Download ASCO 2009 IREvent_Part1_FINAL1

45th ASCO Annual Meeting
Roche and Genentech
Investor Event – Part 1
Sunday, May 31, 2009 - Orlando, Florida
#1
Roche and Genentech
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Various factors may cause actual results to differ materially in the future from those reflected in forward-looking
statements contained in this presentation, among others:
1.  pricing and product initiatives of competitors;
2.  legislative and regulatory developments and economic conditions;
3.  delay or inability in obtaining regulatory approvals or bringing products to market;
4.  fluctuations in currency exchange rates and general financial market conditions;
5.  uncertainties in the discovery, development or marketing of new products or new uses of existing
products, including without limitation negative results of clinical trials or research projects,
unexpected side-effects of pipeline or marketed products;
6.  increased government pricing pressures;
7.  interruptions in production;
8.  loss of or inability to obtain adequate protection for intellectual property rights;
9.  litigation;
10.  loss of key executives or other employees; and
11.  adverse publicity and news coverage.
Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to
mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match
or exceed the historical published earnings or earnings per share of Roche.
For marketed products discussed in this presentation, please see full prescribing information at www.roche.com
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All mentioned trademarks are legally protected.
#2
ASCO 2009 Analyst Meeting Agenda
Sunday, May 31, 2009
Roche and Genentech
6:30 PM
(5 min)
Welcome/
Introductions/
Agenda
Dr. Karl Mahler
Head of Investor Relations, Roche
Kathee Littrell, Ph.D., R.N.
Vice President, Investor Relations, Clinical Support, Genentech
6:35 PM
(10 min)
Opening Remarks
William M. Burns
Chief Executive Officer Division Roche Pharmaceuticals
6:45 PM
(35 min)
Avastin: NSABP
C-08 Data Overview;
Followed by Q&A
Carmen J. Allegra, M.D. (clinical data)
University of Florida, Shands Cancer Center, Professor and Chief, Division of Hematology/
Oncology, Department of Medicine
Philippe Bishop, M.D.
Vice President, Clinical Development, Avastin, Genentech
Varun Nanda
Global Product Strategy, Head of Oncology
7:20 PM
(20 min)
Tarceva: SATURN
and ATLAS Data
Overview
Ivan Melezinek, M.D., Ph.D. (SATURN)
Clinical Science Leader, Tarceva, Roche Pharmaceuticals
Mark “Kip” Benyunes, M.D. (ATLAS)
Senior Group Director, Clinical Hematology/Oncology, Genentech
7:40 PM
(10 min)
Closing Remarks
Hal Barron, M.D.
Executive Vice President, Global Development and Chief Medical Officer
7:50 PM
(10 min)
Q&A
Additional Panel Speakers:
John Orwin, Senior Vice President, Sales and Marketing, BioOncology, Genentech
Stefan Frings, M.D., Ph.D., Lifecycle Leader, Avastin BC/Gyn, Roche Pharmaceuticals
Anne Corder, M.Sc. (Hons), MBA, Lifecycle Leader, Tarceva, Roche Pharmaceuticals
#3
Roche and Genentech
Opening Remarks
William M. Burns
Chief Executive Officer Division Roche Pharmaceuticals
#4
ASCO 2009 Key Takeaways
Roche and Genentech
•  More than 500 scientific abstracts across 20 types of cancer to be
presented
•  Combined Genentech and Roche oncology pipeline includes 27 new
investigational agents in clinical studies
•  Personalized cancer treatments
–  Data supports our approach to develop potential new therapies that
uniquely target the disease
#5
Market Leadership Through Innovation
Roche and Genentech
Breakthrough Clinical Data Drives e Business
ASCO 2007-2009:
Broader Avastin, Herceptin &
Tarceva use (more combinations,
indications, and earlier use)
ASCO 2005:
19.7
Herceptin adjuvant
Avastin mNSCLC; mBC
ASCO 2004:
Tarceva mNSCLC
2L and 3L
ASCO 2003:
Avastin mCRC 1L
CHF
bn
1.6
#6
Roche and Genentech
Understanding Biology to Improve Patient Outcomes
Cancer Type
Marketed Products
Key Products in Development
Gastrointestinal
Avastin, Tarceva, Xeloda
Avastin, Herceptin, Xeloda,
Hedgehog Pathway Inhibitor
Breast
Avastin, Herceptin, Xeloda
Avastin, pertuzumab, T-DM1, Xeloda,
IGF-1R mAb
Lung
Avastin, Tarceva
Avastin, Apomab, dulanermin, Tarceva, IGF-1R
mAb
Hematological
MabThera/Rituxan
Avastin, MabThera/Rituxan, GA101,
dacetuzumab, Apomab, dulanermin, ABT-263
Genito-urinary
Avastin
Avastin, pertuzumab,
Hedgehog Pathway Inhibitor
Skin & Soft Tissue
IGF-1R mAb, Apomab, Hedgehog Pathway
Inhibitor, PLX4032 (B-raf inhibitor)
Brain
Avastin
Childhood Cancers
IGF-1R mAb, Xeloda, Avastin
#7
Roche and Genentech
Personalizing Cancer Treatment
Biomarker Development rough All Stages of the Portfolio
Phase I / II
Prospectively assessing opportunities
for patient selection
IGF-1R mAb
(R1507)
–  Range of candidate
markers
MDM2 antag
(R7112)
-  P53 sequence wild-type
-  MDM2 expression
PLX4032
(R7204)
T-DM1
(R3502)
- BRAFV600E gene
mutation
-  HER2 expression
-  HER2 gene amplification
Phase III / Market
Identifying patients who have an improved
clinical benefit
Herceptin
-  HER2 expression
-  HER2 gene amplification
Avastin
- Range of candidate markers
for hypothesis investigation
Pertuzumab
-  HER Receptor/ligand mRNA
Tarceva
-  EGFR expression (IHC)
-  EGFR gene copy number (FISH)
-  EGFR mutations
-  KRAS mutations
#8
Organizational Setup: Pharma US
CEO Group
S. Schwan
Roche and Genentech
Board Genentech
A. Levinson (Chair)
Genentech gRED
R. Scheller
CEO Genentech
P. Soriot
Comm Ops NA
P. Soriot
Finance NA
S. Krognes
Operations
A. Lee-Karlon
Research
M. Tessier-Lavigne
GPS
I. Clark
Legal NA
R. Kentz
Early Development
S. Bohen
Global Dev. /CMO
H. Barron
HR NA
S. Grossman
Bus. Development
J. McCracken
Techn Ops (GTO)
P. Yang
HR Genentech
D. Smith-Hams
GPS = Global Product Strategy
Corp Relation NA
C. Castro
Global functions
Local/regional support function
#9
Avastin for Adjuvant Colon Cancer
Carmen J. Allegra, M.D.
University of Florida, Shands Cancer Center, Professor and
Chief, Division of Hematology/Oncology, Department of
Medicine
#10
Avastin® (R435)
A Phase III Trial Comparing mFOLFOX6 to
mFOLFOX6 Plus Bevacizumab in Stage II or III
Carcinoma of the Colon: Results of NSABP Protocol
C-08
N. Wolmark et al, ASCO 2009
#11
Avastin Phase III NSABP C-08 Trial:
Study Design
Stage ll + lll Colon Cancer
(N=2,710)
Stratified by # positive
nodes
Randomized
mFOLFOX6
q2w X 6 months
(n=1,356)
*5mg/kg
Primary endpoint
–  Disease-free survival
Statistical planning
assumptions
–  25% reduction in event
rate (HR = 0.75)
mFOLFOX6 + Avastin*
q2w X 6 months followed
by Avastin* for 6 months
(n=1,354)
#12
Avastin Phase III NSABP C-08 Results:
Patient Characteristics
mFOLFOX6
mFOLFOX6 +
Avastin
< 60 yr
58.3%
58.2%
Male
49.8%
49.9%
Stage II (0)
24.9%
24.9%
Stage III (1-3)
45.4%
45.5%
Stage III (4+)
29.7%
29.6%
#13
Avastin Phase III NSABP C-08 Results:
Grade 3+ Toxicities Increased with Avastin (%)
mFOLFOX6
mFOLFOX6 +
Avastin
p value
Hypertension
1.8%
12%
<0.0001
Pain
6.3%
11.1%
<0.0001
Proteinuria
0.8%
2.7%
<0.001
Wound Complications
0.3%
1.7%
<0.001
Median duration of Avastin = 11.5 months
Allegra et al JCO May 4, 2009
#14
Avastin Phase III NSABP C-08 Results:
Disease-free Survival
•  Median follow-up: 35.6 months
mFOLFOX6 + Avastin
mFOLFOX6
HR
P value
Overall DFS based on all events.
Events
(n=603)
n=291
n=312
3-year DFS
77.4%
75.5%
0.89
0.15
#15
Avastin Phase III NSABP C-08 Results:
Disease-free Survival By Stage
Percentage (%)
DFS Stage II
mFOLFOX6 +
Avastin
mFOLFOX6
Difference in rate
HR
P value
DFS Stage III
Events
3-year DFS
N=40
87.4%
N=47
84.7%
∆2.7
0.82
0.35
mFOLFOX6 +
Avastin
mFOLFOX6
Difference in rate
HR
P value
Events
3-year DFS
N=251
74.2%
N=265
72.4%
∆1.8
0.90
0.25
#16
Avastin Phase III NSABP C-08 Results:
Was ere A Significant Transient Effect Of Avastin?
•  Cumulative Hazard Ratio Over Time
P=0.004
P=0.02
P=0.05
P=0.08
P=0.0004
Interval DFS analyses based on DFS events occurring by 1 year, 2 year ,etc.
#17
Avastin Phase III NSABP C-08 Results:
Was ere a Significant Interaction Between the Effect
of Avastin and Time?
Percentage (%)
DFS at 1 Year
Event-free at 1 Year
Time-Treatment Interaction
P = 0.001
mFOLFOX6 +
Avastin
mFOLFOX6
Difference in rate
HR
P value
Events
1-year DFS
N=75
94.3%
mFOLFOX6 + Avastin
N=216
N=122
90.7%
mFOLFOX6
HR
P value
N=190
1.07
0.48
∆3.6
0.60
0.0004
Events
#18
“Evasive Resistance”
-
Escape
?
Response
(dormancy)
Source: Paez-Ribes, Cancer Cell March ‘09
↑Metastasis
#19
Avastin Phase III NSABP C-08 Results:
Status at 36 Months Median Follow-up
mFOLFOX6
mFOLFOX6
+ Avastin
P value
Recurrence (N)
248
227
NS
Death (N)
146
132
NS
Second Cancer (N)
46
47
NS
2-year Survival Post Recurrence (%)
41
37
NS
Recurrence Multiple Sites (%)
18
18
NS
–
–
NS
Sites of Recurrence
Primum non nocere
NS = not statistically significant
#20
Avastin Phase III NSABP C-08:
Conclusion
•  The addition of Avastin to mFOLFOX6 did not result in an overall
statistically significant prolongation in disease-free survival (DFS)
•  There was a transient benefit in DFS during the one year that
Avastin was utilized
•  Consideration should be given to clinical trials assessing longer
duration of Avastin administration
#21
Avastin for Adjuvant Colon Cancer
Philippe Bishop, M.D.
Vice President, Clinical Development, Avastin,
Genentech
#22
Roche and Genentech
NSABP C-08 Provides Insights into Avastin’s
Potential in Early-stage Colon Cancer
Key Takeaways
–  Highly informative trial despite primary endpoint of DFS not met
–  Avastin demonstrated significant on-treatment effect (40% reduction of chance of cancer
returning)
–  Data suggests relationship between duration of Avastin therapy and clinical outcomes
–  Data support our hypothesis that Avastin’s MOA is important in early-stage cancer
–  Avastin’s safety is consistent with previously established profile
What We Know from the Metastatic Setting
–  Clinical benefit of treatment through multiple lines of therapy is well documented in the
metastatic setting (BRiTE, AVF2107)
–  Importance of treatment to progression is also described in studies such as NO16966
Considerations
–  Plan to evaluate whether longer durations of Avastin treatment in the early-stage setting
translate into improved patient outcomes
–  These data may or may not be representative of potential outcomes in other tumor types
(i.e., breast cancer)
#23
Avastin Adjuvant Phase III Program
Roche and Genentech
•  In discussions with NSABP regarding an adjuvant colon cancer trial with longer
duration of Avastin
•  Evaluating next steps
Tumor Type
Trial
Adjuvant Colon
Cancer
NSABP-C08
N
Dosing
Status
N=2,710
•  5 mg/kg q2 weeks
•  Study did not meet its
primary endpoint
AVANT
N=3,451
•  5 mg/kg q2 weeks in
FOLFOX arms
•  7.5 mg/kg q3 weeks in
XELOX arm
•  Study completed enrollment
Q2 2008; expect efficacy
analyses 2010; event-driven
Adjuvant Nonsmall Cell Lung
Cancer
ECOG 1505
N=1,500
•  15 mg/kg q3 weeks
•  Trial ongoing
Adjuvant Breast
Cancer
ECOG 5103 (HER2-)
N=4,950
•  15 mg/kg q3 weeks
•  Trial ongoing
BEATRICE (Triplenegative)
N=2,530
•  Dosing equivalent to 5
mg/kg /per week
•  Trial ongoing
BETH (HER2+ combo
with Herceptin)
N=3,600
•  15 mg/kg q3 weeks
•  Trial ongoing
NSABP = National Surgical Adjuvant Breast and Bowel Project; ECOG = Eastern Cooperative Oncology Group.
#24
Roche and Genentech
Impact Of Avastin On Overall Survival In Patients
With Metastatic Colorectal Cancer:
A Population-based Study from the British Columbia Cancer Agency
•  Median overall survival (OS) significantly increased between 2003/04 and 2006
•  Improvement in survival appears to be limited to patients treated with systemic
therapy (ST) for metastatic disease
•  There were no differences in the proportion of patients receiving oxaliplatin, nor
were there changes in OS in patients not receiving ST, suggesting that OS
improvement was attributable to the introduction of Avastin
Pre-Avastin Era
2003/2004
(n=969)
Avastin Era
2006
(n=448)
P value
Median OS for entire cohort
13.8 mos
17.3 mos
p<0.001
Median OS for patients who
received ST
18.6 mos
23.6 mos
p=.001
Median OS for patients who did not
receive ST
6.1 mos
5.9 mos
p=0.65
D. J. Renouf et al, ASCO 2009 (Abstract #4114)
#25
Roche and Genentech
Avastin for Adjuvant Colon Cancer
Varun Nanda
Global Product Strategy, Head of Oncology
#26
Roche and Genentech
Avastin Target Populations
Each Cancer Type is Different…and Needs a Specific
Treatment Approach
Incidence
Survival
Adjuvant DFS at 3 years*
Metastatic median OS*
72%
(Stage III)
81%
~45%
(OS at 5-years)
18-22 months
~24 months
10-12 months
• Assuming best current care, Incidence: GLOBOCAN 2002 and Roche market research
DFS = Disease-free Survival; OS = Overall Survival.
#27
Avastin Phase III NSABP C-08 Results
Question & Answer Session
#28
Roche and Genentech
Tarceva SATURN Clinical Data Overview
Ivan Melezinek, M.D., Ph.D.
Clinical Science Leader, Tarceva, Roche
Pharmaceuticals
#29
Tarceva® (R1415)
SATURN: A double-blind, randomized, phase III
study of maintenance erlotinib versus placebo
following non-progression with 1st-line platinumbased chemotherapy in patients with advanced
NSCLC.
F. Cappuzzo et al, ASCO 2009
#30
Tarceva Phase III SATURN Trial:
Study Design
Tarceva
150mg/day
Chemonaïve
advanced
NSCLC
n=1,949
4 cycles of
1st-line
platinumbased doublet*
Non-PD
n=889
PD
1:1
Placebo
PD
Mandatory tumor
sampling
Stratification factors:
• 
• 
• 
• 
• 
• 
Co-primary endpoints:
EGFR IHC (positive vs negative vs indeterminate) •  Progression-free survival (PFS) in all patients
Stage (IIIB vs IV)
•  PFS in patients with EGFR IHC+ tumors
ECOG PS (0 vs 1)
CT regimen (cis/gem vs carbo/doc vs others)
Secondary endpoints:
Smoking history (current vs former vs never)
•  Overall survival (OS) in all patients and those with
Region
EGFR IHC+ tumors, OS and PFS in EGFR IHC–
tumors; biomarker analyses; safety; time to
symptom progression; QoL
*Cisplatin/paclitaxel; cisplatin/gemcitabine; cisplatin/docetaxel cisplatin/vinorelbine; carboplatin/gemcitabine; carboplatin/docetaxel carboplatin/
paclitaxel
#31
Tarceva Phase III SATURN Results:
Progression-free Survival
All patients (ITT population)
Tarceva
Placebo
PFS at 12 wks (%)
53
40
PFS at 24 wks (%)
31
17
HR=0.71 (0.62 – 0.82)
Log-rank p <0.0001
Tarceva (n=437)
Placebo (n=447)
#32
Tarceva Phase III SATURN Results:
Progression-free Survival in EGFR IHC+ Patients
Co-primary endpoint
Tarceva
Placebo
PFS at 12 wks (%)
54
40
PFS at 24 wks (%)
32
18
HR=0.69 (0.58 – 0.82)
Log-rank p <0.0001
Tarceva (n=307)
Placebo (n=311)
#33
Tarceva Phase III SATURN Results:
Subgroup Analysis of Progression-free Survival
HR (95% CI)
n
All
0.71 (0.62–0.82)
884
Male
0.78 (0.66–0.92)
654
Female
0.56 (0.42–0.76)
230
Caucasian
0.75 (0.64–0.88)
744
Asian
0.58 (0.38–0.87)
128
Adenocarcinoma
0.60 (0.48–0.75)
401
Squamous-cell
0.76 (0.60–0.95)
359
Never smoker
0.56 (0.38–0.81)
152
Former smoker
0.66 (0.50–0.88)
242
Current smoker
0.80 (0.67–0.97)
490
0.4
0.6
0.8
Favors
Tarceva
1.0
HR
1.2
Favors
Placebo
#34
Tarceva Phase III SATURN Results:
Progression-free Survival According to Biomarker Status
HR (95% CI)
n
All
0.71 (0.62–0.82)
884
EGFR IHC+
0.69 (0.58–0.82)
618
EGFR IHC–
0.77 (0.51–1.14)
121
EGFR FISH+
0.68 (0.51–0.90)
231
EGFR FISH–
0.81 (0.62–1.07)
255
KRAS mutation+
0.77 (0.50–1.19)
90
KRAS wild-type
0.70 (0.57–0.87)
403
0.4
0.6
0.8
1.0
1.2
Favors
Tarceva
HR
Favors
Placebo
#35
Tarceva Phase III SATURN Results:
Progression-free Survival in EGFR Mutation+ Tumors
Tarceva (n=22)
Placebo (n=27)
HR=0.10 (0.04 – 0.25)
Log-rank p <0.0001
#36
Tarceva Phase III SATURN Results:
Progression-free Survival in EGFR Wild Type Tumors
Tarceva (n=199)
Placebo (n=189)
HR=0.78 (0.63–0.96)
Log-rank p=0.0185
#37
Tarceva Phase III SATURN Results:
Safety
•  No new safety signals detected
•  No deterioration of quality of life
AEs occurring in ≥ 10%
of patients
Rash
Diarrhea
Tarceva
(N=433)
All Grades Grade 3/4
60%
9%
20%
2%
*Number of patients with at least 1 dose reduction/interruption
Patients can contribute to more than one category
Placebo
(N=445)
All Grades Grade 3/4
9%
0%
4%
0%
#38
Tarceva Phase III SATURN Results:
Conclusions
•  Tarceva maintenance therapy significantly improved progression-free
survival (PFS) versus placebo
-  Met both co-primary endpoints with statistical significance
-  HR = 0.71 or 29% reduction in hazard (41% improvement in PFS compared
with placebo)
•  Overall survival data immature; expect data 2H 2009
•  Clinical benefit across majority of patient subgroups, irrespective of
histology, race, smoking status or biomarkers
-  EGFR IHC, EGFR FISH and KRAS mutations are not strong predictive factors
and selection of patients based on these is not warranted
-  EGFR mutations are a strong predictive biomarker, but patients with EGFR
wild-type tumours also derive benefit from Tarceva treatment
•  Tolerability profile consistent with previous trials
#39
Roche and Genentech
Tarceva ATLAS Clinical Data Overview
Mark “Kip” Benyunes, M.D.
Senior Group Director, Clinical Hematology/Oncology,
Genentech
#40
Tarceva® (R1415)
A Randomized, Double-blind, Placebo-controlled,
Phase IIIb Trial (ATLAS) Comparing Bevacizumab
(B) erapy With Or Without Erlotinib Aer
Completion Of Chemotherapy With B For First-line
Treatment of Locally Advanced, Recurrent, or
Metastatic NSCLC.
V. A. Miller et al, ASCO 2009
#41
Tarceva Phase IIIb ATLAS Trial:
Study Design
Chemo-naïve
Advanced
NSCLC
N=1,160
4 cycles of
1st-line
chemotherapy*
+ Avastin
Avastin (15mg/kg)+
Tarceva (150mg)
to PD
Non-PD
n=768 (66%)
Eligibility
•  Stage IIIB**/IV NSCLC
•  ECOG performance status 0-1
Stratification factors
•  Gender
•  Smoking history (never vs former/
current)
•  ECOG performance status (0 vs >1)
•  Chemotherapy regimen
1:1
Unblind
at PD
Post progression
therapy
Avastin +
Placebo
to PD
Primary endpoint
•  Progression-free survival in all randomized
patients
Secondary endpoints
•  Overall survival
•  Safety
Exploratory endpoints
•  Biomarker analyses (IHC, FISH, EGFR &
KRAS mutation)
*Carbo/paclitaxel; cis/vinorelbine; carbo or cis/gemcitabine; carbo or cis/docetaxel.
**IIIB wih pleural effusion.
#42
Tarceva Phase IIIb ATLAS Trial:
Randomized Patients by Region
Europe
27
North America
659
Asia
76
Africa
Latin
America
3
Australia
3
#43
Tarceva Phase IIIb ATLAS Results:
Progression-Free Survival
ITT population, investigator assessment
Proportion Without Event
1.0
Avastin + Placebo (n=373)
Avastin + Tarceva (n=370)
0.8
HR=0.722 (0.592-0.881)
Log-rank P=0.0012
0.6
0.4
0.2
0.0
0
3
6
9
12
15
18
21
Progression-Free Survival (months)
No. of patients at risk:
Avastin + Placebo
373
142
58
27
15
6
3
0
Avastin + Tarceva
370
178
81
43
20
6
3
1
#44
Tarceva Phase IIIb ATLAS Results:
Progression-Free Survival in Subgroups
ITT population
Avastin + Placebo
Avastin + Tarceva
Total (n)
Pts with
an Event
(n)
Total
(n)
Pts with
an Event
(n)
HRa
95% CI
Age
<65 years
≥65 years
189
184
119
119
201
169
106
96
0.66
0.69
0.51–0.86
0.53–0.90
Race/ethnicity
White
Black
Asian or Pacific Islander
Other
290
29
45
9
193
21
19
5
293
22
43
12
179
14
5
4
0.75
0.81
0.18
0.43
0.61–0.92
0.41–1.60
0.06–0.55
0.11–1.64
Gender
Male
Female
195
178
122
116
193
177
105
97
0.75
0.63
0.58–0.98
0.48–0.83
Smoking history
Never
Current/former
66
307
36
202
61
309
20
182
0.34
0.76
0.19–0.61
0.62–0.93
ECOG PS at
randomization
0
≥1*
125
245
77
160
126
241
66
136
0.65
0.72
0.47–0.91
0.57–0.91
0.2
* Includes
<1% patients with ECOG PS 2.
0.5
Favors
Tarceva
1
2
Favors
Placebo
#45
Tarceva Phase IIIb ATLAS Results:
Progression-Free Survival in Subgroups
ITT population
Avastin + Placebo
Chemotherapy
Carboplatin + Paclitaxel
Carboplatin + Gemcitabine
Carboplatin + Docetaxel
Cisplatin + Gemcitabine
Other
Avastin + Tarceva
Total
(n)
Events
(n)
Total (n)
Events
(n)
HR
95% CI
174
104
54
32
9
118
68
36
11
5
178
105
46
33
8
97
63
30
7
5
0.68
0.71
0.81
0.43
0.40
0.52–0.89
0.50–1.00
0.49–1.33
0.16–1.16
0.09–1.74
0.2
0.5
Favors
Tarceva
1
2
Favors
Placebo
#46
Tarceva Phase IIIb ATLAS Results:
Summary for Post Chemotherapy Treatment Phase
Safety population
Avastin + Placebo, n (%)
(n=368)
Avastin + Tarceva, n (%)
(n=367)
Any Grade Adverse Event
313 (85.1%)
349 (95.1%)
Grade 3–4 Adverse Event
112 (30.4%)
162 (44.1%)
Grade 5 Adverse Event
4 (1.1%)
8 (2.2%)
Serious Adverse Event
60 (16.3%)
84 (22.9%)
The most common adverse event were rash and diarrhea.
Formal statistical comparison testing between treatment arms was not done.
#47
Tarceva Phase IIIb ATLAS Results:
Conclusions and Future Directions
•  The addition of Tarceva to Avastin after 4 cycles of Avastin and
chemotherapy significantly improved progression-free survival
(HR 0.722, p= 0.0012)
•  Independent review of progression-free survival data is being
conducted
−  Overall survival data are expected in 2H of 2009
•  No new safety signals were observed
•  Biomarker analyses are being conducted - results will be
presented at an upcoming meeting
#48
Tarceva SATURN and ATLAS
Roche and Genentech
Conclusions
•  Both studies met their primary endpoint of improvement in
progression-free survival
•  In SATURN, there was consistency of effect among subgroups
including:
–  Squamous cell carcinoma
–  EGFR wild type
–  KRAS mutations
•  In SATURN, patients with EGFR mutations had marked benefit
•  In ATLAS, biomarker analyses are being conducted and will be
presented at a future meeting
#49
Roche and Genentech
Closing Remarks
Hal Barron, M.D.
Executive Vice President, Global Development and
Chief Medical Officer
#50
ASCO 2009
Roche and Genentech
•  Avastin (NSABP C-08, RIBBON-1, AVADO, and ATLAS)
–  Data supports hypothesis that VEGF plays an important role in all stages of cancer
–  C-08 provides valuable insights for future trials of Avastin in early stage disease
–  Versatility of Avastin: ability to combine with multiple chemotherapies and targeted
agents
–  Changing the natural history of the disease in colorectal cancer
•  Tarceva (SATURN and ATLAS)
–  Evolving treatment regimens are improving patients outcomes in lung cancer
•  Innovation in personalized medicine
–  HER2-positive: Herceptin for gastric cancer
–  BRAF mutation: PLX4032 for advanced melanoma
•  HER2+ Metastatic Breast Cancer
–  T-DM1: Addressing an important unmet medical need for patients who have progressed
on multiple HER2-directed therapies
#51
Roche and Genentech
Roche Group – Oncology Development Pipeline
– 27 New Molecules in Development
Early-stage
Phase I (17 NMEs)
ABT-263
Anti-EGFL7
Anti-PlGF (R7334)
BRAF Inhibitor (R7204)
CIF/MEK Inhibitor
(R7167)
CKI27/Casein Kinase I
(R7304)
GC33/Anti-Glypican-3
MAb1
IAP Antagonist
MDM2 Antagonist
(R7112)
MEK Inhibitor
MetMAb/Anti-cMet
NME Antibody Drug
Conjugate
NME MAb (R7160)
NME Small Molecule
(R4733)
NME Small Molecule
PI3 Kinase Inhibitor
TP300/Topoisomerase I
Inhibitor1
Late-stage
Phase II (8 NMEs)
ABT-869
 Advanced RCC
Anti-IGF-1R (R1507)
 Recurrent or refractory
sarcoma
 Breast cancer
 Advanced NSCLC
Apomab
 Indolent relapsed NHL
 1L mNSCLC
Avastin (R435)
  Extensive small cell lung
cancer
 1L metastatic melanoma
 1L metastatic squamous
NSCLC
 Non-squamous NSCLC
with previously treated
CNS metastases
 Relapsed multiple
myeloma
Dacetuzumab (AntiCD40)
 2L diffuse large B-cell
lymphoma
Dulanermin (rhApo2L/
TRAIL)
 Indolent relapsed NHL
 1L mNSCLC
GA101/3rd Gen. AntiCD20 (R7159)
 Relapsed or refractory
hematologic malignancies
 Indolent NHL
Hedgehog Pathway
Inhibitor (R3616)
 Advanced basal cell
carcinoma
 1L mCRC
 Ovarian cancer
maintenance therapy
MetMAb/Anti-cMet
 2L and 3L mNSCLC
Pertuzumab (R1273)
 Neoadjuvant HER2+ BC
 2L mNSCLC
Trastuzumab-DM1
(R3502)
 1L HER2+ mBC
 2L+ HER2+ mBC
 3L HER2+ mBC
Phase III (2 NMEs)
Avastin
 Adjuvant colon cancer
 Adjuvant HER2- BC
 Adjuvant HER2+ BC
 Adjuvant NSCLC
 Diffuse large B-cell
lymphoma
 1L advanced gastric
cancer
 1L HER2- mBC
 1L HER2+ mBC
 1L metastatic ovarian
cancer
 Gastrointestinal stromal
tumors
 High risk carcinoid
 Hormone refractory
prostate cancer
 Newly diagnosed GBM
 Relapsed platinumsensitive ovarian cancer
 2L HER2- mBC
 2L mCRC
Avastin +/- Tarceva
 1L metastatic nonsquamous, NSCLC
Herceptin
 Adjuvant HER2+ BC
(HERA 2-year treatment)
MabThera/Rituxan
(R105)
 Follicular NHL
Pertuzumab (R1273)
 1L HER2+ mBC
 Platinum-resistant ovarian
cancer1
Tarceva
 Adjuvant NSCLC
 1L metastatic EGFR
mutant+ NSCLC
Trastuzumab-DM1
(R3502)
 2L HER2+ mBC
Xeloda
 Adjuvant BC
 Adjuvant CC
As of May 31, 2009
1 Being develop by Chugai Pharamceuticals
NME = New Molecular Entity
#52
Roche and Genentech
Oncology Late-stage Pipeline
2009 -2011 Key Anticipated Milestones
Phase III Clinical Data Results:
–  Avastin
•  Hormone-refractory prostate
cancer
•  Ovarian cancer studies
•  Adjuvant colon cancer
(AVANT)
•  Adjuvant triple-negative BC
•  Second-line mBC
•  Gastric cancer
–  Herceptin HERA 2-year adjuvant
treatment data (HERA)
–  Rituxan follicular NHL
maintenance data (PRIMA)
Pending Submissions:
– Avastin for 1L mBC
– Herceptin for 1L metastatic
gastric cancer (ToGA )
Pending Approvals:
– Avastin for 1L mBC (AVADO)
– Avastin for 1L metastatic RCC
– Rituxan for previously untreated
and relapsed CLL
– Tarceva for 1L maintenance
therapy for advanced NSCLC
– Xeloda for 1L and 2L mCRC (US)
#53
Roche and Genentech
Preview
Topics to be Addressed Tomorrow
•  ToGA: Herceptin for gastric cancer
•  RIBBON-1 and AVADO: Avastin for 1L mBC
•  Early Stage Pipeline
–  PLX4032 for advanced melanoma
–  T-DM1 for 2L+ mBC
–  ABT-263 for CLL
Roche and Genentech Investor Event – Part 2
June 1, 2009
Rosen Shingle Creek Hotel, Orlando
6:30pm-8:00pm
#54
Question & Answer Session
#55
Roche and Genentech
We Innovate Healthcare
#56