Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study

Kümmel, Sherko; Tondini, Carlo; Abraham, Jacinta; Nowecki, Zbigniew; Itrych, Bartosz; Hitre, Erika; Karaszewska, Bogusława; Juárez-Ramiro, Alejandro; Morales-Vásquez, Flavia; Peréz-García, José Manuel; Cardona‐Huerta, Servando; Monturus, Estefanía; Sequi, Marco; Restuccia, Eleonora; Benyunes, Mark C.; Martín, Miguel

doi:10.1007/s10549-021-06145-3

Cited by 11 publications

(8 citation statements)

References 24 publications

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“…SC trastuzumab was shown to be non-inferior to IV, for both co-primary endpoints (serum trough concentration at pre-dose cycle 8 and pathologic complete response rates), demonstrating that the SC formulation is a valid treatment alternative to IV [ 31 – 34 ]. Further to this, the safety and efficacy profiles for SC trastuzumab in combination with IV pertuzumab and docetaxel as a first-line treatment for patients with HER2-positive MBC in the MetaPHER study (NCT02402712) was found to be consistent with those observed for IV trastuzumab in combination with IV pertuzumab and docetaxel in the CLEOPATRA study (NCT00567190) [ 21 , 35 – 38 ].…”

Section: Introductionmentioning

confidence: 53%

A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting

McCloskey¹,

Ortega²,

Nair³

et al. 2022

PharmacoEconomics Open

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Background The introduction of human epidermal growth factor receptor 2 (HER2)-targeted treatment options, including dual HER2 blockade, has improved the prognosis for patients with HER2-positive breast cancer (BC) substantially. However, most of these treatments are administered via the intravenous (IV) route, which can present many challenges, such as long infusion and observation times, issues associated with repeated IV access, and increased strain on time and resources of medical centers and healthcare professionals. A fixed-dose combination of pertuzumab and trastuzumab for subcutaneous (SC) injection (pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO ® , F. Hoffmann-La Roche Ltd, Basel, Switzerland; PH FDC SC)) has been approved for use alongside chemotherapy for early-stage and metastatic HER2-positive BC. Objectives This systematic literature review was performed to identify evidence relating to time/resource use and resulting cost differences between SC and IV administration of oncology biologics in a hospital setting, and, ultimately, to inform economic modeling and associated health technology assessment of PH FDC SC. Methods Electronic databases (Embase, MEDLINE, and EconLit) were searched on 9 April 2020. Additional hand searches were performed to identify publications not captured in the electronic database search. Publication screening and data extraction (study characteristics, participants, interventions, costs, and time/resource use) were carried out per the standard Cochrane review methodology. The quality of economic evidence of cost analyses was assessed using the 36-item checklist of the National Institute for Health and Care Excellence Single Technology Appraisal Specification for submission of evidence (January 2015). Results The database search identified 2,740 records, of which 237 underwent full text screening. Full text screening, prioritization of publications about patients with a cancer diagnosis, and the addition of four citations identified during the hand search resulted in 72 final included publications, relating to 71 unique studies. This included 40 publications that described the time/resource use and/or costs associated with SC versus IV trastuzumab administration for the treatment of HER2-positive BC, and 28 publications that described time/resource use and/or costs associated with rituximab SC versus IV administration for the treatment of non-Hodgkin’s lymphoma/follicular lymphoma and diffuse large B-cell lymphoma. The majority of publications showed substantial time savings for preparation and administration of SC versus IV therapy, and cost savings associated with reductions in healthcare professional time and resource use for SC administration. Limitations There was a lack of consensus between publications regarding time and cost measurements. In addition, the search was limited to publications related to ...

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Section: Introductionmentioning

confidence: 53%

A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting

McCloskey¹,

Ortega²,

Nair³

et al. 2022

PharmacoEconomics Open

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“…The PFS and OS were significantly improved in the pertuzumab group compared with the placebo group ( 34 ). In MetaPHER, the largest study to evaluate the efficacy and safety of subcutaneous trastuzumab plus intravenous pertuzumab and chemotherapy in patients with HER2+ metastatic breast cancer, safety and efficacy were consistent with histological evidence of intravenous trastuzumab in this combination ( 35 ).…”

Section: Passive Immunotherapy: Antibody-dependent Cytotoxicitymentioning

confidence: 80%

Immunotherapy for HER-2 positive breast cancer

Yang

Liu

et al. 2023

Front. Oncol.

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Immunotherapy is a developing treatment for advanced breast cancer. Immunotherapy has clinical significance for the treatment of triple-negative breast cancers and human epidermal growth factor receptor-2 positive (HER2+) breast cancers. As a proved effective passive immunotherapy, clinical application of the monoclonal antibodies trastuzumab, pertuzumab and T-DM1 (ado-trastuzumab emtansine) has significantly improved the survival of patients with HER2+ breast cancers. Immune checkpoint inhibitors that block programmed death receptor-1 and its ligand (PD-1/PD-L1) have also shown benefits for breast cancer in various clinical trials. Adoptive T-cell immunotherapies and tumor vaccines are emerging as novel approaches to treating breast cancer, but require further study. This article reviews recent advances in immunotherapy for HER2+ breast cancers.

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“…versus s.c. routes have been reported. [64][65][66] Since bintrafusp alfa is a bifunctional agent combining both checkpoint inhibition and anti-TGFβ activities, preclinical studies were carried out to evaluate the mode of action and antitumor activity when bintrafusp alfa was administered in murine models systemically (intraperitoneal) or via the s.c. route. 18 These studies demonstrated that when bintrafusp alfa was administered either s.c. or systemically at five different dose levels, there was comparable antitumor activity at each dose level with either route used (Figure 4).…”

Section: Route Of Administrationmentioning

confidence: 99%

Preclinical and clinical studies of bintrafusp alfa, a novel bifunctional anti-PD-L1/TGFβRII agent: Current status

Gameiro

Strauss

Gulley

et al. 2022

Exp Biol Med (Maywood)

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Bintrafusp alfa (anti-PD-L1/TGFβRII) is a first-in-class bifunctional agent designed to act both as a checkpoint inhibitor and as a “trap” for TGFβ in the tumor microenvironment (TME). This article is designed to review the preclinical studies interrogating the mode of action of bintrafusp alfa and to present a comprehensive overview of recent bintrafusp alfa clinical studies. Preclinical studies have demonstrated that bintrafusp alfa immune-mediating and antitumor activity can be enhanced by combining it with a human papillomavirus (HPV) therapeutic cancer vaccine, a tumor-targeting interleukin 12 (IL-12) immunocytokine and/or an IL-15 superagonist. The importance of TGFβ in HPV-associated malignancies is also reviewed. The clinical studies reviewed span extended phase I cohorts in patients with a spectrum of malignancies, two randomized phase II studies in lung and one in biliary tract cancers in which bintrafusp alfa did not demonstrate superiority over standard-of-care therapies, and provocative results in patients with HPV-associated malignancies, where as a monotherapy, bintrafusp alfa has shown response rates of 35%, compared to overall response rate (ORR) of 12–24% seen with other Food and Drug Administration (FDA)-approved or standard-of-care agents. This article also reviews preliminary phase II study results of patients with HPV+ malignancies employing bintrafusp alfa in combination with an HPV therapeutic vaccine and a tumor-targeting IL-12 immunocytokine in which the combination therapy outperforms standard-of-care therapies in both checkpoint naïve and checkpoint refractory patients. This review thus provides an example of the importance of conducting clinical studies in an appropriate patient population – in this case, exemplified by the role of TGFβ in HPV-associated malignancies. This review also provides preclinical and preliminary clinical study results of the combined use of multiple immune-modulating agents, each designed to engage different immune components and tumor cells in the TME.

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Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study

Cited by 11 publications

References 24 publications

A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting

A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting

Immunotherapy for HER-2 positive breast cancer

Preclinical and clinical studies of bintrafusp alfa, a novel bifunctional anti-PD-L1/TGFβRII agent: Current status

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