MM-302: HERMIONE study
 

Hello ladies and (of course) some gents,

At ASCO I met with representatives from Merrimack who is now conducting a Phase III clinical trial of MM-302 for anthracycline naive, MBC patients who are HER2+. That appears to be the only restriction as to former therapies (enrollees are permitted to have taken Herceptin previously).

MM-302 is a HER2-targeted nanoliposome consisting of the chemotherapeutic antracycline (doxorubicin), encapsulated in a liposomal sphere (which accounts for the trial's prior-therapy exclusion).

The company would like to recruit more enrollees. Here is a link to the HERIMONE clinical trial on clinical trials.gov:

https://www.clinicaltrials.gov/ct2/s...=MM-302&rank=2

The webpage has contact information about entering the trial.

I remember when this compound was in Phase I clinical trials, so it has held up up to make it to Phase III.

Joan

Re: MM-302: HERMIONE study
 

I dont want to sound negative but do they expect this MM-302 to be any more effective than Doxil. It sounds just like it.

I doubt this will interest many but I can tell you Xeljanz (Tofacitinib) is going generic soon. The dose of Xeljanz is 5mg twice a day. I read in a pharmacy magazine that the company that makes Xeljanz has come out with an 11mg Slow Release Xeljanz. They almost always make a slow release tab when a generic is on the horizen.

Paul

Re: MM-302: HERMIONE study
 

@Donocco,
This is similarly delivered as TMD1/Kadcyla with the Adria "hidden" in herceptin or delivered "by" herceptin. It's a targeted chemotherapy, as opposed to targeted non-chemo therapy (herceptin, perjeta, etc). Phase 3 is very promising. Thanks for sharing this, Joan!!
:)

Re: MM-302: HERMIONE study
 

I'm not certain about your reference to tofacitinib. I know that it's used for rheumatoid arthritis. Does it also have another indication for cancer, or in particular HER2+ breast cancer?

Have you ever had any dealings with Merrimack? I know of someone who was in a former trial for MM-302. Two women are still showing a response at 44 and 36 months.

I asked them about using adriamycin (Doxil). That it's a drug that oncologists are steering away from. But they said that that wasn't the case worldwide (which I've heard before from Genentech), and also varies by region in the U.S. And despite its drawbacks, it's still a powerful anticancer drug.

I guess the idea is like Kadcyla. MM-302 is an antibody-drug conjugate delivering the chemotherapy directly to the cancer cells, in order to minimize toxicity to the surrounding healthy tissues. It's designed for those who Perjeta and Kadcyla have failed. So for those never treated with adraimycin, it could be an option.

Joan

Re: MM-302: HERMIONE study
 

SoCalGal, I think our posts crossed in cyberspace!! Glad to see that you're still on the board. We joined around the same time. Joan :)

Re: MM-302: HERMIONE study
 

Im delighted to be mistaken.Years of pharmacy practice have made me too cynical. I hope this MM-302 is a breakthrough

As far as Tofacitinib is concerned it is a Stat 3 inhibitor that is being investigated for various cancers. Ill have to do some research on both. When I had my own pharmacy way back when a pharmacist would call me and say "Guess what Paul they are coming out with a Zofran SR or whatever. Nothing more was said. It was understood that Zofran or whatever was going generic. In those days the generics were priced much lower than the brands. Now shamefully the price charged for the generics are skyrocketing.

Glad to be mistaken

Paul

Re: MM-302: HERMIONE study
 

Thank you Joan for sharing this information. I am always happy to see your posts and admire that you are so active at Asco! I hope you are well.

Re: MM-302: HERMIONE study
 

So Cal Gal--the chemo part of TDM-1 is a maytansinoid not an anthracycline.

Has a somewhat different mechanism of action. Sorry to be so picky, but I didn't want someone to say they failed on anthracyclines when asked if they failed on tdm1, as that might keep them from being offered some alternatives they might otherwise be eligible for.

Re: MM-302: HERMIONE study
 

Micha, Good to hear from you!!

... And Lani, you know that I love you, but just a gentle reminder that the chemotherapy failed the patient, not the other way around. :)

Re: MM-302: HERMIONE study
 

Probably need to add this updated phase of this trial to the Clinical Trials section here. Think we have the beginning phase there, but t is old news.

Glad to hear that this treatment is showing good promise. I think we lost a couple of members who tried the phase 1, but as more of a last ditch effort.

Re: MM-302: HERMIONE study
 

Hi Steph,

Good idea about adding the update!

I was thinking of Chrisy. She was in the phase I trial for MM-302, after her stellar run on T-DM1 clinical trial. She had become Genentech's poster girl because of that, and I remember her speaking on a panel at Genentech's patient advocate briefing at ASCO.

Joan

Re: MM-302: HERMIONE study
 

PS Here's more information about the MM-302 clinical trial, HERIMONE, from the company's website with links for further information. Also, the site notes the trial as Phase 2, but at the meeting the representatives said, Phase 3.

http://www.merrimack.com/pipeline.php

Joan

Re: MM-302: HERMIONE study
 

As it turns out, the HERMIONE clinical trial is phase 2, not phase 3.

Merrimack sent a pdf that details the trial, but here is a link to the web version of that document. Except for never having taken an anthracycline, there's a lot of latitude for drugs that may have failed, including Perjeta and Kadcyla.

They're enrolling in the States, Canada and Europe.

http://bmccancer.biomedcentral.com/a...885-016-2385-z

Joan

Re: MM-302: HERMIONE study
 

Thank you for posting this. I am elated to hear that Phase III recruitment has begun!