- |||||||||| Kadcyla (ado-trastuzumab emtansine) / Roche, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
Review, Journal: HER2-Positive Gastric Cancer and Antibody Treatment: State of the Art and Future Developments. (Pubmed Central) - Apr 13, 2024 However, further improvements in HER2-directed therapy are required as resistance mechanisms and HER2 heterogeneity limit the existing treatment options. This review aims to give an overview of the current standard-of-care HER2-directed therapy in gastric cancer, as well as its challenges and future developments.
- |||||||||| Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrronium) / AstraZeneca, Perjeta (pertuzumab) / Roche
Real-world costs and site-of-care patterns of fixed-dose subcutaneous vs intravenous formulations of pertuzumab and trastuzumab () - Apr 9, 2024 - Abstract #AMCP2024AMCP_173; Results were presented using the following 3 groups: PH biosimilar (PHS) when a trastuzumab biosimilar was used, PH brand (PHB) when trastuzumab Brand (Herceptin) was used, and PHSC (Phesgo; subcutaneous)... PHSC is associated with lower total costs of care compared with PHS and PHB, primarily driven by a combination of lower costs of drug, cost of administration, and slight shift of care from outpatient hospital to lower cost site of care.
- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Journal, FDG PET: Clinicopathological and molecular predictors of [18F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial. (Pubmed Central) - Apr 8, 2024 P2 PHSC is associated with lower total costs of care compared with PHS and PHB, primarily driven by a combination of lower costs of drug, cost of administration, and slight shift of care from outpatient hospital to lower cost site of care. These results highlight the clinical, biological, and metabolic heterogeneity of HER2+?breast cancer, which may facilitate the selection of HER2+?EBC patients likely to benefit from [18F]FDG-PET imaging as a tool to guide therapy.
- |||||||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Tukysa (tucatinib) / Pfizer
Journal, Metastases: Tucatinib Combination Treatment After Trastuzumab-Deruxtecan in Patients With ERBB2-Positive Metastatic Breast Cancer. (Pubmed Central) - Apr 7, 2024 Little is known regarding the outcomes associated with tucatinib combined with trastuzumab and capecitabine (TTC) after trastuzumab-deruxtecan exposure among patients with ERBB2 (previously HER2)-positive metastatic breast cancer (MBC)...The median number of prior treatment lines for metastatic disease at TTC treatment initiation was 4 (range, 2-15), including 82 patients (81.2%) with previous trastuzumab and/or pertuzumab and 94 (93.1%) with previous ado-trastuzumab-emtansine) exposure...In this study, TTC therapy was associated with clinically meaningful outcomes in patients with ERBB2-positive MBC after previous trastuzumab-deruxtecan treatment, including those with brain metastases. Prospective data on optimal drug sequencing in this rapidly changing therapeutic landscape are needed.
- |||||||||| Ogivri (trastuzumab-dkst) / Biocon, Sandoz, Herceptin (trastuzumab) / Roche
Observational data, Journal, Real-world evidence, Patient reported outcomes, Real-world: Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes. (Pubmed Central) - Apr 4, 2024 P, P=N/A Treatment of patients with HER2-positive BC with the trastuzumab biosimilar Ogivri resulted in equivalent symptoms, adverse events, and well-being as found for patients treated with Herceptin as determined by ePRO data. Hence, integration of an ePRO system into research and clinical practice can provide reliable information when investigating the real-world tolerability and outcomes of similar therapeutic compounds.
- |||||||||| inavolisib (GDC-0077) / Roche
Enrollment closed, Combination therapy, Metastases: GO39374: To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer (clinicaltrials.gov) - Mar 27, 2024 P1, N=256, Active, not recruiting, Innovative adjuvant strategies are essential in patients at high risk of distant disease recurrence. Recruiting --> Active, not recruiting
- |||||||||| Kadcyla (ado-trastuzumab emtansine) / Roche, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
Clinical data, Journal, Real-world evidence, Real-world, Metastases: A real-world study of treatment sequences and second-line clinical outcomes in patients with HER2-positive metastatic breast cancer in US community practice. (Pubmed Central) - Mar 26, 2024 Recruiting --> Active, not recruiting This real-world US study showed that approximately two-thirds of 2L patients received subsequent therapy and disease progression was the most common reason for 2L discontinuation highlighting the need for timely 2L treatment with the most efficacious drug to allow patients to achieve longer treatment duration and delayed progression.
- |||||||||| carboplatin / Generic mfg., docetaxel / Generic mfg.
Trial completion date, Metastases: Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - Mar 26, 2024 P3, N=315, Active, not recruiting, This real-world US study showed that approximately two-thirds of 2L patients received subsequent therapy and disease progression was the most common reason for 2L discontinuation highlighting the need for timely 2L treatment with the most efficacious drug to allow patients to achieve longer treatment duration and delayed progression. Trial completion date: Dec 2023 --> Dec 2024
- |||||||||| Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) / Roche, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trial completion date, Trial primary completion date, Metastases: 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) - Mar 18, 2024 P3, N=347, Active, not recruiting, In this first prospective study, HER2DX impacted clinical care in early-stage HER2+ BC and improved the level of confidence of physicians. Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Mar 2025
- |||||||||| Herceptin (trastuzumab) / Roche, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche, Perjeta (pertuzumab) / Roche
Journal: Timing of Administration of Pegfilgrastim and Prophylaxis for Febrile Neutropenia for Patients with Early Breast Cancer Receiving Chemotherapy (Pubmed Central) - Mar 11, 2024 Regarding neoadjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer, taxanes and trastuzumab with the addition of pertuzumab have shown higher pathological complete response rates and elevated incidences of FN...The RDI of all regimens was 99.7%. Although there were some differences in chemotherapy regimens, an earlier timing of PEG prophylaxis(especially 24-48 hours from chemotherapy completion)has been shown to reduce the incidence of FN and increase the RDI.
- |||||||||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Clinical guideline, Journal: Japanese Society of Medical Oncology clinical guidelines: Molecular testing for colorectal cancer treatment, 5th edition. (Pubmed Central) - Mar 11, 2024 Mutational and mismatch repair and BRAF testing are also strongly recommended for screening for Lynch syndrome. Circulating tumor DNA-based minimal residual disease (MRD) testing is strongly recommended for estimating the risk of recurrence based on clinical evidence, although MRD testing was not approved in Japan at the time of the publication of this guideline.
- |||||||||| Balversa (erdafitinib) / J&J, Perjeta (pertuzumab) / Roche
Journal, Stroma: Adipose Stromal Cell-Derived Cancer-Associated Fibroblasts Suppress FGFR Inhibitor Efficacy. (Pubmed Central) - Mar 8, 2024 In this issue of Cancer Research, Hosni and colleagues discover a paracrine mechanism mediated by adipocyte precursor cells through which urothelial carcinomas become resistant to erdafitinib, a recently approved therapy inhibiting fibroblast growth factor receptors (FGFR)...The NRG1-mediated FGFR inhibitor resistance was amenable to intervention with pertuzumab, an antibody blocking the NRG1/HER3 axis...Because fibroblasts with the ASC/FAP signature are enriched in various carcinomas, it is possible that the paracrine signaling conferred by NRG1 is a pan-cancer mechanism of FGFR inhibitor resistance and tumor aggressiveness. See related article by Hosni et al., p. 725.
- |||||||||| Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
The Economic Burden of HER2+ Breast Cancer and the Epidemiological & Economic Impact of Targeted Therapies in the Dominican Republic () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_273; Also, a population estimation model was performed to determine the impact of targeted HER2+ therapies in BC avoided relapses, prevented metastases, life years (LYs) gained, quality-adjusted life years (QALYs), and metastatic BC cost reduction, comparing a base scenario (chemotherapy alone) vs actual scenario (Chemotherapy & Trastuzumab) vs ideal one (Chemotherapy, Trastuzumab, Pertuzumab & Trastuzumab+Emtansine). The treatment of HER2+ BC in DR is more expensive in the metastatic stages than in neo-adyuvance or adyuvance stages, the use of targeted therapies helps to improve patient
- |||||||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
The value of routine trastuzumab-related cardiac toxicity monitoring in gastrointestinal cancers (Section 39) - Mar 5, 2024 - Abstract #AACR2024AACR_7867; The incidence of clinically significant LVEF drop appears low in patients with advanced GI cancers as post-treatment LVEF recovery to baseline was observed at the population level. The value of using TTE to monitor TRCT in these patients with short OS should be further assessed in the perspective of cost effectiveness.
- |||||||||| Pozenveo (poziotinib) / Assertio, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
HER2 TKIs enhance the anti-tumor activity of HER2-targeting CAR-T and CAR-NK cells against NSCLC (Section 2) - Mar 5, 2024 - Abstract #AACR2024AACR_6967; Current HER2-targeting approaches, including antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan, have shown promising response rates...We engineered a series of HER2 CAR constructs utilizing scFvs derived from trastuzumab, pertuzumab, and FRP5, recognizing distinct domains of HER2...Using a HER2 YVMA duplication patient-derived xenograft (PDX) NSCLC model, we observed that the in vivo combination of poziotinib with HER2 CAR-NK cells exhibited superior anti-tumor activity as compared to poziotinib treatment alone. In conclusion, HER2 CAR-T and CAR-NK cells effectively target HER2-mutant and HER2-positive NSCLC, and their combination with HER2 TKIs enhances vulnerability to HER2-targeting strategies.
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