huge news for TN MBC- Ascent trial halted because it worked!!!!

moth

ASCENT phase 3 trial was halted for "compelling evidence of efficacy"!

ie it would have been unethical to continue because the arm that was getting the medicine was clearly benefiting & it would be unethical to deny treatment to the control group. They still need to get FDA approval.

source:

https://twitter.com/aftimosp/status/12472427807510...

"Philippe Aftimos, MD

@aftimosp

·

5h

#OncoAlert Huge news for patients with metastatic breast cancer with the announcement of the halt for "compelling evidence of efficacy" of the ASCENT phase 3 study testing Sacituzumab Govitecan, an anti-Trop2 ADC, in triple-negative MBC. We look forward to the FDA approval #bcsm"

Anonymous

that is wonderful! Happy for all the TNBC sisters 😙<3

Anonymous

Does this happen a lot? Cure-ious is gonna have to parse this out...

Lauriesh

this happened in 2005 with Herceptin for early stage. Its pretty rare. Hope it is as successful for trip neg as herceptin was for her2+

Cure-ious

(Sondra, you know me, of course I'm gonna geek out about this!!)

So, this drug is the IMMU-132 that some here have tried already- it has had good results in phase 2 and now such good results that they closed phase 3 for TNBC early to move the drug along- it is an antibody conjugate, basically a topoisomerase inhibitor that is targeted specifically to cancer cells that express Trop2 protein on the surface. FDA expected to decide about it in June. They previously said the efficacy of the drug is very clear (yippee) however they had major problems with how this small company planned to manufacture it for the market (boo) and its still not clear that the manufacturing problems have all been resolved, but they just hired a new CEO and presumably can figure this out.

Importantly, this medicine also works in ER-positive HER2-negative MBC and there is a phase 3 trial ongoing for that. Phase 2 results for ER-positive disease indicated about a seven month PFS when used as a third or later line treatment, similar to what they see for TNBC, and nearly half of all patients responded to the trial drug, which is high. The study population all had prior hormone therapy as well as chemo in the metastatic setting. At least one person got two years on this drug, and ten were still in therapy at the time of the write-up.

Here is a link for the phase three trial for IMMUN-132 for ER-positive MBC patients (note that many sites are also in UK/europe):

https://clinicaltrials.gov/ct2/show/NCT03901339

(Eligibility requirements for this phase three trial include at least two chemotherapy treatments in the metastatic setting )

The drug is briefly mentioned by UCSF oncologist Hope Rugo here:

https://www.cancernetwork.com/mbcc/hope-rugo-md-fu...

So yeah, this is wonderful, a strong drug that acts completely differently than the endocrine therapies or chemo therapies! Because it is antibody-based, it involves an IV injection. Others here who have tried it will hopefully provide more details about what it is like and side effects, etc.

moth

thank you cure-ious for that explanation!
a lot of time I feel I just want to kick the can down the road, maybe new treatments will appear... and suddenly this is a real treatment to add to the options.

I still hate how oncologists measure time. 7 months It's good but it's not good. i want 7 years

ShetlandPony

But the seven months is an average, and if it works well for a particular person, it might work for two years or more, right?

I place a lot of hope in new treatments being added to our arsenal, moth. I have experienced the can bouncing along ahead, twice in fact. Just when I finished my first mbc treatment, Taxol, Ibrance got approved, and I did get the average time doubled compared to letrozole alone. And then recently, after short and unsuccessful courses of Halaven/eribulin and Doxil, instead of going to a taxane just yet, I enrolled in a phase II trial to get neratinib, and it appears to be working.

JFL

This is great news. I have pretty much exhausted standardtreatment options, other than recycling meds and trying rarely used, usually older drugs. Will need to follow news on this one. I recall someone here is currently on IMMU-132 in a trial with good results.

Shetland, usually the PFS stat is a median, i.e. - half had PFS less than 7 months and half more. There could be very long PFS time periods in the half longer than 7 months. Median would be better than average I would think in this xase

ShetlandPony

Thank you for that important clarification, JFL.

ledascout

Wow, Cure-ious (awesome handle). I love your geeking out! Thank you.

I would love to know more about the SEs for this drug. I have one friend in a trial for ER+ at UCSF, and she's doing fine, but she tends to have really minimal side effects with everything! I have also heard that this one can be pretty tough.

I will be scanned next week, and even though I'm ER+, my onco will likely put me on this I have progression (off-label).

Thanks for any more info,

L

Cure-ious

To update on IMMU-132 (Sacituzumab Govitecan; boy this needs a new name!!); it did indeed get a super-speedy FDA approval (right now for triple-negative but hopefully soon for ER-positive MBC)

Check out the discussion by the always-fabulous Hope Rugo, who runs the clinical trials at UCSF:

https://www.cancernetwork.com/breast-cancer/hope-r...