Zie ook in gerelateerde artikelen hiernaast of hieronder

5 augustus 2026: Bron: ESMO open, Elsevier

Immuuntherapeutische medicijnen Pembrolizumab + Trastuzumab (Herceptin) subcutaan toedienen met 1 injectie = onderhuids toedienen naast chemotherapie geeft dezelfde ziektevrije overleving na 51 maanden studie follow-up van de gerandomiseerde fase studie FeDeriCa vergeleken met IV = intraveneus toedienen bij patiënten met beginnende operabele borstkanker met HER2 positieve expressie.

Zo bleven de invasieve ziektevrije overleving, de eventvrije overleving, de tijd zonder uitzaaiingen op afstand en de algehele overleving vergelijkbaar tussen de twee behandelingen. Er kwamen ook geen nieuwe ernstige bijwerkingen bij en evenmin geen nieuwe zorgen met betrekking tot de veiligheid van het hart.

De onderhuidse toediening met vaste dosis combineert Pembrolizumab en Trastuzumab (Herceptin) in één injectie. De toediening duurt ongeveer 5 tot 8 minuten, gevolgd door een observatieperiode van 15 tot 30 minuten. De toediening via infuus duurt tussen de 60 en 90 minuten. Deze aanpak werd ontwikkeld om de behandeltijd voor de patiënten te verkorten, herhaalde intraveneuze toegang te vermijden en een handigere en patiëntvriendelijkere manier van toediening te bieden tijdens een behandelingskuur die bij een volledige behandeling kan oplopen tot 18 kuren.

De algehele overleving op 4 jaar waren respectievelijk:

95.5% met intraveneuze behandeling
94.1% met onderhuidse behandeling

De belangrijkste resultaten gekopieerd en vertaald uit het studierapport:

De ziektevrije overleving na vier jaar was:

89,6% met intraveneuze toediening van pertuzumab en trastuzumab
88,5% met de onderhuidse toediening van pertuzumab en trastuzumab met vaste dosis

De overlevingstijd zonder gebeurtenissen na vier jaar was:

88,5% met intraveneuze toediening
86,6% met onderhuidse toediening

De vierjarige recidiefvrije periode bij tumoren op afstand was:

92,5% bij intraveneuze toediening
91,9% bij onderhuidse toediening

Vierjarige algehele overleving

95,5% bij intraveneuze toediening
94,1% bij onderhuidse toediening

Hier de grafische afbeelding van de resultaten gekopieerd uit het studieverslag zoals gepresenteerd zal worden op ESMO 2026:

FeDeriCa

Bijwerkingen:

Ook werden geen meer bijwerkingen van graad 3 of hoger gezien:

Bijwerkingen van graad 3 of hoger gedurende de gehele studieperiode traden op bij:

59,1% van de patiënten in de intraveneuze groep
53,2% van de patiënten in de subcutane groep
Ernstige bijwerkingen werden gemeld bij respectievelijk 20,6% en 19,8% van de patiënten.

Bijwerkingen leidden tot stopzetting van de studiemedicatie bij:
12,7% van de patiënten die intraveneus werden behandeld
8,9% van de patiënten die de onderhuidse combinatietherapie kregen

Stopzetting van de HER2-gerichte therapie vanwege bijwerkingen trad op bij respectievelijk 6,0% en 4,8% van de patiënten.

Het volledige studierapport is gratis in te zien. Klik daarvoor op de titel van het abstract:

Original articleVolume 11, Issue 8 1083 28 August 2026 Open access

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

C. Jackisch1,† Send email to csjackisch@gmail.com ∙ S.-A. Im2 ∙ A. Mattar3 ∙ … ∙ B. Wang13 ∙ E. Restuccia14 ∙ A.R. Tan15 … Show more

Affiliations & Notes

1Department of Obstetrics and Gynecology, Sana Klinikum Offenbach, Offenbach, Germany

2Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Korea (the Republic of)

3CRSM, Hospital da Mulher, São Paulo, Brazil

4Division of Medical Oncology, La Princesa Hospital and Health Research Institute, Chair of Personalised Precision Medicine, Universidad Autónoma de Madrid, Madrid, Spain

5Moscow Healthcare Department, City Clinical Oncology Hospital 62, Moscow, Russian Federation

6Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

7Breast Department, Istituto Nazionale Tumori IRCCS ‘Fondazione Pascale’, Napoli, Italy

8Medical Oncology Department, Institut Curie, Université Paris Cité, Paris, France

9Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (the Republic of)

10Krankenhaus Jerusalem, Mammazentrum Hamburg, Hamburg, Germany

11PDO-Clinical Science Oncology, Roche Products Limited, Welwyn Garden City, United Kingdom of Great Britain and Northern Ireland (the)

12Pharma Development Data Science and Analytics, Roche (China) Holding Ltd, Shanghai, China

13Clinical Pharmacology, Genentech Research and Early Development, Genentech, Inc., South San Francisco, United States of America

14Product Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland

15Department of Cancer Medicine, Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, United States of America

†

Present address: Department of Obstetrics and Gynecology, Varisano Clinic Frankfurt Hoechst, Gotenstrasse 6-8, Frankfurt a. M., Germany.

‡

Present address: Biostatistics and Data Science, AstraZeneca, Beijing, China.

Article Info

Publication History:

Published online July 31, 2026

DOI: 10.1016/j.esmoop.2026.108328 Also available on ScienceDirect

User License: Creative Commons Attribution – NonCommercial – NoDerivs (CC BY-NC-ND 4.0) | Elsevier's open access license policy

Highlights

•

Four-year iDFS event-free rates were 89.6 (P + H IV) and 88.5 (PH FDC SC).

•

Four-year EFS event-free rates were 88.5 (P + H IV) and 86.6 (PH FDC SC).

•

Four-year DRFI event-free rates were 92.5 (P + H IV) and 91.9 (PH FDC SC).

•

Four-year OS event-free rates were 95.5 (P + H IV) and 94.1 (PH FDC SC).

•

No new safety signals (including cardiac safety) were observed.

Abstract

Background

FeDeriCa (NCT03493854) showed that the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) was noninferior to intravenous (IV) P and H, with comparable total pathological response rates and safety profiles when given as neoadjuvant therapy for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (BC). We report long-term efficacy and safety.

Materials and methods

Patients received eight neoadjuvant chemotherapy + P IV + H IV cycles or PH FDC SC every 3 weeks (cycles 5-8; 1:1 randomisation). Patients continued adjuvant HER2-targeted treatment to complete 18 cycles.

Results

Data cut-off was 2 June 2023, with a median follow-up of 51.4 (P + H IV arm) and 51.2 months (PH FDC SC arm). Four-year event-free rates (invasive disease-free survival, event-free survival, distant recurrence-free interval, and overall survival) were 89.6 [95% confidence interval (CI) 85.5-93.7], 88.5 (95% CI 84.4-92.5), 92.5 (95% CI 89.2-95.8) and 95.5 (95% CI 92.9-98.1) in the P + H IV arm and 88.5 (95% CI 84.3-92.7), 86.6 (95% CI 82.2-90.9), 91.9 (95% CI 88.4-95.4) and 94.1 (95% CI 91.1-97.1) in the PH FDC SC arm, respectively. No new safety signals (including cardiac safety) were observed.

Conclusions

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.

Acknowledgements

We thank all patients who participated in the trial and their families, the investigators, clinicians and research staff at the 106 centres in 19 countries. Support for third-party writing assistance for this manuscript, furnished by Chantel Swart, PhD, of Nucleus Global, an Inizio Company, was provided by F. Hoffmann-La Roche Ltd.

Data availability

Qualified researchers may request access to individual patient-level data through the clinical study data request platform (https://vivli.org/).
Further details on Roche’s criteria for eligible studies are available at https://vivli.org/members/ourmembers/.
For further details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm.

Funding

This work was supported by F. Hoffmann-La Roche Ltd, Basel, Switzerland, and Genentech, Inc., South San Francisco, USA. The funder of the study had a role in study design, provision of study drugs, protocol development, regulatory and ethics approvals, safety monitoring, data collection, data analysis, data interpretation and writing of the report, in collaboration with the study authors.

Disclosure

CJ received support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd and has received honoraria and travel support from Agendia, Amgen, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, Exact Sciences, Genomic Health, Gilead, GlaxoSmithKline, Hexal, Eli Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Sandoz/Hexal, Sanofi Genzyme, Seattle Genetics/Seagen, TESERO Bio, Teva and Viatris. S-AI received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd, and reports consultancy/advisory roles for AstraZeneca, Daiichi-Sankyo, GSK, Lilly, MSD, Novartis, Roche and Pfizer, and grant/research funding from AstraZeneca, Daiichi-Sankyo, Boryung Pharm, Eisai, Roche and Pfizer. AM received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd and; reports grants from Roche, AstraZeneca, MSD, Novartis, and Daiichi-Sankyo. RC received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd. DS received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd; reports speaker bureaus for Roche/Genentech, Bristol Myers Squibb, BioCad and AstraZeneca, and travel, accommodations and expenses from AstraZeneca, Novartis and Roche. ZN received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd. MDL received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd; reports personal fees from Pfizer, Novartis, Roche, AstraZeneca, Eisai, Eli Lilly, MSD, Pierre Fabre, Exact Sciences, Daiichi-Sankyo, Gilead, Seagen, Menarini-Stemline, Veracyte, Takeda and Ipsen, outside the submitted work. J-YP received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd. KHJ received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd, and reports honoraria for advisory roles (personal) from AstraZeneca, Daiichi-Sankyo, Novartis, Gilead Sciences, Roche, Eisai, Pfizer and MSD. CS received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd and reports travel grants and speaker bureaus for Roche, AstraZeneca, Pfizer, MSD and Novartis. SH received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche, Ltd; is employed by Roche Products Limited; owns stock in F. Hoffmann-La Roche Ltd; and is a patent holder for PH FDC SC. IY received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd; is employed by Roche (China) Holding Ltd; and owns stock in F. Hoffmann-La Roche Ltd. BW received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd; is employed by Genentech, Inc.; and owns stock in F. Hoffmann-La Roche Ltd. ER received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd and is employed by, and owns stock in, F. Hoffmann-La Roche Ltd. ART received research support in the form of third-party medical writing assistance from F. Hoffmann-La Roche Ltd; has received research funding to her institution from AstraZeneca, Arvinas, Daiichi-Sankyo, Genentech, GlaxoSmithKline, Incyclix Bio, Merck, Olema and Pfizer; and has received honoraria from Arvinas, Daiichi-Sankyo, Genentech, Incyclix Bio, Jazz Pharmaceuticals, Lilly and Stemline Therapeutics.

Supplementary data (1)

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Supplementary Tables

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