La revolución de la inmunoterapia: dónde la posicionamos? Javier Puente, MD, PhD

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2 La revolución de la inmunoterapia: dónde la posicionamos? Javier Puente, MD, PhD Hospital Universitario Clinico San Carlos Medical Oncology Department Thoracic & Urological Cancer Unit Complutense University Associate Professor of Medicine

3 Immunotherapy in Advanced RCC: A Renewed Level of Interest? McDermott DF, et al. Sem Oncol 2013

4 Resistance to antiangiogenic therapy is associated with an Immunosuppresive tumor microenviroment in mrcc Xian-De Liu, et al. Cancer Immunol Res 2015; 3(9):

5 Resistance to antiangiogenic therapy is associated with an Immunosuppresive tumor microenviroment in mrcc Xian-De Liu, et al. Cancer Immunol Res 2015; 3(9):

6 Key Late Stage Clinical Development of PD-1 Pathway Inhibitors Agent Target Tumor Type Clinical Development Stage Nivolumab Pembrolizumab Atezolizumab (MPDL3280A) Durvalumab (MEDI4736) Avelumab PD-1 PD-1 PD-L1 Melanoma, NSCLC, RCC Hodgkin s lymphoma Bladder/urothelial, brain, gastric/gej, HCC, HNSCC, SCLC Melanoma, NSCLC mcrc (MSI-high) Breast, bladder/urothelial, gastric/gej, HNSCC, multiple myeloma Bladder/urothelial, NSCLC Breast, RCC Approved (US) Breakthrough Therapy (US) Phase III Approved (US) Breakthrough Therapy (US) Phase III Breakthrough Therapy (US) Phase III PD-L1 Bladder, NSCLC, HNSCC Phase III PD-L1 Merkel cell NSCLC, gastric, ovarian, urothelial Breakthrough Therapy (US) Phase III

7 PD-1/PD-L1 Checkpoint Inhibitors in Advanced RCC

8 Clinical Activity of Nivolumab: Phase I Experience in Multiple Tumor Types Tumor Type N Dose, mg/kg ORR (CR/PR), n (%) SD 24 Wks, n (%) Melanoma (28) 6 (6) NSCLC (18) 5 (7) RCC 33 1 or 10 9 (33) 9 (27) 28 responses (16 melanoma, 6 RCC, and 6 NSCLC) lasted 1 yr among 54 pts with treatment initiation 1 yr before data analysis 13 pts (4 melanoma, 6 NSCLC, 3 RCC) demonstrated nonconventional patterns of response but were not included as responders Topalian SL, et al. N Engl J Med. 2012;366:

9 McDermott, et al J Clin Oncol 2015 Outcomes in patients with previously treated advanced RCC receiving Nivolumab

10 Nivolumab in RCC: phase 2 data Motzer et al J Clin Oncol 2015

11 McDermott et al. ASCO 2016 Long-term OS with nivolumab in previously treated RCC (from phase I and II studies)

12 Phase III trial: Check-Mate 025 Motzer R, et al. N Engl J Med. 2015

13 PFS in Check-Mate 025 Motzer R, et al. N Engl J Med. 2015

14 OS in Check-Mate 025 (primary end-point) Motzer R, et al. N Engl J Med. 2015

15 Phase Ib study of Pembrolizumab + Bevacizumab in mrcc (BTCR-GU14-003) Dudek et al. ASCO 2016

16 Phase Ib study of Pembrolizumab + Bevacizumab in mrcc (BTCR-GU14-003) Dudek et al. ASCO 2016

17 Maximum SLD Reduction From Baseline (%) Efficacy of Atezolizumab in Advanced RCC: Phase Ia Expansion Cohort mg/kg 15 mg/kg 10 mg/kg 3 mg/kg 1200 mg Clear-cell RCC (n = 62) ORR: 15% Median PFS: 5.6 mos Median OS: 28.9 mos Similar activity in VEGF-targeted therapy naive and refractory pts McDermott DF, et al. J Clin Oncol. 2016

18 Atezolizumab in Advanced RCC: preliminary ORR in patient subgroups Pt Subgroup ORR, n (%) No previous VEGFR TKI (n = 24) 3 (13) Previous VEGFR TKI (n = 38) 6 (16) Fuhrman grade 4 and/or sarcomatoid histology (n = 18) 4 (22) Fuhrman grade 4 (n = 16) 4 (25) Sarcomatoid histology (n = 6) 2 (33) MSKCC poor risk (n = 20) 5 (25) MSKCC intermediate/favorable risk (n = 42) 4 (10) McDermott DF, et al. J Clin Oncol. 2016

19 Exploratory analysis of OS by subgroup Motzer R, et al. N Engl J Med. 2015

20 Toxicities Associated with PD- 1/PD-L1 Checkpoint inhibitors

21 CheckMate-025: Treatment-Related Aes ( 10% of Pts) AE, % Nivolumab (n = 406) Everolimus (n = 397) Any Grade Grade 3/4 Any Grade Grade 3/4 Treatment-related AEs Fatigue Nausea 14 < Pruritus Diarrhea Decreased appetite 12 < Rash 10 < Cough Anemia Dyspnea < 1 Edema peripheral < 1 Pneumonitis Mucosal inflammation Dysgeusia Hyperglycemia Stomatitis Hypertriglyceridemia Epistaxis

22 Safety in Check-Mate 025 Motzer R, et al. N Engl J Med. 2015

23 Emerging select TRAEs over time in phase II studies Motzer et al J Clin Oncol 2015

24 CheckMate-025: Change From Baseline in QoL Scores (FKSI-DRS) A clinically meaningful and statistically significant improvement in QoL was seen with nivolumab vs everolimus for the duration of the study 4 Nivolumab 2 0 Worse Better Questionnaire completion rate: 80% during the first yr of follow-up Everolimus Pts at Risk, n Nivolumab Everolimus Motzer R, et al. N Engl J Med Wks

25 CheckMate-025: Change From Baseline in QoL Scores (HR-QoL) Cella D, et al. ASCO 2016

26 PD-L1 Expression and Patient Selection in Advanced RCC

27 Cancer-Specific Survival Relevance of Tumor PD-L1 Expression in RCC Tumoral PD-L1 expression may be associated with: Impaired antitumor immunity More aggressive disease High tumor grade Shorter survival PD-L1 expression < 10% PD-L1 expression 10% Yrs From Nephrectomy to Last Follow-up Thompson RH, et al. Proc Natl Acad Sci USA. 2004;101: Thompson RH, et al. Clin Cancer Res. 2007;13: Krambeck AE, et al. Clin Cancer Res. 2007;13: Frigola X, et al. Clin Cancer Res. 2011;17:

28 CheckMate-025: OS by PD-L1 Expression Motzer R, et al. N Engl J Med. 2015

29 Differential expression of PD-L1 between primary and metastatic sites in clear cell RCC Callea M, et al. Cancer Immunol Res 2015; 3(10):

30 Differential expression of PD-L1 between primary and metastatic sites in clear cell RCC

31 Combination Therapy: Overcoming Innate/Acquired Resistance

32 Change in SLD From Baseline (%) Phase Ib Study of Atezolizumab + Bev: First-line Therapy for Advanced ccrcc Atezolizumab 20 mg/kg + Bev 15 mg/kg q3w Safety Treatment-related grade 3 AEs occurred in 3% of pts (1 case of neutropenia) No grade 4 AEs or deaths were attributed to atezolizumab Efficacy (n = 10) ORR: 40% IC 1 (2 pts), 1 pt each IC 0 or IC unknown SD 24 wks: 50% IC 3 IC 3: 10% PD-L1+ IC 2: 5% to < 10% PD-L1+ IC 1: 1% to < 5% PD-L1+ IC 0: < 1% PD-L1+. IC 1 IC 0 IC 1 IC Days on Study IC 0 IC 0 IC 1 IC Lieu C, et al. ESMO Abstract 1049O.

33 CheckMate-016: Phase I Study of Nivolumab + Ipilimumab in mrcc mrcc; no previous systemic therapy other than cytokine therapy for mrcc or 1 prior adjuvant/neoadjuvant therapy with recurrence 6 mos after last treatment (N = 100) Primary endpoint: Safety Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg IV q3w x 4 doses (n = 47) Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg IV q3w x 4 doses (n = 47) Nivolumab 3 mg/kg + Ipilimumab 3 mg/kg IV q3w x 4 doses (n = 6) Secondary endpoints: ORR, DoR, PFS, OS Nivolumab 3 mg/kg IV q2w Hammers H, et al. ASCO Abstract 4516.

34 CheckMate-016: Response Outcomes Tumor Response, n (%) Nivo 3 mg/kg + Ipi 1 mg/kg (n = 47) Nivo 1 mg/kg + Ipi 3 mg/kg (n = 47) Nivo 3 mg/kg + Ipi 3 mg/kg (n = 6) ORR 18 (38.3) 19 (40.4) 0 CR 4 (8.5) 1 (2.1) 0 PR 14 (29.8) 18 (38.3) 0 SD 17 (36.2) 17 (36.2) 5 (83.3) Median duration of response: Nivolumab 3 mg/kg + ipilimumab 1 mg/kg: 67.7 wks (range: ) Nivolumab 1 mg/kg + ipilimumab 3 mg/kg: 81.1 wks (range: ) Hammers H, et al. ASCO Abstract 4516.

35 CheckMate-016: Select Treatment-Related AEs AE, n (%) Nivo 3 mg/kg + Ipi 1 mg/kg (n = 47) Nivo 1 mg/kg + Ipi 3 mg/kg (n = 47) Nivo 3 mg/kg + Ipi 3 mg/kg (n = 6) Any Grade Grade 3/4 Any Grade Grade 3/4 Any Grade Grade 3/4 Skin disorder 18 (38.3) 0 24 (51.1) 1 (2.1) 3 (50.0) 0 GI disorder 11 (23.4) 1 (2.1) 21 (44.7) 11 (23.4) 3 (50.0) 2 (33.3) Endocrinopathy 11 (23.4) 1 (2.1) 20 (42.6) 0 5 (83.3) 0 Hepatic 7 (14.9) 2 (4.3) 15 (31.9) 10 (21.3) 3 (50.0) 0 Renal disorder 5 (10.6) 1 (2.1) 7 (14.9) 1 (2.1) 2 (33.3) 0 Infusion reaction 4 (8.5) 0 3 (6.4) 0 1 (16.7) 0 Pulmonary 2 (4.3) 0 3 (6.4) Hammers H, et al. ASCO Abstract 4516.

36 Nivolumab plus Sunitinib/Pazopanib

37 Nivolumab plus Sunitinib/Pazopanib Hans Hammers at Genitourinary Cancers Symposium 2016

38 Long Term Responders: PD1 vs PD1/TKI vs PD1/CTLA4 (CAUTION!!!)

39 Ongoing Trials of PD-1/vaccines + VEGF Pathway Blockade in Advanced RCC Agent Phase Intervention Anti-PD1 Nivolumab III Nivolumab + ipilimumab vs sunitinib (CheckMate 214) (NCT ) Pembrolizumab I/II Pembrolizumab +/- Pazopanib (NCT ) Ib Pembrolizumab + Axitinib (NCT ) Ib/II Pembrolizumab + Bevacizumab (NCT ) Anti-PD-L1 Atezolizumab II Atezolizumab ± bevacizumab vs sunitinib (RAPID) (NCT ) III Atezolizumab + bevacizumab vs sunitinib (IMmotion) (NCT ) Avelumab III Avelumab + axitinib vs sunitinib (JAVELIN Renal 101) (NCT ) Cancer vaccines AGS-003 III AGS sunitinib vs sunitinib (ADAPT) (NCT )

40 EAU Guidelines for ccrcm Ljungberg al. EAU guidelines. Available online

41 Conclusions Single-agent PD-1 pathway blockade is efficacious in advanced RCC Nivolumab is approved for pts following progression on antiangiogenic therapy Vigilance for iraes by the entire healthcare team and well-educated pts along with rapid intervention is key to optimal management Biomarkers that predict response are being investigated Tumor grade and mutational load may add value Combination regimens appear to improve outcomes at a cost of increased toxicity Management algorithms will need to be refined Vaccine strategies likely need more work

42 THANK YOU Javier Puente, MD, PhD Hospital Universitario Clinico San Carlos Medical Oncology Department Thoracic & Urological Cancer Unit Complutense University Associate Professor of

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