Case discussion on atezolizumab

1. Case based
discussion

2. Disclaimer

3. Treatment options for patients with metastatic NSCLC who do not
have an actionable driver alteration
CIT monotherapy
1L treatment options
CIT + chemotherapy
CIT + chemotherapy + anti-VEGF
CIT monotherapy
Anti-angiogenic + chemotherapy
≥2L treatment options
Chemotherapy
CIT doublet
Anti-angiogenic + chemotherapy
Chemotherapy
CIT doublet + chemotherapy
2L CIT
Only an option if no CIT used in 1L
After disease progression on
1L CIT regimens,
2L CIT is not an option
A drug is not an option in later lines
if already given in an earlier line
1L = first-line; 2L = second-line; CIT = cancer immunotherapy
NSCLC = non-small cell lung cancer; VEGF = vascular endothelial growth factor
Ganz, et al. Cancer 1989; Bunn, et al. Clin Cancer Res 1998
Schiller, et al. N Engl J Med 2002; Scagliotti, et al. Oncologist 2009

4.  How to choose the best treatment option for the
patient?
 Which Predictive biomarkers for cancer
immunotherapy with immune checkpoint
inhibitors?
– Which platform
– TMB- blood/tissue/none??

5. Overview of predictive biomarkers for immune checkpoint
inhibitors efficacy
Biomark Res. 2020 Aug 26;8:34.

6. Case 1
• 40 yr female, with passive smoking history presented with cough,
breathing difficulty and loss of weight
• Chect x-ray showed mass lesion in left lung
• Good performance status
• Biopsy showed squamous cell carcinoma
• No driver mutation
• PD L1 testing with SP263 – 75%

7. Case 1….
• What would be your preferred regimen in this patient?
oIO mono
oIO-Chemo
oChemo
• What would your choice of immunotherapy in this patient?
• Would you be comfortable with SP263 or would you request for
SP142 based results before initiating Atezolizumab?

8. Time (months)
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38
100
90
80
70
60
50
40
30
20
10
0
OS
estimate
Atezolizumab
Chemotherapy
Censored
+
No. at risk
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
7
4 3 3 3 1
Chemo
107
Atezo
98
Atezolizumab
n=107
Chemotherapy
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)
OS was significantly improved with atezolizumab monotherapy in the TC3
or IC3 expression subgroup7
NE, not estimable; *Stratified; ‡Stratified log-rank
Data cut-off: 10 September 2018
HR*=0.59 (95% CI: 0.40, 0.89); P=0.0106‡
Median follow-up, 15.7 months (range, 0–35)
Median OS is improved by
7.1 months with
atezolizumab over
chemotherapy
IMpower110 met its primary
endpoint of OS in the TC3 or IC3
expression subgroup
13.1 20.2

9. OS benefit in PD-L1 high subgroup for atezolizumab
over chemotherapy was maintained with 22C3 and SP2638
Atezo
(n=107)
Chemo
(n=98)
mOS, mo 20.2 13.1
HR (95% CI)‡ 0.59 (0.40, 0.89)
Atezo
(n=134)
Chemo
(n=126)
mOS, mo 20.2 11.0
HR (95% CI)§ 0.60 (0.41, 0.86)
Atezo
(n=150)
Chemo
(n=143)
mOS, mo 19.5 16.1
HR (95% CI)§ 0.71 (0.50, 1.00)
OS favoured atezolizumab monotherapy over chemotherapy
when PD-L1 expression is measured using either the 22C3 or
SP263 assay within the biomarker evaluable population (BEP) of
the SP142 positive study population
*SP142 TC1/2/3 or IC1/2/3-WT (n=554); 22C3 BEP-WT (n=534); SP263 BEP-WT (n=546)
‡Stratified. §Unstratified
SP142 (TC3 or IC3-WT)* 22C3 BEP-WT (TPS ≥50%)* SP263 BEP-WT (TC ≥50%)*
Time (months)
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38
100
90
80
70
60
50
40
30
20
10
0
OS
estimate
Atezolizumab
Chemotherapy
20
No. at risk
94 85 80 66 61 48 40 34 25 18 16 11 6 5
89 75 65 50 40 33 28 19 12 9 7 6
7
Chemo
107
Atezo
98
Time (months)
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38
100
90
80
70
60
50
40
30
20
10
0
OS
estimate
20
No. at risk
120 114 105 87 73 53 43 34 23 14 11 7 3 3
116 97 84 64 46 32 26 19 11 6 4 3
3
Chemo
134
Atezo
126
Time (months)
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38
100
90
80
70
60
50
40
30
20
10
0
OS
estimate
Atezolizumab
Chemotherapy
20
No. at risk
134 123 113 93 75 56 46 36 26 14 11 7
128 109 94 73 54 41 33 25 12 8 6 5
Chemo
150
Atezo
143
4
2
3 3
2
1 1
1 1
3 3
3 2
3 3
3 3 1
Atezolizumab
Chemotherapy
Additional pre-specified PD-L1 biomarker analyses were performed using the Dako 22C3 PD-L1 IHC assay (exploratory endpoint) and
VENTANA SP263 PD-L1 IHC assay (secondary endpoint) within the SP142 TC1/2/3 or IC1/2/3 WT population

10. 50%
Chemotherapy
n=263
Atezolizumab
n=286
40% 30% 20% 10% 0 10% 20% 30% 40%
Vomiting
Decreased neutrophil count
Hypothyroidism
Thrombocytopenia
Anaemia
Nausea
Neutropenia
Constipation
Increased blood creatinine
Leukopenia
Decreased platelet count
Pruritus
Increased AST
50%
More
frequent
with
chemo
More
frequent
with
atezo
Atezolizumab demonstrated a favourable safety profile compared with
chemotherapy7
The most common all-cause
AEs are those typically
associated with chemotherapy
Proportion of patients (%)

11. IMpower110 vs KN-024 vs KN-042
Attributes IMpower 110 KN-024 KN-042
Difference in
regimens
Atezolizumabvs SoC Pembrolizumabvs SoC Pembrolizumabvs SOC
Approvedlabel 1L metastatic NSCLCwith high PD-
L1 expression (TC ≥ 50% or IC ≥
10%) with no EGFR or ALK genomic
tumor aberrations
1L treatment of patients with NSCLC
expressing PD-L1 [TPS ≥1%] as
determined by an FDA-approved test,
with no EGFR or ALK genomic tumor
aberrations
KN-024 for TPS>50% and KN-042 for
TPS>1%
1L treatment of patients with NSCLC
expressing PD-L1 [TPS ≥1%] as
determined by an FDA-approved test,
with no EGFR or ALK genomic tumor
aberrations
KN-024 for TPS>50% and KN-042 for
TPS>1%
Randomization 1:1 1:1 1:1
Dosing 1200 mg Q3W 200 mg Q3W 200 mg Q3W
Enrollment 587 [285 - Atezo; 287- chemo] 355 [154 - Pembro; 151- chemo] 1274 [637 -equallybetween pembro and
chemo]
Primary
endpoint
OS in PD-L1 pre-specified
population
PFS OS
Patient
characteristics
differentiators
• PD-L1 high: 35%
• Median age: 63
• Sq. vs Non sq.:25% vs 75%
• Male: 74%
• Tobacco exposure:92%
• Asian: 19%
• Liver mets: 17%
• PD-L1 high: 100%
• Median age: 64
• Sq. vs Non sq.:19% vs 81%
• Male: 92%
• Tobacco exposure:97%
• Asian: 14% ( specificallyEast Asian)
• Liver mets: No
• Metastatic : 88%; PD-L1 high: 47%
• Median age: 63
• Sq. vs non-sq.: 38%vs62%
• Male: 72%
• Tobacco exposure:~80%
• Asian: 29%
• Liver mets: No

12. In high PD-L1 high patient groups [IMpower110 vs KN-024 vs KN-042 ]
Attributes. IMpower 110 KN-024 KN-042
Efficacy mOS (high PD-L1): 20.2 vs 13.1
mos. (HR 0.59)
5 yr. OS rate: Not available
[1 yr. OS rate: 66% vs 52%]
mPFS: 8.1 vs 5 mos. (HR 0.63)
ORR: 38% vs 29%
mDOR: NR vs 6.7 mos.
mOS (high PD-L1): 30.3 vs 14.2
mos. (HR 0.64)
5 yr. OS rate: 32% vs 16%
[1 yr. OS rate: 70% vs 55%]
mPFS: 10.3 vs 6 mos. (HR 0.63)
ORR: 45% vs 28%
mDOR: NR vs 6.3 mos.
mOS (high PD-L1):20 vs 12.2 mos.
(HR0.69) - Similar crossing of
curves at 6 mos. similar to
IMpower110
3 yr. OS : 31.3 % vs 18.4%
mPFS: 7.1 vs 6.4 mos. (HR 0.81)
ORR:39% vs 32%
mDOR: 10.8 mos.
Safety G3/4 AE: 16% [ 3% G5]
Serious AE: 28%
TR discontinuation: 6% vs 16%
G3/4 AE: 27%
Serious AE: 22%
TR discontinuation:7% vs 1%
G3/4: 18% [ G5: 2%]
TR discontinuation: 8% vs 7%
Same IO molecule showing
different OS in same patient
population,
OS similar to IMPOWER 110

13. Network meta-analysis of CIT vs Chemo in high PD-L1 in 1L
NSCLC patients with mixed histology - Efficacy
Front Oncol. 2021 Jul 9;11:676732

14. Network meta-analysis of CIT vs Chemo in 1L NSCLC patients -
Safety
J Clin Med 2021 Oct 4;10(19):4583
Forest plots of
risk ratios (RR)
for trAEs
grade>3
compared to
chemo
risk ratios (RR)
for AEs leading
to treatment
discontinuatio
n compared to
chemo

15. Network meta-analysis of CIT vs Chemo in 1L NSCLC patients -
Safety
J Clin Med 2021 Oct 4;10(19):4583
Forest plots of
risk ratios (RR)
for PD-L1 vs
PD-1 inhibitors
any
grade irAEs
Forest plots of
risk ratios (RR)
for PD-L1 vs
PD-1 inhibitors
grade 3–4
irAEs

16. Case 2
• 32 year old male, never smoker
• Presented with
o Cervical lymphadenopathy
o 5 kg weight loss over past 2 months
o Cough over last month
• Past medical history – Unremarkable
o Never smoker, denies alcohol use
• Family history - Father with a history of squamous cell carcinoma of the
lung at age of 67 (former smoker)
• Physical Examination
o PS – 0
o B/L cervical lymphadenopathy
o Largest node measuring 3 cm in size
o Lungs clear

17. Case 2 Contd…………..
• Neck ultrasound demonstrated bilateral cervical lymphadenopathy
• Primary care physician hypothesized a diagnosis of lymphoma and
ordered a PET-CT
• Increased uptake in Left lower lobe and in lymph nodes

18. • Next approach- work up
• Excisional biopsy?
• Molecular testing for driver mutation- EGFR, ALK, BRAF, RET fusion, MET alteration,
KRAS ?
• Ideal workup vs minimal workup; Large panel vs Small panel ?
• MRI brain?
• PD-L1 testing ?
Case 2 Contd…………..

19. Results and Management
• EGFR positive, TP53 Co- mutation
• Patient given Osimertinib
• After few months
• PET CT- lesions increased in size, Clinically felt better
• After few more months
• Disease progression, Lesions increased, interlobular Septal thickening
• Brain MRI : metastasis + (symptomatically stable)
• Would you go for Rebiopsy ?
Case 2 Contd…………..

20. 1 Continue with the same EGFR TKI
2 Start chemotherapy
3 Start atezolizumab + bevacizumab + chemotherapy
5 Other
What treatment would you normally choose for a patient
with EGFR+ NSCLC after exhausting EGFR TKI options?
4 Enroll into a clinical trial

21. Trial OS hazard ratio (95% CI) Weight, %
EGFR mutated
OAK 1.24 (0.71–2.18) 3.5
CheckMate 057 1.18 (0.69–2.02) 3.9
KEYNOTE-010* 0.88 (0.45–1.72) 2.5
POPLAR 0.99 (0.29–3.40) 0.7
Subtotal 1.11 (0.80–1.53) 10.6
0.2 1.0 4.0
Favours PD-1/PD-L1 inhibitor Favours docetaxel
Hazard ratio (95% CI)
*PD-L1 selected population (TPS ≥1%) Lee, et al. JAMA Oncol 2018
CIT monotherapy has limited efficacy in previously
treated EGFR+ NSCLC

22. IRS, immunoreactive score; gives a range of 0–12 as a product of multiplication between positive
cells proportion score (0–4) and staining intensity score (0–3)
*Based on immunochemical staining in mutant and wildtype non-small cell lung cancer tissues
Hung, et al. Oncol Lett 2016
Seto, et al. Lancet Oncol 2014
What is the evidence for the potential role of anti-VEGF
in patients with EGFR+ NSCLC?
EGFR signal activation increases VEGF production
H460
0
VEGF
(pg/ml/10
6
cell)
500
1000
1500
P<0.0001
A549 H1650 H1975
EGFR M- EGFR M+
P=0.0399
0
IRS
Score*
2
4
6
8
10
P=0.0011
EGFR M- EGFR M+
JO25567: EGFR+ NSCLC patients have
increased sensitivity to bevacizumab
0
0
20
40
60
80
100
Time (months)
Progression-free
survival
(%)
2 4 6 8 10 12 14 16 18 20 22 24 26 28
HR=0.54
(95% CI: 0.36–0.79)
Erlotinib + bevacizumab
Erlotinib alone
9.7 mo 16.0 mo

23. DOR Bev+CP (C) Atezo+Bev+CP (B) Atezo+CP (A)
ITT-WT n=134 n=197 n=146
Median DOR (95% CI), mo 6.4 (5.7, 7) 11.5 (8.9, 16.2) 9.2 (7.4, 13.9)
No. of ongoing response, n (%) 18 (13.4%) 77 (39.1%) 53 (36.3%)
IMpower150: Investigator-assessed PFS in the EGFR+
population1
PFS benefit was observed with the addition of atezolizumab to bevacizumab + chemotherapy (Arm B vs
Arm C). No benefit was observed for atezolizumab + chemotherapy over bevacizumab + chemotherapy
(Arm A vs Arm C)
Arm B (atezo + bev + CP) vs Arm C (bev + CP) Arm A (atezo + CP) vs Arm C (bev + CP)
Arm B (atezo + bev + CP) vs Arm C (bev + CP)
HR 0.61 (95% CI: 0.36–1.03)
(Updated PFS analysis)
HR 1.14 (95% CI: 0.73–1.78)
(Updated PFS analysis)
Arm B (atezo + bev + CP) vs Arm C (bev + CP)
Data cut-off: 22 January, 2018.
1. Reck et al. Lancet Respir Med 2019

24. IMpower150: Updated OS in patients with sensitising EGFR
mutations1
At this updated analysis with almost 20 months’ longer follow-up, in the EGFR sensitising subgroup the median
OS was reached for Arm B vs C, showing a continued clear separation of curves and OS benefit with the
addition of atezolizumab to bevacizumab + chemotherapy. No benefit was observed between Arm A vs C
Arm B (atezo + bev + CP) vs Arm C (bev + CP) Arm A (atezo + CP) vs Arm C (bev + CP)
HR=0.60 (95% CI: 0.31, 1.14)
Minimum follow-up: 32.4 mo
(Updated OS analysis)
HR=0.60 (95% CI: 0.31, 1.14)
Minimum follow-up: 32.4 mo
(Updated OS analysis)
Data cut-off: 13 September, 2019.
OS for Arm B versus C was considered final at the second interim analysis, updated data is for descriptive purposes only.
1. Socinski et al. AACR 2020 (CT216)

25. IMpower150: ORR in patients with EGFR+ NSCLC
(second interim OS analysis)1,2
Arm A
(atezo + CP)
Arm B (atezo
+ bev + CP)
+ CP)
Arm C
(bev + CP)
45 34 43
16 (35.6)
(21.9, 51.2)
24 (70.6)
(52.5, 84.9)
18 (41.9)
(27.0, 57.9)
1 (2.2)
(0.1–11.8)
2 (5.9)
(0.7–19.7)
0
15 (33.3)
(20.0, 49.0)
21 (46.7)
(31.7, 62.1)
6 (13.3)
(5.1, 26.8)
5.6 (2.6, 15.2)
3 (18.8)
22 (64.7)
(46.5, 80.3)
5 (14.7)
(5.0, 31.1)
2 (5.9)
(0.7, 19.7)
11.1 (2.8, 18.0)
9 (37.5)
18 (41.9)
(27.0, 57.9)
19 (44.2)
(29.1, 60.1)
3 (7.0)
(1.5, 19.1)
4.7 (2.6, 13.5)
0
SD
PD
Median DOR, mo (95%
CI)
Ongoing responses at
cut-off, n (%)
Number of patients, n
ORR, n (%) (95% CI)
CR
PR
Data cut-off: 22 January, 2018.
aResponses are confirmed. Includes patients with measurable disease. Missing or unevaluable in the EGFR-positive subgroup: three
patients in the ABCP group, two patients in the ACP group, and three patients in the BCP group. One patient in the BCP group had a non-
complete response or non-progressive disease response.
1. Mok et al. ESMO Asia 2018 (LBA9); 2. Reck et al. Lancet Respir Med 2019

26. Q. Who are the ideal patients to receive ABCP
regimen in metastatic NSCLC?
Q. What are your thoughts on subgroup analysis?
Are these results reflective of your clinical practice?
Q. How do you manage non squamous NSCLC
patients with liver metastasis?

27. Case 3
• 65 yr with smoking history presented with multiple pulmonary
nodules.
• Biopsy showed adenocarcinoma EGFR and ALK (-)
• He has type II DM uncontrolled and with renal insufficiency
• PD L1 test with SP142 – 20%

28. Case 3 discussion
• Which platform you use for PD-L1 testing before selecting a first-line
treatment for NSCLC?
• Do you use first-line cancer immunotherapy as:
- a single agent (monotherapy)?
- in combination with chemotherapy?
• What are the most commonly used chemotherapy regimen in 1L non
squamous NSCLC in your practice?
• In this patient what is your preferred chemo-IO regimen?

29. 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

30. 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)

31. IMpower130: PFS and OS by PD-L1 subgroups*
PFS and OS benefit was observed in all PD-L1 subgroups
31
PFS HR (95% CI) OS HR (95% CI)
ITT-WT (primary, formally tested) 0.64 (0.54, 0.77) 0.79 (0.64, 0.98)
TC3/IC3 0.51 (0.34, 0.77) 0.84 (0.51, 1.39)
TC12/IC12 0.61 (0.43, 0.85) 0.70 (0.45, 1.08)
TC0 and IC0 0.72 (0.56, 0.91) 0.81 (0.61, 1.08)
WT = EGFR wild type/ALK negative
*Arms A (atezo+carbo+nab-pac) vs B (carbo+nab-pac)
PD-L1 expression
appeared to enrich for
PFS benefit
OS favoured the
experimental arm across
all PD-L1 subgroups

32. Case 3 discussion
• What are your impressions and conclusions of the data in the PD-L1
negative subgroup
(TC0 and IC0)?
• Based on the IMpower130 data, do you think it is necessary to test
any first-line patients for PD-L1 expression?

33. 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.

34. Marketed in India by:
Roche Products (India) Pvt. Ltd.
146-B, 166 A, Unit No. 7, 8, 9, 8th Floor, R City Office, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086
Maharashtra; Tel No. +91 22 50457300; Fax No. +91 22 50457301
M-IN-00001263
ABRIDGED PRESCRIBING INFORMATION contd…
(Tecentriq ®) SUMMARY OF PRESCRIBING INFORMATION: Generic Name: Atezolizumab Injection, Brand Name: Tecentriq®. Composition: Active ingredient: Atezolizumab.
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
Disclaimer:
® = Registered Trade Mark F. Hoffmann - La Roche Limited, Basel, Switzerland.
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.drugsafety@roche.com within one business day/24 hours.
This promotional input is not valid after 21/02/2023 or any update

35. THANK YOU!