Prostate Cancer -Newer Antiandrogens & Emerging Therapies Targeting a “Watchful Waiting” and Resistance Population

This report details current unmet need, changing regulatory requirement, reimbursement challenges & market dynamics of Prostate Cancer drugs. Report mention pipeline Antiandrogens, late stage prostate cancer pipeline drugs/new Mechanism of action & major companies developing Prostate cancer drugs. It also provides insight on clinical development strategy of combination pipeline/marketed drugs & therapeutic competitive landscape to find treatment paradigm fit & market potential of new drugs for treatment of Prostate Cancer.
 
 Increase in prevalence of Prostate cancer and availability of new treatment options (Zytiga, Xtandi, Cabazitaxel and Xofigo) in last few years has extended role of newer oral Antiandrogens to treat metastatic CRPC patient populations where the unmet need was high. This has expanded WW market size of Prostate cancer drugs to $7b in 2016 from $2.5b in 2011. Now nmCRPC, HSPC and Xtandi/Zytiga resistance population are the markets where in new pipeline drugs are under development. 
 Reported PhII clinical data of Xtandi, ARN-509 and ODM-201 in nmCRPC when indirectly compared demonstrate the bar is high for ARN-509 to compete against Xtandi in nmCRPC market and while ODM-201 is few years behind in clinical development. While in mHSPC reported clinical results of STAMPEDE study opens door for docetaxel combination approach as standard of care in first line setting.
 
 Around 8 plus drugs are in PhIII development for Prostate cancer treatment and 26 plus drugs are in PhII development (21 small molecules) - success of a few (ARN-509, ODM-201, AZD 5363, GX301) in coming years will expand nmCRPC ($3.5be), mHSPC market ($1be) and Xtandi/Zytiga resistant population ($1be) market by 2023. Longer duration of therapy and high prevalence makes earlier setting market more attractive and bigger for newer options than the late stage if they succeed.
 
 For drugs targeting through androgen pathway - Now trials and clinical development is underway for second and third generation androgen receptor inhibitors (ARN-509, ODM-201, ODM-204, EPI-506, VT-464, TAS-3681 and DR103). While androgen synthesis inhibitors still needs a proof of concept in clinic due to failure of TAK-700 & TOK-001. Expected data from VT-464 (Apr 2017) & ASN-001 will be important to watch to taste the success for this class. Androgen receptor degrader is another MoA in development from a decade and success of in clinic compound GTX-758 (Data expected anytime from now as study completed in March 2016- less likely to succeed) will decide the proof of concept.
 
 Other than pipeline drugs targeting androgen pathway, NCE targeting AKT pathway (AZD5363, Ipatasertib) appears to be more promising to succeed in late stage, while drugs acting through PARP inhibition (Olaparib, Niraparib) still needs a taste of success. Other interesting pipeline asset is LHRH agonist LMIS 50 mg, which is designed to overcome the drawbacks of the commercial depot products containing GnRH agonists by using a proprietary delivery system. 
 
 Also 6 therapeutic vaccines are in clinical development to treat prostate cancer. Recently launched PD-L1 IO therapy has increased hope of treating cancer in much safer way. Current ongoing studies of late stage IO mab are in Ph I/II clinical development and would be able to answer of PTEN hypothesis for role of PD-1, PD-L1 inhibitor to treat prostate cancer in coming years. 
 
 Resistant development is another challenge with long term use of Xtandi/Zytiga and needs to be addressed by pipeline second/third generation Antiandrogens/ combination approach with IO/PARP/AKT inhibitors to treat mCRPC. Increase in pricing pressure in developed market again put inference on Combination approach unless the advantage is significant and improve the Q0L in earlier setting. Due to that, drugs targeting adjuvant setting has high bar to deliver (Atezolizumab, GX301, Mipsagargin and Olaparib) in the clinical development to add significant value. 
  

 1. Executive Summary
 
 Antiandrogens- Expanding Role of new Oral Antiandrogens in early treatment armamentarium of Prostate Cancer and Other indications-
  Current Role of Oral antiandrogen therapy and its limitations
 o nmCRPC and HSPC- Next growth driver of New Oral Antiandrogens – ARN-509 or Xtandi or ODM-201- Who will win the race?
 o WW Targeted Patient population and expected Market size expansion of Anti androgens in each stage
 o Zytiga patent expiry – Game Changer in Antiandrogen Class
 o New Pipeline early stage Antiandrogens
  Targeting Xtandi and Zytiga Resistance population- A way to Fast track drug development?
 
 Immuno-Oncology drug –Potential in Prostate Cancer and ongoing combination studies with Antiandrogens & with Pipeline Prostate Cancer drugs
 Other Late stage Pipeline drugs for treatment of Prostate Cancer- AKT inhibitors or PARP inhibitors or a new MoA combination with Antiandrogen- Competing to Xtandi/Zytiga or targeting Xtandi/Zytiga Resistance Population?
 
 2. Prostate Cancer

  Stages of prostate cancer
  Signs and symptoms of prostate cancer
  Causes of prostate cancer
  Treatment of prostate cancer
  Unmet need of prostate cancer
  Current market size of prostate cancer
 
 3. Xtandi
  Xtandi – current uptake
 o Xtandi current US prescription trend and its uptake
  Xtandi Price issue
 o Xtandi uptake in Europe
 o Xtandi uptake in Japan
  Xtandi- additional opportunities in Prostate Cancer
 o Xtandi in nmCRPC- PROSPER study
  Urology opportunity / Xtandi as a preferred urology drug
  Xtandi Market Potential in nmCRPC
 • Xtandi Price Issue in nmCRPC
 • Xtandi duration of therapy in nmCRPC
 o Xtandi – additional clinical trials in Prostate Cancer
  Xtandi in M1 Hormone Sensitive patients
  Xtandi in Mo Hormone Sensitive patients
  Xtandi other ongoing clinical studies
 o Xtandi with Pfizer early stage Prostate cancer Pipeline drug
  Xtandi in Other Indications
 o Xtandi Potential in Breast Cancer
 o Xtandi in Hepatocellular Carcinoma
  Xtandi in combination with New pipeline drugs
  Xtandi with IO combo- please refer chapter no. 7
 
 4. Zytiga +ARN-509- How big is it has potential to change the treatment paradigm of Prostate Cancer? A competitive threat post Zytiga patent expiry for Xtandi?
 
Zytiga generic entry: An opportunity for ARN-509 or A threat for JNJ?
  Zytiga patent Expiry- more worries for early entry in US market than Ex-US
  Use patents of Zytiga : the 438 Patent
  Ongoing clinical trial of Zytiga with ARN-509
  Ongoing clinical trials of Zytiga with Xtandi
  New formulation under development for Zytiga/Xtandi
  Combination studies of Zytiga with other targeted therapy vs. combination study of Xtandi with other targeted therapies, Ongoing Clinical trials
  Combination of Zytiga with Onapristone
 
 5. Pipeline Antiandrogens: Androgen Receptor Inhibitors vs. Androgen Synthesis inhibitors-
 
Androgen Receptor inhibitors: Who could be the major threat to Xtandi?
 • ARN-509- A better Xtandi is in making
 o Ongoing Clinical trials of ARN-509 and our expectations
 o ARN-509- Clinical data comparison vs. Xtandi and other pipeline candidates
 • ODM-201- Does its safety differentiate it against ARN-509/Xtandi?
 • ODM-201 and ODM-204 has potential to challenge current leader Xtandi and Zytiga
 • EPI-001 and EPI-506
 • SHR3680
 • GT0918 (Proxalutamide)
 • ONC1-13B
  Other early stage pipeline Antiandrogens and our view –
 • DR103
 • AZD3514
 • HE3232 (Apoptone)
 • BMS-641988
  Androgen Synthesis inhibitors: TAK-700 and TOK-001 Failure in clinical trials creates “No hope” for VT-464 & other Cyp17 lyase inhibitor?
 • TAK-700- How it is different from Zytiga?
 • GALATERONE (TOK-001)
 • VT-464
 • ASN001
  Selective Androgen Receptor Degraders
 • GTX-758
  Indirect near term key competitors to Zytiga/Xtandi in Post chemo setting:
 • OGX-011
 • TAS-3681
 • ARV-330
 • PROTAC (Proteolysis Targeting chimera) platform of ARVINAS pharmaceutical
 
 6. Targeting Xtandi and Zytiga Non Responder and Resistant population
 
Causes of resistance -Emerging mechanisms of Resistance to Xtandi/Zytiga
  How do the Mechanism of resistance to the Zytiga and Xtandi differ and do some of them overlap?
  Can AR-V7 splice biomarker be used to determine whether Xtandi and Zytiga will work??
  What other studies are looking at different ways to overcome resistance??
  Who will win the race for AR-V7 variant mCRPC??
 
 7. Combination of drugs with IO therapy
 
Pembrolizumab
  Durvalumab with or without Tremelimumab
  Atezolizumab (Tecentriq)
  Nivolumab
 
 8. New pipeline drugs
  AZD 5363
  ADXS31-142 (ADX-PSA)
  [68Ga]RM2 or Ga-bombesin
  Recombinant adenovirus (Ad5-SGE-REIC/Dkk3)
  SM-88
  Mobilan (M-VM3)
  Dendritic cells DCVAC
  LMIS 50 mg
  NBTXR3
  Niraparib
  GX301
  ODX (Osteodex)
  BHR-200 (transdermal estradiol gel)
  Mipsagargin (G-202)
  PROSTVAC-V/F
  ProstAtakÂ
  99mTc-MIP-1404 injection
  PectaSol –C Modified Citrus Pectin
  ATL-101
  MVI-816
  Olaparib (Lynparza)
  TAK-385 (Relugolix)
  Ipatasertib (GDC-0068, RG7440)
  LY3023414
  PSMA ADC
  Zoptrex (Zoptarelin doxorubicin)
  


List Of Tables

 Table 1: Competitive landscape of phase I/II clinical data comparison of ARN-509 vs.
 Enzalutamide vs. ODM-201
 Table 2: Non metastatic CRPC- phase I/II clinical data comparison of ARN-508 vs. Enzalutamide vs. ODM-201- long term safety profile in Ph III is key to watch
 Table 3: Competitive landscape of mHSPC- STAMPEDE study data raise bar for newer
 Antiandrogen
 Table 4: Key study status of IO combination studies for prostate cancer
 Table 5: Stages of prostate cancer and its therapeutic options with drugs
 Table 6: Calculation of Targeted patient population Prechemo/Postchemo-US geography
 Table 7: Reported sales of Xtandi/ Zytiga
 Table 8: Sales of drugs in 2014 and 2015
 Table 9: Reported sales of Xtandi
 Table 10: Completed study of Xtandi in prostate cancer
 Table 11: Subgroup analysis shows benefit in MO
 Table 12: Ongoing study of Xtandi in prostate cancer
 Table 13: Xtandi market potential
 Table 14: Price related Petition in US
 Table 15: Treatment to rPFS would extend duration in TERRAIN study
 Table 16: Xtandi ongoing clinical trials in breast cancer
 Table 17: Xtandi ongoing clinical trials in other indication
 Table 18: Reported sales of Zytiga
 Table 19: List of companies who filed PARA IV
 Table 20: Ongoing clinical trials of Zytiga
 Table 21: Prostate cancer Xtandi vs. Zytiga in post chemo patients
 Table 22: Pipeline androgen receptor inhibitor
 Table 23: Upregulated GR protein expression
 Table 24: Ongoing clinical trials of ARN-509
 Table 25: AR affinity of newer antiandrogen
 Table 26: Ongoing clinical trials of ODM-201
 Table 27: ODM-201 clinical studies
 Table 28: ODM-201 patient type in dualides study
 Table 29: Ongoing clinical trials of ODM-204
 Table 30: Targeted product profile in mCRPC
 Table 31: Ongoing clinical trials of EPI-506
 Table 32: AZD3514 Ph I clinical data in prostate cancer
 Table 33: Clinical trial status of TOK-001
 Table 34: Ongoing clinical trials of VT-464
 Table 35: List of androgen receptor inhibitor discontinued or on hold due to various reasons
 Table 36: AR-V7+ had poor responses regardless of therapy
 Table 37: Possible MOA of resistance with Xtandi and Zytiga
 Table 38: Pipeline drugs for Prostate cancer treatment in combination with IO therapy
 Table 39: New pipeline drugs for Prostate cancer
 Table 40: Clinical trial study design of ADXS 31-1-42+ Pembrolizumab


List Of Figures

 Chart 1: Zytiga and Xtandi weekly TRx since Oct 2013
 Chart 2: Zytiga and Xtandi weekly NBRx since Oct 2013
 Chart 3: Prostate Cancer Current and Future Treatment Options
 Chart 4: Natural history of Prostate cancer
 Chart 5: Difference in Scrips given by Urology and Oncology
 Chart 6: Comparison of recent TRx share trends
 Chart 7: Ongoing Xtandi trials targeting earlier stage prostate cancer patients and
 Market size
 Chart 8: Quarterly net sales of novel hormonal therapies
 Chart 9: Xtandi- Duration of Therapy in Various Study
 Chart 10: Distribution of various breast cancer subtypes
 Chart 11: Xtandi Addressable Patient Population in US to treat Breast Cancer
 Chart 12: ODM-201- Permeability to Blood Brain Barrier
 Chart 13: Efficacy Results from Phase 1 study of ODM-201
 Chart 14: ODM-201-how it is different from Xtandi and ARN-509
 Chart 15: ODM-204- A derived structure from Zytiga and Xtandi
 Chart 16: Positioning of ODM-204
 Chart 17: Target product profile in mCRPC
 Chart 18: EPI-506- Androgen Receptor Binding Site
 Chart 19: Trial designee of EPI 506
 Chart 20: EPI-506- Target Prostate Cancer Patient
 Chart 21: APOPTONE in preclinical model in CRPC
 Chart 22: Phase 3 study size for TOK-001 vs. Xtandi/Zytiga
 Chart 23: OncoGenex – Mechanism of Action
 Chart 24: ARV-330 – Mechanism of Action
 Chart 25: PROTAC Platform of Arvinas Pharmaceuticals
 Chart 26: Emerging mechanisms of Resistance to Xtandi/Zytiga
 Chart 27: Xtandi/Zytiga- Shorter rPFS of AR-V7+ Patients
 Chart 28: MOA of Action of ADX- PSA
 Chart 29: Recognized Prostate Cancer Cells by ADX-PSA
 Chart 30: Killed cancer cells by ADX- PSA
 Chart 31: Step by Step Lm-LLo Immuno modulation of Pembrolizumab
 Chart 32: REIC/ Dkk-3 – Western Blot Analysis
 Chart 33: Dendritic Cells
 Chart 34: Clinical Trial study design of NBTXR3 in Prostate Cancer
 Chart 35: Preliminary Efficacy of Osteodex in Cancer
 Chart 36: MOA of Mipsagargin
 Chart 37: MVI-816 (pTVG-HP) Plasmid DNA Vaccine Targeting PAP
 Chart 38: MOA of AKT inhibitor –Ipatasertib
 Chart 39: MOA of AKT inhibitor –LY3023414 (PH II)

Companies mentioned:
 • Pfizer
 • Medivation
 • Astellas
 • Valeant pharmaceuticals
 • Turing pharmaceuticals
 • Abbott
 • Johnson & Johnson
 • Tokai pharmaceuticals
 • Bayer pharmaceuticals
 • AstraZeneca
 • Teva pharmaceuticals
 • Mylan
 • Bind therapeutics
 • NanoString Technologies
 • Zenith Technologies
 • Actavis
 • Apotex
 • Par pharmaceuticals
 • Citron pharma
 • Dr. Reddy’s Laboratories
 • Sun pharma
 • Wockhardt
 • Amneal pharmaceuticals
 • West-ward pharmaceuticals (Hikma pharmaceuticals)
 • Hetero Labs.
 • BTG International Ltd.
 • Janssen pharmaceuticals
 • Amerigen pharmaceuticals
 • Aragon pharmaceuticals
 • Sanofi
 • Arno Therapeutics
 • Invivis pharmaceuticals
 • Orion pharmaceuticals
 • Endo pharma
 • ESSA pharma
 • Jiangsu Hengrui Medicine Co.
 • Suzhou Kintor pharmaceuticals Inc.
 • Allchem pharma
 • Harbor Bioscience
 • Bristol-Myers Squibb pharma
 • Takeda pharma
 • Viamet pharmaceuticals
 • Innocrin pharmaceuticals
 • Asana Bioscience
 • GTx pharma
 • OncoGenex pharmaceuticals
 • Taiho Oncology
 • Arvinas pharmaceuticals
 • Roche pharmaceuticals
 • Merck pharmaceuticals
 • Sotio pharma
 • Foresee pharmaceuticals
 • Advantagene
 • Progenics pharmaceuticals
 • Econugenics
 • Bavarian Nordic
 • Mediolanum S.p.A
 • Piramal Imaging S.A
 • Panacela Labs
 • BHR pharma
 • DexTech Medical AB
 • ATLAB pharma
 • Madison Vaccines
 • Millennium pharmaceuticals
 • Genetech
 • Eli Lilly Company
 • Inspyr Therapeutics
 • Momotaro-Gene Inc.
 • Tyme Technology
 • Advaxis
 • Aeterna Zentaris Inc.
 • Nanobiotix
  


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