New Approval Mechanism for Breast Cancer using pathologic Complete Response

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1 New Approval Mechanism for Breast Cancer using pathologic Complete Response Sandra M. Swain, MD, FACP Medical Director, Washington Cancer Institute MedStar Washington Hospital Center Professor of Medicine Georgetown University March 7, 2014

2 Sandra Swain, MD Steering Committee (Uncompensated) - Roche / Genentech Contracted Research: Puma /( Pfizer), BMS, Sanofi-Aventis, Roche / Genentech

3 How can we speed drug development in today s climate?

4 ASCO Strategies Trial Design Practice/Process Improvement Policy Clinically meaningful outcomes FDA ASCO endpoint workshops Streamlined eligibility criteria Optimizing data collection Community Research Forum Workload assessment tool Practice readiness Breakthrough therapy designation Insurance coverage Advocacy for cooperative groups and community based research

5 Design: Clinically Meaningful Outcomes Goal: Trials with greater impact and meaning to patients Molecular targets increasing expectations No tolerance for incremental change ASCO workgroup proposed new benchmarks led by Lee Ellis, MD Benchmarks vetted by experts Invited public comment Complex, controversial topic J Clin Oncol March 17, 2014

6 Innovative Ideas for Breast Cancer Drug Approval

7 Milestones of HER2/anti HER2 therapies in BC EGFR discovery Cohen neu oncogene discovery Weinberg Her2 cloned Ullrich and Coussens FDA approves single agent trastuzumab for 2nd line and in combination with paclitaxel for 1st line MBC Amplification of Her2/neu correlates with shorter survival Slamon FDA approves lapatinib + capecitabine for MBC FDA approves pertuzumab + trastuzumab + docetaxel for MBC EGFR MoAb inhibited growth Mendelsohn Her2 amplification in breast cancer Aaronson FDA approves trastuzumab in adjuvant setting FDA approves TDM1 for MBC MBC : metastatic breast cancer MoAb : monoclonal antibody SM SWAIN

8 FDA Expedited Programs Designations Fast Track: clinical or nonclinical evidence of unmet need Breakthrough: Preliminary clinical evidence suggests improvement over available therapies (more intensive FDA guidance) Priority Review: 6 mo review (vs 10 mo) Approval Pathways Accelerated Approval Guidance for Industry Expedited Programs for Serious Conditions Drugs and Biologics Draft Guidance June 2013

9 Breakthrough Therapies Signed into law July 9, 2012 As of Feb 24, designations granted At least 14 for oncology (2 of 4 approvals: Ibrutinib and obinutuzumab) Granted early in development process, ideally during or after phase I Allows FDA to work closely with sponsor and provide commitment to expedite review Potential to cut down time to approval

10 Accelerated Approval Pathway Positive benefit risk profile Surrogate endpoint reasonably likely to produce clinical benefit Postmarketing confirmatory trials required and usually underway at time of application May be withdrawn if confirmatory trial fail to verify benefit

11 Guidance for Industry: Pathologic Complete Response in Neoadjuvant Treatment of High Risk Early Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval Uniform definition of pcr for regulatory purposes Summarize relationship known between pcr and prognosis Describe trial designs and patient populations where pcr reasonably likely to predict clinical benefit Trial designs permit confirmation of clinical benefit and support conversion to regular approval Draft: FDA issued May 2012

12

13 CTNeoBC Trials Trials Patients AGO ECTO 1355 EORTC 10994/BIG GeparDuo 907 GeparQuattro 1495 GeparTrio 2072 GeparTrio Pilot 285 NOAH 334 NSABP B NSABP B PREPARE 733 TECHNO 217 Total Cortazar, et al Lancet e pub 2014

14 Event-Free-Survival and Overall Survival with 3 pcr definitions CTNeoBC ypn0 important, no real difference ypt0/is or ypt0 Cortazar, et al Lancet epub 2014

15 pcr (ypt0/is ypn0) and Event-Free-Survival and Overall Survival CTNeoBC HR=0.48, (95% CI: 0.43, 0.54) HR=0.36, (95% CI: 0.31, 0.42) Cortazar, et al Lancet e pub 2014

16 pcr and Event-Free-Survival HR-pos/HER2 neg Breast Cancer CTNeoBC HR=0.63, (95% CI: 0.38, 1.04) HR=0.49, (95% CI: 0.33, 0.71) HR=0.27, (95% CI: 0.14, 0.50) Cortazar, et al Lancet e pub 2014

17 pcr and Event-Free-Survival HER2 pos Breast Cancer CTneoBC HR=0.39, (95% CI: 0.31, 0.50) HR=0.58, (95% CI: 0.42, 0.82) HR=0.25, (95% CI: 0.18, 0.34) Cortazar et al, Lancet epub 2014

18 pcr and Event-Free-Survival Triple Negative Breast Cancer HR=0.24, (95% CI: 0.18, 0.33) Cortazar et al Lancet epub 2014

19 Trial level correlation between treatment effect on pcr and event free survival or overall survival Cortazar, et al Lancet e pub 2014

20 Conclusions CTNeoBC ypt0/is ypn0 had stronger association with outcome than ypt0/is Strongest association of pcr with outcome TNBC HR+: high grade and HER2 neg HER2+: HR neg Increase in pcr did not predict improved EFS and OS at a trial level Cortazar, et al Lancet epub 2014

21 Why did Increase pcr not predict EFS and OS? Heterogeneous tumor subtypes Specific treatment (trastuzumab) only used in 3 trials so absolute overall differences in pcr were low (1 11%) but high for NOAH (20%) with 13% difference in EFS Factors unrelated to primary tumor response

22 Neoadjuvant Pathway to Accelerated Approval Goal: to market highly effective drugs sooner Not a lesser standard or easy route to market for marginal drugs Target patients at high risk for recurrence and death Utilize superiority designs Design trials to detect a large improvement in pcr Choose drugs with high likelihood of meaningfully improving long-term outcomes Tatiana M. Prowell, March 2013

23 Concerns about Neoadjuvant Pathway to Accelerated Approval Delay between initial approval & confirmation of (or failure to confirm) clinical benefit Limited data on cumulative toxicity (e.g., neuropathy) and rare/late toxicity (e.g., CHF, secondary malignancy) Uncertainty about magnitude of improvement in pcr needed to improve EFS/OS May vary by breast cancer subtype Some patients with pcr will relapse and many with residual disease will not Potential negative impacts on drug development Assessing risks of drug studied first in early-stage breast cancer Diminished drug development in advanced breast cancer Tatiana M. Prowell March 2013

24 Number of trials Single Trial Model: One large RCT to assess pcr & EFS/OS Multi-Trial Model: Accelerated approval based on smaller RCT(s) demonstrating large absolute improvement in pcr rate Conversion to regular approval based on large RCT(s) with DFS/EFS/OS as primary endpoint Tatiana M. Prowell, March 2013

25 Panel Discussion Summary Do we believe the advantages of granting accelerated approval (AA) based on a Neoadjuvant trial with pcr as endpoint outweighs the concerns? Does pcr predict clinical benefit? Generally yes Minimum improvement 20% High risk only, 20-25% 5 year relative risk of recurrence

26 Oncology Drugs Advisory Committee Meeting September 12, 2013

27 sbla submission for Pertuzumab PERJETA is a HER2/neu receptor antagonist indicated for: Neoadjuvant treatment of breast cancer, in combination with trastuzumab and docetaxel for patients with HER2 positive, locally advanced, inflammatory, or early stage breast cancer (>2 cm in diameter) as part of a complete early breast cancer regimen containing either fluorouracil, epirubicin and cyclophosphamide (FEC) or carboplatin

28 NOAH Trial: 5 yr Outcomes EFS OS Gianni: Lancet Oncology (In Press)

29 NeoSphere: Study design and objectives Patients with operable or locally advanced /inflammatory* HER2 positive BC TH (n=107) docetaxel ( mg/m 2 ) trastuzumab (8 6mg/kg) THP (n=107) docetaxel ( mg/m 2 ) trastuzumab (8 6mg/kg) pertuzumab ( mg) S U R G Phase II design Primary endpoint: Comparison of pcr rates TH vs THP TH vs HP THP vs TP Chemo naïve & primary tumors >2cm (N=417) HP (n=107) trastuzumab (8 6mg/kg) pertuzumab ( mg) TP (n=96) docetaxel ( mg/m 2 ) pertuzumab ( mg) E R Y Secondary endpoints: Clinical response DFS Breast conservation rate Biomarker evaluation Study dosing: q3w x 4

30 NeoSphere: Primary endpoint pathologic complete response (breast only) (ITT population) p= p= p= pcr, % 95% CI H, trastuzumab; P, pertuzumab; T, docetaxel p values from Cochran Mantel Haenszel test and adjusted for multiplicity TH THP HP TP Gianni L, et al. Lancet Oncol 2011 DOI: /S (11)

31 NEOSPHERE pcr (ypt0/isypn0) T + H: 21% T + H + P 39% Difference is 18% P= Difference is 24% in ER neg and 10% in ER pos

32 TRYPHAENA Cardiac safety primary endpoint Supportive trial Arm A: 73 pts P + H x 6 with FEC x 3 T x 3 pcr 56% Arm B: 75 pts FEC x 3 P + H x 3 with T x 3 pcr 55% Arm C: 77 pts P + H with T x 3 and carbo x 3 (all x 6) pcr 64% Herceptin completes 1 year

33 TRYPHAENA: Cardiac Safety (%) LVEF Decline LVSD Grade >3 Ongoing LVEF < 50% ARM A ARM B ARM C LVEF decline > 10% and < 50%

34 CLEOPATRA confirmatory overall survival analysis 1 year Overall survival (%) % 89% 2 years 81% 69% 3 years 66% 50% Ptz + T + D: 113 events; median not reached Pla + T + D: 154 events; median 37.6 months HR= % CI p= n at risk Ptz + T + D Time (months) Stopping boundary Pla + T + for D concluding 406statistical 383 significance 350 at 324 this second 285interim 198 analysis 128 was p D, docetaxel; Pla, placebo; Ptz, pertuzumab; T, trastuzumab Swain SM et al. Lancet Oncology

35 APHINITY: Study Schema S U R G E R Y N=3,806 Central confirmation of HER2 status R A N D O M I Z A T I O N Chemotherapy plus trastuzumab and pertuzumab Chemotherapy plus trastuzumab and placebo F O L L O W U P 10 Y E A R S Accrual: 11/11 8/13 Randomisation within 7 weeks HR: of surgery.75 Start treatment within 1 week Anti HER2 therapy for a total of 1 year (52 weeks) Radiotherapy and/or endocrine therapy may be started at the end of adjuvant chemotherapy

36 Pertuzumab HER2+ Breast Cancer Development Program Large safety experience Early Breast Cancer (EBC) Neoadjuvant (EBC) S U R G E R Y Adjuvant (EBC) Metastatic (MBC) NEOSPHERE APHINITY 1L CLEOPATRA TRYPHAENA 1L PERTAIN Perjeta treated patients >500 in neoadjuvant studies ~4500 in completed or ongoing studies Data included in this application Ongoing

37 ODAC September 12, 2013 Has Perjeta demonstrated a favorable benefit to risk evaluation for the neoadjuvant treatment of early breast cancer? Vote: 13 yes, 1 abstention Reasons for yes Totality of evidence CLEOPATRA survival benefit APHINITY already accrued Robust clinical development by company: N of 1 Safety reasonable

38 Pertuzumab Neoadjuvant Approval September 30, 2013 Accelerated approval for pertuzumab used in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2 positive, locally advanced, inflammatory or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.

39 BERENICE Study Design Investigator choice Cohort A ddac x 4 Weekly T x 12 P 840mg 420 mg 3-weekly H 8/kg 6mg/kg 3-weekly S U R G E R Y P 420 mg 3-weekly H 6mg/kg 3-weekly F O L L O W U P Cohort B FEC x 4 D x 4 P 840mg 420 mg 3-weekly H 8/kg 6mg/kg 3-weekly S U R G E R Y P 420 mg 3-weekly H 6mg/kg 3-weekly F O L L O W U S Swain and C Dang, Co-PI P

40 NCCN Guidelines V Neoadjuvant and Adjuvant Breast (T2 or N1) AC paclitaxel + trastuzumab + pertuzumab TCH +pertuzumab AC docetaxel + trastuzumab + pertuzumab FEC docetaxel + trastuzumab + pertuzumab FEC paclitaxel + trastuzumab + pertuzumab Pertuzumab + trastuzumab + docetaxel FEC Pertuzumab + trastuzumab + paclitaxel FEC

41 Milestones of HER2/anti HER2 therapies in BC EGFR discovery Cohen neu oncogene discovery Weinberg Her2 cloned Ullrich and Coussens FDA approves single agent trastuzumab for 2nd line and in combination with paclitaxel for 1st line MBC Amplification of Her2/neu correlates with shorter survival Slamon FDA approves lapatinib + capecitabine for MBC FDA approves pertuzumab + trastuzumab + docetaxel for MBC EGFR MoAb inhibited growth Mendelsohn MBC : metastatic breast cancer MoAb SM : monoclonal SWAIN antibody Her2 amplification in breast cancer Aaronson FDA approves trastuzumab in adjuvant setting FDA approves TDM1 for MBC FDA approves Pertuzumab + Trastuzumab neoadjuvant

42 Springtime in Washington D.C.

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