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Sequential treatment with ipilimumab and BRAF inhibitors in patients with metastatic melanoma: data from the Italian ipilimumab expanded access programme (EAP)
  1. Paolo Antonio Ascierto1,
  2. E Simeone1,
  3. V Chiarion Sileni2,
  4. P Queirolo3,
  5. M Del Vecchio4,
  6. L Di Guardo4,
  7. M Guidoboni5,
  8. P Marchetti6,7,
  9. GC Antonini Cappellini6,
  10. PF Ferrucci8,
  11. F Cognetti9,
  12. MG Bernengo10,
  13. M Guida11,
  14. R Marconcini12,
  15. M Mandalà13,
  16. C Cimminiello14,
  17. G Rinaldi15,
  18. M Aglietta16,
  19. L Calabrò17 and
  20. M Maio17
  1. Aff1 grid.417893.00000000108072568Istituto Nazionale Tumori Fondazione "G. Pascale" Naples Italy
  2. Aff2 grid.419546.b0000000418081697Institute of Oncology IOV-IRCCS Padua Italy
  3. Aff3 grid.410345.70000000417567871San Martino Hospital-National Institute for Cancer Research Genoa Italy
  4. Aff4 grid.417893.00000000108072568National Cancer Institute Milan Italy
  5. Aff5 Romagna National Cancer Institute Meldola Italy
  6. Aff6 Dermathopatic Institute of the Immaculate Rome Italy
  7. Aff7 grid.7841.aSant'Andrea HospitalUniversity Sapienza Rome Italy
  8. Aff8 grid.15667.330000000417570843Istituto Europeo di Oncologia Milan Italy
  9. Aff9 grid.417520.50000000417605276Regina Elena National Cancer Institute Rome Italy
  10. Aff10 University Hospital St John the Baptist Turin Italy
  11. Aff11 National Cancer Research Center "Giovanni Paolo II" Bari Italy
  12. Aff12 "Gathered Hospitals of Santa Chiara" Pisa Italy
  13. Aff13 grid.452246.3Papa Giovanni XXIII Hospital Bergamo Italy
  14. Aff14 grid.18887.3e0000000417581884San Raffaele Hospital Milan Italy
  15. Aff15 Paolo Giaccone Polyclinc University Hospital Palermo Italy
  16. Aff16 Piedmont Oncology Foundation Candiolo Italy
  17. Aff17 grid.24704.350000 0004 1759 9494Hosptal of Siena Istituto Toscano Tumori Siena Italy

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Meeting abstracts


Data to guide the order in which ipilimumab and vemurafenib are used in patients with advanced melanoma are limited. Here are reported outcomes from patients treated in the ipilimumab EAP who received both drugs.


Patients with pretreated, BRAFV600 mutation-positive advanced melanoma who had received BRAF inhibitor before or after ipilimumab were eligible for analysis.


93 patients were eligible: 48 patients received a BRAF inhibitor after ipilimumab and 45 patients ipilimumab after a BRAF inhibitor. Median overall survival (OS) was 14.5 and 9.9 months for the two groups, respectively (P=0.04). Among patients who received a BRAF inhibitor first, 18 (40%) had rapid disease progression and were unable to complete ipilimumab treatment as for protocol (rapid progressors). For this group median OS from the cessation of treatment with a BRAF inhibitor was 1.2 months. 27 patients had slower disease progression and were able to complete all four doses of ipilimumab (slow progressors); median OS was significantly longer (12.7 months; P<0.0001).Younger age and the presence of brain metastasis were significantly associated with a poorer outcome (P=0.02).


This EAP data suggests that pretreated, BRAF-mutated patients who have rapid disease progression upon failing treatment with a BRAF inhibitor die in one month, so they may benefit from receiving ipilimumab as the first part of their sequential regimen, otherwise clinical benefit may be limited due to them not being able to receive the full induction treatment.