Therapeutic Class Overview: Newer Oral Anti Androgens – Expanding Role in the treatment Paradigm of Prostate Cancer

Published: February 2014
No. of Pages: 44
  

XTANDI (Enzalutamide) – Does it have potential to compete against ARN-509 in earlier setting?

Zytiga (Abiraterone Acetate) – Ongoing Combination trials creates potential beyond Patent Expiry

In recent past approval and launch of various newer treatment options like Xtandi (Enzalutamide, Astellas/Medivation), Zytiga (Abiraterone acetate, JNJ), Jevtana (Cabazitaxel, Sanofi), & Xofigo (radium Ra 223, Boehringer Ingelheim) has evolved the treatment paradigm of treating late stage prostate cancer. In coming years, we expect this to repeat in early stage prostate cancer treatment (nmCRPC, before Prostectomy) due to launch of newer antiandrogens in this setting.  Longer duration of therapy and high prevalence makes this earlier setting market more lucrative and bigger for newer options than late stage if they succeed.

In coming years, we expect second generation antiandrogens (Androgen synthesis inhibitors/Androgen receptor inhibitors, Xtandi, ARN-509, ODM-021, Zytiga, TAK-700, TOK-001) to replace them and expand their use beyond current levels in nmCRPC (non metastatic Castrate resistance Prostate cancer) patients and also in pre-prostectomy (Chart 3).  This newer agents will expand these markets atleast by $10b ($6b in pre prostectomy, $4b nmCRPC) if get success.

TAK-700 (Takeda), ARN-509 (JNJ) and Xtandi are strong candidates to get success in early stage prostate cancer and in next two years PhIII clinical data from EL-04, PROSPER and SPARTAN study, will decide who will lead this market.  While TAK-700 has a first launch advantage it is important to see how ARN-509, compete to Xtandi in earlier setting and in terms of safety for penetrating in early prostate cancer market.  Other than these PhIII studies, Xtandi PhII data from neoadjuvant PC and ARN-509 data in preprostectomy patients will decide their use in earlier setting. We estimate $2.8b peak sales for Xtandi in mCRPC setting, while in earlier setting it has potential to generate atleast ~$2b if it gets success in PROSPER , STRIVE, TERRAIN and neoadjuvant study.

Therapeutic Class Overview: Newer Oral Anti Androgens – Expanding Role in the treatment Paradigm of Prostate Cancer

Table of Contents

Executive Summary

Future role of Oral Antiandrogens in treatment of Prostate Cancer

  • Current Role of Oral antiandrogen therapy and its limitations
  • What changes are expected for oral antiandrogen therapy role in treatment of prostate cancer based on ongoing clinical trials
  • Oral Anti-androgens use in earlier setting
  • WW Targeted Patient population and expected Market size expansion of Anti androgens in each stage
  • Ongoing early stage clinical trials of Antiandrogens and our view on its outcome
  • Xtandi in neoadjuvant setting
  • TAK-700 in early stage PC- Is TAK-700 would be the rst drug tbe launched as rst line
  • therapy in combination with ADT in nmCRPC hormone naïve patients????
  • Zytiga + Xtandi
  • ARN-509- One stop solution for earlier setting?
  • Zytiga + ARN-509- Tablet vs. Capsule formulation- how it will gfurther in clinical
  • development???
  • Prostate Cancer Stage wise Key upcoming Milestones of Antiandrogens

Xtandi: -How big it could be???

  • Xtandi current prescription trend and its uptake
  • Next important milestone- Xtandi approval in Pre chemsetting based on PREVAIL data Our expectation
  • Xtandi in Japan
  • Xtandi in early stage prostate Cancer
  • Xtandi ongoing clinical trials in Prostate Cancer and our view on each
  • PROSPER Study – DARN-509 stands ahead in terms of clinical development in this setting?
  • Xtandi Competition , upcoming milestone and Market potential in each stage of prostate cancer patients

Xtandi vs. Zytiga- DZytiga patent expiry is a Major threat for Xtandi???

  • Zytiga Patent expiry – When texpect and Implications on Xtandi
  • 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

Pipeline Antiandrogens: Androgen Receptor inhibitors: Whcould be the major threat tXtandi?

  • 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?
  • Other pipeline Antiandrogens and our view –
  • EPI-001
  • AZD3514
  • HE3232 (Apoptone)
  • BMS-641988

Androgen Synthesis inhibitors: Dthe pipeline candidates have potential treplace Zytiga?

  • TAK-700- How it is different from Zytiga?
  • TOK-001

Indirect near term key competitors tZytiga/Xtandi in Post chemo setting:

  • OGX-011

List Of Tables

Table 1 Anti Androgens In Prostate Cancer Ongoing Key Early Stage Clinical Trials Of Anti Androgens In Treatment Of Prostate Cancer
Table 2 Anti Androgens In Prostate Cancer
Table 3 Anti Androgens In Treatment Of Prostate Cancer  Early Stage Prostate Cancer –Anti Androgens Market  Expansion -Year 2016 And Beyond
Table 4 Anti Androgens In Treatment Of Prostate Cancer Late Stage Prostate Cancer –Anti Androgens Market Size Year 2016 And Beyond Clinical Data Comparison- Xtandi Vs. Zytiga
Table 7 Anti Androgens In Treatment Of Prostate Cancer Xtandi – Key Ongoing Phiii/Iv Clinical Trials In Prostate Cancer And Our View
Table 8 Anti Androgens In Treatment Of Prostate Cancer Xtandi – Key Ongoing Phii/I Clinical Trials In Prostate Cancer And Our View
Table 9 Anti Androgens In Treatment Of Prostate Cancer Xtandi – Potential In Early Stage Of Prostate Cancer
Table 10 Anti Androgens In Treatment Of Prostate Cancer Xtandi – Potential In Late Stage Prostate Cancer
Table 11 Anti Androgens In Treatment Of Prostate Cancer Xtandi – Market Model In Late Stage Prostate Cancer (Pre+ Post Chemo Crpc)  Xtandi + Zytiga- Ongoing Key Clinical Trials
Table 13 Anti Androgens In Treatment Of Prostate Cancer Ongoing Key Clinical Trials- Zytiga + Other Targeted Therapies
Table 14 Anti Androgens In Treatment Of Prostate Cancer Pipeline Early Stage Androgen Receptor Antagonist
Table 15 Anti Androgens In Treatment Of Prostate Cancer  Arn-509 – Ongoing Clinical Trials
Table 16 Anti Androgens In Treatment Of Prostate Cancer Arn-509 – Clinical Data Comparision Vs. Odm-201 Vs. Xtandi
Table 17 Anti Androgens In Prostate Cancer Azd 3514 Ph I Clinical Data In Prostate Cancer
Table 18 Anti Androgens In Prostate Cancer Pipeline Early Stage Androgen Synthesis Inhibitor
Table 19 Anti Androgens In Prostate Cancer Comparison Of Cy17 Inhibitors Pipeline Drugs  Acting On Androgen Synthesis
Table 20 Anti Androgens In Prostate Cancer Clinical Data Comparision- Zytiga Vs. Tak-700 Vs. Tok-001

List Of Charts

Chart 1 Anti Androgens In Prostate Cancer Drugs Acting Through Various Pathways  To Treat Prostate Cancer Current Use Of Anti Androgens In Treatment Of Prosta
Chart 3 Anti Androgens In Prostate Cancer Currently Available Treatment Options Of Prostate Cancer Current & Future Use Of Xtandi In Treatment Of Prostate Cancer
Chart 6 Anti Androgen Therapy In Prostate Cancer Odm-201 Different Mechanism Of Action Than Arn -509/ Xtandi
Chart 7 Anti Androgen Therapy In Prostate Cancer Odm-201 Different Mechanism Of Action Than Arn -509/ Xtandi
Chart 8 Anti Androgen Therapy In Prostate Cancer  Odm-201 Vs. Xtandi In Mouse Vcap Xenograft Model
Chart 9 Anti Androgen Therapy In Prostate Cancer  Odm-201 In Phi/Ii Pc Study
Chart 10 Anti Androgens In Prostate Cancer Apoptone In Preclinical Model In Crpc
Chart -11 Anti Androgens In Prostate Cancer Tak-700 - Drugs Acting Through Androgen Pathway In Pc
Chart 12 Anti Androgen Therapy In Prostate Cancer Ogx-011 In Ph Ii Study In Mcrpc

Published By: MP Advisors
Product Code: MP Advisors21


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