Sometimes ORR is predictive, most of the time it’s merely transient in difficult to treat cancers. The reason is obvious — tumor escape via heterogeneity. Shrinking tumors temporarily is a goldmine for business people, but fools gold in most cases for patients with dire prognoses in cancers still considered terminal. ORR is a perfect business model, the trials are quick, the approvals are quick and the riches are quick. Unfortunately, in difficult cancer indications, those types of ORRs typically result in short survival for patients. ORR is not helpful unless it links to lengthened survival confirmed by comprehensive and lengthy follow up. Unfortunately, this is not typically the case.
Autologous cancer vaccines that work are anticipated to have a diametrically opposed MOA to those described above. While immune response and tumor stabilization may occur early, evidence of true efficacy may require lengthy trials to establish long term survival trends. ORR may be delayed and/or simply nonexistent when tumors die but leave shells to elude western preconceived ideas of efficacy.
Jon D. Loves short trials. There is a reason for this. They fit a business model and appeal to the short attention span of most humans.
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