e20039 Background: As the first agent to show survival advantage in metastatic melanoma, Ipilimumab (Yervoy, BMS) is being gradually introduced into health services worldwide. It's unique immune mediated side effects requires the incorporation of follow-up guidelines to prevent toxic sequella. We report on safety and efficacy results of refractory melanoma patients (pts) treated on an international expanded access program of Ipilimumab. Methods: Between 4/2010 and 12/2011 183 pts were treated. Pts received Ipilimumab 3 mg/kg q3w for 4 doses. Pts with evidence of clinical benefit at week 12 (CR, PR or SD), were eligible for re-induction upon progression. Results: All pts were pretreated for metastatic disease (median:1 line,range 1-5). 140 pts(77%) had M1c disease, 63 pts(34%) had brain metastasis and 84 (46%) had LDH above ULN, reflecting poor prognostic characteristics of this cohort. Patients received 3.6 doses of Ipilimumab on average. 11% received less than 4 cycles due to toxicity. Grade 3/4 immune-related adverse events were noted in 19.6% with the most common all grades toxicity being diarrhea (17.5%), pruritus (14%) rash (13%) and fatigue (8.7%). Grade 5 toxicity was noted in 4 patients (2%). Five pts were treated with anti TNF antibodies (Infliximab) for steroid resistant toxicity. Objective responses were noted in 16 pts (8.7%;4 CR, 12 PR), 26 pts(14.2%) had stable disease, overall yielding clinical benefit in 23%. Patients with stage IIIc, M1a and M1b were more likely to benefit (52% Vs 23% of the group, p<0.001) as well as patients previously treated by immunotherapy (p=0.026). Median OS was 9.2 months with 1 year survival of 42%. 34 pts (18.6%) are alive beyond 20 months, the majority of them received no further treatment. Factors favoring survival included stage IIIc, M1a and M1b, LDH below ULN and lymphocyte count at week 6 above 1000/ml (p values: <0.001,<0.001, 0.03 respectively). None of the 14 ocular melanoma pts exhibited clinical benefit. Conclusions: Our cohort reflects rapid adoption of this new modality. Ipilimumab had significant clinical benefit, comparable with previous reports, in a heterogenous group of patients, including those with poor prognostic factors.
MA 11.11 Italian Nivolumab Expanded Access Program in Non-Squamous NSCLC Patients: Results in Never Smokers and EGFR Positive Patients