Promising Experimental Drug to Watch

Wow! Sounds very promising! Good to hear this.

Very promising.

Thank you for posting.

My caution about this drug is that so far in trials it has had a 50% rate of Grade 3 or higher Adverse Events (for breast cancer; it was 64% in I think gastro), 22..9% had a serious (life-threatening) Adverse Event and the drug has directly caused 5 deaths so far. The rate of Interstitial Lung Disease has been so high it required an outside independent agency to monitor for the duration of the trials.

I once experienced a Grade 3+ Adverse Event (on a different drug) that made me so miserable I told my oncologist I would rather die. The risk is too high for me on this drug, and I really have a hard time trying to understand why nobody cares how toxic it is. We need to demand better than this!

I've had some people ask me where I got this information - most of it is right in the press releases on the company's website, the rest is in the Phase I and II trial results.

ann723, I believe that we always have a choice. We may each have different priorities along the Quality of Life vs Quantity of Life continuum, but we always have a choice. The first thing my oncologist brings up when we are evaluating treatment choices is the risk vs potential benefit so I can make an informed decision, and he's not afraid to tell me when he believes the risk (of toxicity) outweighs the potential benefit. And I understand it means that at some point I will have no acceptable options left.

Some noted oncologists have been very vocal recently about the unacceptable level of toxicity for recent drug approvals, and they've been leading some very enlightening conversations on social media. Several have stated that a rate above 10% for AEs Grade 3 and higher is unacceptable. Grade 3 is "severe, but not immediately life threatening", Grade 4 is life threatening, Grade 5 is death from the AE. Having already experienced a Grade 3+ AE that made me wish I was dead, a 50% chance that I would go through that experience again is too high for me, it's no deal. I don't want to stay alive only to be that miserable. But I understand that others may feel differently.

Something similar happened when capecitabine was first approved. The original approved dosage was so toxic that people refused to take it. A few years later we learned that a dosage that was half the amount originally approved was just as effective and drastically reduced the rate and severity of Adverse Events.

There needs to be more focus in the early trial phases of minimum effective dosage rather than maximum "tolerated" dosage. Even after a rate 50% Grade 3 and higher and several deaths due directly to the drug, they state that they never reached a dose-limiting level of toxicity!

Anyway, so far it's only been trialed as a third line treatment for HER2+, after Herceptin and Kadcyla have failed. They just started the first trial for HER2-low (DESTINY-Breast04).

My personal opinion is that they won't let anything get in the way of accelerated approval for this drug because they have almost US$7 billion riding on it.