{"doi":"10.1200/jco.2010.28.15_suppl.7531","title":"Phase II trial of ipilimumab (IPI) and paclitaxel/carboplatin (P/C) in first-line stage IIIb/IV non-small cell lung cancer (NSCLC).","abstract":"7531 Background: IPI is a fully human monoclonal antibody that potentiates immune response by selectively inhibiting CTLA-4. CA184- 041 is a randomized, double-blind phase II study of first-line IPI in recurrent/metastatic lung cancer in combination with P (175 mg/m2)/C (AUC=6). Methods: 203 pts with chemotherapy-naive, recurrent or stage IIIb/IV NSCLC were randomized 1:1:1 to receive either: IPI (10 mg/kg IV q3wks) + concurrent (CON) IV P/C (175 mg/m2 and AUC=6, q3wks); or IPI + sequential (SEQ) P/C, or P/C alone (PBO). After P/C, IPI was administered as continuation maintenance therapy q12 wks until toxicity or disease progression. Efficacy was assessed by mWHO and novel immune- related response criteria (irRC), providing a more comprehensive evaluation of immunotherapeutics (Clin Canc Res 2009;15:7412). The primary objective compared immune-related progression-free survival (irPFS) between CON and PBO and SEQ and PBO using a log-rank test with one-sided alpha of 0.1. Results: Baseline characteristics were generally balanced between the arms. The Table presents PFS and immature OS using the irRC and mWHO. IPI plus P/C was generally well tolerated. Grade (Gr) 3/4 AEs were 58%, 52% and 42% for CON, SEQ and PBO, respectively. Generally reversible and manageableGr 3/4 immune-related AEs (pre-selected to reflect IPI mechanism of action) were 20% and 15% for CON and SEQ, respectively. Conclusions: Ipilimumab addition to P/C, in concurrent and sequential regimens, extended irPFS in NSCLC pts compared with P/C alone. Safety results suggest a moderate added toxicity to the P/C regimen due to ipilimumab with no novel toxicities and rare and comparable drug-related death rates across all arms. These results support further investigation of ipilimumab in NSCLC. IPI + P/C P/C CON (n = 70) SEQ (n = 68) PBO (n = 66) irPFS Median mo 5.52 5.68 4.63 95% CI 4.17, 6.74 4.76, 7.79 4.14, 5.52 p value 0.094 0.026 HR 0.775 0.686 95% CI 0.53, 1.13 0.47, 1.01 PFS Median mo 4.11 5.13 4.21 95% CI 2.76, 5.32 4.17, 5.72 2.76, 5.32 p value 0.250 0.024 HR 0.882 0.691 95% CI 0.61,1.27 0.48, 1.00 OS Median mo 11.01 11.56 9.99 95% CI 8.38, 12.75 9.26, 14.39 6.97, 13.63 p value 0.429 0.104 HR 0.962 0.748 95% CI 0.63, 1.48 0.48, 1.18 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb, Infinity Pharmaceuticals AstraZeneca, Boehringer Ingelheim, Genentech, Lilly, Merck, Roche Bristol-Myers Squibb, Infinity Pharmaceuticals AstraZeneca, Lilly, Merck, Roche Bristol-Myers Squibb","journal":"Journal of Clinical Oncology","year":2010,"id":2018,"datarank":2.9992687182961655,"base_score":3.9889840465642745,"endowment":3.9889840465642745,"self_citation_contribution":0.5983476069846413,"citation_network_contribution":2.4009211113115243,"self_endowment_contribution":0.5983476069846413,"citer_contribution":2.4009211113115243,"corpus_percentile":null,"corpus_rank":null,"citation_count":53,"citer_count":53,"citers_with_citation_signal":48,"citers_with_endowment":48,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.0826,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2010-05-20","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":23834,"name":"I. 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