CytRx Corporation (CYTR) has released unscrubbed data of its Phase 3 pivotal trial for aldoxorubicin as a monotherapy in soft tissue sarcoma. As this successful clinical trial nears completion, it has taken many people by surprise because interim data was perceived by only scholars as a success. However, as previously described by several authors (see here and here), it is no surprise at all that the trial has met several, if not all, primary PFS endpoints and will pass FDA's rigorous approval requirements very soon upon full maturation.
Because there was quite a bit of data included in the press release, and some data seemingly omitted, we will attempt to explain points of active contention. This article is objectively pro-CYTR, with only 30 years of scientific scrutiny as our guide, but balanced articles exist, such as here and (con) here. I want to admit that I really enjoy the articles that adversaries submit. If we all agreed on all points in life, there would be fewer frontiers of discovery broken in science. This philosophically makes the tremendous breakthrough against tumor barriers spearheaded by aldoxorubicin much more pleasing to observe.
As the company stated in the press release, the primary endpoints are three cohorts of PFS. CYTR didn't state what the significant increase in PFS for the aldoxorubicin patients was as a unit of time in the three cohorts, but simply reported statistical significance respectively. The company also did not state at what time point the data that they provided was. They merely displayed raw data hazard ratio and p values to qualify the future FDA submissions. Some people might not understand why it is not presented in its entirety and see it as a "dodge" or "doctored data", such as this article states. There is a very good reason. The company is
