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Prostate Cancer: Update Bulletin #3 [July 2018]

Product Code:
Publication Date:
July 2018

This edition presents key opinion leader (KOL) views on recent developments in the treatment of prostate cancer. Topics covered include KOL views on Merck & Co.’s presentation of data from the KEYNOTE-199 study at the 2018 ASCO conference; this trial is evaluating Keytruda (pembrolizumab) in patients with metastatic castrate-resistant prostate cancer (mCRPC). AstraZeneca and Merck & Co.’s presentation of data from the Phase II Study-08 is also discussed, with results showing that the combination of the PARP inhibitor Lynparza (olaparib) and Zytiga (abiraterone acetate; Johnson & Johnson) demonstrates superior radiologic progression-free survival (rPFS) compared with Zytiga alone. Opinion leaders also provide their candid views on the FDA’s recent approval of Sun Pharmaceuticals and Churchill Pharmaceuticals’ novel formulation of abiraterone acetate, Yonsa which will directly compete with J&J’s Zytiga in the mCRPC setting.

Business Questions:

• At the 2018 ASCO conference, Merck & Co. presented data from the Phase II KEYNOTE-199 study, evaluating the PD-1 inhibitor Keytruda (pembrolizumab) as a treatment for mCRPC, but how do KOLs perceive the reported disease control rate, which averaged just 11 percent across the whole study?
• What is the impact of the KEYTRUDA-199 data in terms of securing regulatory approval for Keytruda in mCRPC? What more does Merck & Co. need to do to secure this goal?
• Do results from the Phase II study combining Keytruda with the androgen receptor inhibitor Xtandi (enzalutamide; Pfizer/Astellas) suggest that combination therapy is a more viable option for Keytruda in this indication?• BP4
• At the 2018 ASCO conference, AstraZeneca and Merck & Co. presented data from a Phase II study combining the PARP inhibitor Lynparza (olaparib) with Zytiga (abiraterone acetate: J&J), but how do KOLs perceive this combination, particularly given that overall survival was extended by just 1.8 months?
• How surprised are KOLs by the finding that patients who responded to the Zytiga plus Lynparza combination did so regardless of their DNA-mutation status, given that Lynparza targets DNA repair defects?
• If approved, where in the treatment paradigm will the Zytiga plus Lynparza combination sit?
• What benefits, if any, will Churchill Pharmaceuticals and Sun Pharmaceuticals’ novel abiraterone acetate therapy Yonsa offer, and how does it compare with J&J’s Zytiga, which contains the same active ingredient?
• How successfully will Yonsa compete with Zytiga and what can Churchill and Sun Pharmaceuticals do to differentiate their product?
• Zytiga faces exposure to generic competition by the end of 2018, following the US Patent Trial Appeal board’s decision to invalidate one of the product’s last remaining patents, but what, if anything, can secure Zytiga’s market share? Can J&J’s recently launched next-generation androgen-receptor inhibitor Erleada (apalutamide) maintain J&J’s foothold in the prostate cancer market?


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