Poster Presentation COSA-IPOS Joint Scientific Meeting 2012

Four-year survival update for metastatic melanoma (MM) patients (pts) treated with ipilimumab (IPI) + dacarbazine (DTIC) on phase 3 study CA184-024 (#711)

Michele Maio 1 , Igor Bondarenko 2 , Caroline Robert 3 , Luc Thomas 4 , Claus Garbe 5 , Alessandro Testori 6 , Stephen Francis 7 , Kevin Chin 8 , Jedd Wolchok 9
  1. University Hospital of Siena, Siena, Italy
  2. Dnepropetrovsk State Medical Center, Dnepropetrovsk, Ukraine
  3. Institute Gustave Roussy, Villejuif, France
  4. Lyon 1 University, Centre Hospitalier Lyon Sud, Pierre Bénite, France
  5. University Medical Center, Tuebingen, Germany
  6. Istituto Europeo di Oncologia, Milan, Italy
  7. Bristol-Myers Squibb, Braine-I’Alleud, Belgium
  8. Bristol-Myers Squibb, Wallingford, CT, United States
  9. Memorial Sloan-Kettering Cancer Center, New York, NY, United States

An analysis of 177 pts from 3 phase I/II IPI studies conducted at NCI demonstrated 5-yr survival rates of 13-25%. In other phase II trials, IPI monotherapy was associated with long-term survival of 4+ yrs in some pts with MM. IPI in combination with DTIC in previously untreated MM patients significantly improved OS in phase III study CA184-024. Safety data from study 024 has been previously published. Here we report 4-yr survival data from study 024, the longest IPI survival follow-up from a phase III study.

Pts with treatment-naive MM were randomized to receive either IPI (10 mg/kg) + DTIC (850 mg/m2) or placebo + DTIC (850 mg/m2) given at Wks 1, 4, 7, 10 followed by DTIC q 3 wks through Wk 22. Pts with stable disease or better then received IPI or placebo q 12 wks as maintenance. This analysis reports OS with updated last known alive date or death date based on data collected through April 2012.

Median OS for was 11.2 m [95% CI, 9.4-13.6] for IPI + DTIC (N=250) and 9.1 m [95% CI, 7.8-10.5] for placebo + DTIC (N=252). The 4-yr overall survival rates in the current analyses were 19.0% [95% CI, 14.2-24.2] for IPI + DTIC and 9.6% [95% CI, 6.1-13.5] for placebo + DTIC.

The 4-yr survival rates observed in an extended follow-up of a completed phase III trial suggests that IPI 10 mg/kg in combination with DTIC continues to demonstrate a survival benefit compared to the control arm. The continued survival of some patients at 4 yrs suggests that prolonged survival may indeed be obtained in some pts with treatment-naive MM. This observation of long-term survival benefit in a phase III RCT is consistent with observations from phase I/II studies of IPI in patients with advanced melanoma.