A Surprising Decision for Telik

All the Telik (Nasdaq: TELK  ) critics, including myself, got a little egg on their faces today when the drugmaker announced that the FDA had removed the partial hold it had put on the development of its lead drug, Telcyta.

Telcyta is a chemotherapeutic agent that was in testing for non-small cell lung cancer and ovarian cancer. After Telik reported in early June that patients treated with Telcyta in two phase 3 trials had died significantly sooner than patients who had received the placebo, the Food and Drug Administration temporarily blocked Telik from testing the drug.

Eleven days after enacting the complete hold on Telcyta testing, the FDA reduced it to a partial hold and allowed Telik to continue dosing of the drug to patients already enrolled in an ongoing phase 3 study on refractory ovarian cancer labeled Assist-5. Monday's news likely allows Telik to continue enrolling patients in this study if it wants to do so.

After the first three phase 3 studies of Telcyta were reported as failures, Telik's management said it would likely take an interim look at the 120 patients enrolled in the Assist-5 trial to determine how it would continue developing Telcyta for ovarian cancer.

The Assist-5 trial was to have enrolled 244 patients initially, but Telik has not given word on whether it will continue enrolling patients after it takes an interim peek at the data. Phase 2 studies with Telcyta for non-small cell lung cancer are also expected in the future.

The end of the clinical hold announced Monday doesn't strike me as a particularly positive event for Telik. It will still have to demonstrate that Telcyta has some benefit in treating ovarian and non-small cell lung cancer, and the results of earlier studies are not convincing at all.

Here's how Telcyta fared compared with goals for the three phase 3 studies announced earlier in the year.

Study Name

Treating

Goal

Study Results

Assist-1

Third-line ovarian cancer

Overall survival

Median survival for patients with Telcyta was 5.1 months shorter than those in the control arm

Assist-2

Third-line non-small cell lung cancer

Overall survival

Median survival for patients with Telcyta was 1.5 months shorter than those in the control arm

Assist-3

Second-line ovarian cancer

Objective response rate

Data not available:  About 25% of patients didn't continue the study because of disease progression

Telik noted that the patients in the control arm of the Assist-1 trial did live longer than it had expected them to, but still, it doesn't appear to me that Telcyta is helping anyone.

Telik had said that if the clinical hold on Telcyta were lifted, it would seek a partner to help fund further development. With trial results like these, I don't see how Telik will ever convince an oncology-focused drugmaker like Genentech (NYSE: DNA  ) or AstraZeneca (NYSE: AZN  ) to go anywhere near Telcyta.


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