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

  • ID: 4043275
  • Report
  • Region: Global
  • 200 Pages
  • MP Advisors
1 of 6

FEATURED COMPANIES

  • Abbott
  • Arvinas pharmaceuticals
  • DexTech Medical AB
  • Innocrin pharmaceuticals
  • Nanobiotix
  • Sun pharma
  • MORE

Increase in prevalence of Prostate cancer and availability of new treatment options (Zytiga, Xtandi, Cabazitaxel and Xofigo) in last few years has extended the 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.

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.

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Note: Product cover images may vary from those shown
2 of 6

FEATURED COMPANIES

  • Abbott
  • Arvinas pharmaceuticals
  • DexTech Medical AB
  • Innocrin pharmaceuticals
  • Nanobiotix
  • Sun pharma
  • MORE
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

- nmCRPC and HSPC- Next growth driver of New Oral Antiandrogens –      ARN-509 or Xtandi or ODM-201- Who will win the race?
- WW Targeted Patient population and expected Market size expansion of  Anti androgens in each stage
- Zytiga patent expiry – Game Changer  in  Antiandrogen Class
- 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

- Xtandi current US prescription trend  and its uptake

- Xtandi Price issue

- Xtandi uptake in Europe
- Xtandi uptake in Japan

- Xtandi- additional opportunities in Prostate Cancer

- 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

- Xtandi – additional clinical trials in Prostate Cancer

- Xtandi in M1 Hormone Sensitive patients
- Xtandi in Mo Hormone Sensitive patients
- Xtandi other ongoing clinical studies

- Xtandi with Pfizer early stage Prostate cancer Pipeline drug

- Xtandi in Other Indications

- Xtandi Potential in Breast Cancer
- Xtandi  in Hepatocellular Carcinoma

- Xtandi in combination with New pipeline drugs
- Xtandi with IO combo

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

- Ongoing Clinical trials of ARN-509 and  our expectations
- 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 workjQuery151008280421685093486_1485871579168
- 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)

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
Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Abbott
  • Arvinas pharmaceuticals
  • DexTech Medical AB
  • Innocrin pharmaceuticals
  • Nanobiotix
  • Sun pharma
  • MORE

This report details current unmet need, changing regulatory requirement, reimbursement challenges & market dynamics of Prostate Cancer drugs. The eport 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

Note: Product cover images may vary from those shown
5 of 6
  • ATLAB pharma
  • Abbott
  • Actavis
  • Advantagene
  • Advaxis
  • Aeterna Zentaris Inc.
  • Allchem pharma
  • Amerigen pharmaceuticals
  • Amneal pharmaceuticals
  • Apotex
  • Aragon pharmaceuticals
  • Arno Therapeutics
  • Arvinas pharmaceuticals
  • Asana Bioscience
  • Astellas
  • AstraZeneca
  • BHR pharma
  • BTG International Ltd.
  • Bavarian Nordic
  • Bayer pharmaceuticals
  • Bind therapeutics
  • Bristol-Myers Squibb pharma
  • Citron pharma
  • DexTech Medical AB
  • Dr. Reddy’s Laboratories
  • ESSA pharma
  • Econugenics
  • Eli Lilly Company
  • Endo pharma
  • Foresee pharmaceuticals
  • GTx pharma
  • Genetech
  • Harbor Bioscience
  • Hetero Labs.
  • Innocrin pharmaceuticals
  • Inspyr Therapeutics
  • Invivis pharmaceuticals
  • Janssen pharmaceuticals
  • Jiangsu Hengrui Medicine Co.
  • Johnson & Johnson
  • Madison Vaccines
  • Mediolanum S.p.A
  • Medivation
  • Merck pharmaceuticals
  • Millennium pharmaceuticals
  • Momotaro-Gene Inc.
  • Mylan
  • NanoString Technologies
  • Nanobiotix
  • OncoGenex  pharmaceuticals
  • Orion pharmaceuticals
  • Panacela Labs
  • Par  pharmaceuticals
  • Pfizer
  • Piramal Imaging S.A
  • Progenics pharmaceuticals
  • Roche pharmaceuticals
  • Sanofi
  • Sotio pharma
  • Sun pharma
  • Suzhou Kintor pharmaceuticals Inc.
  • Taiho Oncology
  • Takeda pharma
  • Teva pharmaceuticals
  • Tokai pharmaceuticals
  • Turing pharmaceuticals
  • Tyme Technology
  • Valeant pharmaceuticals
  • Viamet pharmaceuticals
  • West-ward pharmaceuticals (Hikma pharmaceuticals)
  • Wockhardt
  • Zenith Technologies
Note: Product cover images may vary from those shown
6 of 6
Note: Product cover images may vary from those shown
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