Immuno-Oncology (IO) in Non-Small Cell Lung Cancer (NSCLC)A clinical review of the competitive landscape, approved therapies, trial outcomes and experienced investigators in this highly targeted space.

Top 10 Sponsors of Active IO NSCLC Trials

Trial Breakdown by Phase and Status

Where are these trials taking place?

The Competitive Landscape

Source: Trialtrove® September 2018

LOCATIONS NUMBER OF TRIALSUnited States 344Spain 107Canada 91France 90Japan 81Australia 80United Kingdom 77South Korea 70Germany 69Italy 65China 63Netherlands 52Taiwan 46Belgium 45Poland 37

10

92

81

51

39

30

18

18

1714

Bristol-Myers SquibbMerck & Co.RocheAstraZenecaOno Pharmaceutical

IncyteNovartisPfizerEli LillyCelgene

200

150

100

50

0

Tria

l cou

nt

Planned Open Closed

I I/II II II/III III III/IV IV

Bristol-Myers Squibb and Merck are the leading

sponsors of active IO NSCLC trials, as developers of the top PD-1 inhibitors, Opdivo

and Keytruda

Trial activity is primarily in three major geographical regions: North America, Europe and Asia. Trials

conducted in recent years have seen a slight

shift towards the East

87% of all industry-sponsored, ongoing or

planned IO NSCLC trials are early stage

(Phase I–II)

**Pipeline investment is predominantly focused on PD-1 agents with IDO inhibition being trialed as a new IO approach

95Opdivo

71Keytruda

39Tecentriq

27Imfinzi

21Yervoy

What are the top 5 approved IO therapies, ranked by number of active NSCLC studies?

PD-1 antagonist CTLA-4 antagonistPD-L1 antagonist

Source: Trialtrove® September 2018

Major takeaways from trial outcomes:

Trials evaluating PD-1/PD-L1 inhibitors represent 84% of all IO NSCLC trials

PD-1 and PD-L1 antagonist therapies dominate the leading approved drugs based on the number of active trials for NSCLC

Out of 37 trials in Trialtrove with confirmed outcomes, 29 achieved positive results, three of which completed early due to positive outcomes (CheckMate-078, Keynote-024 and Keynote-189).

Lack of efficacy was the main reason for trial failures: four primary endpoint misses and two early terminations. Additionally, two trials were terminated due to safety findings.

Global Distribution of Sitetrove Investigators

South America: 177 (3.5%)

North America: 2382 (47%)

Africa: 3 (<.01%)

Western Asia/Middle East:

35 (.7%)

AsiaPAC: 963 (19%)

Eastern Europe: 294 (5.8%)

Western Europe: 1216 (24%)

38% of these investigators are *not* currently tied to an ongoing or planned IO NSCLC trial and may be suitable candidates to take on new trials in this space

Source: Sitetrove® September 2018

5070 investigators are experienced in industry-sponsored IO NSCLC trials, globally.o More than half of these investigators are located in the Americas alone,

while the remainder are largely spread across Europe and AsiaPAC.o Less than 1% of these investigators fall within Western Asia,

the Middle East and Africa.

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