I heard from a reliable source (someone who directly talked with the lead investigator for the NKTR-214 trial) that 9 patients were not evaluated because the trial already reached its efficacy endpoint. This may be part of what’s confounding the data. It’s not going to matter in the long run because the drug will perform has it’s going to perform and this will eventually come to light. I added to my position this morning when the stock was below $60.
"Loser: Nektar Therapeutics and Bristol-Myers Squibb
The clear loser at this year’s ASCO is Nektar, which is developing a new immunotherapy that is being combined with Bristol’s Opdivo. The narrative among skeptics is that Bristol is rushing the drug, NKTR-214, too fast in an effort to catch up to Merck. The data presented will do nothing to blunt that charge.
There were really two problems for Nektar. One was that it had a confusing study design. It had decided to start big trials aimed at getting regulatory approval if it met highly optimistic hurdles in its earliest studies. But it expanded those studies before those hurdles were hit, and the new patients hadn’t had time to respond to the drug, making the results worse. That’s largely a communication problem. The other, though, is that it and Bristol were making this huge decision based on very small numbers of patients. For instance, 85% of patients responded to the NKTR-214/Opdivo combo, compared to an expected 65% response rate for Opdivo in other studies. But that amazing response is just from 13 patients, without a control group. Is that enough data for such a big bet? Really, we’ll have to wait for the approval trials to know. Investors don’t like confusion, and they don’t like waiting, so Nektar shares are down 30%
But it expanded those studies before those hurdles were hit, and the new patients hadn’t had time to respond to the drug, making the results worse. That’s largely a communication problem.
Interesting. Best explanation I have heard so far. Before this announcement this weekend did they tell anyone they were adding new patients to the study? Or did this just catch us all by surprise.
You really think they didn’t explain this at the conference today? Jeez.