Therapeutic Class Overview: Newer Oral Anti Androgens – Expanding Role in The Treatment Paradigm of Prostate Cancer
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.
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 to be 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 go further 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 chemo setting 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 – Do ARN-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- DO ZYTIGA PATENT EXPIRY IS A MAJOR THREAT FOR XTANDI?
Zytiga Patent expiry – When to expect 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
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?
Other pipeline Antiandrogens and our view –
EPI-001
AZD3514
HE3232 (Apoptone)
BMS-641988
ANDROGEN SYNTHESIS INHIBITORS: DO THE PIPELINE CANDIDATES HAVE POTENTIAL TO REPLACE ZYTIGA?
TAK-700- How it is different from Zytiga?
TOK-001
INDIRECT NEAR TERM KEY COMPETITORS TO ZYTIGA/XTANDI IN POST CHEMO SETTING:
OGX-011
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 to be 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 go further 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 chemo setting 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 – Do ARN-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- DO ZYTIGA PATENT EXPIRY IS A MAJOR THREAT FOR XTANDI?
Zytiga Patent expiry – When to expect 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
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?
Other pipeline Antiandrogens and our view –
EPI-001
AZD3514
HE3232 (Apoptone)
BMS-641988
ANDROGEN SYNTHESIS INHIBITORS: DO THE PIPELINE CANDIDATES HAVE POTENTIAL TO REPLACE ZYTIGA?
TAK-700- How it is different from Zytiga?
TOK-001
INDIRECT NEAR TERM KEY COMPETITORS TO ZYTIGA/XTANDI IN POST CHEMO SETTING:
OGX-011
