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Resultados de sobrevida a largo plazo en CheckMate 057 y CheckMate 017

This article discusses the long-term survival outcomes in CheckMate 057 and CheckMate 017 clinical trials of Nivolumab in patients with lung cancer. It examines the efficacy, safety, and impact on quality of life of immunotherapy in these studies.

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Resultados de sobrevida a largo plazo en CheckMate 057 y CheckMate 017

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  1. Resultados de sobrevida a largo plazo en CheckMate 057 y CheckMate 017 Mariano Provencio Servicio Oncología Médica Hospital Universitario Puerta de Hierro, Madrid

  2. De un tiempo a esta parte…. ¿De dónde venimos?

  3. La supervivencia global en cáncer de pulmón…. Inmunoterapia Soria J C et al. Ann Oncol 2010;21:2324-2332

  4. La definición de largo superviviente era (una excepción) para aquellos que vivían más de 2 años y rara vez más de 5 años en aquellos con posibilidad de resección de metástasis Damme VV et al. LungCancer 2013

  5. ¿La inmunoterapia da resultados a largo plazo? • Nivolumab: longfollow up • Trials • CheckMate 003: DATOS A 3 Y 5 AÑOS CONSOLIDADOS • CheckMate 017: DATOS A 3 y 4 AÑOS CONSOLIDADOS • CheckMate 057: DATOS A 3 y 4 AÑOS CONSOLIDADOS

  6. Anti-PD-1 demonstrates encouraging survival in pre-treated patients: nivolumab as an example CA209-003: phase 1follow-up study, up to 5 prior lines of therapy, stage IIIB/IV squamousand non-squamous (NSCLC cohort OS rate, % (95% CI) 100 90 Group Died/Treated Median OS, mo (95% CI) 3-year 1-year 2-year Censored 1 mg/kg 3 mg/kg 10 mg/kg 26/33 23/37 50/59 9.2 (5.3, 11.1) 14.9 (7.3, 30.3) 9.2 (5.2, 12.4) 33 (17, 49) 56 (38, 71) 38 (26, 50) 15 (5, 30) 42 (24, 58) 20 (11, 31) 15 (5, 30) 27 (12, 43) 14 (7, 25) 80 70 60 50 OS (%) 2-year OS = 42% 40 3-year OS = 27% 30 20 10 0 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 63 66 Months Since Initiation of Treatment Pts at Risk Nivolumab 1 mg/kg 33 37 59 26 34 51 21 26 35 16 21 29 9 17 22 7 14 16 6 13 14 6 12 12 4 11 11 4 9 10 4 9 9 3 7 9 1 5 6 1 2 4 0 1 2 0 1 2 0 1 2 0 1 1 0 1 1 0 1 0 0 1 0 0 1 0 0 0 0 Nivolumab 3 mg/kg Nivolumab 10 mg/kg 70% of patients had 3–5 prior lines of therapy; 46% of these patients had received 12 prior lines of therapy and 54% had received 35 prior lines of therapy. Brahmer J, et al. Poster presented at ASCO 2014 (Abstract 8112).

  7. AARC 2017

  8. Brahmer J et al. Presented at AACR Annual meeting 2017. Abstract #: CT077. Oral presentation

  9. Hazard Ratio 0.59% CI: 0.44, 0.79, p=0.00025]

  10. Kaplan–Meier Estimates of OS(2 Years Minimum Follow-up) ASCO 2016

  11. Kaplan–Meier Estimates of OS (2 Years Minimum Follow-up) ASCO 2016

  12. ESMO MADRID 2017

  13. OS (4 years’ minimum follow-up) CheckMate 057 (non-SQ NSCLC) CheckMate 017 (SQ NSCLC) CI = confidence interval; HR = hazard ratio; NSCLC = non-small cell lung cancer; OS = overall survival;; SQ = squamous.. OS data are based on a May 2018 database lock (minimum of 4 years of follow-up). Median follow-up was not reported. PFS, ORR, and DOR data are based on a June 22, 2017, database lock (minimum of 40.3 months follow-up for survival). Median follow-up was not reported. aInvestigator-assessed. bAmong responders (n = 27, n = 12 in the nivolumab and docetaxel groups, respectively).1. Data on file. NIVO 415. Princeton, NJ: Bristol-Myers Squibb.

  14. ¡¡ CALIDAD DE LA RESPUESTA !! ESMO MADRID 2017

  15. Seguridad a largo plazo

  16. 1.0 40 30 0.9 Worse 20 0.8 10 Population Norm* 0 0.7 -10 Lung Cancer Norm(UK-based): 0.67† Nivolumab Nivolumab 0.6 -20 LCSS Symptom Burden Index Change From Baseline Better Mean EQ-5D Utility Index Score Docetaxel Docetaxel -30 0.5 -40 12 24 30 36 42 48 54 60 0.4 0 12 24 30 36 42 48 54 60 0 Time (weeks) Time (weeks) EQ-5D Utility Index Mean ScoresOver Time While On Treatment* LCSS SymptomBurden Index (On-Treatment)†

  17. Influencia de los biomarcadores largo plazo

  18. 2-year OS Rates Overall and by PD-L1 Expression Level in CheckMate057 (non-SQ NSCLC) aKaplan–Meier estimates, with error bars indicating 95% ClsbFor the comparison of the full Kaplan–Meier survival curves for each treatment group

  19. ESMO MADRID 2017

  20. CheckMate:057 Efficacy: OS by PD-L1 Expression: 4-Year Minimum Follow-up 1% PD-L1 5% PD-L1 10% PD-L1 Among patients with PD-L1 not evaluable/unknown: mOS (95% CI) for nivolumab (n = 61) was 9.20 (5.91, 12.75) mo mOS (95% CI) for docetaxel (n = 66) was 10.48 (7.20, 13.90) mo HR (95% CI) for the comparison of nivolumab to docetaxel was 0.89 (0.62, 1.28) CI = confidence interval; HR = hazard ratio; mo = months; NSCLC = non-small cell lung cancer; NSQ = nonsquamous; OS = overall survival; PD-L1 = programmed death-ligand 1. Data based on a May 2018 database lock (minimum of 4 years of follow-up). Median follow-up not reported. Symbols represent censored observations. Data on file. NIVO 416. Princeton, NJ: Bristol-Myers Squibb.

  21. CheckMate:057 Efficacy: OS by PD-L1 Expression: 4-Year Minimum Follow-up AARC 2017

  22. Conclusiones • La inmunoterapia: sí ha cambiado la supervivencia • Hace sólo unos años la supervivencia a más de 2 años era la excepción • Nivolumab en segunda línea • Supervivencia global a 3 años del 17% • Supervivencia libre de progresión del 10% • Calidad de la duración de la respuesta • No empeora la toxicidad • Mejora la calidad de vida • Se mantiene el beneficio de acuerdo a la determinación de PDL1 • Todos los estudios tienen puntos de crítica porque ningún ensayo puede responder todas las dudas a la vezEl futuro es imposible verlo sin la inmunoterapia

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