1214P - Establishing the need for immuno-oncology (IO) therapy (tx) in second-line (2L) small cell lung cancer (SCLC)

Abstract

Background: 2L tx for SCLC is heavily dependent on 1L platinum (PT) response. NCCN guidelines recommend PT retreatment if recurrence is > 3-6 months post 1L PT; while alternative options should be considered for rapid relapse (topotecan [TOP] in 2L PT-resistant). In 2016, nivolumab (NIVO) +/- ipilimumab (IPI), were added to 2L NCCN guidelines. This study evaluates 2L SCLC patterns of care and outcomes and attempts to contextualize CheckMate 032 data by creating a matched real-world comparator. Methods: Adult SCLC pts receiving systemic tx from the Flatiron Health database were selected (01Jan2011-30Sep2017). Index date was SCLC diagnosis (dx). Pts were included if: not on clinical trial; no secondary malignancy within 3 years (y); no IO use; and ≥2 months (mo) of medical data on/after dx. PT sensitivity was based on a 90 day gap. Median, 1-y and 2-y overall survival (OS) by Kaplan-Meier was calculated from 2L initiation to death. Median duration of therapy (mDoT) was assessed. A matched 2L cohort was constructed using CheckMate 032 Inclusion/Exclusion criteria (I/E). Results: 2,056 pts initiated 1L tx (full cohort), of which 628 pts went on to 2L; 42% received TOP and 58% other txs. Within 2L, mean age was 65y; 69% were white, 51% were female, 98% had a smoking history and 95% were treated in the community. Of 2L pts, 68% had extensive and 27% had limited disease at dx. 372 were PT-sensitive and 231 pts were PT-resistant. Upon matching for CheckMate 032 I/E, 903 pts were identified of whom 254 initiated 2L. For the full and matched cohorts respectively, 2L mDoT for TOP was 2.0 mo (SD = 2.5) and 2.2 mo (SD = 2.7) and for other tx was 2.6 mo (SD = 2.2) and 2.8 mo (2.4). Median, 1-y and 2-y OS results for the full/ matched cohorts and CheckMate 032 are shown (Table).Table: 1214POverall survival from diagnosis and 2L initiation in Flatiron Health and CheckMate 032median OS, months [95%CI]1-year / 2-year survival (%)FULL COHORTFrom DiagnosisAll (N = 2056)11.6 [11.1,12.3]48.6/ 22.0Limited disease (n = 680)19.6 [18.0,21.5]71.9/ 42.3Extensive disease (n = 1,263)9.4 [8.9,9.9]35.2/ 10.5From Initiation of 2LAll (n = 628)4.2 [3.7,4.7]13.3/ 3.3PT-sensitive (n = 372)5.4 [4.4,6.2]15.9/ 4.2PT-refractory (n = 231)3.0 [2.6,3.6]9.1/ 2.9MATCHED COHORTFrom DiagnosisAll (N = 903)12.5 [11.5,14.3]47.0/ 26.4Limited disease (n = 348)23.8 [20.0,29.5]72.0/ 49.5Extensive disease (n = 507)9.8 [8.9,10.6]37.9/ 12.1From Initiation of 2LAll (n = 254)4.9 [4.0,6.2]14.6/ 3.8PT-sensitive (n = 158)6.3 [5.6,7.5]18.4/ 6.0PT-refractory (n = 90)2.7 [2.1,3.3]5.6/ 1.9CHECKMATE 032NIVO 3 mg/kg cohort (n = 98)4.4 [3.0–9.3]33/ NRNIVO 1 mg/kg + IPI 3 mg/kg (n = 61)7.7 [3.6–18.0]43/ NRNIVO 3 mg/kg + IPI 1 mg/kg (n = 54)6.0 [3.6–11.0]35/ NR*NR=not reported; PT=platinum; NIVO=nivolumab; IPI=ipilimumab Open table in a new tab *NR=not reported; PT=platinum; NIVO=nivolumab; IPI=ipilimumab Conclusions: This large retrospective data set highlighting 2L SCLC outcomes demonstrates poor survival in this setting underscoring the need for novel tx. Results from CheckMate 032 present IO as a potential option for SCLC pts. Editorial acknowledgement: This study was funded by Bristol-Myers Squibb, Inc. All authors contributed to and approved the presentation. Editorial assistance was provided by PAREXEL, funded by Bristol-Myers Squibb. Legal entity responsible for the study: Bristol-Myers Squibb. Funding: Bristol-Myers Squibb. Disclosure: L. Schwartzberg: Consultant: Bristol-Myers Squibb, Merck, Pfizer, Astra Zeneca, Amgen. J.R. Penrod, Y. Yuan, T. Gu, T.K. Le, P. Abraham, B. Korytowsky, G. Selvaggi: Employee, Stock ownership: Bristol-Myers Squibb.