Sequencing of Ipilimumab Plus Nivolumab and Encorafenib Plus Binimetinib for Untreated


Journal

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333

Informations de publication

Date de publication:
10 01 2023
Historique:
pubmed: 2 9 2022
medline: 10 1 2023
entrez: 1 9 2022
Statut: ppublish

Résumé

Limited prospective data are available on sequential immunotherapy and BRAF/MEK inhibition for SECOMBIT is a randomized, three-arm, noncomparative phase II trial (ClinicalTrials.gov identifier: NCT02631447). Patients with untreated, metastatic A total of 209 patients were randomly assigned (69 in arm A, 71 in arm B, and 69 in arm C). At a median follow-up of 32.2 (interquartile range, 27.9-41.6) months, median OS was not reached in any arm and more than 30 patients were alive in all arms. Assuming a null hypothesis of median OS of ≤ 15 months, the OS end point was met for all arms. The 2-year and 3-year OS rates were 65% (95% CI, 54 to 76) and 54% (95% CI, 41 to 67) in arm A, 73% (95% CI, 62 to 84) and 62% (95% CI, 48 to 76) in arm B, and 69% (95% CI, 59 to 80) and 60% (95% CI, 58 to 72) in arm C. No new safety signals emerged. Sequential immunotherapy and targeted therapy provide clinically meaningful survival benefits for patients with

Identifiants

pubmed: 36049147
doi: 10.1200/JCO.21.02961
doi:

Substances chimiques

binimetinib 181R97MR71
BRAF protein, human EC 2.7.11.1
encorafenib 8L7891MRB6
Ipilimumab 0
Nivolumab 31YO63LBSN
Proto-Oncogene Proteins B-raf EC 2.7.11.1

Banques de données

ClinicalTrials.gov
['NCT02631447']

Types de publication

Randomized Controlled Trial Clinical Trial, Phase II Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

212-221

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Auteurs

Paolo A Ascierto (PA)

Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, I.N.T. IRCCS Fondazione "G. Pascale" Napoli, Naples, Italy.

Mario Mandalà (M)

Department of Oncology and Haematology, Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.
University of Perugia, Perugia, Italy.

Pier Francesso Ferrucci (PF)

Biotherapy of Tumors Unit, Department of Experimental Oncology, European Institute of Oncology, IRCCS, Milan, Italy.

Massimo Guidoboni (M)

Immunotherapy and Cell Therapy Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Piotr Rutkowski (P)

Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska Curie National Research Institute of Oncology, Warsaw, Poland.

Virginia Ferraresi (V)

Department of Medical Oncology 1, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Ana Arance (A)

Department of Medical Oncology, Hospital Clínic Barcelona, Barcelona, Spain.

Michele Guida (M)

Rare Tumors and Melanoma Unit, IRCCS Istituto dei Tumori "Giovanni Paolo II," Bari, Italy.

Evaristo Maiello (E)

Oncology Unit, Foundation IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

Helen Gogas (H)

First Department of Medicine, National and Kapodistrian University of Athens, Zografou, Greece.

Erika Richtig (E)

Department of Dermatology, Medical University of Graz, Graz, Austria.

Maria Teresa Fierro (MT)

Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy.

Celeste Lebbè (C)

Department of Oncology-Pathology, Karolinska Institutet and Karolinska University Hospital Solna, Stockholm, Sweden.

Hildur Helgadottir (H)

Immunotherapy and Cell Therapy Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Paola Queirolo (P)

IRCCS Ospedale Policlinico San Martino, Skin Cancer Unit, Genova, Italy.
Division of Melanoma Sarcoma and Rare Tumors, IRCCS European Institute of Oncology, Milan, Italy.

Francesco Spagnolo (F)

IRCCS Ospedale Policlinico San Martino, Skin Cancer Unit, Genova, Italy.

Marco Tucci (M)

Department of Interdisciplinary Medicine, Oncology Unit, University of Bari "Aldo Moro," Bari, Italy.

Michele Del Vecchio (M)

Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Maria Gonzales Cao (M)

Department of Medical Oncology, University Hospital Dexeus, Barcelona, Spain.

Alessandro Marco Minisini (AM)

Academic Hospital "Santa Maria della Misericordia," Udine, Italy.

Sabino De Placido (S)

Department of Clinical Medicine and Surgery, University of Naples "Federico II," Naples, Italy.

Miguel F Sanmamed (MF)

Department of Immunology and Oncology, Clínica Universidad de Navarra, Pamplona, Spain.

Domenico Mallardo (D)

Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, I.N.T. IRCCS Fondazione "G. Pascale" Napoli, Naples, Italy.

Marcello Curvietto (M)

Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, I.N.T. IRCCS Fondazione "G. Pascale" Napoli, Naples, Italy.

Ignacio Melero (I)

Department of Immunology and Oncology, Clínica Universidad de Navarra, Pamplona, Spain.

Giuseppe Palmieri (G)

Immuno-Oncology & Targeted Cancer Biotherapies, University of Sassari, Unit of Cancer Genetics, IRGB-CNR, Sassari, Italy.

Antonio M Grimaldi (AM)

Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, I.N.T. IRCCS Fondazione "G. Pascale" Napoli, Naples, Italy.
Medical Oncology Unit, AORN San Pio Benevento, Benevento, Italy.

Diana Giannarelli (D)

Regina Elena National Cancer Institute, IRCCS-Biostatistical Unit, Rome, Italy.

Reinhard Dummer (R)

Department of Dermatology, University and University Hospital Zurich, Zurich, Switzerland.

Vanna Chiarion Sileni (V)

Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy.

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Classifications MeSH