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.
Key Topics Covered:
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
- 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