Stato dell arte dell immunoterapia. Il Paziente con NSCLC Francesco Ferraù Oncologia Medica Ospedale S.Vincenzo, Taormina
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1 I CONVEGNO REGIONALE SIFO MEETING DI PRIMAVERA IL FARMACISTA CLINICO E I NUOVI MODELLI DI CURA Taormina, 11/12/13 maggio 217 Stato dell arte dell immunoterapia. Il Paziente con NSCLC Francesco Ferraù Oncologia Medica Ospedale S.Vincenzo, Taormina
2 Possibilità terpeutiche per personalizzare la terapia nel Paziente con NSCLC Chemotherapy Targeted Therapy Checkpoint Inhibitors Histologic subtyping for chemotherapy Genomicsdriven TKIs: EGFR ALK ROS1 Anti PD-1 Anti PD-L1 Anti CTLA-4 Qual è il setting ottimale per il giusto trattamento nel giusto Paziente (prima linea, seconda linea, linee successive)?
3 CTLA-4 and PD-1/PD-L1 Checkpoint Blockade for Cancer Treatment Priming phase (lymph node) Effector phase (peripheral tissue) Dendriti c cell T-cell T-cell migration T-cell Cancer cell MH C TC R TC R MH C PD-1 mabs: Nivolumab Pembrolizumab CTLA-4 mabs: Ipilimumab Tremelimumab Dendriti c cell B7 CD 28 CTLA -4 T-cell T-cell PD -1 PD-L1 Cancer cell PD-L1 mabs: Atezolizumab Avelumab Durvalumab Ribas A. N Engl J Med. 212;366:
4 Frequently asked questions: Check mechanism point of action inhibitors augments T-Cell The mechanism of action of ipilimumab differs from those activation of traditional chemotherapy or small-molecule inhibitors, CTLA-4 were developed as anticancer therapies under the theory that through blockade of the CTLA-4-mediated inhibitory signal, the activity of T-cells may be activated against tumor antigens and their activity harnessed for treatment of cancer. 3,13 A T-cell activation T-cell inhibition T-cell remains activ ated CTLA-4 Activation TCR CD28 Activation TCR CD28 CTLA-4 Inhibition Activation TCR CD28 CTLA-4 Activation MHC APC B7 MHC APC B7 MHC B7 APC Ipilimumab blocks CTLA-4 B TCR: MHC antigen CD28: B7 CTLA-4: B7 lpilimumab T-cell activation T-cell inhibition CTLA-4 blockade/ T-cell proliferation Figure 1 (A and B) Role of CTLA-4 in T-cell responses and the impact of CTLA-4 blockade with ipilimumab. Ipilimumab mechanism of action (A) and brake and pedal analogy (B) as used to explain the mechanism to patients and caregivers. Abbreviations: CTLA, cytotoxic T-lymphocyte antigen; APC, antigen-presenting cell; MHC, major histocompatibility complex; TCR, T-cell receptor. Ledezma B, Cancer Manag Res 214
5 KEYNOTE-24: Pembrolizumab vs CT as First-line Therapy for Advanced NSCLC Open-label phase III trial Stratified by ECOG PS ( vs 1), histology (squamous vs nonsquamous), and enrollment region Pts with stage IV NSCLC and ECOG PS /1, no previous systemic therapy, no actionable EGFR/ALK mutations, and PD- L1 TPS 5%* (N = 35) Pembrolizumab 2 mg IV Q3W for up to 35 cycles (n = 154) Chemotherapy (histology based) for up to 6 cycles (n = 151) Until PD or unacceptable toxicity Until PD (crossover to pembrolizumab allowed) Primary endpoint: PFS Secondary and exploratory endpoints: ORR, OS, DoR, and safety Reck M, et al. N Engl J Med. 216;375:
6 PFS (%) OS (%) KEYNOTE-24: Survival Outcomes PFS OS Pembro (n = 154) CT (n = 151) Pembro (n = 154) CT (n = 151) Median PFS, mos HR (95% CI).5 ( ); P < Mos Reck M, et al. N Engl J Med. 216;375: Median OS, mos NR NR HR (95% CI).6 ( ); P = Mos 21 Slide credit: clinicaloptions.c
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9 CheckMate-26: Nivolumab vs CT in First-line Therapy for Advanced NSCLC Stratified by PD-L1 expression (< 5% vs 5%) and histology (squamous vs nonsquamous) Pts with stage IV/recurrent NSCLC, no previous systemic therapy, no actionable EGFR/ALK mutations, PD-L1 expression 1%* (N = 541) * 1% tumor cell staining using 28-8 complementary diagnostic IHC assay. Primary endpoint: PFS ( 5% PD-L1 positive) Nivolumab 3 mg/kg IV Q2W (n = 271) Chemotherapy (histology based) for up to 6 cycles (n = 27) Until PD or unacceptable toxicity Until PD (crossover to nivolumab allowed) Secondary endpoints: PFS ( 1% PD-L1 positive), ORR, OS Socinski M, et al. ESMO 216. Abstract LBA7_PR. Slide credit: clinicaloptions.c
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12 IMMUNOTERAPIA DI PRIMA LINEA NEL NSCLC NEL TUMORE POLMONARE NON MICROCITOMA LE EVIDENZE DI LETTERATURA INDICANO CHE PEMBROLIZUMAB E SUPERIORE ALLA CHEMIOTERAPIA NIVOLUMAB NON E SUPERIORE ALLA CHEMIOTERAPIA PEMBROLIZUMAB E NIVOLUMAB SONO MEGLIO TOLLERATI DELLA CHEMIOTERAPIA MAGGIO 217: PEMBROLIZUMAB HA INDICAZIONE MA NON RIMBORSABILITA PER NSCLC IN PRIMA LINEA
13 Impact of Tumor Mutation Burden on the Efficacy of First- Line Nivolumab in Stage IV or Recurrent Non-Small Cell Lung Cancer: An Exploratory Analysis of CheckMate 26 Solange Peters, 1 Benjamin Creelan, 2 Matthew D. Hellmann, 3 Mark A. Socinski, 4 Martin Reck, 5 Prabhu Bhagavatheeswaran, 6 Han Chang, 6 William J. Geese, 6 Luis Paz-Ares, 7 David P. Carbone 8 1 Oncology Department, Lausanne University Hospital, Lausanne, Switzerland; 2 H. Lee Moffitt Cancer Center, Tampa, FL, USA; 3 Memorial Sloan Kettering Cancer Center, New York, NY, USA; 4 Florida Hospital Cancer Institute, Orlando, FL, USA; 5 LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany; 6 Bristol-Myers Squibb, Princeton, NJ, USA; 7 Hospital Universitario Doce de Octubre, CNIO and Universidad Complutense, Madrid, Spain; 8 Ohio State University Comprehensive Cancer Center, Columbus, OH, USA
14 PFS (%) PFS by Tumor Mutation Burden Tertile CheckMate 26 TMB Analysis: Nivolumab in First-line NSCLC Nivolumab Arm Chemotherapy Arm Median PFS, months (95% CI) Low n = (1.5, 5.6) Medium High n = 49 n = (2.7, 6.9) (5.1, NR) Median PFS, months (95% CI) Low n = (5.4, NR) Medium High n = 53 n = (4.3, 8.6) (4.2, 8.5) High 4 Low Low 2 1 High Medium Medium Months Months Data for patients with low and medium TMB were pooled in subsequent analyses
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19 Grade of toxicity Kinetics of Appearance of iraes Diarrhea, colitis Rash, pruritus Hypophysitis Liver toxicity Time course (weeks) Weber JS, et al. J Clin Oncol 212;3:2691 7
20 LA CHEMIOTERAPIA NELLO SCENARIO TERAPEUTICO ATTUALE DEL NSCLC 2% 8% LA CHEMIOTERAPIA NEL NSCLC : ALIVE AND WELL
21 CheckMate 17 and 57: Nivolumab vs Docetaxel in Previously Treated Advanced NSCLC Open-label, randomized phase III trials CheckMate 17: Squamous NSCLC CheckMate 57: Nonsquamous NSCLC Pts with stage IIIB/IV squamous NSCLC and ECOG PS -1 with failure of 1 previous platinum doublet chemotherapy (N = 272) Nivolumab 3 mg/kg IV Q2W (n = 135) Docetaxel 75 mg/m 2 IV Q3W (n = 137) Primary endpoint: OS Until disease progression or unacceptabl e toxicity Pts with stage IIIB/IV nonsquamous NSCLC and ECOG PS -1 who failed 1 prior platinum doublet chemotherapy ± TKI therapy (N = 582) Nivolumab 3 mg/kg IV Q2W (n = 292) Docetaxel 75 mg/m 2 IV Q3W (n = 29) Until disease progression or unacceptabl e toxicity Secondary endpoints: ORR, PFS, efficacy by PD-L1 expression, safety, QoL Brahmer J, et al. N Engl J Med. 215;373: Borghaei H, et al. N Engl J Med. 215;373: Slide credit: clinicaloptions.com
22 OS (%) OS (%) CheckMate 17 and 57: OS With a Minimum 2-Yr Follow-up 1 CheckMate 17: Squamous Nivo (n = 135) Docetaxe l (n = 137) 1 CheckMate 57: Nonsquamous Nivo (n = 292) Docetaxe l (n = 29) 8 Median OS, mos Median OS, mos yr OS, % yr OS, % yr OS, % yr OS, % HR (95% CI).62 (.47-.8) HR (95% CI).75 ( ) Nivolumab Docetaxel Nivoluma b Docetaxel Mos Mos Borghaei H, et al. ASCO 216. Abstract 925. Slide credit: clinicaloptions.com 22
23 KEYNOTE-1: Pembrolizumab vs Docetaxel in Advanced PD-L1 Positive NSCLC Multicenter, randomized, open-label phase II/III trial Pts with advanced NSCLC who progressed after platinum-based chemotherapy (and TKI if EGFR+ or ALK+); 1% PD-L1+ tumor cells; ECOG PS /1 (N = 134) Pembrolizumab 2 mg/kg IV Q3W (n = 345) Pembrolizumab 1 mg/kg IV Q3W (n = 346) Docetaxel 75 mg/m 2 IV Q3W (n = 343) Treatment continued for 24 mos or until PD or unacceptable toxicity Primary endpoints: OS, PFS Secondary endpoints: DoR, ORR, safety Herbst RS, et al. Lancet. 216;387: Slide credit: clinicaloptions.c
24 OS (%) OS (%) KEYNOTE-1: OS in Pts With PD-L1 TPS 1% and TPS 5% Pembrolizumab 2 mg/kg (n = 344) Pembrolizumab 1 mg/kg (n = 346) Pts With PD-L1 TPS 1% mos, Mos 1-Yr OS, % Docetaxel (n = 343) Mos 5 HR (95% CI).71 ( ).5 ( ) Herbst RS, et al. Lancet. 216;387: Pts With PD-L1 TPS 5% Pembrolizumab 2 mg/kg (n = 139) Pembrolizumab 1 mg/kg (n = 151) mos, Mos Docetaxel (n = 152) Mo5 s HR (95% CI).54 ( ).5 (.36-.7) Slide credit: clinicaloptions.c
25 OAK: Atezolizumab vs Docetaxel in Progressive Advanced NSCLC Multicenter, randomized, open-label phase III trial Metastatic or locally advanced NSCLC (2L/3L), PD on prior platinum-based treatment (N = 1225) Stratified by PD-L1 expression, histology, prior chemotherapy regimens Atezolizumab 12 mg IV Q3W (n = 425) Docetaxel 75 mg/m 2 IV Q3W (n = 425) No crossover allowed Until loss of clinical benefit Until PD Primary endpoints (first 85 pts enrolled): OS in ITT population; OS in pts with 1% PD-L1 expression Secondary endpoints: ORR, PFS, DoR, safety Rittmeyer A, et al. Lancet. 216;389: Slide credit: clinicaloptions.c
26 OS (%) OAK: OS in ITT Population Median: 9.6 mos (95% CI: 8.6- Landmark OS, % 12 Mos 18 Mos Atezolizumab 55 4 Docetaxel Median: 13.8 mos 11.2) (95% CI: ) Mo s HR:.73 (95% CI ; P =.3) Rittmeyer A, et al. Lancet. 217;389: Slide credit: clinicaloptions.com
27 IMMUNOTERAPIA DI LINEE SUCCESSIVE ALLA PRIMA NEL NSCLC NEL TUMORE POLMONARE NON MICROCITOMA LE EVIDENZE DI LETTERATURA INDICANO CHE NIVOLUMAB E SUPERIORE ALLA CHEMIOTERAPIA PEMBROLIZUMAB E SUPERIORE ALLA CHEMIOTERAPIA ATEZOLIZUMAB E SUPERIORE ALLA CHEMIOTERAPIA TUTTI GLI ANTICORPI SONO MEGLIO TOLLERATI DELLA CHEMIOTERAPIA MAGGIO 217: NIVOLUMAB HA INDICAZIONE E RIMBORSABILITA PER NSCLC PRETRATTATO (qualunque istologia)
28 Select Ongoing Randomized Phase III Trials of PD-1/PD-L1 Therapy in Advanced NSCLC Trial* Disease Setting Treatment CheckMate 227 (NCT ) First line Nivolumab or nivolumab + ipilimumab or nivolumab + Plt doublet CT vs Plt doublet CT KEYNOTE-42 (NCT222894) First line/pd-l1+ Pembrolizumab vs Plt doublet CT KEYNOTE-189 (NCT257868) First line (nonsq) Plt/pemetrexed ± pembrolizumab KEYNOTE-47 (NCT ) First line (sq) Cb/pac or nab-pac ± pembrolizumab IMpower 11 (NCT249342) First line/pd-l1+ Atezolizumab vs Plt doublet CT IMpower 13 (NCT ) First line (nonsq) Cb/nab-pac vs Cb/nab-pac ± atezolizumab IMpower 131 (NCT ) First line (sq) Cb/pac or nab-pac + atezolizumab vs Cb/nab-pac IMpower 132 (NCT ) First line (nonsq) Plt/pemetrexed ± atezolizumab IMpower 15 (NCT ) First line (nonsq) Atezolizumab + Cb/pac ± bev vs Cb/pac/bev JAVELIN Lung 1 (NCT ) First line/pd-l1+ Avelumab vs Plt doublet CT JAVELIN Lung 2 (NCT ) Post-CT/PD-L1+ Avelumab vs docetaxel NEPTUNE (NCT ) First line Durvalumab + tremelimumab vs Plt doublet CT *All trials enrolling pts as of February 217. Slide credit: clinicaloptions.com
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