2. NSCLC Background
Non Small Cell Lung Cancer (NSCLC) Disease Overview
Lung cancer remains the leading cause of cancer-related deaths.1
Every year, more than 2.2 million people are diagnosed with lung cancer
globally – up to 85% with non-small cell lung cancer (NSCLC).1,2
Early detection of NSCLC can change the treatment pathway for patients
and increase the options available.3
3. PD-L1 Background
PD-L1 Expression in NSCLC
• PD-L1 expression on tumour cells and immune cells has been shown in
clinical studies to inform about the enhanced likelihood to benefit from PD-
L1/PD-1 therapies.4-7
• PD-L1/PD-1 therapies have demonstrated progression-free survival (PFS),
objective response rate (ORR), and overall survival (OS) benefits in NSCLC and
several other indications.4-7
• NSCLC remains a significant clinical and economic burden globally, and there
is a need for additional treatment options.8-10
• VENTANA PD-L1 assays are validated to inform about the likelihood and
degree of potential patient benefit from specific PD-L1/PD-1 therapies.4,11-13
4. NSCLC Disease Overview
Stage at diagnosis
Tumor is more than 3cm but not
more than 4cm, has not spread to
lymph nodes
Stage I
Tumor is more than 5cm but not
more than 7cm, may have spread to
the lymph nodes
Stage II
Tumor has spread to lymph nodes
and possibly other nearby structures
or organs
Stage III
Tumor has spread to the other lung,
heart, and possibly distant organs
Stage IV
Previous PD-L1 approvals focus on Stage IV (metastatic) cancers.
• This includes VENTANA PD-L1 (SP142) Assay in mNSCLC.
The IMpower010 clinical study focused on (early) cancers Stage IB through Stage IIIA.
5. Background
Expanding PD-L1 testing into early NSCLC represents a unique opportunity
More than half of those diagnosed with NSCLC are
diagnosed at an early or locally advanced stage (Stage I-III),
where the cancer has not spread outside the lungs and
nearby lymph nodes.14,15
About half of all people with early lung cancer experience a
cancer recurrence following surgery.16
Stage I
26%
Stage II
9%
Stage III
25%
Stage IV
40%
Stage at Diagnosis
6. NSCLC Disease Overview
TECENTRIQ changes the treatment pathways for eNSCLC
Current
Standard of Care
New Treatment
Pathway
TECENTRIQ treatment takes place in the adjuvant setting since the therapy is provided following
surgery and chemotherapy.
9. IMpower010
A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody)
Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely
Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Patients
(inclusion criteria)
• N=1280
• Complete resection (surgery) of tumor
• Stage IB-IIIA tumor
• Tumor tissue for PD-L1 analysis
TECENTRIQ
Best
Supportive
Care
R
Primary endpoints:
Disease Free Survival:
• PD-L1 TC ≥1% stage II-IIIA population
• All-randomized stage II-IIIA population
• ITT population (stage IB-IIIA)
Secondary endpoints:
• Overall Survival (OS) in ITT population
• DSF in PD-L1 TC ≥50% stage II-IIIA
population 3-y and 5-y DFS in all 3
populations
Cisplatin-based
chemotherapy
Additional clinical trial design details are available here.
10. TECENTRIQ
Outcome data is favorable for patients with PD-L1 expression ≥1% TC
DFS Kaplan-Meier Plot for the Subpopulation of Patients with
Stage II-IIIA NSCLC and PD-L1 (SP263) TC Expression Level
• 60% of patients receiving TECENTRIQ were
disease-free at 3 years vs 48% with best
supportive care
• 34% reduction in risk of disease recurrence
or death
(HR=0.66*; 95% CI, 0.50, 0.88; P=0.004; median follow-up ~32 months)
11. TECENTRIQ® (atezolizumab)
Intended Use Statement
TECENTRIQ (atezolizumab)
checkpoint inhibitor therapy - humanized anti-PD-1 monoclonal antibody that competitively inhibits
the PD-1 receptor and blocks ligand binding (PD-L1 and PD-L2)
from Roche
Indication
TECENTRIQ, as a single agent, is indicated as adjuvant treatment following resection and platinum-based
chemotherapy for patients with NSCLC whose tumors have PD-L1 expression on ≥1% of tumor cells, as
detected by an FDA-approved test.
12. NSCLC Overview
Guidelines will support PD-L1 testing in eNSCLC
• eNCSLC PD-L1 testing is included in the NCCN Clinical Practice Guidelines in
Oncology.
• The update was following the TECENTRIQ eNSCLC product launch
• To view the most recent and complete version of the guidelines, go online to
www.NCCN.org.
