP) regimen faces competition from new therapies, emphasizing the need for biomarkers to guide treatment. Patients with ERBB2-high scores had significantly better median PFS (33.9 vs. 10.6 months, hazard ratio [HR] = 0.40, 95% CI: 0.24-0.69, p < 0.001) and OS (not reached vs. 30.8 months, HR = 0.26, 95% CI: 0.13-0.49, p < 0.001) compared to ERBB2-low patients. Based on these findings, further validation of this biomarker in tumor samples from the CLEOPATRA phase III trial is ongoing, which could help optimize treatment strategies in this population."

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

Collaboration Between Palliative Care and Oncology in the Era of Personalized Medicine. (PubMed, J Palliat Med) - "However, next-generation sequencing revealed a human epidermal growth factor receptor 2 mutation, and targeted treatment with trastuzumab and pertuzumab led to marked clinical recovery and six months of sustained benefit. Traditional CPS may be inaccurate, underscoring the need for flexible, multidisciplinary collaboration between oncology and palliative care. In the context of precision medicine, prognostic discussions must be individualized, balancing therapeutic potential with patient values and the realities of evolving evidence."

Journal • Oncology • Palliative care • HER-2

Adjuvant Metronomic Chemotherapy After Surgery in pT1-T2 N0 M0 HER2-Positive and ER/PR-Positive Breast Cancer Plus Targeted Therapy, Anti-Hormonal Therapy, and Radiotherapy, with or Without Immunotherapy: A New Operational Proposal. (PubMed, Cancers (Basel)) - "Today, MCTP finds application in maintenance therapy after standard of care and in advanced breast cancer when the patient's clinical condition is already seriously compromised by metastatic disease; in this context, it is used as a first-line treatment, in pre-treated subjects, or as a rescue treatment. Here, the use of adjuvant oral MCTP after surgery at an early stage in HER-2 and hormone-positive local breast cancer is proposed, where effective treatment options are available, such as anti-HER2 therapy (e.g., trastuzumab, pertuzumab), anti-hormonal therapy (e.g., tamoxifen, letrozole), radiotherapy, and, in case of strong PD-1 positivity, immunotherapy."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Real-world comparative effectiveness and safety of Pertuzumab in patients with HER2+ metastatic breast cancer: A pan-Canadian population-based cohort study. (PubMed, Int J Cancer) - "We assessed the comparative effectiveness and safety of pertuzumab plus trastuzumab and chemotherapy versus trastuzumab and chemotherapy for patients with HER2+ metastatic breast cancer (mBC) in Canada. Pertuzumab use in practice was associated with statistically significant improved survival without apparent safety concerns among patients with mBC. Real-world evaluations allow for assessments of publicly funded treatments to inform funding policies."

HEOR • Journal • Real-world evidence • Breast Cancer • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Pyrotinib and Nab-Paclitaxel in HER2-Positive Breast Cancer (PANHER Trial): A Prospective, Single-Arm, Phase II Trial. (PubMed, Cancer Sci) - P2 | "Trastuzumab and pertuzumab combined with chemotherapy represent the standard therapy for first-line treatment of HER2-positive metastatic breast cancer (BC). Pyrotinib combined with nab-paclitaxel demonstrated promising efficacy for HER2-positive advanced breast cancer, with an acceptable safety profile. Trial Registration: chictr.org, ChiCTR1900023653."

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

Differences in Responses to Neoadjuvant Anti-HER2 Therapy between HER2 2+ISH+ and HER2 3+ in HER2-Positive Breast Cancer. (PubMed, Cancer Res Treat) - "In HER2 2+ISH+ patients, treated with pertuzumab and trastuzumab in combination had no significant improvement in pCR (19.12% vs. 12.24%; p=0.287) and DFS (p=0.908) than using alone. Drug sensitivity assay showed poor efficacy with dual anti-HER2 drugs in HER2 2+ISH+ cell lines, however, T-Dxd drugs had a satisfactory effect...In this subgroup, dual anti-HER2 drugs did not exert significant improvement in pCR and DFS. Therefore, treatment optimization is warranted, with ADC drugs as potential options."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Early Access Program in oncology: Retrospective study at a Portuguese hospital (ECOP 2024) - "During the study period were submitted 163 EAP requests for abiraterone, amivantamab, bevacizumab, durvalumab, encorafenib, enfortumab, everolimus, erdafitinib, lenvatinib, lurbinectedin, niraparib, nivolumab, olaparib, pembrolizumab, pertuzumab, ramucirumab, sacituzumab govitecan, selpercatinib, trifluridine/tipiracil, trametinib+dabrafenib, trastuzumab-deruxtecan and tucatinib. Conclusion Most cases correspond to metastatic disease, EAPs facilitate timely access to innovative therapies for patients with high unmet medical needs. The majority of situations were financed, which confirms the importance of EAPs in an era where oncology is constantly innovating."

Retrospective data • Gastrointestinal Disorder • Oncology

The impact of ethnicity on benefit from novel drugs approved for breast cancer treatment: a systematic review and meta-analysis of randomized phase 3 trials of the last decade. (SABCS 2024) - "23 phase III RCTs were identified in the aBC setting, with 1547 (11.1%) patients of Asian ethnicity. Experimental drugs tested included CDK4/6i (palbociclib, ribociclib, abemaciclib), SERD (elacestrant), PI3Ki (alpelisib), PARPi (olaparib, talazoparib), broad variety of anti-HER2 drugs (tucatinib, trastuzumab deruxtecan, pertuzumab, T-DM1, neratinib, margetuximab), anti-PD-1 and anti-PD-L1 drugs (pembrolizumab, atezolizumab) and anti-TROP2 drug (sacituzumab govitecan). 16 RCTs provided HR (95%CI) for PFS in the subgroup of Asians and 17 RCTs for Non-Asians."

IO biomarker • P3 data • Retrospective data • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

CUPISCO: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (clinicaltrials.gov) - P2 | N=528 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Nov 2024

Trial completion • Trial completion date • Oncology

Screening or Early Detection of Brain Metastases and the Treatment in the Era of New Agents (GBCC 2025) - "Advances in systemic therapy have been greatest in HER2-positive breast cancer, where the current NCCN guidelines include a growing list of CNS-active regimens, such as tucatinib-capecitabine-trastuzumab, T-DXd, T-DM1, high dose trastuzumab and pertuzumab, neratinib-capecitabine, and lapatinib-capecitabine...There are a number of novel blood-brain-barrier (BBB) penetrant HER2-targeted tyrosine kinase inhibitors (e.g. ZN1041, IAM1363) in early-phase clinical trials. For patients with HER2-negative tumors, the data are more sparse; however, activity of chemotherapy drugs such as capecitabine, anthracyclines, platinums, and eribulin has been reported...Ongoing clinical trials are testing a wide variety of ADCs, such as patritumab deruxtecan, datopotamab deruxtecan, ARX788, and others...For example, the ELECTRA trial is testing the combination of elacestrant and abemaciclib. Overall, the expanding array of systemic options with clinically meaningful intracranial activity, as..."

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 • Triple Negative Breast Cancer • ER • HER-2

Safety and Efficacy of Anti-Human Epidermal Growth Factor 2 Agents in the Treatment of Biliary Tract Cancers: A Systematic Review. (PubMed, JCO Precis Oncol) - "In patients with HER2-expressing BTCs, anti-HER2 therapies are viable options, particularly in the second-line setting."

Journal • Review • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Adjuvant pertuzumab or placebo + trastuzumab + chemotherapy (P or Pla + T + CT) in patients (pts) with early HER2-positive operable breast cancer in APHINITY: Final analysis at 11.3 years' median follow-up (ESMO-BC 2025) - No abstract available

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

Social costs and Quality of life in breast cancer patients enrolled in GIM30-RAPID: a prospective, observational, multicenter study evaluating the safety of ReAl-life Pertuzumab (P) and Trastuzumab (T) Fixed Dose combination (FDC) (ESMO-BC 2025) - No abstract available

Clinical • HEOR • Observational data • Breast Cancer • Oncology • Solid Tumor

Real-World Evidence of Trastuzumab and Pertuzumab with Taxanes or Vinorelbine as a First-Line Treatment for HER2-Positive Metastatic Breast Cancer (ESMO-BC 2025) - No abstract available

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

Clinical outcomes in patients (pts) with stage cT1/T2cN0 HER2[+] breast cancer (BC) treated with neoadjuvant trastuzumab and pertuzumab (HP): An exploratory analysis from the PHERGain trial (ESMO-BC 2025) - No abstract available

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

Safety and efficacy of neoadjuvant disitamab vedotin in combination with pertuzumab with or without toripalimab for HER2-positive breast cancer: An open-label phase II trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06178159 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2