Viewing a single comment thread. View all comments

H2AK119ub t1_ixvuxi7 wrote

Reply to comment by bilyl in Brain cancer vaccine succeeds at prolonging survival in Phase 3 trial by Sorin61

The effect on OS for primary disease from point of randomization is 3 months (compared to the external controls). The FDA will need to decide if that is clinically meaningful.

1

bilyl t1_ixw1apo wrote

Considering that there are plenty of oncology drugs that give one month of OS because of the dismal outcomes of specific cancers, this is a sure thing. Getting this data in a phase III trial just seals it.

5

H2AK119ub t1_ixw1tnd wrote

Can you name an example of this "one month life extension" drug in oncology?

2

bilyl t1_ixwgjia wrote

I’ll have to do a bit of research, but off the top of my head there are a couple of drugs that are in that range: Vemurafenib (metastatic lung cancer, ~3-4 months OS improvement), Crizotinib (~4 months), trodelvy (3.2 months for metastatic triple negative BC), trastuzumab (gastric cancer, <3 months), cetixumab (CRC, 1.5 months).

6

H2AK119ub t1_ixwrb6q wrote

Not sure why you've focused on (mostly) old drugs and kinase inhibitors (known to be very dirty). Vemurafenib (BRAFi) is indicated and used in melanoma not NSCLC (another first for FBDD), Crizotinib (ALKi) is focused on ALK fusions, Trodelvy is a first in class ADC, Trastuzumab makes billions annually and is SOC in HER2+ breast cancer, and cetuximab is an old EGFR mAb that has been mostly supplanted by anti-VEGF mAb's in CRC (with FOLFOX chemo).

2

bilyl t1_ixxoyi6 wrote

I didn’t specify anything about whether newer drugs fall into this category, but it was very routine that older targeted inhibitors (especially kinase inhibitors like you said) were approved in the past 15 years (not that long ago!! I was in graduate school at that time) for very marginal benefits. So yeah, there are way better drugs now but drugs with marginal benefit were being approved “back then” because there was nothing better and because survival was really dismal.

1

[deleted] t1_ixwjh5s wrote

[deleted]

1

H2AK119ub t1_ixwptan wrote

This is not how a clinical trial works at all. Nor is it how SOC treatment works for primary disease. Doctors (ie, oncologists) don't just try "random" treatment options.

1

twnbay76 t1_ixx29ez wrote

The question was about how the average was calculated, i.e. simple mean, weighted average, etc...

And they are correct in the sense that patients that are unresponsive to medications are placed on other medications and modes of care. But yeah, certainly not randomly!

1