Check Out the Latest on Keytruda Late Stage Phase 3 Trial Data!

[Fiercefighter13]

Hi all!! There are many articles, so I didn't attach any of them, as they are all worth a good long look! Merk has announced that their drug Keytruda is at the end stages of their phase 3 trials and is a "smashing" success for triple negative, HR+ Metz, and early staged high risk patients as well. They are talking of "significant" survival as well as complete NED not only of tumors but free cells!! They are indicating they may have a key to no more progression with these two types of breast cancer, and possibly others as well. Fingers crossed, hopes up, and prayers......This may be a huge and significant step forward for all of us!! Because this is an established drug and has it's marketing and manufacturer already in place it won't take too long for approval once they get there (hopefully very soon), this is a keeper!! Take care, and fight on sisters!!

[Silver126]

Thanks for sharing! You warmed my heart tonight, let’s hope this is the key to a cure❤️

[Fiercefighter13 in reply to Silver126]

It’s so promising! I’m hoping it’s approved soon, and realistically it may be!

[Pbsoup]

wait. It is also promising for er+ patients? I thought it was more for triple negative. Even so how exciting!

[Fiercefighter13 in reply to Pbsoup]

Yes! The phase 3 trial coming to its conclusion was only HR+, HER2- Very promising, actually home run results…..better than any other therapy out there at the moment. Very exciting results!!

[Split in reply to Fiercefighter13]

I think you may be referring to the early stage er+her2-breast cancer study. Merck site:

Merck Announces Phase 3 KEYNOTE-756 Trial Met Primary Endpoint of Pathological Complete Response (pCR) Rate in Patients With High-Risk, Early-Stage ER+/HER2- Breast Cancer

July 28, 2023 6:45 am ET

KEYTRUDA® (pembrolizumab) plus chemotherapy before surgery significantly improved pCR rate compared to neoadjuvant placebo plus chemotherapy

KEYNOTE-756 is the first positive Phase 3 study with an immunotherapy regimen to demonstrate a statistically significant improvement in pCR rate in the neoadjuvant setting for this cohort of patients.

—

For metastatic breast cancerthe situation is as explained by awesome4ever

[Fiercefighter13 in reply to Split]

That sounds like the site that I had seen. My head is in such a fog from Covid, it’s hard to think clearly but I think you are right! Thank you!!

[Aprilfoolz1]

thanks for posting !

[mbashura]

Thank you for keeping all of us informed.

[love2golfwell]

Thank you for sharing this information, this does sound very promising!

[TammyCross]

I wonder about ER+ with HER2 low. (That was considered HER2 negative until recently.) This sounds amazing. Have to look at the studies. What is the success rate? How many benefited? How many dropped out?

How is Keytruda on side effects, for those who have been on it?

[Fiercefighter13 in reply to TammyCross]

Hi there!! I did not go further into looking at trial information itself. I saw many articles hit the news screen and I read so many of them and some had better information than others. Usually I would have dug into the information looking for the details, but I'm recovering from a bad case of Covid and I'm not feeling great yet. I'm not enjoying the after effects even though I've cleared the virus. My head is in a fog still and I'm still coughing up a storm. I will go searching for more information as I go feeling better, and post any articles I find in hopes of getting to the nitty gritty of all of this! Take care!

[TammyCross in reply to Fiercefighter13]

Oh, that is too bad! You did your job alerting us to this. It should be up to us to pursue further.

[awesome4ever]

I have read many articles and studies based on clinical trials and never seen Keytruda being given alone and benefiting those with estrogen positive cancer. It from what I have seen has been combined with an already approved chemotherapy agent so it would be difficult to validate which agent was effective. It certainly is starting to show when used as a combined treatment increases the PFS of some patients. If you have proven studies(not anecdotal) that show Keytruda given alone for patients with ER+ HER2- effective please share. I see ones on early stage estrogen positive cancers but not MBC .

merck.com/news/merck-announ...

I'm sure we would all be appreciative to read them. Thank you for your post.

[Fiercefighter13 in reply to awesome4ever]

Hi there, thank you for your thoughts and for sharing information you have seen. I saw many articles yesterday coming from journals showing that it is at the end of phase 3 trials with exceeding success. I looked up articles again today and found several, here is one of them msn.com/en-gb/health/other/... I had found one article by Merk itself yesterday stating that is in trials for metastatic breast cancer and I should have copied the article but did not, I will have to dig into the internet and find it again. I am not sure if the Metastatic part of the trials is only for PDL-1 or all Metz that are HR+ as the article did not specify, but I will keep looking to find that article. I would assume that they are statistically seeing improvement with Keytruda over the standard chemo agents alone, or the trial would not be what they are calling a success. Of course as with everything there are always many shades of grey and articles can be skewed to look black or white. Either way, every step taken to find better medications for control or hopes of a cure are always a good thing. I have not looked at the studies themselves, as I am recovering from a nasty case of Covid and my body and brain are "off" still, and I'm not up to my usual stamina for digging hard into research or anything else for that matter (for now, as I am getting better). Any additional information you may find will be great, I will keep looking as I am able at this time. Take care!!

[awesome4ever in reply to Fiercefighter13]

Thank you for sharing. Please be kind to yourself as you heal from Covid.

I was in talks with a researcher just recently for this very trial and yes you do have to be confirmed to have PD-L1 to qualify. This trial consists of two arms...one Keytruda + chemotherapy agent or arm 2 is placebo plus chemotherapy agent and have metastatic HR+/HER2- breast cancer. So it is has I mentioned studying Keytruda either with the patient receiving the drug or a placebo....but always the patient receives a proven chemotherapy. It at this time is not being studied as a potential treatment on it's own for MBC. Their goal is to increase PFS. This is exactly how Merck got it approved for lung, cervical, melanoma etc. It's promising but they are not confident enough to say it will ever be anything other than an adjuvent for increasing PFS at this time. Here's a link to the trial I was recruited for but declined.

classic.clinicaltrials.gov/...

Please take care of yourself and heal.

[Fiercefighter13 in reply to awesome4ever]

Thank you for sharing this very valuable information! I find myself chasing whatever information I can and some days it feels like I’m chasing rainbows and unicorns. That being said, rainbows do appear here and there. In the meantime I am taking life slow and easy healing from this awful disease’s aftermath. Take good care!!

[mariootsi]

Here's hoping

[tab78FN]

Hi all. Great info as always on this site. I've had wonderful response from Keytruda (an immune checkpoint inhibitor). I had a "high" TMB which suggested I would be a good responder. And I was! Now 4 scans with NEAD!!

I have lobular MBC ER+/PR Neg (was previously PR+) and HER low (previously considered HER2 Neg). I'm on fulvestrant for the past 2 years and am continuing on that. Onc said no reason to mess with that.

I had some adverse effects from the Keytruda and may not be able to receive it again. However, all the effects were mostly tolerable as I continued to work full time. Since Keytruda activates the entire immune system to fight the cancer, sometimes other inflammatory responses happen.

1. Rheumatology: Checkpoint Inhibitor Induced-rheumatoid arthritis (treated w/ steroids then Humira injections, which took care of it);

2. Endocrine: Hypothyroid - known side effect, treated effectively with Synthroid

3. Dermatology: Panniculitis and Erythema Nordosum - which means an inflammation of the subcutaneous tissue. Really they were painless nodules starting on my legs and moving up my body. Steroids for that.

4. GI: some colitis with increased GI distress and decreased appetite/weight loss.

All those things got better when I stopped the Keytruda but by then my scans showed NED/NEAD!!! I'm no longer on any meds for arthritis, the skin is back to normal, my appetite has returned. I'm still on Synthroid and that is fine.

So, long story, but sharing my journey. I was given Keytruda under another indication, not as part of a trial but not totally off label.

I'm so grateful to God and the science that is part of his creation. I'm hopeful for more good news coming out of these trials. Finding a way to boost the body's own immune system to fight cancer makes a lot of sense.

Cheers, Tami

[Fiercefighter13]

Thank you so much for sharing your story!! My own doctor has had her eye on Keytruda for me as well, lobular er+ pr+ her2-. Not at a point yet that she wants to try it yet as Xeloda is working it’s charms well for me right now. But these new trials and studies look very promising and your journey confirms the trial results. I am so grateful to you for sharing your journey. We all need these uplifting real life examples to help us keep up the good fight! Wishing you all the best!! Take care!!!

[LadyKatarina]

I attened a lecture by a U prof here in MN back before pandemic when we still had MBC conferences. Immune therapy (which Keytruda is) did not have great success rates for MBC as compared to other cancers. But that is almost 4 years ago now--trials and results change rapidly! A friend with lymphoma got very ill from Keytruda--but his mets were gone after treatment. Keep up the good research!