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The Latest in Immuno-Oncology: A Deep Dive into Non-Small Cell Lung Cancer (NSCLC)

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    Report

  • 41 Pages
  • October 2018
  • Region: Global
  • Citeline
  • ID: 4775311
Highlights:
  • New therapies are emerging that harness the immune system to treat cancer, with the PD-1/L1 inhibitor class at the forefront

  • Trial activity within NSCLC is particularly intense, as Opdivo and Keytruda consolidate their leading positions with additional studies, particularly as backbone therapies

  • Clinical successes are driving high patient demand for IO trials, resulting in shorter enrollment durations

  • PD-1/L1 inhibitors are outperforming other IO drug classes on a variety of clinical benchmarks

  • $18bn opportunity within NSCLC for the PD-1/L1 inhibitor class, as it transforms the treatment algorithm

  • Varying approaches to combination strategies will allow developers to differentiate within the class

  • Ongoing biomarker validation work will help to further segment patients and optimize treatment

Table of Contents

OVERVIEWABOUT THE AUTHORS
IMMUNO-ONCOLOGY OVERVIEW
Immuno-oncology mechanisms and timelines
PD-1 and PD-L1 inhibition
CLINICAL TRIAL LANDSCAPE
Active trials
Therapies in competitive trials
Trends in trial durations
Trial outcomes
CLINICAL DEVELOPMENT BENCHMARKS
Development landscape
Probability of success, likelihood of approval, and time to market
COMMERCIAL MARKET POTENTIAL
Patient potential
Competitive landscape
Market forecast
CHALLENGES AND EMERGING DYNAMICS
Differentiation and combinations in the PD-1/L1 class
PD-L1 and TMB as biomarkers
Upcoming catalysts
BIBLIOGRAPHY
LIST OF FIGURES
Figure 1: Timeline for first approvals of IO drugs in the US, 2010–18
Figure 2: PD-L1 expression by tumor cells to evade immune system
Figure 3: Competitive PD-1/L1 trials by phase and status
Figure 4: Trials of IO agents in NSCLC initiated from 2013–18
Figure 5: Top 10 sponsors of competitive IO NSCLC trials
Figure 6: Top five approved and unapproved IO therapies, ranked by number of active NSCLC trials
Figure 7: Ongoing or planned combination trials of IO agents in NSCLC
Figure 8: Average trial enrollment and treatment periods for NSCLC IO trials, 2008–18
Figure 9: Outcomes of NSCLC IO trials, 2013–18
Figure 10: Development status of PD-1/L1 agents in oncology
Figure 11: Phase transition benchmarks of the leading IO drug classes
Figure 12: Development timelines for PD-1/L1 in NSCLC, by clinical stage
Figure 13: Incident cases of NSCLC in the US, Japan, and five major EU markets, by country, 2017–37
Figure 14: Treatment snapshot and patient segmentation for NSCLC
Figure 15: Treatment algorithm for advanced or metastatic NSCLC in the US
Figure 16: Comparative assessment of PD-1/L1 inhibitors in NSCLC
Figure 17: NSCLC sales across the US, Japan, and five major EU markets, by drug class, 2017–26
Figure 18: PD-1/L1 inhibitor sales in NSCLC across the US, Japan, and five major EU markets, 2017–26
Figure 19: Potential near-term segmentation of first-line NSCLC patients
Figure 20: TMB trials ranked by top five industry sponsors, primary drugs, indications, and status
Figure 21: Expected repositioning of the PD-1/L1 class by January 2020
LIST OF TABLES
Table 1: Average trial enrollment and treatment periods for NSCLC IO trials, by phase, 2013–18
Table 2: High-impact catalysts for IO therapies in the NSCLC market, 2018–19