Phase II study SECOMBIT (sequential combo immuno and target therapy study): A subgroup analysis with a longer follow-up.

Media type: E-Article

Title: Phase II study SECOMBIT (sequential combo immuno and target therapy study): A subgroup analysis with a longer follow-up

Contributor: Ascierto, Paolo Antonio; Mandalà, Mario; Ferrucci, Pier Francesco; Guidoboni, Massimo; Rutkowski, Piotr; Ferraresi, Virginia; Arance, Ana Maria; Guida, Michele; Maiello, Evaristo; Gogas, Helen; Richtig, Erika; Fierro, Maria Teresa; Lebbe, Celeste; Helgadottir, Hildur; Melero Bermejo, Ignacio; Palmieri, Giuseppe; Giannarelli, Diana; Grimaldi, Antonio Maria; Dummer, Reinhard; Chiarion-Sileni, Vanna

imprint: American Society of Clinical Oncology (ASCO), 2022

Language: English

DOI: 10.1200/jco.2022.40.16_suppl.9535

ISSN: 0732-183X; 1527-7755

Keywords: Cancer Research ; Oncology

Origination:

Footnote:

Description: 9535 Background: To investigate the best sequential strategy, we started the SECOMBIT study, a randomized three parallel arms phase 2 study (NCT02631447). We used the combination of encorafenib/binimetinib (E+B) as targeted therapy (T-T) and the combination of ipilimumab/nivolumab (I+N) as immunotherapy (I-O). We explored the two different sequences and the “sandwich” strategy with a short course of target therapy, switched by combo immunotherapy at the best response, and not at progression of disease. In our previous report we have observed a trend in favor of the arms where I-O was given as first, confirmed by the first report of the DreamSeq study, a phase III study which compared the two different sequences with T-T and I-O. Here we updated the study data with a subgroup analysis. Methods: From Nov 2016 to May 2019, 37 centers in 9 countries enrolled 251 patients with untreated, metastatic BRAFV600 melanoma. Patients were randomized to Arm A [E+B until PD, followed by I+N], or Arm B (I+N until PD, followed by E+B) or Arm C (E+B for 8 weeks, followed by I+N until PD, followed by E+B). The overall survival (OS) is the primary endpoint of the study. Secondary endpoints included total progression-free survival (tPFS), 2- and 3-years survival rate, best overall response rate, duration of response, biomarkers evaluation. Results: The study primary endpoint was met in each arm with at least 30 patients alive at 24 months. The median follow-up estimated with the reverse Kaplan-Meier method was 37.1 months (IQR: 32.8-46.4). The OS at 2 and 3 years was calculated in the three arms for all patients, and in the subgroups normal or elevate LDH level and < 3 or ≥ 3 metastatic sites. OS and tPFS rates at 2 and 3 years are shown in the table. Conclusions: With a 37.1 months median follow-up, 2 and 3-years OS as well as tPFS rates are higher in Arm B and C. In line with recent findings, the SECOMBIT results confirm a better trend in favor of Arm B and C treatment sequence. The analysis of the secondary endpoints is ongoing. Clinical trial information: NCT02631447. [Table: see text]

Access State: Open Access

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