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Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of Clinical Medicine- F.Todua Medical Center Department of Oncology and Hematology (Tbilisi, Georgia)

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Page 1: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and

Others

Ivane Kiladze,MDResearch Institute of Clinical Medicine- F.Todua

Medical CenterDepartment of Oncology and Hematology (Tbilisi,

Georgia)

Page 2: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Disclosure

• No conflicts of interest

Page 3: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Advanced Studies in Lung Cancer Program for phD

Page 4: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Agenda

❑ Introduction

❑ Immunotherapy (IO) for resectable NSCLC

❑ Update in the treatment of locally advanced NSCLC

❑ First-line IO for metastatic disease

❑ Second-line IO

❑ Immunotherapy in EGFR/ALK-positive patients

❑ Progression after 1st line IO with or without chemo

❑ Conclusions

Page 5: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Introduction

➢ Statistics in 2012 identified lung cancer as the most common

cancer worldwide contributing 13% of the total number of new

cases

➢ Worldwide more than 1 in 10 of all cancers diagnosed in men

are lung cancers

➢ Lung cancer is the leading cause of cancer-related deaths

worldwide

➢ Properly staging the extent of disease at diagnosis influences

the approach to treatment and prognosis

➢ Despite ostensibly curative therapy for stage I–III NSCLC,

30–60% of patients go on to develop metastatic disease

➢ Very heterogeneous diseaseHowlader N et al, SEER Cancer Statistics Review (CSR) 2017 Jemal A et al. Global cancer statistics. CA Cancer J Clin 2011

Page 6: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Lung Cancer Statistics

Page 7: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Lung Cancer Mortality

Siegel et al. CA 2018

Page 8: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Staging

Page 9: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Stage at Diagnosis

Page 10: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Late diagnosis

Page 11: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Molecular classification starts with

histology

www.mh-hannover.de/35818

Page 12: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Why do we care about the molecular classification?

Page 13: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 14: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

The issue is the Tissue!

Page 15: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

From tissue to molecular signaling

Hannavan and Weinber, Cell 2000

Page 16: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

MDT Team

Page 17: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Milestones in targeted therapy for NSCLC

J.Rotow and T.G. Bivona, Nature Reviews Cancer.2017

Page 18: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Surgery

Page 19: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Neoadjuvant Immunotherapy for resectable disease

Page 20: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

✓Neoadjuvant nivolumab well tolerated and did not delay surgery.

✓SD (18/21, 85%), PR- 2 (10%), PD 1 (5%)

✓A major pathological response

(<10% viable tumour cells in resection specimen) was achieved in 9/20 (45%)

completely resected patients

(independently of PD-L1 expression)

Page 21: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Locally advanced NSCLC

Page 22: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

RTOG 06-17 Trial

Page 23: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

RTOG 06-17 Trial

Page 24: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 25: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 26: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Results:PFS

Page 27: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 28: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 29: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 30: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 31: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Metastatic Disease

Page 32: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Targeted agents in NSCLC

Page 33: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Targeted Therapy

JAMA2014; 311(19)

Page 34: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

TKIs in EGFR-mutated NSCLC

Ferrara et al, JTO, 2017

Page 35: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

PFS with 1st and next-generation ALK-TKIs

Page 36: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Facts: death rates falling

• Death rates due to cancer fell by only 8% between 1950 and 2012.

• By 67% in the case of heart disease

• By 77% for cerebrovascular diseases

• By 66% for pneumonia and influenza.

Filipovich A. Cancer World 2017

Page 37: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Immunotherapy

Page 38: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Immunity against cancer

Theory of immune surveillance in tumor immunology

The immune system recognizes tumor Ag as “foreign” and rejects emerging cancer cells continuously

“Cancer develops if an Imbalance

between host immune response and

the tumor environment occurs”

Br. Med. J. 1957

Page 39: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

The vertebrate immune system

Page 40: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Innate and Adaptive immune systems

Page 41: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

T-cells are essential to immunological control of cancer

Page 42: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

T-cell activation requires 1+3 signals

Page 43: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Timeline of cancer immunotherapy

Page 44: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Checkpoint Inhibitors

Page 45: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

IMMUNOTHERAPY

Page 46: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Update in the treatment of lung cancer

'End of an Era' for Chemo in Non-Small Cell

Lung Cancer ?

Page 47: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Brahmer JR, et al. ASCO2017

Page 48: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

KEYNOTE-024: PFS and OS

Page 49: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Conclusions

Page 50: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

ASCO 2018

Page 51: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 52: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

KEYNOTE-042: Study Design

Page 53: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Overall Survival

Page 54: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Overall Survival

Page 55: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

KEYNOTE-042: OS in Subgroups of PD-L1 TPS >1% Population

Page 56: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

KEYNOTE-042: Safety in All Treated Patients

Page 57: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 58: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Immunotherapy+anti-VEGFR+ChT

Socinski MA, et al ASCO 2018

Page 59: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of
Page 60: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Second line immunotherapy

Page 61: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

EGFR-positive NSCLC

Lee CK, et al. J Thoracic Oncol.2017; Lee CK, et al. JAMA Oncol. 2018; Borgaei H, et al N England J Med, 2015; Herbst RS, et al Lancet 2016; Gainor JF, et al ClinCancer Res. 2016; Cho JH, et al. Cancer Res Treat 2018

Page 62: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

EGFR-positive NSCLC

Page 63: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Progression after Immunotherapy

Page 64: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Progression after Immunotherapy

Page 65: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

TMB in Lung Cancer

Schumacher and Schreiber, Science 2015

Page 66: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Is PDL>1% a selection criterion in II line treatment?

Borghaei H, et al. ASCO 2018.

Page 67: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Borghaei H, et al. ASCO 2018

Page 68: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Not only CTLA-4 and PD-1/PD-L1

Page 69: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Need of patient selection

• Selection by PD-L1 expression

• Selection by Tumor Mutation Burden (TMB)

• Clinical Criteria

Page 70: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Unanswered Questions

➢Are there some patients for whom

immunotherapy with chemotherapy is superior

to immunotherapy alone?

➢Are combinations of immunotherapy going to

be superior to a single agent?

➢How do we integrate targeted agents?

➢How do we deal with tumors once they've

progressed after PD-1 monotherapy?

Page 71: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

New Trials in NSCLC

Roberto Ferrara et al. 2017 Scientific Advances in Thoracic Oncology

Page 72: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

IMMUNE-Mediated Adverse Events

Page 73: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Epilogue: How Immunotherapy has changed a patient’s life

2014 2015

2016 2018

Page 74: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Conclusions:

❑ Immunotherapy with immune checkpoints inhibitors has changed the way we treat and will treat many cancers, including NSCLC and (hopefully) SCLC.

❑ Response to ICI is related to the balance between innate (myeloid cells) and adaptive (T lymphocytes) immunity

❑ More research is needed on predictive factors (PDL1, TMB) in order to extend the benefit of ICI.

❑ Combinations of ICIs, combinations of PD-1/PD-L1 inhibitors with chemo and radiotherapy, and dual blockade of IC and VEGF pathways are promising strategies

❑ Beware of toxicities, mainly with combo regimens

❑ Many trials ongoing and in preparation

Page 75: Novel Approaches in Non-Small Cell Lung Cancer ... 2018/21 Eylul...Novel Approaches in Non-Small Cell Lung Cancer - Immunotherapy and Others Ivane Kiladze,MD Research Institute of

Acknowledgments


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