Replies to post #167678 on NorthWest Biotherapeutics Inc (NWBO)

[Virgilio]

The DSMB met and stopped this trial 4 months ago and here it is published today in the NEJM.

I don't even want to think about it, the first time I heard of the publication was 10 months and a 1/2 ago...10 months and a 1/2!!!

[flipper44]

Keytruda PFS for lung cancer median exceeded SOC by 3.9 months.
Keytruda OS one year survival milestone for lung cancer exceeded SOC by 20%. 69% to 49%.

Adverse events of grade 3 or higher occurred in 67.2% of the patients in the pembrolizumab-combination group and in 65.8% of those in the placebo-combination group.

[iwasadiver]

Of course I read them, all of them; there're 4 in one publication. 4. And it's great news for cancer patients. But it's still a precise gun and it's no joke that Merck has all but dropped every other drug in their pipeline to focus on Keytruda. Read what I was saying; Merck has huge amounts of money to promote and give the public a perception that could block something that might be even better.

Merck is Merck because of how they got there. I'm in this business and I have friends in upper executive level positions in major drug companies that know what I'm talking about. There is more to medicine than results in a trial as you well know, and I'm telling you Merck is not just doing what they're doing because it's good for patients (no one in business is, including NWBO) and why they've suddenly shifted all these resources in a giant gamble for one drug is not the norm of a mainstream company in the drug business.

By "Shiny Object" I mean the new thing, the big splash, the thing that gets everyone talking that doesn't know shit about anything (the general public). This has a strategic impact in making any other equal or better treatment less visible and have less impact. The timing is not lost on me either.

[longfellow95]

You fail to mention that 67% of the Keytruda group had SAE's of grade 3 or higher.

And that 6.7% of the same group died of Treatment related adverse events.

And that 13.8% of the Keytruda group had trial drugs discontinued as a result of adverse events.

And that you are 10 times more likely to experience acute kidney injury with the Keytruda combo compared to placebo combo.


Then there is the Immune-mediated adverse events. You are twice as likely to experience these with the Keytruda combo.


Duration of response was an improvement over placebo, but was still short at a median of 11.2 months. In other words, the majority of Keytruda combo patients had disease progression or had died before a year was out.


The article also states:

Although the outcomes in the placebo-combination group appeared to be poorer than those in patients who had received pemetrexed and a platinum-based drug in some historical studies,23-25 the rates of disease control and progression-free survival were consistent with those in many landmark studies.

Not to mention that 30% of the Keytruda combo had at least one subsequent therapy 'while continuing to participate in the trial or outside the trial.'



So all in all, no, I don't consider these results as outstanding.

Far from it.