1241PCLINICAL OUTCOME OF ADVANCED NON-SMALL CELL LUNG CANCER PATIENTS (ANSCLC PTS) ON PHASE I TRIALS IN THE DRUG DEVELOPMENT UNIT (DDU) AT THE ROYAL MARSDEN HOSPITAL (RMH)

Abstract Aim: Relapse to licensed antitumor therapies in ANSCLC is almost inevitable. Novel agents in phase I trials may benefit such pts. Methods: Retrospective study of ANSCLC pts allocated to phase I trials in the DDU at RMH (1/2005-12/2013). Results: 132 ANSCLC pts were allocated to ≥ 1 phase I clinical trials (152 total allocations). ANSCLC subtypes were adenocarcinoma 84 (63%), squamous cell 42 (32%) and other NSCLC 6 (5%). Mutation status was known in 34 (26%) ANSCLC pts, of which actionable KRAS and EGFR mutation were found in 11 (8%) and 2 (1.5%) pts, respectively. Median prior therapies 3 (range 1-6). 88 (67%) ANSCLC pts started ≥ 1 phase I trials (total 103); 34 pts (26%) did not start due to progressive disease (PD) and 10 (7%) for other reasons. Pts received targeted therapy (TT)-chemotherapy combos (n= 21 [24%]), HDAC-inhibitors (n = 14 [16%]), TT-TT combos (n = 12 [13%]), PI3K pathway inhibitors (n = 9 [10%]), novel chemotherapies (n= 8 [9%]), IGFR -1R inhibitors (n= 7 [8%]) and other TTs (n = 17 [20%]) such as PARP and angiogenesis inhibitors. Of 72 evaluable pts, there were 8 (11%) RECIST partial responses (PR) and 42 (58%) stable disease (SD) > 4 months (m). Most common toxicities were ≤ grade 2 rash and gastrointestinal (rash n = 23 [26%]; nausea-vomiting n = 29 [33%]; diarrhoea: n = 18 [20%]; mucositis n = 17 [19%]). Grade ≥ 3 toxicities were in 19 pts (21%), mainly diarrhoea (n = 6 [7%]), rash (n = 5 [6%] and drug reaction (n = 3 [3%]). Factors associated with pts who started trial versus (v) who did not due to progression were platinum sensitivity (p = 0.016), better RMH Prognostic Score (0-1 vs 2-3; p = 0.016), higher haemoglobin (p = 0.011) and albumin (p = 0.006). Median survival for pts who started trial v those who did not start because of PD was 241 days v 154 (p = 0.0045). Pts who started trial had a median time to progression of 131 days, 61% of these pts were alive at 6 ms v 36 % who did not start trial. Conclusions: Phase I trial therapies provided benefit in ANSCLC pts with PR comparable to standard therapies. These data suggest that with the emergence of promising novel agents, phase I trials should be considered earlier in ANSCLC treatment with mutational testing to guide therapy. Disclosure: All authors have declared no conflicts of interest.