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• W2978242011 abstract "Abstract Background Nivolumab (N) + ipilimumab (I) has been approved for the 1st line treatment of IMDC intermediate and poor risk advanced RCC. However, administration of N+I in a fixed regimen with 4 induction cycles may result in more treatment related adverse events (AEs) compared with N alone. It is hypothesized that a tailored approach starting treatment with N alone and using N+I as immunotherapeutic boost will improve efficacy outcomes as compared to N alone and reduce AEs. Methods This multicentric European study enrolled 258 1st and 2nd line (after TKI) pts with IMDC intermediate and poor risk, advanced clear cell RCC between Oct. 2016 and Dec. 2018. Pts started with N 240 mg Q2W induction. Pts with early significant PD (week 8) or either SD or PD at week 16 received 2-4 N+I boost cycles. Responders (PR/CR) to N monotherapy continued with maintenance with N+I boosts only for progression. The primary endpoint is confirmed investigator assessed objective response rate (ORR) per RECIST independent in 1st and 2nd line. Secondary endpoints include activity of N monotherapy, remission rate with N+I boosts, safety, overall survival and QoL. Results 108 1st and 99 2nd line pts were analyzed for efficacy. Median age was 65 y (range 20-87). 70 % were intermediate and 27 % poor risk. Confirmed ORR with 1st line N monotherapy was 28.7 % (95 % CI 20 - 38). Best overall response (BOR) after N induction ± N+I boosts was 37 % (95 % CI 28 - 47) and 28 % (95 % CI 20 - 38) in 1st and 2nd line, respectively. 102 pts received N+I boosts for either SD (n = 35) or PD (n = 67) until week16. Of these, 12 (12 %) and 54 (53%) had a PR/CR and SD, respectively. Two (6%) pts entering boosts for SD had PD afterwards compared to 51% with early PD. Treatment-related AEs will be presented. Table . LBA57 1st line (n = 108) 2nd line (n = 99) n (%) Nivo mono ORR N ± N+I BOR Nivo mono ORR N ± N+I BOR Complete response 2 (1.9) 2 (1.9) 0 4 (4.0) Partial response 29 (26.9) 38 (35.2) 18 (18.2) 24 (24.2) Stable disease 26 (24.1) 26 (24.1) 23 (23.2) 25 (25.3) Progressive disease 13 (12.0) 38 (35.2) 16 (16.2) 43 (43.4) Early PD/Boost W8 22 (20.4) 26 (26.3) Not evaluable * 16 (14.8) 4 (3.7) 16 (16.2) 3 (3.0) * Including patients with early end of study e.g. due to death or immune related AEs Conclusions TITAN–RCC is the first study to assess the impact of a tailored approach using N+I as an immunotherapeutic boost. In 1st line, this significantly improved ORR compared to N mono. Further follow-up is ongoing to characterize duration and depth of response. Clinical trial identification EudraCT: 2016-002307-26. Legal entity responsible for the study AIO-Studien-gGmbH, Berlin, Germany. Funding Bristol-Myers Squibb GmbH & Co.KGaA. Disclosure M. Grimm: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self): Amgen; Honoraria (self): Apogepha; Honoraria (self): Astellas; Honoraria (self): AstraZeneca; Honoraria (self): Bayer HealthCare; Honoraria (self): Hexal; Honoraria (self), Advisory / Consultancy: Intuitive Surgical; Honoraria (self): Janssen Cilag; Honoraria (self): Ipsen Pharma; Honoraria (self): Medac; Honoraria (self): MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: ONO Pharma; Honoraria (self): Pfizer; Honoraria (self): Sanofi Aventis. M. Schmidinger: Honoraria (self): Astellas; Honoraria (self): BMS; Honoraria (self): EISAI; Honoraria (self): Eusa Pharma; Honoraria (self): Exelexis; Honoraria (self): Ipsen; Honoraria (self): MSD; Honoraria (self): Pfizer; Honoraria (self): Roche. I. Duran Martinez: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Non-remunerated activity/ies: Ipsen; Honoraria (self), Research grant / Funding (self), Travel / Accommodation / Expenses: Roche Genentech; Honoraria (self), Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Pharmacyclyc; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: MSD. G. Baretton: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): MSD; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Pfizer. P. Barthelemy: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Janssen Cilag; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Astellas. B. Melichar: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Merck Serono; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Astellas; Honoraria (self), Advisory / Consultancy: Servier; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Pfizer. L. Albiges: Honoraria (institution): Pfizer; Honoraria (institution): Novartis; Honoraria (institution): BMS; Honoraria (institution): Ipsen; Honoraria (institution): Roche; Honoraria (institution): MSD; Honoraria (institution): AstraZeneca. All other authors have declared no conflicts of interest." @default.
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• W2978242011 title "Tailored immunotherapy approach with nivolumab in advanced renal cell carcinoma (TITAN-RCC)" @default.
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