EXHIBIT J
ASCO Clinical Data Update May 31, 2015 The Langham Hotel, Chicago
Forward-looking Statements This presentation contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Clovis Oncology s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences are discussed in Clovis Oncology s filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Clovis Oncology undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. 2
Tonight s Agenda Introductions 6:00-6:05 Rociletinib data review 6:05-6:20 Rucaparib data review 6:20-6:35 Q&A 6:35-7:00 3
Corporate Overview Two drugs with Breakthrough Therapy designation Two NDA and MAA filings planned within next 12-18 months Rociletinib planned for July 2015 Rucaparib planned for mid-2016 Preparing for potential Q4 US launch of rociletinib Building European commercial organization Global rights to two late-stage oncology products Third targeted therapy under development 4
Rociletinib Update ASCO 2015
Rociletinib is a Differentiated EGFR TKI Potent inhibitor of T790M and activating EGFR mutations Consistent ORR ~60% in T790M-positive patients throughout the program Truly wild-type EGFR-sparing, as designed essentially no cutaneous toxicity Minimal interstitial lung disease, no fatalities Consistent response rates greater than 35% in centrally-confirmed T790Mnegative patients Perhaps related to IGF1-R inhibition Well tolerated Discontinuation due to AEs in only 2.5% of patients at 500mg BID dose Only common grade 3 toxicity is readily-managed, typically asymptomatic hyperglycemia Distinct mechanism(s) of acquired resistance emerging vs. competitor 6
Recent New England Journal of Medicine Manuscript PFS from 51 patients estimated at around 13mo with early data 7
Clovis Rociletinib Program Based in the US, with Very Advanced Patients Included Majority of patients (84%) from US Asian NSCLC patients likely have superior outcomes versus non-asian patients Approximately half of patients have CNS disease at study entry CNS metastases are a negative prognostic factor Inclusion criteria broad No exclusions for diabetes or cardiovascular disease Over 80% of patients come onto rociletinib directly off prior TKI No re-treatment effect confounding data 72% of patients had ECOG performance status of one or higher Commercial HBr tablet formulation used by all patients in all data presented in 2015 8
Efficacy of Rociletinib (CO-1686) in Plasma-genotyped T790M-positive NSCLC Patients ASCO 2015
TIGER-X: Phase 1/2 Trial of Rociletinib Key eligibility criteria Advanced or recurrent NSCLC with a documented activating EGFR mutation Prior treatment with EGFR-directed therapy Recent biopsy available or willing to undergo a new on-study biopsy; plasma samples collected Phase 2 only Disease progression while on treatment with EGFR-directed therapy T790M-positive biopsy at the time of entering study Treated stable CNS metastases are allowed Phase 1 (Dose Escalation) Phase 2 Expansion Cohorts Rociletinib Treatment 21-day cycles; escalate to MTD 2nd-line patients PD upon 1 immediate prior TKI >2nd-line patients PD upon 2 TKI or chemotherapy 500mg BID 625mg BID 750mg BID Key outcome measures Safety Tolerability PK profile ORR 11
TIGER-X: Patient Analysis Groups Analysis group Rociletinib dose Subjects Analysis 500mg BID** 625mg BID 750mg BID 1000mg BID Total N All patients who received HBr Safety analysis 119 236 95 6 456 rociletinib # Centrallyconfirmed tissue T790M+* Paired plasma & tissue T790M result available* Plasma T790M+* Efficacy analysis (ORR) Comparative efficacy in patients by T790M status in plasma and tissue Efficacy analysis (ORR) 48 114 77 4 243 42 59 83 4 188 30 49 65 3 147 # Received at least one dose of Rociletinib HBr; *Received HBr formulation in 2014 or earlier; **Includes patients switched from 900mg BID free base formulation. HBr=hydrobromide. 12
TIGER-X: Patient Baseline Characteristics All patients who received rociletinib HBr tablet formulation 500mg BID 625mg BID 750mg BID 1000mg BID TOTAL N 119 236 95 6 456 Median age, years 63 64 62 65 63 Female, % 75 64 66 83 67 Enrolled in US, % 81 84 86 100 84 Asian ethnicity, % 16 20 25 17 20 ECOG PS grade 0, % 25 28 33 50 28 Median no. of prior Rx 3 2 2 4 2 Number of prior TKIs, 1/>1 (%) 56/44 55/45 59/41 33/67 56/44 Immediate prior TKI, % 79 84 91 67 84 History of CNS disease, % 40 42 43 50 41 History of diabetes, % 8 13 6 0 10 History of cardiovascular disease, % 13 15 13 0 14 13
Best Response to Rociletinib (All Doses) in 243 Centrally Confirmed Tissue T790M+ Patients 100 SLD Change from Baseline (%) 80 60 40 20 0 20 40 500mg 625mg 750mg 1000mg Total N 48 114 77 4 243 ORR (%) 60 54 46 75 53 DCR (%) 90 84 82 100 85 ORR, objective response rate; DCR, disease control rate 500mg BID HBr 625mg BID HBr 750mg BID HBr 1000mg BID HBr + Ongoing 60 80 100 SLD, sum of longest diameters 14
Maturing PFS in 270 Centrally Confirmed T790M+ Patients at 500mg or 625mg BID 1.0 Probability of PFS 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 All patients No baseline CNS disease At Risk (Events) 270 (0) 163 (0) 187 (39) 118 (16) 104 (71) 68 (32) 57 (80) 37 (38) 29 (89) 20 (44) 9 (90) 8 (45) 8 (92) 7 (47) + Censored (35% maturity) All Patients No Baseline CNS Disease Median PFS All Patients No Baseline CNS Disease 5 (94) 5 (48) 2 (94) 2 (48) 2 (94) 2 (48) 2 (94) 2 (48) Months 8.0 10.3 0 2 4 6 8 10 12 14 16 18 20 22 24 Time (months) 1 (94) 1 (48) 0 (94) 0 (48) *Data analyzed 27 Apr 2015. PFS=progression-free survival. 15
Hyperglycemia Readily Managed with Oral Agents Hyperglycemia is caused by iatrogenic insulin resistance, mediated by a rociletinib metabolite (M502) that inhibits IGF1-R/IR Hyperglycemia was not expected in humans since it was not observed in preclinical testing Once understood, a monitoring and treatment algorithm (monitor blood and/or urine glucose; treat when necessary with oral insulin sensitizing agents or SGLT2 inhibitors) was introduced into trial protocols This approach has been successful in reducing grade 3 hyperglycemia Prior to September 2014, grade 3/4 hyperglycemia was observed in 22% of patients on rociletinib 500mg BID After September 2014, grade 3 hyperglycemia was observed in 8% of such patients 17
Best Response to Rociletinib (All Doses) in Plasma T790M+ Patients 100 SLD Change from Baseline (%) 80 60 40 20 0 20 40 500mg 625mg 750mg 1000mg Total N 30 49 65 3 147 ORR (%) 57 55 49 67 53 DCR (%) 80 84 82 100 82 ORR, objective response rate; DCR, disease control rate 500 mg BID HBr 625 mg BID HBr 750 mg BID HBr 1000 mg BID HBr + Ongoing 60 80 100 SLD, sum of longest diameters 18
Rociletinib Activity Observed in Central T790M Negative Patients Best response for target lesions in centrally confirmed T790M- patients Change from Baseline (%) 100 80 60 40 20 0-20 -40-60 -80-100 500 BID HBr 500 BID HBr 625 BID HBr 750 BID HBr ORR=37% (13/35) + Ongoing Hypotheses to explain this activity 1. Tissue heterogeneity 2. Assay sensitivity 3. IGF1-R/IR activity 4. TKI retreatment effect 86% patients directly off TKI 20
500mg is the Go-forward Dose for Rociletinib No rociletinib MTD defined in phase 1 study Common for well-tolerated targeted agents Rociletinib prospectively examined at three dose levels in large numbers of patients (750mg deselected early) 500mg BID recently selected as go-forward dose rather than 625mg BID, given equivalent efficacy and superior tolerability Objective response rate ~60% in centrally confirmed T790M+ patients Hyperglycemia less common (<10% grade 3 now); management simple No ILD reported at this dose; no fatalities at any dose No cutaneous toxicity of note 22
TIGER-3 Explicitly Addresses Rociletinib Activity in T790M- Negative Patients Later line mut EGFR NSCLC Screening biopsy for T790M status Includes T790M neg and pos N ~ 250 1:1 Randomization N ~ 250 Rociletinib 500mg BID Single agent chemotherapy PD by RECIST 1.1 Plasma T790M Tissue T790M + + Primary EP = PFS in T790M+ patients Step-down analysis of PFS in all patients TIGER-3 is a unique all-comer trial Only an all-comer design allows full evaluation of performance of plasma test TIGER-3 may act as basis for PMA for plasma test 23
Rociletinib Conclusions Rociletinib is a novel, unique EGFR tyrosine kinase inhibitor with FDA Breakthrough Therapy designation Consistent responses and durable patient benefit observed in a very advanced, large, Western patient population using commercial drug formulation Thorough dose-response evaluation enabled selection of optimal dose: 500mg BID Very well tolerated with only 2.5% discontinuations from adverse events Uniquely EGFR wild-type sparing with essentially no cutaneous toxicity Very low risk of interstitial lung disease Consistent responses in T790M-negative patients, offering opportunity to become the treatment for all patients with acquired resistance to EGFR TKI On track for NDA and MAA filing in July 2015 Combination studies launching 2H15 25
Rucaparib Update ASCO 2015
Rucaparib is a Differentiated PARP Inhibitor Unique enzyme binding characteristics vs other PARP inhibitors Potent inhibitor of PARP-1/-2/-3 Inhibitor of tankyrases at clinically relevant concentrations Consistent pharmacokinetics across a population of patients Well tolerated Compelling efficacy versus suitably evaluable peer Aside from rucaparib, only olaparib has been evaluated in more than four to 13 BRCA mut ovarian cancer patients at the recommended dose US FDA Breakthrough Therapy designation granted (April 2015) 27
Rucaparib Intensive Ovarian Cancer Development 3-5 th Line All- Solid Tumors Study 10 Part 1 TODAY S FOCUS 4 th or 5 th Line Study 10 Study 10 BRCA mut Part 2a Part 2b 2 nd Line and greater BRCA mut & BRCA-like ARIEL2 Part 1 4 th or 5 th Line BRCA mut & BRCA-like Switch Maintenance BRCA mut & BRCA-like ARIEL3 ARIEL2 Part 2 Foundation Medicine HRD Assay 2011 2012 BRCA mut & BRCA-like CoDx 2013 2014 2015 2016 2017 Rucaparib development studies Rucaparib registration enabling CoDx registration enabling 30
Results of ARIEL2: A phase 2 trial to prospectively identify ovarian cancer patients likely to respond to rucaparib using tumor genetic analysis ASCO 2015
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Overall Similar Genomic LOH Levels Between Matched Archival Tumors and Screening Biopsies Increased genomic LOH levels found in only a subset of screening biopsies compared to matched archival tumors All patients (114 matched pairs) BRCA wt patients (89 matched pairs) LOH high archival LOH low archival LOH high archival LOH low archival LOH high screening 67 15 LOH high screening 44 13 LOH low screening 0 32 LOH low screening 0 32 Classified into LOH high and LOH low groups based on the prespecified genomic LOH cutoff. 37
Primary Efficacy Analysis: PFS in BRCA mut and BRCA-like versus Biomarker Negative Patients PFS 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 Progression-free survival by HRD molecular subgroup BRCA mut BRCA-like Biomarker Negative 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Available (endpoint reached) Time (months) BRCA mut 40 (0) 39 (0) 35 (1) 35 (1) 28 (3) 27 (3) 18 (5) 17 (5) 10 (8) 7 (10) 5 (11) 4 (11) 1 (12) 0 (12) BRCA-like 81 (0) 72 (2) 48 (15) 45 (16) 24 (24) 23 (24) 13 (26) 12 (26) 5 (28) 4 (29) 3 (29) 2 (30) 1 (30) 1 (30) 0 (30) Biomarker Negative 69 (0) 62 (0) 37 (17) 35 (18) 18 (27) 16 (29) 8 (31) 7 (31) 3 (33) 1 (34) 1 (34) 0 (35) HRD Subgroup BRCA mut Median PFS, mo (90% CI) 9.4 (7.3, Not Reached) BRCA-like 7.1 (3.7, 10.8) Biomarker Negative 3.7 (3.5, 5.5) Subgroup Comparison BRCA mut vs Biomarker Negative BRCA-like vs Biomarker Negative CI=confidence interval. Hazard Ratio (90% CI) 0.47 (0.35, 0.64) 0.61 (0.41, 0.92) 38
In BRCA wt Tumors, the BRCA-like Subgroup Derives Enhanced Benefit from Rucaparib HRD Subgroup Median PFS, mo (90% CI) Overall Response Rate, % (N) RECIST RECIST + CA-125 BRCA mut 9.4 (7.3, NR) 69 (27/39) 82 (32/39) BRCA-like 7.1 (3.7, 10.8) 30 (22/74) 45 (33/74) BRCA wt Biomarker Negative 3.7 (3.5, 5.5) 13 (8/62) 21 (13/62) 39
Response Rate Striking in BRCA mut Tumors Change from Baseline (%) 120 100 80 60 40 20 0-20 -40-60 ORR (RECIST or CA-125) 82% ORR similar in germline (81%) and somatic (88%) patients 4 CRs in somatic BRCA mut group Median duration of response = 9.3 months+ Germline Indeterminate Somatic Subclonal Somatic Ongoing -80-100 40
Rucaparib is Generally Well Tolerated Adverse Event* Treatment-Related AEs Reported in 15% of Patients Number of Patients Total N=204, n (%) Total Grade 3/4 Nausea 135 (66) 6 (3) Asthenia/Fatigue 124 (61) 13 (6) ALT/AST increased** 81 (40) 23 (11) Dysgeusia 77 (38) 0 Decreased appetite 63 (31) 2 (1) Vomiting 55 (27) 2 (1) Anemia/Decreased hemoglobin 54 (27) 33 (16) Constipation 52 (26) 1 (1) Diarrhea 38 (19) 3 (2) *No cases of myelodysplastic syndrome or acute myeloid leukemia reported;**alt/ast elevations are transient, self-limiting, and not associated with other signs of liver toxicity. 41
Study 010 examined Rucaparib in gbrca mut Ovarian Cancer Specifically CO-338-010 Phase 2 portion overview Patient Population Women with gbrca mut high grade ovarian cancer ECOG PS 0-1 2 4 prior treatment regimens 600mg BID rucaparib Stage 1 ( 2/21 responders; fulfilled) Simon 2-stage study design 3 PRs in first 5 patients Stage 2 (Target N=41; complete) Key objectives Overall response rate by RECIST 1.1 and GCIG CA-125 Safety and tolerability Duration of response 42
Striking Activity in Patients with 3 Prior Lines of Therapy Overall response and duration of response in patients with gbrca-mutated advanced ovarian cancer who received 3 or more prior lines of chemotherapy Rucaparib^ Objective response rate (RECIST) 61% Complete response 13% Partial response 48% Median DoR (mo) 11.3+ ^Rucaparib data from 23 patients from ARIEL2 and study 010 44
Rucaparib Ovarian Cancer Trials Enrolling in 2015 The HRD algorithm will be applied prospectively to two ongoing trials ARIEL2 Part 2 (N=300) Single arm in HGOC patients who have received 3 prior chemotherapy regimens (NCT01891344) ARIEL3 (N=540) Randomized maintenance study rucaparib vs placebo in HGOC patients who have received 2 platinum regimens (NCT01968213) 45
New Indications are Well Suited to the Clovis-Foundation Approach Breast Cancer RUBY study Rucaparib treatment in MBC patients with BRCA-like signature RIO study Neoadjuvant biomarkers Gastroesophageal Cancer PLATFORM study Rucaparib maintenance in patients with BRCA mut or BRCA-like signature Castration-refractory Prostate Cancer In planning New data showing 20% of CRPC patients are HRD+ Robinson (2015) Cell 47
Rucaparib Conclusions Rucaparib is a novel, unique PARP inhibitor The only PARP inhibitor with FDA Breakthrough Therapy designation Best-in-class efficacy in BRCA mut ovarian cancer Only PARP inhibitor with demonstrated efficacy in a prospectivelydefined BRCA-like population Very well tolerated Unique patient selection strategy with Foundation Medicine comprehensive genetic analysis of tumors Well positioned to capitalize on emerging insights on role of DNA repair defects (HRD) in other common solid tumors NDA filing planned in mid-2016 48
Q&A Replay will be available at www.clovisoncology.com