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.
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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. 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.