45th ASCO Annual Meeting Roche and Genentech Investor Event Part 1 Sunday, May 31, 2009 - Orlando, Florida #1
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ASCO 2009 Analyst Meeting Agenda Sunday, May 31, 2009 Roche and Genentech 6:30 PM (5 min) 6:35 PM (10 min) 6:45 PM (35 min) 7:20 PM (20 min) 7:40 PM (10 min) 7:50 PM (10 min) Welcome/ Introductions/ Agenda Opening Remarks Avastin: NSABP C-08 Data Overview; Followed by Q&A Tarceva: SATURN and ATLAS Data Overview Closing Remarks Q&A Dr. Karl Mahler Head of Investor Relations, Roche Kathee Littrell, Ph.D., R.N. Vice President, Investor Relations, Clinical Support, Genentech William M. Burns Chief Executive Officer Division Roche Pharmaceuticals 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 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 Hal Barron, M.D. Executive Vice President, Global Development and Chief Medical Officer 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 Breakthrough Clinical Data Drives e Business ASCO 2003: Avastin mcrc 1L ASCO 2005: Herceptin adjuvant Avastin mnsclc; mbc ASCO 2004: Tarceva mnsclc 2L and 3L Roche and Genentech ASCO 2007-2009: Broader Avastin, Herceptin & Tarceva use (more combinations, indications, and earlier use) 19.7 CHF bn 1.6 #6
Roche and Genentech Understanding Biology to Improve Patient Outcomes Cancer Type Marketed Products Key Products in Development Gastrointestinal Breast Lung Hematological Genito-urinary Skin & Soft Tissue Brain Childhood Cancers Avastin, Tarceva, Xeloda Avastin, Herceptin, Xeloda Avastin, Tarceva MabThera/Rituxan Avastin Avastin, Herceptin, Xeloda, Hedgehog Pathway Inhibitor Avastin, pertuzumab, T-DM1, Xeloda, IGF-1R mab Avastin, Apomab, dulanermin, Tarceva, IGF-1R mab Avastin, MabThera/Rituxan, GA101, dacetuzumab, Apomab, dulanermin, ABT-263 Avastin, pertuzumab, Hedgehog Pathway Inhibitor IGF-1R mab, Apomab, Hedgehog Pathway Inhibitor, PLX4032 (B-raf inhibitor) Avastin 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 Phase III / Market Identifying patients who have an improved clinical benefit IGF-1R mab (R1507) Range of candidate markers Herceptin - HER2 expression - HER2 gene amplification MDM2 antag (R7112) - P53 sequence wild-type - MDM2 expression Avastin - Range of candidate markers for hypothesis investigation PLX4032 (R7204) - BRAF V600E gene mutation Pertuzumab - HER Receptor/ligand mrna T-DM1 (R3502) - HER2 expression - HER2 gene amplification Tarceva - EGFR expression (IHC) - EGFR gene copy number (FISH) - EGFR mutations - KRAS mutations #8
Organizational Setup: Pharma US Roche and Genentech CEO Group S. Schwan Board Genentech A. Levinson (Chair) CEO Genentech P. Soriot Genentech gred R. Scheller 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 Primary endpoint Disease-free survival Statistical planning assumptions 25% reduction in event rate (HR = 0.75) mfolfox6 q2w X 6 months (n=1,356) mfolfox6 + Avastin* q2w X 6 months followed by Avastin* for 6 months (n=1,354) *5mg/kg #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 Events (n=603) 3-year DFS mfolfox6 + Avastin n=291 77.4% mfolfox6 n=312 75.5% HR 0.89 P value 0.15 Overall DFS based on all events. #15
Avastin Phase III NSABP C-08 Results: Disease-free Survival By Stage DFS Stage II DFS Stage III Percentage (%) Events 3-year DFS mfolfox6 + Avastin N=40 87.4% mfolfox6 N=47 84.7% Difference in rate 2.7 HR 0.82 P value 0.35 Events 3-year DFS mfolfox6 + Avastin N=251 74.2% mfolfox6 N=265 72.4% Difference in rate 1.8 HR 0.90 P value 0.25 #16
Avastin Phase III NSABP C-08 Results: Was ere A Significant Transient Effect Of Avastin? Cumulative Hazard Ratio Over Time P=0.02 P=0.004 P=0.0004 P=0.05 P=0.08 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? DFS at 1 Year Event-free at 1 Year Percentage (%) Events 1-year DFS mfolfox6 + Avastin N=75 94.3% mfolfox6 N=122 90.7% Difference in rate 3.6 HR 0.60 P value 0.0004 Time-Treatment Interaction P = 0.001 Events mfolfox6 + Avastin N=216 mfolfox6 N=190 HR 1.07 P value 0.48 #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 Sites of Recurrence NS NS = not statistically significant Primum non nocere #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
NSABP C-08 Provides Insights into Avastin s Potential in Early-stage Colon Cancer Roche and Genentech 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 N Dosing Status Adjuvant Colon Cancer Adjuvant Nonsmall Cell Lung Cancer Adjuvant Breast Cancer NSABP-C08 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 ECOG 1505 N=1,500 15 mg/kg q3 weeks Trial ongoing ECOG 5103 (HER2-) N=4,950 15 mg/kg q3 weeks Trial ongoing BEATRICE (Triplenegative) BETH (HER2+ combo with Herceptin) N=2,530 Dosing equivalent to 5 mg/kg /per week Trial ongoing 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 Median OS for patients who did not receive ST 18.6 mos 23.6 mos p=.001 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* 72% (Stage III) 81% ~45% (OS at 5-years) Metastatic median OS* 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 Chemonaïve advanced NSCLC n=1,949 4 cycles of 1st-line platinumbased doublet* Non-PD n=889 Tarceva 150mg/day 1:1 PD Placebo PD Mandatory tumor sampling Stratification factors: EGFR IHC (positive vs negative vs indeterminate) Stage (IIIB vs IV) ECOG PS (0 vs 1) CT regimen (cis/gem vs carbo/doc vs others) Smoking history (current vs former vs never) Region Co-primary endpoints: Progression-free survival (PFS) in all patients PFS in patients with EGFR IHC+ tumors Secondary endpoints: Overall survival (OS) in all patients and those with 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 Male Female Caucasian Asian Adenocarcinoma Squamous-cell Never smoker Former smoker Current smoker 0.71 (0.62 0.82) 884 0.78 (0.66 0.92) 654 0.56 (0.42 0.76) 230 0.75 (0.64 0.88) 744 0.58 (0.38 0.87) 128 0.60 (0.48 0.75) 401 0.76 (0.60 0.95) 359 0.56 (0.38 0.81) 152 0.66 (0.50 0.88) 242 0.80 (0.67 0.97) 490 0.4 0.6 0.8 1.0 1.2 Favors Tarceva HR 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 Tarceva Placebo AEs occurring in 10% (N=433) (N=445) of patients All Grades Grade 3/4 All Grades Grade 3/4 Rash 60% 9% 9% 0% Diarrhea 20% 2% 4% 0% *Number of patients with at least 1 dose reduction/interruption Patients can contribute to more than one category #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 Non-PD n=768 (66%) Avastin (15mg/kg)+ Tarceva (150mg) to PD 1:1 Avastin + Placebo to PD Unblind at PD Post progression therapy 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 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 North America 659 Europe 27 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 0.8 0.6 0.4 0.2 Avastin + Placebo (n=373) Avastin + Tarceva (n=370) HR=0.722 (0.592-0.881) Log-rank P=0.0012 0.0 0 3 6 9 12 15 18 21 No. of patients at risk: Progression-Free Survival (months) 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) HR a 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 * Includes <1% patients with ECOG PS 2. 0.2 0.5 Favors Tarceva 1 2 Favors Placebo #45
Tarceva Phase IIIb ATLAS Results: Progression-Free Survival in Subgroups ITT population Avastin + Placebo Avastin + Tarceva Chemotherapy Carboplatin + Paclitaxel Carboplatin + Gemcitabine Carboplatin + Docetaxel Cisplatin + Gemcitabine Other Total (n) 174 104 54 32 9 Events (n) 118 68 36 11 5 Total (n) 178 105 46 33 8 Events (n) 97 63 30 7 5 HR 0.68 0.71 0.81 0.43 0.40 95% CI 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 Conclusions Roche and Genentech 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 Late-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 MAb 1 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 Inhibitor 1 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 (Anti- CD40) 2L diffuse large B-cell lymphoma Phase II (8 NMEs) Dulanermin (rhapo2l/ TRAIL) Indolent relapsed NHL 1L mnsclc GA101/3 rd Gen. Anti- CD20 (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 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 Phase III (2 NMEs) 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 cancer 1 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
Oncology Late-stage Pipeline 2009-2011 Key Anticipated Milestones Roche and Genentech 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
Preview Topics to be Addressed Tomorrow Roche and Genentech 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