Atezolizumab in first line metastatic lung cancer

1. Optimizing
Treatment For
First-line NSCLC
The contents of this deck are of a promotional nature M-IN-00001050
IMpower 110/130/150

2. Table of content
• Disease background- NSCLC
• Evolving landscape of lung cancer treatment
• IMpower 110 study
• IMpower 150 study
• IMpower 130 study
• Summary

3. Introduction: Non-small cell lung cancer1-8
1. Pikor, et al. Lung Cancer 2013; 2. Howlader, et al. SEER Cancer Statistics Review 2016; 3. Carter, et al. RadioGraphics
2014; 4. American Cancer Society 2016: NSCLC; 5. Varghese, et al. J Thorac Oncol 2014; 6. Vavala, et al. Curr Respir
Care Rep 2014; 7. Pelosof, et al. JNCI 2017; 8. Dempke. Anticancer Research 2015
01
Slower growing tumour with varying
initial ORR according to driver
mutation/targeted therapy
02
NSCLC accounts for about 80–85%
of all lung cancers
03
~15% of patients with NSCLC are
never smokers
04
Median age of 70 years and typically
present with cough, chest pain and
dyspnoea
05
Metastasis occurs later in the
disease process:
55% of patients have distant disease
at diagnosis
06
Targeted agents have improved
survival rates
in NSCLC patients with driver mutations

4. Evolving landscape of lung cancer treatment1
1980s 2000s 2015+
NSCLC vs SCLC
Chemotherapy
Chemotherapy
± anti-angiogenics Targeted therapy Cancer immunotherapy
Histological subtype
Molecular pathology (EGFR / ALK / ROS1 / BRAF)
Checkpoint inhibition
1. Figure adapted from Pao, et al. Lancet Oncol 2011

5. There is an unmet need in the treatment of patients with
NSCLC with no actionable biomarker
1. Gutierrez, et al. Clin Lung Cancer 2017; 2. Barlesi, et al. Lancet 2016
Molecular profiling of 17,664 patients with NSCLC by the
French Cooperative Thoracic Intergroup (IFCT)2
Overall survival stratified by therapy type (N = 805)
in patients with NSCLC1
However, a significant
portion of patients with
NSCLC have no known
actionable biomarker
KRAS
29%
EGFR
11%
HER2
1%
ALK
5%
PI3K
2%
Unknown
35%
Full WT
15% BRAF
2%
5.1 31.8
1.0
0.8
0.6
0.4
0.2
0
0
Time (months)
OS
estimate
36
12
6 24 30
18 42 48
12.7
Targeted therapies
have improved
outcomes in NSCLC
Targeted therapy (n=131)
Non-targeted cytotoxic
therapy (n=482)
Observation (n=192)
Targeted therapy vs
non-targeted therapy
HR=0.47 (95% CI: 0.36–0.63)
P<0.0001

6. Global phase III studies of Atezolizumab in first-line
treatment of NSCLC
1L
mNSCLC
Arm A
Atezolizumab
Arm B
Carbo/Cis + Pem (Non-squamous)
Carbo/Cis + Gem (Squamous)
Non-squamous and
squamous
N=572
NCT02409342
R
• IMpower110: Is atezolizumab monotherapy, a
better agent than chemotherapy in PD-L1 selected
chemotherapy-naive patients?
Arm A
Atezolizumab + Carbo/Nab-Pac
Arm B
Carbo/Nab-Pac
Non-squamous
ITT: N=723
ITT-WT: N=679
NCT02367781
R
• IMpower130: Is a steroid-sparing
chemotherapy regimen a better combination
partner for atezolizumab?
Arm A
Atezolizumab + Carbo/Pac
Arm B
Atezolizumab + Carbo/Pac/Bev
Arm C
Carbo/Pac/Bev
Non-squamous
N=1202
NCT02366143
R
• IMpower150: Does the addition of atezolizumab
to the SoC bevacizumab plus paclitaxel and
carboplatin add clinical benefit? Is there
improved clinical benefit if bevacizumab is
replaced by atezolizumab?

7. IMpower110 (Squamous & non-squamous NSCLC)
Atezolizumab monotherapy compared with a Platinum Agent (Cisplatin or Carboplatin) +
(Pemetrexed or Gemcitabine) in IL NSCLC

8. NON-SQUAMOUS: Carboplatin
or cisplatin + pemetrexed¶
SQUAMOUS: Carboplatin or
cisplatin + gemcitabineǁ
IMpower110: a randomised, phase III, multicentre study
Spigel, et al. ESMO 2019 (Abs LBA78)
Survival
follow-up
Stage IV non-squamous
or squamous NSCLC
Chemotherapy naïve
PD-L1 selected*
EGFR/ALK negative
Stratification factors:
• Sex
• ECOG PS
• Histology
• PD-L1 IHC expression‡
N=572§
Maintenance
(no crossover permitted)
4 or 6 cycles
R
1:1
PD or loss of
clinical
benefit**
PD‡‡
NON-SQUAMOUS:
pemetrexed
SQUAMOUS:
Best Supportive Care
Atezolizumab
1200 mg q3w
Primary endpoint: OS in WT population
(excluding patients with EGFR+/ALK+ NSCLC)
Key secondary endpoints: investigator-assessed
PFS, ORR and DOR (per RECIST version 1.1)
Atezolizumab
1200 mg q3w
*PD-L1 positive defined as TC1/2/3 or IC1/2/3 (PD-L1 expression ≥1% on TC or IC), with tumour PD-L1 expression determined by IHC
assay (VENTANA SP142 IHC assay) performed by a central laboratory; ‡TC1/2/3 and any IC vs TC0 and IC1/2/3; §554 patients in the
WT population; ¶Cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 6 + pemetrexed 500 mg/m2 IV q3w; ǁCisplatin 75 mg/m2
+ gemcitabine 1250 mg/m2 or carboplatin AUC 5 + gemcitabine 1000 mg/m2 IV q3w; **Defined as any of the following: signs or
symptoms of PD; decline in ECOG PS; progression at critical anatomical sites that cannot be managed by permitted medical
interventions; ‡‡By RECIST v1.1

9. IMpower110: prevalence of PD-L1 expression*
*PD-L1 status determined using the VENTANA SP142 PD-L1 IHC assay
Data cut-off: 10 September 2018 Spigel, et al. ESMO 2019 (Abs LBA78)
Arm A (atezo) Arm B (chemo)
TC3 or IC3 WT
≥ 50% TC or ≥ 10% IC
Prevalence
(%)
0
10
20
30
40
50
60
70
80
90
100
38.6% 35.4%
59.9% 58.5%
TC1/2/3 or IC1/2/3 WT
≥ 1% TC or IC
TC2/3 or IC2/3 WT
≥ 5% TC or IC
100.0% 100.0%
n=107 n=98 n=166 n=162 n=277 n=277
Prevalence of PD-L1
expression was similar
between treatment arms

10. IMpower110: baseline characteristics
Date cut-off: 10 September 2018
Spigel, et al. ESMO 2019 (Abs LBA78)
Characteristic, n (%)
TC1/2/3 or IC1/2/3 WT TC3 or IC3 WT
Arm A (atezo)
n=277
Arm B (chemo)
n=277
Arm A (atezo)
n=107
Arm B (chemo)
n=98
Age <65 y 143 (51.6) 134 (48.4) 59 (55.1) 43 (43.9)
Male 196 (70.8) 193 (69.7) 79 (73.8) 64 (65.3)
White 227 (81.9) 240 (86.6) 87 (81.3) 82 (83.7)
Asian 45 (16.2) 30 (10.8) 20 (18.7) 15 (15.3)
Never used tobacco 37 (13.4) 35 (12.6) 9 (8.4) 15 (15.3)
Non-squamous histology 192 (69.3) 193 (69.7) 80 (74.8) 75 (76.5)
ECOG PS 0 97 (35.0) 102 (36.8) 35 (32.7) 38 (38.8)
Baseline characteristics were well balanced
between arms and PD-L1 subgroups

11. 50
100
80
60
Overall
Survival
(%)
Months
40
30
10
90
70
20
0
0
No. at risk
2 4 6 8 10 12 14 16 18 20 22 24 28 30 32 34 36
94 85 80 66 61 48 40 34 25 18 16 11 6 5 2
89 75 65 50 40 33 28 19 12 9 7 6
26
7
4 3 3 3 1
38
Chemotherapy
107
Atezolizumab
98
Atezolizumab
Chemotherapy
Censored
IMpower110: OS in the TC3/IC3 population
NE, not estimable; *Stratified; ‡Stratified log-rank
Data cut-off: 10 September 2018
Spigel, et al. ESMO 2019 (Abs LBA78)
Median follow-up at
primary analysis,
15.7 mo (range, 0–35)
HR,* 0.59 (95% CI: 0.40, 0.89); P = 0.0106‡
Median OS, 20.2 mo
(95% CI: 16.5, NE)
Median OS, 13.1 mo
(95% CI: 7.4, 16.5)
The primary endpoint of OS in
the PD-L1 high subgroup
was met
Landmark
Arm A (atezo)
n=107
Arm B (chemo)
n=98
6-month OS
(95% CI), %
76.3
(68.2, 84.4)
70.1
(60.8, 79.4)
12-month OS
(95% CI), %
64.9
(55.4, 74.4)
50.6
(40.0, 61.3)

12. IMpower110: OS in key subgroups
(TC3/IC3-WT population)
*The 1 patient in the ≥85 years subgroup is not
included, and 1 patient’s race was unknown;
‡Unstratified; §Stratified
Data cut-off: 10 September 2018
Spigel, et al. ESMO 2019 (Abs LBA78)
‡
§
*
OS benefit observed in all clinically relevant subgroups

13. IMpower110: subsequent treatment
Data cut-off: 10 September 2018 Spigel, et al. ESMO 2019 (Abs LBA78)
Arm A (atezo)
n=277
Arm B (chemo)
n=277
Patients with ≥ 1 therapy, n (%) 82 (29.6) 137 (49.5)
Chemotherapy 77 (27.8) 68 (24.5)
Immunotherapy 7 (2.5) 80 (28.9)
Targeted therapy 14 (5.1) 12 (4.3)
Nearly a third of patients in the control arm
received subsequent cancer immunotherapy
The proportion of patients who received
subsequent chemotherapy or targeted therapy
was similar across the PD-L1 subgroups

14. 100
80
60
Progression-Free
Survival
(%)
Months
40
30
10
90
70
50
20
0
0
No. at risk
2 4 6 8 10 12 14 16 18 20 22 24 28 30 32 34 36
82 72 60 45 31 25 21 16 13 10 8 4 4 2
74 62 36 26 16 13 8 5 5 1 1 1
26
4
38
Chemotherapy
107
Atezolizumab
98
Atezolizumab
Chemotherapy
Censored
Landmark
Arm A (atezo)
n=107
Arm B (chemo)
n=98
6-month PFS
(95% CI), %
59.8
(50.4, 69.2)
38.3
(28.5, 48.1)
12-month PFS
(95% CI), %
36.9
(27.0, 46.9)
21.6
(12.6, 30.6)
IMpower110: PFS in TC3/IC3 population
*Investigator assessed per RECIST 1.1; ‡Stratified; §Stratified log-rank; ¶For descriptive purposes
only Data cut-off: 10 September 2018
Spigel, et al. ESMO 2019 (Abs LBA78)
HR,‡ 0.63 (95% CI: 0.45, 0.88); P = 0.0070§¶
Median PFS, 8.1 mo
(95% CI: 6.8, 11.0)
Median PFS, 5.0 mo
(95% CI: 4.2, 5.7)
There was a clinically meaningful improvement
in PFS* in the atezolizumab arm
PFS was not formally tested in the TC3/IC3
population due to the hierarchical statistical plan

15. Median DOR
(range), mo
NE
(1.8+ to 29.3+)
6.7
(2.6 to 23.9+)
Arm B
0
10
20
30
40
50
60
Response
(%)
38.3%
28.6%
TC3 or IC3 WT
Arm A (atezo)
Arm B (chemo)
PR CR
Arm A
IMpower110: confirmed ORR (TC3 or IC3 population)
+, censored
Data cut-off: 10 September 2018
Spigel, et al. ESMO 2019 (Abs LBA78)
Arm A (atezo) Arm B (chemo)
TC2/3 or IC2/3 WT n=166 n=162
ORR (95% CI), %
30.7
(23.8, 38.3)
32.1
(25.0, 39.9)
Median DOR
(range), mo
NE
(1.8+ to 29.3+)
5.8
(2.6 to 23.9+)
TC1/2/3 or IC1/2/3 WT n=277 n=277
ORR (95% CI), %
29.2
(24.0, 35.0)
31.8
(26.3, 37.6)
Median DOR
(range), mo
NE
(1.8+ to 29.3+)
5.7
(2.4 to 23.9+)
Confirmed ORR was improved with Atezolizumab
in the TC3/IC3 population

16. IMpower110: updated safety profile
*Pooled atezolizumab monotherapy patients (across indications and therapy lines)
‡Grade 3–4 AE/immune-mediated AEs: number of patients whose highest grades of AE/immune-mediated AEs are 3 or 4
§Immune-mediated AEs (imAEs) were defined per a sponsor-specified list of terms, regardless of whether the events led to
systemic glucocorticoid, endocrine therapy, or other immunosuppressant use
±AData cut-off: 10 September, 2018
Follow-up: 13.7 months
Jassem, et al. ASCO 2020 (Abs e21623)
Adverse events Atezolizumab
N=286
Chemotherapy
N=263
Pooled atezolizumab
monotherapy
population*
N=3178
Grade 3–4 AEs‡ 86 (30.1) 138 (52.5) 1482 (46.6)
Related Grade 3–4 AEs‡ 37 (12.9) 116 (44.1) 496 (15.6)
Grade 5 AEs 11 (3.8) 11 (4.2) 119 (3.7)
Related Grade 5 AEs 0 1 (0.4) 11 (0.3)
AE leading to any treatment withdrawal 18 (6.3) 43 (16.3) 226 (7.1)
Immune-mediated AEs§ 115 (40.2) 44 (16.7) 1097 (34.5)
Grade 3–4 immune-mediated AEs‡§ 19 (6.6) 4 (1.5) 248 (7.8)
Immune-mediated AEs requiring
corticosteroids use
30 (10.5) 3 (1.1) 247 (7.8)
The atezolizumab arm and pooled atezolizumab monotherapy population demonstrated a
favourable safety profile compared with chemotherapy

17. Arm B (chemo)
n=263
Arm A (atezo)
n=286
Vomiting
Decreased neutrophil count
Hypothyroidism
Thrombocytopenia
Anaemia
Nausea
Neutropenia
Constipation
Increased blood creatinine
Leukopenia
Decreased platelet count
Pruritus
Increased AST
40% 30% 20% 10% 0 10% 20% 30% 40% 50%
50%
More
frequent
with
chemo
More
frequent
with
atezo
IMpower110: all-cause AEs (>5% difference
between arms)
AST, aspartate aminotransferase
Spigel, et al. ESMO 2019 (Abs LBA78)

18. IMpower110: summary
• Atezolizumab represents a promising 1L treatment option in patients with PD-L1–high
NSCLC
• IMpower110 is a positive study that demonstrated statistically significant and clinically
meaningful improvement of OS in the TC3 or IC3 WT population versus platinum-based
chemotherapy
(HR, 0.59 [95% CI: 0.40, 0.89]; P = 0.0106)
• In the TC3 or IC3 WT population, Atezolizumab showed meaningful improvement in PFS,
ORR and DOR versus chemotherapy
• The safety profile of Atezolizumab was consistent with prior observations; no new or
unexpected safety signals were identified
• Atezolizumab had a favourable safety profile compared with chemotherapy, and the safety
data were consistent with those from a pooled Atezolizumab monotherapy population
• Patients treated with Atezolizumab had a longer treatment exposure than patients treated
with chemotherapy
Spigel, et al. ESMO 2019 (Abs LBA78); Jassem, et al. ASCO 2020 (Abs e21623)

19. IMpower150 (non-squamous NSCLC)
phase 3 study of Atezolizumab plus chemotherapy and bevacizumab in1L advanced non-
squamous mNSCLC

20. Until PD or
loss of clinical
benefit
Until PD
Atezolizumab
Atezolizumab
+
Bevacizumab
Bevacizumab
Until PD or
loss of clinical
benefit
Stage IV Non-Squamous
NSCLC
Chemotherapy naïve
Stratification factors:
• Sex
• PD-L1 IHC expression*
• Liver mets
N=1202
R
1:1:1
A: Atezolizumab +
Carboplatin +
Paclitaxel
C: Carboplatin +
Paclitaxel +
Bevacizumab
B: Atezolizumab +
Carboplatin +
Paclitaxel +
Bevacizumab
Maintenance
(No crossover permitted)
Non-squamous
IMpower150: phase III study of first-line atezolizumab plus
chemotherapy and bevacizumab in non-squamous NSCLC
*PD-L1 testing by SP142 IHC assay
NCCN guidelines version 6 2020; Planchard, et al. Ann Oncol 2018 (updated 18 Sept 2019)
NCT02366143; GO29436
Key clinical questions:
• Does the addition of atezolizumab to the SoC bevacizumab
+ paclitaxel + carboplatin add clinical benefit?
• Is there improved clinical benefit if bevacizumab is replaced
by atezolizumab?
Atezolizumab + bevacizumab + carboplatin + paclitaxel
and bevacizumab + carboplatin + paclitaxel are
category 1 NCCN and ESMO recommended systemic
therapies for advanced metastatic disease in NSCLC
Co-primary endpoints:
• Investigator-assessed PFS in ITT-WT and Teff-high WT
• OS in ITT-WT

21. Atezolizumab anti-cancer immunity is enhanced through
bevacizumab’s VEGF-mediated effects
1. Gabrilovich, et al. Nat Med 1996; 2. Oyama, et al. J Immunol 1998; 3. Goel, et al. Physiol Rev 2011
4. Motz, et al. Nat Med 2014; 5. Hodi, et al. Cancer Immunol Res 2014; 6. Wallin, et al. Nat Commun 2016
7. Gabrilovich and Nagaraj. Nat Rev Immunol 2009; 8. Roland, et al. PLoS One 2009
9. Facciabene, et al. Nature 2011; 10. Voron, et al. J Exp Med 2015; 11. Chen and Mellman. Immunity 2013
12. Hodge, et al. Int J Cancer 2013; 13. Herbst, et al. Nature 2014
Bevacizumab inhibits VEGF-mediated
suppression of dendritic cell maturation,
enabling efficient priming and
activation of T-cell responses1,2
Bevacizumab normalises the tumour
vasculature, resulting in an increased
infiltration of T cells into the tumour3-6
Bevacizumab decreases the
activity of MDSCs and Treg cells,
and enables reprogramming of
the tumour microenvironment6-10
Atezolizumab’s ability to restore anti-cancer immunity through
T cell-mediated cancer cell killing11,13 is further enhanced through
bevacizumab’s VEGF-mediated immunomodulatory effects
Chemotherapy-induced
immunogenic cell death can trigger
the release of tumour antigens11,12

22. Baseline characteristics were well balanced between
arms
*The Teff gene signature high cut-off ≥‒1.91 was used; ‡1 patient in Arm A had
unknown PD-L1 IHC expression; §One patient had EGFR exon 19 deletion and
also tested ALK positive per central lab
TC1/2/3 or IC1/2/3 = TC or IC ≥1% PD-L1+; TC0 and IC0 = TC and IC <1% PD-L1+
Data cut-off: 22 January 2018
Socinski, et al. ASCO 2018 (Abs 9002)
Baseline characteristics
Arm A:
atezo + CP
(N=402)
Arm B:
atezo + bev + CP
(N=400)
Arm C (control):
bev + CP
(N=400)
Median age (range), years 63 (32–85) 63 (31–89) 63 (31–90)
Sex, male, n (%) 241 (60) 240 (60) 239 (60)
ECOG PS, 0, n (%) 180 (45) 159 (40) 179 (45)
Tobacco use history, n (%)
Current smoker | Previous smoker
Never smoker
98 (24) | 227 (57)
77 (19)
90 (23) | 228 (57)
82 (21)
92 (23) | 231 (58)
77 (19)
Liver metastases, yes, n (%) 53 (13) 52 (13) 57 (14)
EGFR mutation, positive, n (%) 45 (11) 34§ (9) 45 (11)
ALK rearrangement, positive, n (%) 9 (2) 11 (3) 20 (5)
KRAS mutation, positive/tested, n (%) 36/124 (29) 47/106 (44) 38/115 (33)
Teff gene signature expression, high, n (%)* 177 (44) 166 (42) 148 (37)
PD-L1 expression, n (%)‡
TC1/2/3 or IC1/2/3
TC0 and IC0
213 (53)
188 (47)
209 (52)
191 (48)
195 (49)
205 (51)
There was an approximate 50:50 split between
PD-L1-positive and –negative patients
10% of patients had EGFR
mutations, and these
patients were balanced
across the three arms
14% of patients had liver
metastases at baseline,
which were a stratification
factor in IMpower150

23. Median follow-up 39.8 months (updated OS analysis)
OS analysis for Arm B vs Arm C was considered final at the second interim analysis: data are
shown for descriptive purposes only
Data cut-off: 13 September, 2019
Socinski, et al. AACR 2020 (Abs CT216)
Median, 19.5 mo
(95% CI: 17.0, 22.2)
Median, 14.7 mo
(95% CI: 12.9, 17.1)
Arm B: atezo + bev + CP
Arm C: bev + CP
HR=0.80 (95% CI: 0.67, 0.95)
P=0.01
Median follow-up: 39.8 mo
(Updated OS analysis)
There was a significant OS benefit with the addition of
atezolizumab in the ITT-WT (Arm B vs Arm C)
Landmark OS, %
Arm B:
atezo + bev + CP
(N=359)
Arm C:
bev + CP
(N=337)
12-month 67% 61%
18-month 53% 41%
24-month 43% 34%
The improvement in
median OS of 4.5 months
is clinically meaningful

24. ORR and DOR were improved in the ITT population
*Investigator-assessed, confirmed per RECIST v1.1
Data cut-off: 22 January 2018 Socinski, et al. ASCO 2018 (Abs 9002)
Arm A: atezo + CP
Arm B: atezo + bev + CP
Arm C: bev + CP
PR CR
0%
10%
20%
30%
40%
50%
60%
70%
80%
Arm A Arm B Arm C
ITT
PD-L1–High
TC3 or IC3
PD-L1–Low
TC1/2 or IC1/2
PD-L1–Negative
TC0 and IC0
Arm A Arm B Arm C Arm A Arm B Arm C Arm A Arm B Arm C
Objective
Response
Rate
*
(%)
Median DOR
(range), mo
8.3
(1.9–26.0)
11.5
(2.0–29.0)
6.0
(1.5–23.1)
12.2
(1.9–26.0)
22.1
(2.8–29.0)
7.0
(1.5–22.1)
8.3
(2.8–24.5)
10.4
(2.7–24.3)
6.9
(2.8–23.1)
7.6
(1.9–24.9)
8.2
(2.0–24.6)
5.5
(2.0–16.6)
40%
56%
41%
62%
69%
49%
44%
58%
41%
31%
51%
36%
A high proportion of patients
responded to treatment with
atezolizumab + bevacizumab + chemo
Median DOR:
Arm B 11.5 months
Arm C 6.0 months 24

25. OS benefit was observed across all PD-L1 subgroups in the
ITT-WT (Arm B vs Arm C)
*Unstratified HR.
Data cut-off: January 22, 2018
Socinski, et al. ASCO 2018 (Abs 9002)
HR*=0.82
(95% CI: 0.62, 1.08)
(Second interim
OS analysis)
17.1 mo
14.1 mo
PD-L1–Low
TC1/2 or IC1/2
HR*=0.80
(95% CI: 0.55, 1.15)
(Second interim
OS analysis)
16.4 mo 20.3 mo
HR*=0.70
(95% CI: 0.43, 1.13)
(Second interim
OS analysis)
15.0 mo
PD-L1–High
TC3 or IC3
25.2 mo
PD-L1–Negative
TC0 and IC0
PD-L1-high patients
derived the most benefit
Atezo+Bev+CP (n=71)
Bev+CP (n=65)
Atezo+Bev+CP (n=121)
Bev+CP (n=105)
Atezo+Bev+CP (n=167)
Bev+CP (n=172)

26. Efficacy in key subgroups
EGFR TKI
EGFR TKI
EGFR+ after EGFR TKIs

27. EGFR+ subgroups in IMpower150
*Includes exon 19 deletion and Leu858Arg mutations.
‡WT refers to patients without EGFR or ALK genetic alterations.
Subgroup N representative at CCOD: 13 Sept 2019, following additional source
documentation verification. Reck, et al. Lancet Respir Med 2019
27
EGFR mutation
(n=124)
Sensitising
EGFR mutation*
(n=91)
Sensitising EGFR
mutation and
prior TKI therapy
(n=78)
ITT-WT‡
(n=1,042)
EGFR mutation
or ALK
rearrangement
(n=160)
ITT population
(N=1,202)

28. Clinically meaningful PFS benefit was observed for Arm B vs
Arm C in patients with EGFR Mut+/ALK+ NSCLC
*Unstratified HR
Data cut-off: September 15, 2017
Kowanetz, et al. AACR 2018 (Abs CT076 - presented by Socinski)
Arm B: atezo + bev + CP (n=44)
Arm C: bev + CP (n=64)
HR*=0.59
(95% CI: 0.37, 0.94)
(Primary analysis)
Median, 6.1 mo
(95% CI: 5.7, 8.4)
Time (months)
Progression-Free
Survival
(%)
Median, 9.7 mo
(95% CI: 6.9, 15.2)
The PFS KM curves
separate at around
6 months

29. OS benefit in patients with sensitizing EGFR mutations
Minimum follow-up 32.4 months (updated OS analysis)
OS for Arm B versus C was considered final at the second interim analysis, updated data is for descriptive purposes
only
Data cut-off: 13 September 2019
Socinski et al. AACR 2020 (Abs CT216)
Median, 29.4 mo
(95% CI: 24.9, NE)
Median, 18.1 mo
(95% CI: 11.7, 27.8)
Median, 19.0 mo
(95% CI: 13.5, 28.5)
Median, 18.1 mo
(95% CI: 11.7, 27.8)
29
HR=0.60
(95% CI: 0.31, 1.14)
Minimum follow-up: 32.4 mo
(Updated OS analysis)
HR=1.00
(95% CI: 0.57, 1.74)
Minimum follow-up: 32.4 mo
(Updated OS analysis)
Arm B vs Arm C Arm A vs Arm C
No benefit was observed between
Arm A vs C
There was continued clear
separation of curves and OS benefit
with the addition of atezolizumab to
bevacizumab + chemotherapy

30. ORR and DOR were improved with bevacizumab + Atezolizumab
+ chemotherapy in patients with EGFR+ NSCLC
*Unstratified HR
Data cut-off: 22 January, 2018
Reck, et al. Lancet Respir Med 2019
71
42
0
20
40
60
80
ORR
(%)
Atezolizumab
+ bevacizumab
+ CP
(n=31)
Bevacizumab
+ CP
(n=23)
Median DOR, mo 11.1 4.7
n=24 n=18
ORR and DOR
ORR increased from 42% to 71%
with the addition of atezolizumab
to bevacizumab + chemotherapy
CR rate 6%
CR rate 0%

31. Efficacy in key subgroups
Liver metastases

32. HR=0.41 (95% CI: 0.26, 0.62)
(Updated PFS analysis)
Clinically meaningful PFS was observed for Arm B vs Arm C
(ITT) in patients with liver metastasis at baseline
Unstratified HR
Data cut-off: January 22 2018
Reck et al. Lancet Respir Med 2019
Patients with liver metastases have
clinically meaningful survival benefit with
the IMpower150 regimen, despite liver
metastases being a negative prognostic
factor in NSCLC
6 months 12 months 18 months
Arm B (ABCP) 58.0% 34.0% 23.3%
Arm C (BCP) 37.8% 1.8% 1.8%
Landmark PFS
Median 5.4 mo
(95% CI 4.1–6.0)
Median 8.2 mo
(95% CI 5.7–10.3)

33. An OS benefit was observed in patients with liver metastases
when bevacizumab was added to atezolizumab
Data cut-off: 22 January, 2018
Socinski, et al. ASCO 2019 (Abs 9012)
Reck, et al. Lancet Respir Med 2019
No OS benefit was observed
when comparing Arm A
with Arm C
Liver metastases (ITT)
Arm B vs Arm C
Liver metastases (ITT)
Arm A vs Arm C
HR=0.52 (95% CI: 0.33, 0.82)
(Second interim OS analysis)
HR=0.87 (95% CI: 0.57, 1.32)
(Second interim OS analysis)
The KM curves separate early
and stay separated;
atezolizumab + bevacizumab
+ chemotherapy improves OS
6 months 12 months 18 months
Arm B (ABCP) 60.0% 40.7% 34.9%
Arm C (BCP) 35.9% 17.3% 11.5%
6 months 12 months 18 months
Arm B (ABCP) 40.0% 25.4% 14.3%
Arm C (BCP) 35.9% 17.3% 11.5%
The combination of both atezolizumab and
bevacizumab are important for the clinically relevant OS
benefit in patients with liver metastases

34. Addition of bevacizumab to atezolizumab + chemotherapy
improved ORR and DOR in patients with liver metastases
*Unstratified HR
Data cut-off: 22 January, 2018 Socinski, et al. ASCO 2019 (Abs 9012)
Reck, et al. Lancet Respir Med 2019
Atezolizumab +
bevacizumab + CP
(n=31)
Bevacizumab
+ CP
(n=23)
Median DOR, mo 10.7 4.6
DOR HR v
bevacizumab + CP
(95% CI)
0.39
(0.21–0.73)
–
60.8
41.1
0
20
40
60
80
ORR
(%)
ORR and DOR
n=51 n=56
mDOR was nearly doubled with addition of
bevacizumab to atezolizumab + chemotherapy in
patients with liver metastases

35. Efficacy in key subgroups:
Patients with
bulky disease
≥3rd quartile
<3rd quartile
An exploratory analysis from IMpower150 evaluated efficacy in
Arm B vs Arm C using two different measures of bulky disease
High disease burden
Low disease burden
≥median
<median

36. IMpower150: efficacy outcomes of high and low disease burden
subgroups defined by SLD and number of metastatic sites
Data cut-off: 13 September, 2019
Minimum follow-up 32.4 months
*Pts with baseline measurable disease. SLD, sum of the longest diameter
3rd quartile was 108mm, with ‘high’ defined as SLD ≥108mm and ‘low’ defined as <108mm
Median number of metastatic sites at baseline: the median number of sites was 2, with ‘high’
defined as ≥2 metastatic sites and ‘low’ defined as <2 metastatic sites
Jotte, et al. ASCO 2020 (Abs e21637)
High burden
(SLD ≥3rd quartile)
Low burden
(SLD <3rd quartile)
High burden
(no of met sites ≥median)
Low burden
(no of met sites <median)
Arm B
Atezo + bev
+ CP
(n=91)
Arm C
Bev
+ CP
(n=85)
Arm B
Atezo + bev +
CP
(n=266)
Arm C
Bev
+ CP
(n=252)
Arm B
Atezo + bev
+ CP
(n=210)
Arm C
Bev
+ CP
(n=190)
Arm B
Atezo + bev
+ CP
(n=149)
Arm C
Bev
+ CP
(n=148)
Median OS,
months
15.5 10.7 20.3 17.1 17.6 12.5 22.5 21.5
OS HR
(95% CI)
0.70
(0.5–0.97)
0.83
(0.68–1.02)
0.72
(0.58–0.90)
0.89
(0.67–1.17)
ORR, %* 62 41 53 40 57 40 53 40
These data further support the use of
atezolizumab + bevacizumab +
chemotherapy as a first-line option for
patients with a high disease burden
The clinical benefit from addition of atezolizumab to
bevacizumab + CP was observed in patients with and
without bulky disease, regardless of the approach used
to define ‘bulky’. This benefit was even more pronounced
in the high disease burden subgroups

37. Atezolizumab + bevacizumab + chemotherapy was well tolerated with a
safety profile consistent with the known safety profiles of each drug
*Related to any study treatment. ‡Including fatal haemorrhagic AEs: Arm A: 2; Arm B: 6; Arm C: 3. §Immune-related AEs were
defined using MedDRA Preferred Terms that included both diagnosed immune conditions and signs and symptoms potentially
representative of immune-related events, regardless of investigator-assessed causality. ¶In Arm A, 1 patient had grade 5 acute
hepatitis and 1 patient had grade 5 interstitial lung disease. Data cut-off: 22 January 2018
Socinski, et al. ASCO 2018 (Abs 9002)
Incidence, n (%)
Arm A:
atezo + CP
(n=400)
Arm B:
atezo + bev + CP
(n=393)
Arm C (control):
bev + CP
(n=394)
Median doses received (range), n
Atezolizumab
Bevacizumab
10 (1-43)
NA
12 (1-44)
10 (1-44)
NA
8 (1-38)
Treatment-related AE*
Grade 3-4
Grade 5‡
377 (94%)
172 (43%)
4 (1%)
370 (94%)
223 (57%)
11 (3%)
377 (96%)
191 (49%)
9 (2%)
Serious AE 157 (39%) 174 (44%) 135 (34%)
AE leading to withdrawal from any treatment 53 (13%) 133 (34%) 98 (25%)
Immune-related AEs§ in > 5 patients in any arm All grade Grade 3-4 All grade Grade 3-4 All grade Grade 3-4
Rash 119 (30%) 14 (4%) 117 (30%) 9 (2%) 53 (14%) 2 (1%)
Hepatitis¶
Laboratory abnormalities
42 (11%)
36 (9%)
12 (3%)
10 (3%)
54 (14%)
48 (12%)
20 (5%)
18 (5%)
29 (7%)
29 (7%)
3 (1%)
3 (1%)
Hypothyroidism 34 (9%) 1 (<1%) 56 (14%) 1 (<1%) 18 (5%) 0
Pneumonitis¶ 23 (6%) 8 (2%) 13 (3%) 6 (2%) 5 (1%) 2 (1%)
Hyperthyroidism 11 (3%) 0 16 (4%) 1 (<1%) 5 (1%) 0
Colitis 3 (1%) 2 (1%) 11 (3%) 7 (2%) 2 (1%) 2 (1%)
• The safety profiles of ABCP and ACP were similar to A, B and C+P individually; no new safety
signals were identified with the combinations
There was a higher
proportion of treatment-
related grade 3–5 AEs and
AEs of special interest in
Arm B; this was expected,
due to the additive effects of
four drugs instead of three

38. IMpower150: Conclusion
IMpower150 is a positive study in 1L non-squamous NSCLC, with statistically
significant and clinically meaningful improvement in both co-primary
endpoints of OS and PFS for the Atezo+Bev+CP arm vs. Bev+CP arm
Additional patient characteristics beyond PD-L1 expression may be considered
when making CIT treatment decisions for non-squamous NSCLC patients
Liver
metastases
EGFR
mutations
Clinical benefit was observed in key subgroups of patients with EGFR/ALK
genomic alterations and liver metastases at baseline, with the addition of
bevacizumab to atezolizumab + chemotherapy
Atezolizumab in combination with chemotherapy ± bevacizumab is well
tolerated and its safety profile is consistent with known safety risks

39. Summary
IMpower 150: Phase III multicentre, international, randomised, open-label, 3-arm trial in
chemotherapy-naïve patients with non-squamous mNSCLC (Atezolizumab + Bevacizumab +
carbo/pac vs Bevacizumab + carbo/pac)
Atezolizumab + Bevacizumab + carbo/pac is the first CIT combination to demonstrate
meaningful OS in EGFR+ patients and patients with liver metastases
Atezolizumab + Bevacizumab + carbo/pac nearly doubled PFS benefit at 12 months:
12-month PFS was 38% with Atezolizumab + Bevacizumab + carbo/pac vs 20% with Avastin +
carbo/pac alone

40. Summary (cont.)
Atezolizumab + Bevacizumab + carbo/pac delivered a statistically significant OS benefit vs
Bevacizumab + carbo/pac alone:
Higher ORR with Atezolizumab + Bevacizumab + carbo/pac (56%) vs. Bevacizumab +
carbo/pac (40%)
Atezo + bev + pac+ carbo Beva + carbo + pac
19.8 months
29.4 months
13.3 months
14.9 months
18.1 months
9.4 months
ITT
EGFR mutation
Liver metastases

41. IMpower130 (non-squamous NSCLC)
phase 3 study of carboplatin and nab-paclitaxel with or without atezolizumab in1L advanced
non-squamous NSCLC

42. Rationale for combining Atezolizumab
with chemotherapy
1. Chen and Mellman. Immunity 2013; 2. Herbst, et al. Nature 2014
3. Hodge, et al. Int J Cancer 2013
Atezolizumab has the ability to
restore anti-cancer immunity by
preventing T-cell deactivation1,2
Atezolizumab
Chemotherapy-induced
immunogenic cell death can trigger
the release of tumour antigens1,3
Chemotherapy
The goal of CIT combinations is to create a more favourable environment
to maximise the potential of the immune system to eliminate cancer

43. IMpower130 trial design
*Patients with a sensitising EGFR mutation or ALK translocation must have experienced
progression (during or after treatment) or intolerance to treatment with one or more EGFR TKIs or
ALK inhibitors‡PD-L1 testing by SP142 IHC assay
Survival
follow-up
Atezolizumab
until PD or loss
of clinical benefit
Pemetrexed
until PD
Atezolizumab
Pemetrexed
or BSC
Stage IV non-squamous
NSCLC
Chemotherapy naïve*
ECOG PS 0–1
Stratification factors:
•Sex
•PD-L1 IHC expression‡
•Liver mets
ITT: N=723
ITT-WT: N=679
R
2:1
Arm A: atezolizumab
+ carboplatin +
nab-paclitaxel
(4–6 cycles)
Arm B: Carboplatin +
nab-paclitaxel
(4–6 cycles)
Maintenance
Non-squamous
Switch maintenance to
pemetrexed was permitted
in the control arm
Dosing:
Atezolizumab: 1,200mg q3w
Carboplatin: AUC 6 q3w
Nab-paclitaxel: 100mg/m2 on days 1, 8, 15 q3w
The use of nab-paclitaxel in IMpower130
provides an alternative, potential steroid-
sparing chemotherapy regimen
Crossover from Arm B to Arm A
was initially permitted; crossover
was not permitted following the
June 2016 protocol amendment
Despite the protocol amendment, 41% of patients
in the control arm crossed over to atezolizumab
on-study, with a total of 59% of patients in the
control arm receiving subsequent CIT
Co-primary endpoint: INV-assessed PFS in ITT-WT;
OS in ITT-WT
secondary endpoints: INV-assessed PFS and OS in ITT; INV-
assessed PFS and OS in PD-L1 selected populations (TC2/3
or IC2/3 and TC1/2/3 or IC1/2/3)

44. Baseline characteristics were generally well balanced
between arms (ITT-WT*)
Data are n (%); *32 patients in the atezo + CnP arm and 12 patients in the CnP arm had EGFR or ALK genomic
alterations and were not included in the ITT-WT population; ‡PD-L1-high (TC3 or IC3): patients with PD-L1 expression
in ≥50% of TC or ≥10% of IC; §PD-L1-low (TC1/2 or IC1/2): patients with PD-L1 expression in ≥1% and <50% of TC or
≥1% and <10% of IC; ¶PD-L1-negative (TC0 and IC0): patients with PD-L1 expression in <1% of TC and <1% of IC
Cappuzzo, et al. ESMO 2018 (Abs LBA53)
Atezo + CnP
(n=451)
CnP
(n=228)
Age group (years)
<65
65–74
75–84
≥85
227 (50.3%)
174 (38.6%)
48 (10.6%)
2 (0.4%)
114 (50.0%)
84 (36.8%)
29 (12.7%)
1 (0.4%)
Sex
Female
Male
185 (41.0%)
266 (59.0%)
94 (41.2%)
134 (58.8%)
Liver metastases at enrolment
Present
Not present
69 (15.3%)
382 (84.7%)
31 (13.6%)
197 (86.4%)
Bone metastases 126 (27.9%) 63 (27.6%)
Race
White
Black or African American
Asian
Multiple
Unknown
402 (89.1%)
17 (3.8%)
12 (2.7%)
1 (0.2%)
19 (4.2%)
210 (92.1%)
8 (3.5%)
3 (1.3%)
0
7 (3.1%)
Atezo + CnP
(n=451)
CnP
(n=228)
ECOG PS
0 189 (42.0%) 91 (39.9%)
Tobacco use history
Never
Current
Previous
48 (10.6%)
92 (20.4%)
311 (69.0%)
17 (7.5%)
51 (22.4%)
160 (70.2%)
Planned 4 vs 6 cycles
4 cycles
6 cycles
227 (50.3%)
224 (49.7%)
119 (52.2%)
109 (47.8%)
PD-L1 tumour expression
PD-L1-high‡
PD-L1-low§
PD-L1-negative¶
88 (19.5%)
128 (28.4%)
235 (52.1%)
42 (18.4%)
65 (28.5%)
121 (53.1%)

45. Median: 7.0 mo
(95% CI: 6.2, 7.3)
Median: 5.5 mo
(95% CI: 4.4, 5.9)
Progression
Free
Survival
(%)
HR=0.64
(95% CI: 0.54, 0.77)
P < 0.0001
Median follow-up: ~19 mo
PFS (%) 6 months 12 months
Atezo + CnP (n=451) 56.1% 29.1%
CnP (n=228) 42.5% 14.1%
Investigator-assessed PFS was significantly improved with
addition of Atezolizumab to carboplatin + nab-paclitaxel (ITT-WT)
Median follow-up: ~19 months
West et al. Lancet Oncol 2019
PFS was also significantly improved in the ITT population
Landmark 12-month PFS was
doubled with the addition of
atezolizumab to carboplatin
and nab-paclitaxel

46. Median: 18.6 mo
(95% CI: 16.0, 21.2)
Median: 13.9 mo
(95% CI: 12.0, 18.7)
Overall
Survival
(%)
HR=0.79
(95% CI: 0.64, 0.98)
P = 0.033
OS (%) 1 year 2 years
Atezo + CnP (n=451) 63.1% 39.6%
CnP (n=228) 55.5% 30.0%
OS was significantly improved with addition of
Atezolizumab to carboplatin + nab-paclitaxel (ITT-WT)
Median follow-up: ~19 months
West et al. Lancet Oncol 2019
OS was also significantly improved in the ITT population
OS is significantly improved in the
Atezo + CnP arm versus the CnP
arm, despite 59% of patients in the
control arm receiving subsequent
CIT (including 41% crossover
to atezolizumab)

47. West, et al. Lancet Oncol 2019
0.1 1 10
Population n (%) Atezo + CnP CnP HR (95% CI)
Female 279 (41.1) 21.4 12.8 0.66 (0.46, 0.93)
Male 400 (58.9) 16.0 14.2 0.87 (0.66, 1.15)
<65 years 341 (50.2) 19.2 16.6 0.79 (0.58, 1.08)
≥65 years 338 (49.8) 16.1 12.6 0.78 (0.58, 1.05)
ECOG PS*
0 280 (41.3) 20.8 19.7 0.85 (0.59, 1.22)
1 397 (58.6) 15.2 11.9 0.77 (0.58, 1.00)
2 1 (0.1) N/A N/A N/A (N/A, N/A)
Never smoker 65 (9.6) 28.2 19.5 0.55 (0.26, 1.19)
Current/previous smoker 614 (90.4) 18.1 13.9 0.81 (0.65, 1.02)
No liver mets at enrolment 579 (85.3) 21.1 15.2 0.73 (0.57, 0.92)
Liver mets at enrolment 100 (14.7) 10.0 8.8 1.04 (0.63, 1.72)
PD-L1-high (TC3 or IC3) 130 (19.1) 17.3 16.9 0.84 (0.51, 1.39)
PD-L1-low (TC1/2 or IC1/2) 193 (28.4) 23.7 15.9 0.70 (0.45, 1.08)
PD-L1-negative (TC0 and IC0) 356 (52.4) 15.2 12.0 0.81 (0.61, 1.08)
ITT-WT 679 (100) 18.6 13.9 0.79 (0.64, 0.98)
Favours atezo+CnP Favours CnP
Median OS (mo)
An OS benefit was observed across clinically relevant
subgroups in the ITT-WT population
Stratified HR for ITT-WT; unstratified HR for all other subgroups
*One patient had an unknown ECOG PS.

48. HR=0.98
(95% CI: 0.41, 2.31)
Overall
Survival
(%)
Median: 14.4 mo
Median: 10.0 mo
Progression
Free
Survival
(%)
Median: 7.0 mo
Median: 6.0 mo
HR=0.75
(95% CI: 0.36, 1.54)
OS
Investigator-assessed PFS
No PFS or OS benefit was observed over chemotherapy
alone in patients with EGFR/ALK+ NSCLC
Cappuzzo, et al. ESMO 2018 (Abs LBA53)
IMpower150 remains the only phase III study to
demonstrate clinical benefit of a CIT combination
regimen (atezolizumab in combination with bevacizumab
plus chemotherapy) in patients with EGFR/ALK+ NSCLC
Atezo+CnP (n=32)
CnP (n=12)

49. Atezo+CnP
(n=220)
CnP
(n=72)
Median DOR, mo (95% CI) 8.4 (6.9, 11.8) 6.1 (5.5, 7.9)
P value (stratified)* 0.0004
ORR and DOR were improved in Arm A versus
Arm B (ITT-WT)
The number of missing or unevaluable cases was 42 (9.4%) in the atezo + CnP arm and 27 (11.9%) in the CnP
arm
*For descriptive purposes only.
Cappuzzo, et al. ESMO 2018 (Abs LBA53)
49.2
31.9
2.5 1.3
46.8
30.5 30.4
38.1
11
18.1
0
10
20
30
40
50
60
Response
(%)
n=220 n=72 n=11 n=3 n=209 n=69 n=136 n=86 n=49 n=41
ORR CR PR SD PD
A higher proportion of patients
have a complete or partial
response in the experimental arm
compared with the control arm

50. Atezolizumab + carboplatin + nab-paclitaxel was well tolerated with a
safety profile consistent with the known safety profiles of each drug
Data are n (%) or median (range); safety data are included for the CnP arm for patients up until crossover
49/232 patients treated with CnP received pemetrexed switch maintenance
*Related to any treatment
Cappuzzo, et al. ESMO 2018 (Abs LBA53)
Atezo + CnP
(n=473)
CnP
(n=232)
Treatment duration, median (range), mo
Nab-paclitaxel
Carboplatin
Atezolizumab
Pemetrexed
2.8 (0–7)
2.3 (0–6)
6.9 (0–32)
–
2.7 (0–5)
2.3 (0–5)
–
3.5 (0–16)
All-cause AE, n (%)
Grade 3–4
Grade 5
471 (99.6%)
381 (80.5%)
25 (5.3%)
230 (99.1%)
164 (70.7%)
13 (5.6%)
Treatment-related AE, n (%)*
Grade 3–4
Grade 5
455 (96.2%)
346 (73.2%)
8 (1.7%)
215 (92.7%)
140 (60.3%)
1 (0.4%)
Serious AE, n (%)
Treatment-related serious AEa
240 (50.7%)
112 (23.7%)
88 (37.9%)
30 (12.9%)
Treatment-related AEs of special interest, n (%)
Grade 3–4
Grade 5
168 (35.5%)
24 (5.1%)
3 (0.6%)
34 (14.7%)
6 (2.6%)
0
AE leading to any treatment withdrawal, n (%) 125 (26.4%) 51 (22.0%)
AE leading to any dose interruption or modification, n (%) 402 (85.0%) 186 (80.2%)
There was a higher proportion of treatment-related
grade 3–5 AEs and AEs of special interest in the
Atezo+CnP arm, which is expected, due to the
additive effects of three drugs instead of two

51. Key conclusions IMpower 130
Atezo plus chemotherapy had a safety profile consistent with AEs associated with single-agent therapy;
no new safety signals were identified
IMpower130 demonstrated statistically significant and clinically relevant OS benefit when atezolizumab
was added to carboplatin + nab-paclitaxel, despite the high crossover rate
IMpower130 was a positive phase III study for atezolizumab in 1L NSCLC, providing an alternative
CIT + chemotherapy regimen for patients with chemotherapy-naïve NSCLC
An OS and PFS benefit was observed across key clinical subgroups, except in patients with EGFR/ALK+
NSCLC or patients with liver metastases, supporting use of the IMpower150 regimen in those patients
IMpower130 demonstrated a PFS benefit and a higher ORR when atezolizumab was added to
carboplatin + nab-paclitaxel

52. For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.
Full prescribing information available on request. For scientific information on Roche Medicinal Product please write to india.medinfo@roche.com
For all Adverse Events/Special Situation Reports with Roche Medicinal Product please report the same to india.drugssafety@roche.com within
one business day/24 hours. This promotional input is not valid after 14/12/2022
Marketed in India by:
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ABRIDGED PRESCRIBING INFORMATION
(Tecentriq ®) SUMMARY OF PRESCRIBING INFORMATION: Generic Name: Atezolizumab Injection, Brand Name: Tecentriq®. Composition: Active ingredient: Atezolizumab.
Tecentriq is supplied as a single-use vial containing preservative-free, colorless to slightly yellow solution, at an active ingredient concentration of 60 mg/mL as follows:14 mL vial containing a total of 840 mg Atezolizumab 20 mL vial containing a total of 1200 mg Atezolizumab. Indications:
Tecentriq® is indicated for- Urothelial carcinoma (UC) Tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma after prior chemotherapy or who are considered cisplatin ineligible. Non-small cell lung cancer- Tecentriq is also indicated
for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Tecentriq in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-
small cell lung cancer (NSCLC). In patients with EGFR, mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. Atezolizumab in combination with nab-paclitaxel and carboplatin,
is indicated for first-line treatment of patients with metastatic non-squamous NSCLC who do not have EGFR or ALK genomic tumor aberrations. Atezolizumab as monotherapy for the first line treatment of patients of metastatic NSCLC whose tumors have a PD L1 expression > 50% tumor
cells or > 10% tumor infiltrating immune cells and who do not have EGFR or ALK genomic tumor aberrations. Small cell lung cancer Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-
SCLC).Triple-negative breast cancer Tecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumor have PD-L1 expression ≥1%, and who have not received prior
chemotherapy for metastatic disease. Hepatocellular carcinoma Atezolizumab, in combination with Bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.Type of dosage form:
Tecentriq® is available in single use vials as Concentrate for solution for infusion. Dosage and Administration: Tecentriq must be administered as an intravenous infusion under the supervision of a qualified healthcare professional. Do not administer as an IV push or bolus. The initial
dose of Tecentriq must be administered over 60 minutes. If the first infusion is tolerated all subsequent infusions may be administered over 30 minutes. The recommended dose of Tecentriq in monotherapy or combination therapy:840 mg administered by IV infusion every 2 weeks, or 1200
mg administered by IV infusion every 3 weeks Tecentriq monotherapy 2L NSCLC, 1L NSCLC, 2L UC & 1L UC in Cisplatin ineligible patients Tecentriq combination therapy 1L non-squamous NSCLC:Tecentriq in combination with bevacizumab, paclitaxel, and carboplatin:During the
induction phase, Tecentriq is administered according to its dosing schedules by intravenous (IV) infusion and bevacizumab, paclitaxel and carboplatin are administered every 3 weeks for four or six cycles. The induction phase is followed by a maintenance phase without chemotherapy in
which Tecentriq is administered according to its dosing schedules by IV infusion and bevacizumab is administered every 3 weeks. Tecentriq in combination with nab-paclitaxel and carboplatin:During the induction phase, the recommended dose of Tecentriq is 1200 mg administered by IV
infusion, followed by nab-paclitaxel and carboplatin every 3 weeks for four or six cycles. For each 21-day cycle, Tecentriq, nab-paclitaxel and carboplatin is administered on day 1. In addition, nab-paclitaxel is administered on days 8 and 15. The induction phase is followed by a
maintenance phase without chemotherapy in which 1200 mg Tecentriq is administered by IV infusion every 3 weeks.1L ES-SCLC: Tecentriq in combination with carboplatin and etoposide. During the induction phase, Tecentriq is administered according to its dosing schedules by IV
infusion and carboplatin and etoposide are administered by IV infusion every three weeks for four cycles. Carboplatin and etoposide are administered on day 1 of each cycle, and etoposide is also administered on days 2 and 3. The induction phase is followed by a maintenance phase
without chemotherapy in which Tecentriq is administered according to its dosing schedules by IV infusion. 1L TNBC: Tecentriq in combination with nab-paclitaxel: The recommended dose of Tecentriq is 840 mg administered by IV infusion, followed by 100 mg/m2 nab-paclitaxel. For each
28-day cycle Tecentriq is administered on days 1 and 15, and nab-paclitaxel is administered on days 1, 8 and 15. HCC: Tecentriq in combination with bevacizumab. Tecentriq is administered according to its dosing schedules by IV infusion, and bevacizumab 15 mg/kg is administered every
3 weeks. Duration of Treatment: Patients are treated with Tecentriq until disease progression or unacceptable toxicity in UC, NSCLC & ES-SCLC and patients are treated until disease progression or unacceptable toxicity in 1L TNBC.Contraindications: Tecentriq is contraindicated in
patients with a known hypersensitivity to Atezolizumab or any of the excipients. Warnings and Precautions: Immune-mediated pneumonitis: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with Tecentriq. Treatment with Tecentriq should be permanently
discontinued for Grade 3 or 4 pneumonitis. Immune-mediated hepatitis: Cases of hepatitis, some leading to fatal outcomes, have been observed in clinical trials with Tecentriq. Treatment with Tecentriq should be permanently discontinued for Grade 3 or Grade 4 events. Immune-
mediated colitis: Cases of diarrhea or colitis have been observed in clinical trials with Tecentriq. Treatment with Tecentriq should be permanently discontinued for Grade 4 diarrhea or colitis. Immune-mediated endocrinopathies: Hypothyroidism, hyperthyroidism, adrenal insufficiency
and type 1 diabetes mellitus, including diabetic ketoacidosis, have been observed in clinical trials with Tecentriq. For Grade 4 Hypophysitis, treatment with Tecentriq should be permanently discontinued. Immune-mediated meningoencephalitis: Meningoencephalitis has been observed in
clinical trials with Tecentriq. Permanently discontinue for all grades of meningoencephalitis. Immune-mediated neuropathies: Myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome, which may be life threatening, were observed in patients receiving Tecentriq. Permanently
discontinue Tecentriq for all grades of immune mediated neuropathies. Immune-mediated pancreatitis: Pancreatitis, including increases in serum amylase and lipase levels, has been observed in clinical trials with Tecentriq. Treatment with Tecentriq should be permanently discontinued
for Grade 4, or any grade of recurrent pancreatitis. Immune-mediated myocarditis: Myocarditis has been observed in clinical trials with Tecentriq. Tecentriq should permanently discontinued for Grade 3 or 4 myocarditis. Immune-mediated myositis: Cases of myositis, including fatal
cases, have been observed in clinical trials with Tecentriq. Treatment with Tecentriq should be permanently discontinued for Grade 3 recurrent myositis or Grade 4 events. Immune-mediated nephritis: Nephritis has been observed in clinical trials with Tecentriq. Treatment with Tecentriq
should be permanently discontinued for Grade 3 or 4 nephritis. Infusion related reactions: Infusion related reactions (IRRs) have been observed in clinical trials with Tecentriq. Tecentriq should be permanently discontinued in patients with Grade 3 or 4 infusion related reactions.Immune-
mediated severe cutaneous adverse reactions: Immune-mediated severe cutaneous adverse reactions (SCARs), including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients receiving Tecentriq. Patients should be monitored
for suspected severe skin reactions and other causes should be excluded. Tecentriq should be permanently discontinued for Grade 4 skin reactions, and corticosteroids should be administered. For confirmed SJS or TEN, Tecentriq should be permanently discontinued. Special populations:
Patients with autoimmune disease were excluded from clinical trials with Tecentriq. In the absence of data, Tecentriq should be used with caution in patients with autoimmune disease, after assessment of the potential risk-benefit. Embryofetal toxicity: Based on the mechanism of action,
the use of Tecentriq may cause fetal harm. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus resulting in fetal death. Pregnant women should be advised of the potential risk to the
fetus. Women of childbearing potential should be advised to use highly effective contraception during treatment with Tecentriq and for 5 months after the last dose. Disease Specific precautions: Use of Atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in
metastatic non-squamous non-small cell lung cancer Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel and carboplatin before initiating treatment. Use of atezolizumab in combination with nab-paclitaxel in metastatic
triple negative breast cancer: Neutropenia and peripheral neuropathies occurring during treatment with Atezolizumab and nabpaclitaxel may be reversible with interruptions of nab-paclitaxel. Physicians should consult the nab paclitaxel summary of product characteristics (SmPC) for
specific precautions and contraindications of this medicine. Patients excluded from clinical trials: Patients with the following condition were excluded from clinical trials: a history of autoimmune disease, history of pneumonitis, active brain metastasis, HIV, hepatitis B or hepatitis C infection,
significant cardiovascular disease and patients with inadequate hematologic and end-organ function. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment; systemic immune stimulatory agents within 4 weeks or systemic immunosuppressive medicinal
products within 2 weeks prior to study entry were excluded from clinical trial. Use in Special population:Fertility: Based on animal studies, Tecentriq may impair fertility in females of reproductive potential while receiving treatment. Contraception: Female patients of childbearing potential
should use highly effective contraception and take active measures to avoid pregnancy while undergoing Tecentriq treatment and for at least 5 months after the last dose. Pregnancy: There are no clinical studies of Tecentriq in pregnant women. Tecentriq is not recommended during
pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus. Labor and Delivery: The use of Tecentriq during labor and delivery has not been established. Lactation: There is no information regarding the presence of atezolizumab in human milk, the effects
on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown. Because of the potential for serious adverse reactions in breastfed infants from Tecentriq, advise women not to breastfeed
during treatment and for at least 5 months after the last dose. Pediatric use: Tecentriq is not approved for use in patients under the age of 18 years. The safety and efficacy of Tecentriq in this population has not been established. Tecentriq did not demonstrate clinical benefit in pediatric
patients in a clinical trial. Geriatric use: No overall differences in safety or efficacy were observed between patients ≥ 65 years of age and younger patients. Postmarketing Experience: Lung infection, Immunodeficiency, Blood sugar increased, chest infection, Pneumonitis, Platelet count
low, Neutropenia, Hypothyroidism, Bedridden, Hip facture. Undesirable Effects: This is not the complete list. The very commonly reported Adverse Events (AEs) with Tecentriq in monotherapy includes fatigue, decreased appetite, cough, nausea, dyspnea, , diarrhea, pyrexia, vomiting,
arthralgia, Musculoskeletal pain, back pain, urinary tract infection, asthenia, pruritus, rash, headache and in case of combination therapy it includes anemia, neutropenia, thrombocytopenia, leukopenia, hypothyroidism, constipation, peripheral oedema, lung infection, peripheral neuropathy,
nasopharyngitis, alopecia, hypertension. No new adverse drug reactions have been identified from post marketing experience. Interactions with other medicinal products and other forms of interaction: No formal pharmacokinetic drug-drug interaction studies have been conducted
with atezolizumab. Since atezolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. Overdose: There is no information on overdose with Tecentriq. Storage: Vials: - Store in a refrigerator at 2°C - 8°C. Keep vial in the outer carton in
order to protect from light. DO NOT FREEZE. DO NOT SHAKE. This medicine should not be used after the Expiry Date shown on the pack. The diluted solution for infusion should be used immediately. If the solution is not used immediately, it can be stored for up to 30 days at 2°C-8°C, or
24 hours at ambient temperature (≤ 25°C) if prepared under aseptic conditions. This medicinal product must not be mixed with other medicinal products. Shelf-life: 3 Years for Atezolizumab Injection 1200mg/20ml and 2 Years for Atezolizumab Injection 840mg/14ml Please read full
prescribing information before usage. Details of Permission or License Number with date:IMP-063/2017 dated 31 March 2017 [1200mg/20ml] and dated 27 Sept 2019 [840mg/14ml].Date of Revision: Current at December 2021, Version 20.0

53. Thank You