NSCLC: Terapia medica nella fase avanzata. Paolo Bidoli S.C. Oncologia Medica H S. Gerardo Monza

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1 NSCLC: Terapia medica nella fase avanzata Paolo Bidoli S.C. Oncologia Medica H S. Gerardo Monza

2 First-line Second-line Third-line Not approved CT AND SILENT APPROVAL Docetaxel 1999 Paclitaxel Gemcitabine 1998 Docetaxel 2002 Gefitinib 2003 Erlotinib Pemetrexed 2004 Bevacizumab 2006 Cisplatin* 1978 Carboplatin* 1989 Vinorelbine 1994 ~8 ~2 ~ Median overall survival, months Best supportive care Single-agent platinum Doublets Bevacizumab + PC *Label does not include NSCLC-specific indication Standard Therapies Food and Drug Administration. At Accessed August 28, 2006.; National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology. Non-small cell lung cancer v Accessed August 28, Schrump et al. Non-small cell lung cancer. In: Cancer: Principles and Practice of Oncology. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005.

3 HER2 EGFR mutants ALK ROS/RE T b-raf K-ras K-ras Adeno LCC/NOS SCC SCLC Courtesy G Scagliotti

4 THE FIRST HIT ON HISTOLOGY Sandler NEJM 2006

5 THE SECOND HIT ON HISTOLOGY Scagliotti JCO 2008

6 MAINTENANCE TREATMENT Paz Ares JCO 2013

7 THE DRIVERS OF CHOICE PS 0 PS 1 Reck JTO JCO 2014 pemetrexed PS 0: 17.2 months versus placebo PS 0: 12.9, p = 0.059; pemetrexed PS 1: 12.9 months versus placebo PS 1: 10.7, p = 0.121

8 Benefit of first-line EGFR TKIs: 9 randomized phase III studies

9 Solomon BJ 2014 Crizotinib in first line

10 Second-line options for metastatic NSCLC in 2015 EGFR Mut+ pretreated front-line with EGFR- TKIs ALK+ pretreated front-line with crizotinib EGFR WT/ALKnonsquamous EGFR WT/ALKsquamous Consider clinical trials with new irreversible inhibitors Consider clinical trials with new inhibitors Consider platinum re-challenge or clinical trials Platinum doublet + bevacizumab OR platinum + pemetrexed +/- bevacizumab Ceritinib or Platinum + pemetrexed +/- bevacizumab Erlotinib or Pemetrexed or Docetaxel Erlotinib or Docetaxel

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16 Randomize 1:1 CheckMate 017 (NCT ) - Study Design Primary Endpoint: Stage IIIb/IV SQ NSCLC 1 prior platinum doublet-based chemotherapy ECOG PS 0 1 Pre-treatment (archival or fresh) tumor samples required for PD-L1 analysis N = 272 Nivolumab 3 mg/kg IV Q2W until PD or unacceptable toxicity n = 135 Docetaxel 75 mg/m 2 IV Q3W until PD or unacceptable toxicity n = 137 OS Additional Endpoints: Investigator-assessed ORR Investigator-assessed PFS Correlation between PD-L1 expression and efficacy Safety Quality of life (LCSS) Patients stratified by region and prior paclitaxel use One pre-planned interim analysis for OS At time of DBL (December 15, 2014), 199 deaths were reported (86% of deaths required for final analysis) The boundary for declaring superiority for OS at the pre-planned interim analysis was P <0.03 LCSS = Lung cancer symptom scale Brahmer J, et al. NEJM 2015

17 OS (%) CheckMate 017: Overall 12-month OS rate = 24% Survival 12-month OS rate = 42% 18-month OS rate = 28% 18-month OS rate = 13% mos, months (95% CI) Nivolumab n = (7.33, 12.62) Docetaxel n = (5.29, 7.39) # events HR = 0.62 (0.48, 0.81); P = Nivolumab Docetaxel 33 Number of Patients at Risk Time (months) Nivolumab Docetaxel Based on August 2015 DBL. Minimum follow-up for survival: 18 months mos = median overall survival. Symbols refer to censored observations. Reckamp K, et al. Presented at the 16th World Conference on Lung Cancer; September 6 9, 2015; Denver, Colorado, USA. Oral

18 Randomize 1:1 CheckMate 057 (NCT ) Study Design Stage IIIB/IV non-sq NSCLC Pre-treatment (archival or recent) tumor samples required for PD-L1 ECOG PS 0 1 Failed 1 prior platinum doublet Prior maintenance therapy allowed a Prior TKI therapy allowed for known ALK translocation or EGFR mutation N = 582 Nivolumab 3 mg/kg IV Q2W until PD or unacceptable toxicity n = 292 Docetaxel 75 mg/m 2 IV Q3W until PD or unacceptable toxicity n = 290 Primary Endpoint OS Additional Endpoints ORR b PFS b Safety Efficacy by tumor PD-L1 expression Quality of life (LCSS) Patients stratified by prior maintenance therapy and line of therapy (second- vs third-line) PD-L1 expression measured using the Dako/BMS automated IHC assay 14,15 Fully validated with analytical performance having met all pre-determined acceptance criteria for sensitivity, specificity, precision, and robustness a Maintenance therapy included pemetrexed, bevacizumab, or erlotinib (not considered a separate line of therapy); b Per RECIST v1.1 criteria as determined by the investigator. Paz-Ares L, et al. ASCO 2015

19 CheckMate 057 (NCT )- OS Nivolumab (n = 292) Docetaxel (n = 290) mos, mo HR = 0.73 (96% CI: 0.59, 0.89); P = H. Borghaei, L. Paz-Ares, N Engl J Med Sep 27

20 Anti PD1/PD-L1 agents: open questions How to select patients? Clinical characteristics? PD-L1 expression or other biomarkers? Treatment duration Best tool(s) to assess drug activity? Patient communication

21 AURA (AZD9291): best % change in target-lesion size Janne PA, NEJM 2015

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23 Alectinib: Best systemic and best tumor response ORR = 55% Gadgeel SM et al; Lancet Oncology 2014; 15: For personal use only

24 Second-line options for metastatic NSCLC in 2016 EGFR Mut+ pretreated front-line with EGFR- TKIs ALK+ pretreated front-line with crizotinib EGFR WT/ALK- /ROS1- nonsquamous Squamous Consider clinical trials with new irreversible inhibitors Consider clinical trials with new inhibitors Consider platinum re-challenge or clinical trials NIVOLUMAB Osimertinib (T790M+) Ceritinib or alectinib DOCETAXEL +ANTIANGIO GENIC AGENTS NIVOLUMAB

25 Benchè i dottori lo curassero, gli cavassero sangue e gli facessero prendere molte medicine, tuttavia guarì. LEV NIKOLAEVIC TOLSTOJ

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