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Targeted Agents In Breast Cancer

Wonderful Music With New Instruments



       Peter M Ravdin, MD, PhD
          San Antonio, Texas


                                       1
Trends In Cancer Mortality In Women in US
At This Rate We Will Beat Breast Cancer In 2040
             Is the cause screening ??
             Is the cause better therapy ??

             Probably some of both.

             Not yet prevention.
Targeted Agents In Breast Cancer

            Accelerated Progress
1. Its expression is only found to a limited extent in
       normal adult tissues
2. Its expression in cancer correlates with its anti-
       cancer effects.
3. It can be combined with other agents without
       unexpected toxicity


                                                         3
Targeted Agents In Breast Cancer

       Why All The Excitement Now

1. Knowledge about metabolic, signalling, and
     control pathways is advancing
2. Methodologies for detecting and quantitating
     macromolecules are improving
3. Methods for screening large libraries of compounds
     are maturing.

                                                        4
Targets In Breast Cancer

 The Estrogen Receptor.
          ER
   (Discovery late 1970s)




                            5
Targets In Breast Cancer
       The Grandmother of Them All
         The Estrogen Receptor.
Restricted expression in tissues in the adult.
     Toxicity issues: Expression in endometrium
                      Expression in bone
                      Expression in CNS
    Methodologies for detecting
             Still an issue
                                                  6
Targets In Breast Cancer
  Tamoxifen: An Agent Targeting The
         Estrogen Receptor.

Useful In
    Metastatic Disease   50 % RR
    Adjuvant Therapy     40 % HR
    Prevention           40 % RR



                                      7
Targets In Breast Cancer
Tamoxifen Effects Are Long Term




         45 %    32 %     7%
          Relapse Reductions      8
Targets In Breast Cancer


          HER2
   (Discovery late 1980s)




                            9
Targets Agents In Breast Cancer
      Second Major Target
             Her2

  Restricted expression in the adult
      Expression in heart ?
  Methodologies for detecting
           Still an issue
           In adjuvant therapy do Her2
             “negative“ cases respond
                                         10
NSABP B-47
 Chemotherapy With or Without Trastuzumab After Surgery in Treating
 Women With Invasive Breast Cancer


Groups: Arm 1. DC q3w * 6


        Arm 2. AC qw2 or 3w * 4 then P qw * 12


        Arm 3. DC and Trastuzumab q3w * 6 and then Tras. q3w * 11


        Arm 4. AC qw2 or 3w * 4 then P and Tras. qw * 12 then Tras . Q3w * 12



 Eligibility
 1. HER2 0 or 1 by IHC. If Her2 = 2, FISH negative. If Her2 = 3 ineligible
 2. Node positive. If Node Negative. N0 with ER/PgR negative or Grade 3
Targets/Agents In Breast Cancer
        Active Classes (1990‘s)
  HER2-targeted agents
          Pertuzumab and trastuzumab-maytansine immunoconjugate)

  VEGF-targeted agents    aflibercept
                  anti-VEGF monoclonal antibody bevacizumab

  Dual EGFR/HER2-targeted agents
                 afatinib [BIBW 2992] and neratinib,

  Multitargeted tyrosine kinase inhibitors
                    sunitinib, pazopanib
  Mammalian target of rapamycin (mTOR)
                  everolimus

  Poly (ADPribose) polymerase 1 inhibitors
                   iniparib, olaparib.
                                                                   12
Targets In Breast Cancer

Development of A New Agent

  Metastatic Disease
  NeoAdjuvant Therapy

  Adjuvant Therapy

  Prevention

                             13
Adjuvant Treatment: What Is Involved ?
             Lots of variations but this is a common way.
        Radiation: 4-6 weeks
        High risk of local recurrence
        Inconvenient, bothersome.

        Chemotherapy: 3-6 months
        Unacceptable risk of dying of cancer
        Tolerable, but obnoxious.

        Biological Therapy: 1 year
        Only if Her2 positive
        Usually low toxicity antibodies.

        Hormone therapy: 5 years
        Only if ER (estrogen receptor positive
        Usually low toxicity pills.

  XRT
  Chemo
  Bio
  Hormone
Time (yrs)
PFS Results in MBC of A Trial
Letrozole + Lapatinib vs Letrozole
OS Results of A Trial
Letrozole + Lapatinib vs Letrozole
QOL Results of A Trial
Letrozole + Lapatinib vs Letrozole




    10% of the L + L patients had Grade 3 / 4 diarrhea
AI’s +/- Everolimus
        Neoadjuvant Study

Letrozole + Everolimus (Better Response)
                         More Toxicity
Letrozole             Gr 3/4 23 % vs 4 %)



         1st Line MBC Study
  Exemestane + Everolimus     (Pending)

  Exemestane
Bisphosphonates ? !

         Not really a
Specifically Targeted Agents
Can Zoledronic Acid (An Osteoporosis
   Treatment) Improve Outcomes?
Inhibition of Multiple Steps in Tumor Cell Metastasis
  Primary tumor                   Angiogenesis                                        Invasion




                    Inhibits
                  angiogenesis                                                       Decreases
                                                                                   matrix invasion

                                   Induces
      Synergy with                                             Stimulates immune
                                 tumor cell
    anticancer drugs                                              surveillance
                                 apoptosis

                                                                                     Decreases
                                                                                  adhesion to bone




  Metastases              Micrometastases               Adhesion &
                                                                                        Arrest in distant
                                                       extravasation
                                                                                            capillary
                                    Adapted from Mundy GR, et al. Nat Rev Cancer. 2002;2:584-593.
                                                                                                            20
Austrian BC Study Group 12 Trial
                   Design
                 Results Presented in 2008
•   Accrual 1999-2006
•   1,803 premenopausal breast cancer patients
•   Endocrine-responsive (ER and/or PR positive)
•   Stage I&II, <10 positive nodes
•   No chemotherapy except neoadjuvant
•   Treatment duration: 3 years            Tamoxifen 20 mg/d

                                              Tamoxifen 20 mg/d
Surgery        Goserelin     Randomize      + Zoledronic acid 4 mg q6m
 (+RT)        3.6 mg q28d    1 : 1 : 1: 1
                                              Anastrozole 1 mg/d
                Endocrine Neoadjuvant
                       Therapy                Anastrozole 1 mg/d
                                            + Zoledronic acid 4 mg q6m
                                                                         21
Secondary Endpoints: ZOL vs No ZOL
                              RFS                                                                     OS
                         100                                                                          100
                              90                                                                            90
                              80                                                                            80
Recurrence-free survival, %




                              70                                                                            70




                                                                                      Overall survival, %
                                       Relative Reduction of Relapse                                                 Relative Reduction of Death
                              60                                                                            60
                              50                      35 % !                                                50                      40 % !
                              40                                                                            40
                              30             No. of   Hazard ratio (95% CI)                                 30             No. of   Hazard ratio (95% CI)
                                             events        vs No ZOL        P value                                        events        vs No ZOL        P value
                              20       ZOL     54      0.653 (0.46 to 0.92)  .014                           20
                                                                                                                     ZOL     16      0.595 (0.32 to 1.11)  .101
                              10       No ZOL 82                                                            10       No ZOL 26
                               0                                                                             0
                                   0   12    24    36   48     60    72        84                                0   12    24    36   48     60    72       84
                                       Time since randomization, months                                              Time since randomization, months




                                                                                                                                                                    22
AZURE: Study Design

Accrual September 2003 - February 2006

                                                Standard therapy


          3,360
         patients               R
        Stage II/III
                                             Standard therapy +
                                            Zoledronic acid 4 mg
174 centres                         6 doses      8 doses        5 doses
• UK (123 centres; 2710 patients)   Q3-4 weeks   Q 3 months    Q 6 months
• Eire (10 ; 247)
                                            6             30                60
• Australia (28 ; 226)                               Months
• Spain (8 ; 107)
• Portugal (1 ; 32)                        Treatment duration 5 years
• Thailand (2 ; 25)
• Taiwan (2 ; 13)
AZURE: Disease Free Survival
NO EFFECT ! BIG SURPRISE


       100
   %                                                      %
       80


       60             Zoledronic acid: N= 1681
                      Control: N= 1678


       40        Adjusted HR = 0.98
                 95% CI [0.85,1.13] p=0.79

       20 No. at risk:
     ZOL: 1681 1591 1465    1354   1243   580    83
    CONT: 1678 1583 1445    1344   1252   561    71       CONT:
        0
             0   1    2    3    4   5            6    7
                       TIME (YEARS)
AZURE: Overall Survival by Menopausal Status

               Premenopausal                                 Postmenopausal

% Surviving
 100



  80                                          80

                Zoledronic acid N= 1131
  60            Control N= 1127               60               Zoledronic acid N= 550
                                                               Control N= 551

  40       Adjusted HR = 1.01                 40        Adjusted HR = 0.71
           95% Difference inp=0.93
            No CI [0.81,1.26] Deaths                    29% CI [0.54,0.94] p=0.017
                                                        95% Decrease in Deaths
           157 vs 156 deaths                            86 vs 120 deaths
  20                                          20


   0                                               0
       0   1     2    3    4   5     6    7            0 1     2    3    4      5       6   7
                  TIME (YEARS)                                  TIME (YEARS)
There Are Many Promising Ideas

  Some of these will be good

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Targeted Agents in Breast Cancer: Examining Advances in Management of Breast Cancer - Dr. Peter Ravdin

  • 1. Targeted Agents In Breast Cancer Wonderful Music With New Instruments Peter M Ravdin, MD, PhD San Antonio, Texas 1
  • 2. Trends In Cancer Mortality In Women in US At This Rate We Will Beat Breast Cancer In 2040 Is the cause screening ?? Is the cause better therapy ?? Probably some of both. Not yet prevention.
  • 3. Targeted Agents In Breast Cancer Accelerated Progress 1. Its expression is only found to a limited extent in normal adult tissues 2. Its expression in cancer correlates with its anti- cancer effects. 3. It can be combined with other agents without unexpected toxicity 3
  • 4. Targeted Agents In Breast Cancer Why All The Excitement Now 1. Knowledge about metabolic, signalling, and control pathways is advancing 2. Methodologies for detecting and quantitating macromolecules are improving 3. Methods for screening large libraries of compounds are maturing. 4
  • 5. Targets In Breast Cancer The Estrogen Receptor. ER (Discovery late 1970s) 5
  • 6. Targets In Breast Cancer The Grandmother of Them All The Estrogen Receptor. Restricted expression in tissues in the adult. Toxicity issues: Expression in endometrium Expression in bone Expression in CNS Methodologies for detecting Still an issue 6
  • 7. Targets In Breast Cancer Tamoxifen: An Agent Targeting The Estrogen Receptor. Useful In Metastatic Disease 50 % RR Adjuvant Therapy 40 % HR Prevention 40 % RR 7
  • 8. Targets In Breast Cancer Tamoxifen Effects Are Long Term 45 % 32 % 7% Relapse Reductions 8
  • 9. Targets In Breast Cancer HER2 (Discovery late 1980s) 9
  • 10. Targets Agents In Breast Cancer Second Major Target Her2 Restricted expression in the adult Expression in heart ? Methodologies for detecting Still an issue In adjuvant therapy do Her2 “negative“ cases respond 10
  • 11. NSABP B-47 Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer Groups: Arm 1. DC q3w * 6 Arm 2. AC qw2 or 3w * 4 then P qw * 12 Arm 3. DC and Trastuzumab q3w * 6 and then Tras. q3w * 11 Arm 4. AC qw2 or 3w * 4 then P and Tras. qw * 12 then Tras . Q3w * 12 Eligibility 1. HER2 0 or 1 by IHC. If Her2 = 2, FISH negative. If Her2 = 3 ineligible 2. Node positive. If Node Negative. N0 with ER/PgR negative or Grade 3
  • 12. Targets/Agents In Breast Cancer Active Classes (1990‘s) HER2-targeted agents Pertuzumab and trastuzumab-maytansine immunoconjugate) VEGF-targeted agents aflibercept anti-VEGF monoclonal antibody bevacizumab Dual EGFR/HER2-targeted agents afatinib [BIBW 2992] and neratinib, Multitargeted tyrosine kinase inhibitors sunitinib, pazopanib Mammalian target of rapamycin (mTOR) everolimus Poly (ADPribose) polymerase 1 inhibitors iniparib, olaparib. 12
  • 13. Targets In Breast Cancer Development of A New Agent Metastatic Disease NeoAdjuvant Therapy Adjuvant Therapy Prevention 13
  • 14. Adjuvant Treatment: What Is Involved ? Lots of variations but this is a common way. Radiation: 4-6 weeks High risk of local recurrence Inconvenient, bothersome. Chemotherapy: 3-6 months Unacceptable risk of dying of cancer Tolerable, but obnoxious. Biological Therapy: 1 year Only if Her2 positive Usually low toxicity antibodies. Hormone therapy: 5 years Only if ER (estrogen receptor positive Usually low toxicity pills. XRT Chemo Bio Hormone Time (yrs)
  • 15. PFS Results in MBC of A Trial Letrozole + Lapatinib vs Letrozole
  • 16. OS Results of A Trial Letrozole + Lapatinib vs Letrozole
  • 17. QOL Results of A Trial Letrozole + Lapatinib vs Letrozole 10% of the L + L patients had Grade 3 / 4 diarrhea
  • 18. AI’s +/- Everolimus Neoadjuvant Study Letrozole + Everolimus (Better Response) More Toxicity Letrozole Gr 3/4 23 % vs 4 %) 1st Line MBC Study Exemestane + Everolimus (Pending) Exemestane
  • 19. Bisphosphonates ? ! Not really a Specifically Targeted Agents
  • 20. Can Zoledronic Acid (An Osteoporosis Treatment) Improve Outcomes? Inhibition of Multiple Steps in Tumor Cell Metastasis Primary tumor Angiogenesis Invasion Inhibits angiogenesis Decreases matrix invasion Induces Synergy with Stimulates immune tumor cell anticancer drugs surveillance apoptosis Decreases adhesion to bone Metastases Micrometastases Adhesion & Arrest in distant extravasation capillary Adapted from Mundy GR, et al. Nat Rev Cancer. 2002;2:584-593. 20
  • 21. Austrian BC Study Group 12 Trial Design Results Presented in 2008 • Accrual 1999-2006 • 1,803 premenopausal breast cancer patients • Endocrine-responsive (ER and/or PR positive) • Stage I&II, <10 positive nodes • No chemotherapy except neoadjuvant • Treatment duration: 3 years Tamoxifen 20 mg/d Tamoxifen 20 mg/d Surgery Goserelin Randomize + Zoledronic acid 4 mg q6m (+RT) 3.6 mg q28d 1 : 1 : 1: 1 Anastrozole 1 mg/d Endocrine Neoadjuvant Therapy Anastrozole 1 mg/d + Zoledronic acid 4 mg q6m 21
  • 22. Secondary Endpoints: ZOL vs No ZOL RFS OS 100 100 90 90 80 80 Recurrence-free survival, % 70 70 Overall survival, % Relative Reduction of Relapse Relative Reduction of Death 60 60 50 35 % ! 50 40 % ! 40 40 30 No. of Hazard ratio (95% CI) 30 No. of Hazard ratio (95% CI) events vs No ZOL P value events vs No ZOL P value 20 ZOL 54 0.653 (0.46 to 0.92) .014 20 ZOL 16 0.595 (0.32 to 1.11) .101 10 No ZOL 82 10 No ZOL 26 0 0 0 12 24 36 48 60 72 84 0 12 24 36 48 60 72 84 Time since randomization, months Time since randomization, months 22
  • 23. AZURE: Study Design Accrual September 2003 - February 2006 Standard therapy 3,360 patients R Stage II/III Standard therapy + Zoledronic acid 4 mg 174 centres 6 doses 8 doses 5 doses • UK (123 centres; 2710 patients) Q3-4 weeks Q 3 months Q 6 months • Eire (10 ; 247) 6 30 60 • Australia (28 ; 226) Months • Spain (8 ; 107) • Portugal (1 ; 32) Treatment duration 5 years • Thailand (2 ; 25) • Taiwan (2 ; 13)
  • 24. AZURE: Disease Free Survival NO EFFECT ! BIG SURPRISE 100 % % 80 60 Zoledronic acid: N= 1681 Control: N= 1678 40 Adjusted HR = 0.98 95% CI [0.85,1.13] p=0.79 20 No. at risk: ZOL: 1681 1591 1465 1354 1243 580 83 CONT: 1678 1583 1445 1344 1252 561 71 CONT: 0 0 1 2 3 4 5 6 7 TIME (YEARS)
  • 25. AZURE: Overall Survival by Menopausal Status Premenopausal Postmenopausal % Surviving 100 80 80 Zoledronic acid N= 1131 60 Control N= 1127 60 Zoledronic acid N= 550 Control N= 551 40 Adjusted HR = 1.01 40 Adjusted HR = 0.71 95% Difference inp=0.93 No CI [0.81,1.26] Deaths 29% CI [0.54,0.94] p=0.017 95% Decrease in Deaths 157 vs 156 deaths 86 vs 120 deaths 20 20 0 0 0 1 2 3 4 5 6 7 0 1 2 3 4 5 6 7 TIME (YEARS) TIME (YEARS)
  • 26. There Are Many Promising Ideas Some of these will be good