I was expecting north of 3 months OS advantage. Granted, this is second line treatment so 2 months over the placebo is considered remarkable.
Although, the market doesn't seem convinced.
As an orphan drug, the bar is lower. I use to think I would work with a loved one for an extra two months, but not after taking care of both parents at home and chasing experimental therapy. Quality of life was not there. Some may disagree, but there are the other test results that are inconclusive and the side effects need sorted. Getting to/thru the FDA to production is no given. Best to all those who can get an extra two months who want to try...I think more are learning that two months is not the answer.
I definitely agree with you about quality of life, however the result from Napoli has open up many doors, that's why practitioner like myself are excited to know that it is working. For example, oncologist may want to start using this in the FOLFOX regimen. MM398 certainly has a better side effects profile and tolerability than the good old ironotecan. I am hoping to see more trials in the post market setting
The rarity of the disease affects the number of drug companies willing to invest. The FDA sets the bar lower on effectivity and safety. I agree this has nothing to do with the two months survival, but a great deal to do with how lenient the FDA will be in considering the 2 Months.
And you would be wrong. These are patients already treated with gemcitabine who have failed. Statistically significant results in prolonging overall survival. Not many drugs can do that even for two months,
I agree with your assessment.
When Abraxane with gemcitabine got approved for 1st line pancreatic cancer, both drugs were previously approved ON THEIR OWN in other cancers and thus proved their true efficacy potential. Whereas, MACK's nanoparticle irinotecan on its own failed to demonstrate efficacy so this causes doubts in the oncologists and FDA minds!
So this could be a fluke! especially with only 2-months difference in OS. So my opinion is that the FDA may ask another trial before approving this drug!
Give me a break "regulatory expert"
1. Other cancers are other diseases with other risk / benefit equations. It doesn't matter what else abraxane was approved in. I bet you dollars to doughnuts abraxane would fail as a monotherapy as well.
2. A Fluke? Do you know what statistical significance means? This is a 50% improvement in survivial, and likely there are some super responders in that group that are really benefiting.
3. The primary endpoint was agreed upon by FDA and EMA.
Approval is a slam dunk.
The number of morons on this board is increasing exponentially. Luckily the smart money is watching as well.
Sentiment: Strong Buy
Ridiculous and you know it. Why don't you shorts just give it a rest? What you are attempting to do is so transparent, and pitiful. The drug worked in second line pancreatic cancer which is one of, if not the, toughest illnesses to treat anywhere. As well, MACK has a diagnostic, so when they decide to go PIII with a diagnostic in pancreatic they can pick out the patients in whom their drug works best.
It's a new day in Pancreatic Cancer, and MACK will be a major player.
Clearly you don't know anything about pancreatic cancer. We are talking about a disease with five year survival around 5%. This is one of the most deadliest cancers. I can't even remember thenumber of PIII that studies failed in the past 2-3 years. This was a winner and worth all the attention.
Sentiment: Strong Buy
Exactly - in 1st line pancreatic cancer, median PFS with Gem is about 3-4 months and OS is about 7-8 months. Abraxane added less than 2 months to that equation and was approved. The 1.9 months improvement in OS for MM-398 is a more dramatic increase to the 2nd line equation - i.e. a 50% improvement vs a 25% improvement for Abraxane in 1st line. As some other posters pointed out, given that the 1.9 month improvement was statistically significant at P
Yes, you of course are a short so let's not be cagey about what you're about. You also know nothing about second line pancreatic cancer. A clear win is a clear win, and with the diagnostic in a Phase III trial this could easily by a front line(multi billion dollar) drug.