Current Clinical Challenges in Prostate Cancer
Current Clinical Challenges in Prostate Cancer
Immunology therapy has been a debatable topic in all of cancer with considerable discussion and little promise until recent years. After initial submission of limited data, and a convoluted review process that did not involve the usual divisions at the FDA, sipuleucel-T was initially not approved. The trials initially submitted included two relatively small randomized trials which were considerably smaller than typical for FDA approvals. The sponsors then designed and implemented a much larger trial called D9902B or the IMPACT study which was conducted in patients with asymptomatic or minimally symptomatic mCRPC. There was no benefit in terms of progression free survival or radiographic response, but the group randomized to initial treatment with sipuleucel-T had better OS compared to the placebo group. It has been questioned whether the control group did worse than might have been anticipated however our review of the data do not support this concept and the control group in this study did no worse than patients in other analogous trials.
Immunology Therapy: Sipuleucel-T
Immunology therapy has been a debatable topic in all of cancer with considerable discussion and little promise until recent years. After initial submission of limited data, and a convoluted review process that did not involve the usual divisions at the FDA, sipuleucel-T was initially not approved. The trials initially submitted included two relatively small randomized trials which were considerably smaller than typical for FDA approvals. The sponsors then designed and implemented a much larger trial called D9902B or the IMPACT study which was conducted in patients with asymptomatic or minimally symptomatic mCRPC. There was no benefit in terms of progression free survival or radiographic response, but the group randomized to initial treatment with sipuleucel-T had better OS compared to the placebo group. It has been questioned whether the control group did worse than might have been anticipated however our review of the data do not support this concept and the control group in this study did no worse than patients in other analogous trials.
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