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  • Immune biomarker correlates from a Phase II study of ipilimumab (IPI) with carboplatin and paclitaxel (CP) in patients with unresectable stage III or IV metastatic melanoma (MM)

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Immune biomarker correlates from a Phase II study of ipilimumab (IPI) with carboplatin and paclitaxel (CP) in patients with unresectable stage III or IV metastatic melanoma (MM)
  1. Réjean Lapointe1,
  2. Rahima Jamal2,
  3. Leon van Kempen3,
  4. Pamela Thebault4,
  5. Karl Belanger2,
  6. Jennifer Friedmann5,
  7. Jean-Pierre Ayoub2,
  8. Eftihia Cocolakis3,
  9. Shirin Kazemi3,
  10. Jeanne Dionne2,
  11. Caroline Lambert3,
  12. Huy Le3,
  13. Cecile Grange6,
  14. Jean-Francois Cailhier6,
  15. Alan Spatz3 and
  16. Wilson Miller3
  1. Aff1 grid.410559.c0000000107432111Université de Montréal / Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM) Montreal PQ Canada
  2. Aff2 grid.14848.310000000122923357Centre Hospitalier de Université de Montréal Montreal PQ Canada
  3. Aff3 grid.14709.3b0000000419368649Jewish General HospitalMcGill University Montreal PQ Canada
  4. Aff4 grid.14848.310000000122923357Université de Montréal Montreal PQ Canada
  5. Aff5 grid.14709.3b0000000419368649Jewish General HospitalMcGill University Montreal PQ Canada
  6. Aff6 grid.14848.310000000122923357Université de Montréal Montreal PQ Canada

http://dx.doi.org/10.1186/2051-1426-3-S2-P259

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    Meeting abstracts

    Background

    Pivotal studies with anti-CTLA-4 (Ipilimumab or IPI) demonstrated increased overall survival (OS) both as single agent (10.1 months) and with DTIC (11.2 months). We've previously reported an encouraging safety profile with IPI plus CP and early efficacy results. We now report updated 1-year OS and immune biomarker correlates of patient response.

    Methods

    30 patients were randomized in a 1:2 ratio to arm A (C (AUC=6) and P (175mg/m2) every 3 weeks × 5 and IPI (3mg/kg) every 3 weeks × 4 starting at week 4) or arm B (similar dosing to arm A except IPI was given on week after CP). Tumor biopsies were collected at screening and week 8, and immune monitoring bloods were collected throughout.

    Results

    Median OS was 16.1 months, with a 1-year OS of 56.5% for all patients with no differences between arms. Overall median follow-up was 23.2 months. Best overall response rate (BORR) and disease control rate (DCR) were 26.7% and 56.7% by irRC. BORR in patients whose tumors were wild type for BRAF and NRAS was 44%, compared to 8% in patients with a mutation in BRAF or NRAS. Clinical responses correlated with the abundance of peri and intratumoral CD3+ inflammatory cells in the pretreatment biopsy, but not with CD4/CD8 ratios or CD20 infiltrate. Circulating levels of some chemokines were elevated in non-responders compared to responders. While IPI influenced B cells and monocyte differentiation, this did not correlate with clinical outcome. Lower levels of PD-1 on CD4 and CD8 T cells were observed in responders compared to non-responders.