Whack-a-mole next...

[SoCalGal]

Welp...after 12 years of MBC and constant treatment, my slow progression has finally sped up. Latest PETscan showed mucho metabolic activity in sternum, manubrium and lungs.

BRAIN MRI
Brain MRI no bueno, 6mm fucker in right frontal, scheduled for True Beam zap next week. New words this month: intramedullary, meninges, meningeal, intrathecal, Ommaya reservoir, Rickham port, Buckingham palace (just wondered if you were still reading)...

SPINE MRI
C2 SPINAL CORD !!! has a lesion IN THE CORD !!! which points to Leptomeningeal disease. Sob sob sob. I decided to wait on the spinal tap because I'm not putting anything into my head at this time anyhow and the taps can be false negatives and I wanted to go dance Thursday night no do a spinal tap.

Will do whack a mole approach until I can gather more opinions and gather more wits. I got fitted for the head and face suffocation mask. Why the docs let me do that "fitting" without Ativan is a mistake they won't make again. Someone had the gall to say it's like a spa treatment! Yes, if the spa you attend has a 300 pound sweaty hot sumo wrestler sit on your face while they wipe you all down with ice water. I've been to many spa treatments in my lifetime, there's never been a spa MRI machine as part of the rejuvenation!

C2 cord lesion is also the reason I'm feeling random numbness on my right (unaffected) breast, arm pit, and creepy crawlies on my scapula. All right side.

C2 lesion due to be zapped via SBRT also next week - hoping like mad it doesn't cause a terrible side effect like PARALYSIS from the neck down and hope I don't drool while I'm unconscious from the scoop of Ativan I plan to swallow prior.

L1 is again crazy hot and since I just had rads in 2016 it is too dangerous for lower paralysis for rads again and no surgery either, too complicated unless risks of surgery outweigh risk of none. L1 is the cause of random numbness in groin, right tush, right leg, outside calf and bottom of foot.

But hey, what's a little Cancer Fire among friends?!?

There is so much uncertainty with regard to treatment and options.

Not sure I can put a reservoir in my head and pour in chemo. Not sure that intrathecal herceptin will suddenly work on cancer that is herceptin resistant, and how would my allergy reaction handle herceptin in my CNS? I am the course-of-least-resistance-girl, and none of that sounds good. Also on the forefront of my mind is that I DO NOT HAVE SYSTEMIC CONTROL. I just went back on Herceptin/xeloda and have no idea if that has had one iota of affect. Too soon to know.

I did look into the her2+ CAR T trial at City of Hope. I signed consent and will be on some list for some steps in the future. It's very early phase, slow cautious enrollment, and not sure again, on my herceptin allergy and inserting engineered trastuzamab into all my hopped up Tcells. I don't quite understand all the science, but I'm on a need to know intake for now, due to extreme emotional overload. And fear. And grief. And anxiety. And F-bombs.

I also signed Death with Dignity papers and got that started. Sorted out the important who wants what with my kids, while I'm still able to interject and add stories with these various pieces and dishes and jewelry and art. And now I know what I can give away to other friends and family.

I am not writing the ending but I do not wish to be caught off guard, somewhat paralyzed and unprepared.

The rads oncologist called me at 9:30 last night to say they scheduled me for Monday. I haven't really had time to deep obsess if this is the right place for the right procedure but have kind of made peace with my inability to figure out a different plan. These same people have been zapping me for the past 23 years. They must know their stuff. The last brain zap in 2008 got rid of the spot. I'm thinking he's had 10 more years of experience, so he can surely hit this new spot with similar success.

I'm not sure how hard I am willing to fight unless QOL can be reasonable. Time in and of itself it not significant. BUT time with reasonable QOL is worth the fight.

I welcome all input and ideas!
And with much gratitude to all my friends on here, old and new, friends still here and those in a different "place" your company on this journey has been priceless.
Love, Flori

[donocco]

SCG

A long shot, but I remember reading about long term control of metastatic pancreatic cancer using Low Dose Naltrexone (4.5mg at bedtime) combined with intravenous Alpha Lipoic Acid 600mg IV twice a week . Look at the protocol. I dont see anything with these drugs specific to pancreatic cancer. Low dose Naltrexone stimulates the production of a natural brain opiate called Met-Enkephalon and this compound is an immunostimulant.
You would have to find a doctor willing to use these things. Oncologists tend to be super conservative.

Paul

[Lucy]

That's a lot to have to take in! It sounds like you got a lot of answers too. Not necessarily good answers but sometimes the knowing is better than speculating so that you can make informed decisions - like the QOL issues you mentioned. But it also sounds like it brings up a lot more questions too. I hate this disease! And I'm sorry you're having to deal with and go through all this.

Is perjeta part of your drug cocktail?

Sending cyber hugs, prayers and good thoughts your way.

[Pamelamary]

Flori - hard to find words, but just keep dancing as long as you can.
Sending love and strength.....Pam

[tricia keegan]

Flori, I wish I had words of wisdom and advice but can only send you my best wishes and love and I'm hoping this won't be as tough as it sounds.

[StephN]

Whack, whack, whack! Go after as many lesions as your team will engineer. Go shrink your tumor load.
I have never had intravenous Alpha Lipoic Acid, but I have taken a 300 mg tablet that also has 330 mg of biotin almost daily for many years. The container says it promotes Glutathione and antioxidant status. Some study I read about pointed me to this supplement.

You have my love and forever admiration for your "come and get me" attitude, along with "if you get me, you will be sorry."

Ned in your head, coming right up. YESSSSS.

[Carol Ann]

Hi Flori, no words of wisdom or advice, everyone before me has already said everything so much better than I can. I am sending you all the love and strength I can. Like Pam says, keep dancing as long as you can.


Carol Ann

[Donna H]

Sometimes all you can do is "dance it out"..... Your spirit and fight are amazing. Love it! I don't have any advice or wisdom. Just know we are all thinking good thoughts and sending it your way.

[jaykay]

Aw, f__k, Flori! No words of wisdoms, only love and positive thoughts.

[Laurel]

Welp. Leave it to you to disperse the worst damn news and still make me laugh! You should have been a comedy writer.

Well, f*#k, the news is shit and I can easily understand feeling dazed and unable to fully take the helm. I mean, where to steer the danged ship to keep it off the shoals? Wack-a-mole until you can find some systemic treatment is seemingly the only course.

I do not blame you for being loathe to pour crap into your CNS. Sheesh, sometimes I think these Oncs figure they can scare us to death rather than bother to treat us! You have the balls of 7 men, Flori, so if anyone can toe up to the line for intrathecal infusions, it's you. Still, I do not blame you for not relishing the idea.

Flori, please try to keep us posted. You know we are all here in your corner, scared with you and for you, and wishing we could DO something to pull you from the fire! I have to end now, because I cannot see through my tears. Just keep dancing in that fire as long as you can, my friend, as we pray for healing rains.

[donocco]

Flori

If you don't want anymore traditional treatment you could try one of the Alternative clinics in Southern California that treat cancer with diet and vitamins
that reduce inflammation. I know there is one in Costa mesa, but they exist in other cities in Southern California. I read the results of some of these treatment and have to admit Im impressed. Hope this helps a bit.

Paul.

Ps. Just an afterthought. As far as oral Lipoic acid goes it might be a good idea
to separate taking the Lipoic Acid from divalent metals like zinc. Lipoic acid appears to be a metal chelator. Believe it or not I reads this in Hulda Clarks book " a Cure for all Cancers. She used Lipoic acid quite frequently with her patients. After reading this I did some research on it and she was correct. The research on Lipoic acid indicated that it inhibits Nuclear Factor Kapa Beta which when activated acts in a very strong way to enhance the survival and growth of cancer cells. Interesting.

[caya]

Good luck Flori! Sending positive vibes and hugs!


all the best
caya

[Bunty]

Buckingham Palace!! Your spirit is amazing Flori. Sending you love and support.
Marie xx

[Kim in CA]

Dear Flori,

I can't imagine how very tired you must be of this battle that just rages on and on and on....

I was so hoping you would finally get some positive results. At the risk of sounding a little whack-o, I am attaching this link for your perusal.

https://www.mycancerstory.rocks/ I am keeping this protocol (Joe Tippen's) in my back pocket because I know there will come a time when I can't keep on with the Kadcyla, as the side effects are many, and my quality of life has really suffered. The use of anthelmintics seems very safe, and I figure, when all else has failed, what have I got to lose. If nothing else, it is a most fascinating read, and I've always liked thinking outside of the box!

Sending you my best positive thoughts and big hugs!
Kim

[Donna H]

Joe Tippen's journey is amazing. And I totally agree with his outlook and the path he took. It was his choice and it is working for him. And he doesn't have worms! Always a good thing.

[donocco]

They have been using anti-worm drugs for a long time. The first one used was levamisole.
It seems to stimulate T cell action. It was used for colon cancer after surgery then for some reason it fell out of use. One problem with Levamisole was possible bone marrow depression so it would be good to have Felbamisole (Joe Tippens drug) monitored by a physician. Only physicians who use alternative therpy to treat cancer would be willing to try it. There is a human drug related to Felbamisole called Mebendazole but the Felbamisole seems to be more effective. Vetinary drugs are much cheaper than human drugs and just as effective. Levamisole for vetinary use in treating worms is cheap. The human version Ergamisol is very expensive and is the same drug. I agree that Joe Tippens journey is amazing to read.

Paul

[donocco]

Felbendazole not Felbamisole. I guess I was confusing Felbendazole with the anti-siezure drug Felbamate. I managed to Xerox some articles about Felbamisole as a treatment for cancer. Sounds very interesting. I think the brand name sold is called Panacur

[donocco]

I read what I printed out about Fenbendazole. It seems to work by blocking microtubules like Taxol but has few side effects unlike Taxol. it also inhibits Glucose uptake in the cancer cells and cancer cells are very dependent on large amounts of Glucose. Joe Tibbems used the 1gm Panacur C packets each containing 222mg Fenbendazole. He took one packet daily for 3 days, went off of the drug for 4 days, then started again for 3 days then off,then on etc etc. He apparently plans to take it for the rest of his life with his doctors blessing. Very interesting.

Paul

[Laurel]

Just read Joe Tippen's story (see Kim in CA's post above) and find it fascinating.

[donocco]

I also was fascinated by the Joe Tippen story. Quackwatch would call it phony but I have long lost any trust in the powers that be as far as cancer is concerned. It has become a very political disease, politics being and inclusive word for power and money.

Kim in California mentioned about using it "just in case". Not a bad idea, I would do the same thing but those who think like this might also think about "stocking up" now with the Fenbendazole. It is available now OTC but in a few months a few years, who knows. Lambert Vet supply sells it in 1000ml 10% bottles.

Working at Sloan kettering in 1978 forced me to come to face with some very unpleasant realities that were very frightening. It still is a very frightening situation. In the late 1970s the late Linus Pauling came out with the idea that high doses of Vitamin C might be preventative of cancer so I said to myself: "Why not take Vitamin C, it really cant hurt me and who knows , it just might help. I still take it and Selenium and some other things ie Coenzyme Q10 (it also lowers my blood pressure) and Lipoic acid (this also helps with blood sugar. OK fine BUT

Lets go back to the year 1994. I had my own pharmacy then. The FDA wanted to take all the supplements off the market and make things like Vitamin C 1000mg, Vitamin E 400 units, Selenium 200mcg etc etc prescription drugs. This really shook me up. It never occurred to me that things like this could happen. I had been taking Vitamin C in what could be called megadoses for 26 years. it would suddenly be unavailable? To make a long story short, the FDA backed down due to congressional pressure. I guess people were threatening individual congressmen (and women) with non re-election if the FDA wasnt stopped. They stopped there anti supplement tirade for the time being. Supposedly they are going to try again. Who knows?

OK fine, suppose some people did stock up on Vitamin C, Selenium, "Fenbendazole"
whatever. What about the expiration dates? The Vitamin C you buy today will say expires 9/21 on the bottle next to the lot number. So will the selenium etc etc or maybe 5/22.

Thats a hard one to answer. But the Veteran's Administration throws out by law millions of dollars of expired drugs. I think it was in the late 1990s. They started saving expired drugs to test the potency after the suppossed expiration date. Most of these drugs were still pharmacologically active 5, 10 even 15 years after the expiration date.
They begged the FDA to let them use these drugs but the FDA refused. Some drugs like nitroglycerin are very unstable but minerals like zinc gluconate, potassium gluconate,
magnesium chloride are probably pharmacologically active for many decades if not longer. Yet if you buy a bottle of Zinc Sulfate from Walgreens today it will say "expires 7/21 or something like that. What about Fenbendazole? I dont know. It probably would be more stable in powder form that the 10% liquid.

Sorry this has been so long winded. Please excuse the inevitable spelling errors. If you want to work with your doctor using unproven but possibly effective therapy you have to be able to get and afford this therapy. Prices are going sky high with drugs.

Paul

[DianaMK]

You have been such an inspiration to all of us. Sending you love and support. F$ck cancer

[StephN]

Looking in to say a big hello and see how the Whacking is going. There are improvements in this form of treatment all the time.

Take care and enjoy your days and those "swing dance" evenings!

[Laurel]

Hey there Flori!


I've been thinking about you, too, and wondering what you are whacking with as well! Remaining hopeful.


L.

[Carol Ann]

Me too Flori! Chiming in to say you've been on my mind, hoping things are going as well as they can be for you.


Carol Ann

[Cathya]

Hi Flori;

Thinking of you and your battle. Hoping for all the best and praying for you.

Cathy

[Becky]

Whack, whack whack away!

[Mary Jo]

So happy I checked in tonight. You are one of my old friends on here and you are an inspiration. God Bless you Flori.

[Nguyen]

Hello SoCalGal,

Perhaps you can look into this?


"
The American Society of Clinical Oncology’s (ASCO) Targeted Agent and Profiling Utilization Registry (TAPUR) clinical study has added the enrollment of additional patient groups and continues to grow with more than 500 participants and 16 therapies now available. The purpose of TAPUR is to help cancer patients who have exhausted standard options access targeted study drugs matched to the genomic profiles of their cancers and provide physicians assistance in interpreting genomic results and identifying potential treatment options. (1)"

https://news.cancerconnect.com/breas...U-3m1JEn5mDyg/

Nguyen

[donocco]

Id also think about that anti-worm drug Fenbendazole. I was impressed reading about the metastatic lung cancer patient Joe (Tibbens ?) Very impressed

Paul

[donocco]

Its Joe Tippens. He has been cancer free for 4 years. He is on Facebook. Appraently other people have used Fenbendazole with some success. Dont forget clinical trials with Phase o ne drugs are about determining toxicity and maximum tolerated doses, not efficacy. It seems that Fenbendazole offers some hope

Paul

[knick]

Hi Flori,
I think you said it best-it's frustrating to be scared of your own body. Thank you for sharing your experiences here with us.
I'm certain that clinical trials aren't a favorite option at present, but I did want to suggest a few that I'm aware of, which are helping patients, or appear poised to.
DS-8201a: It's in many clinics in So-Cal (LA for example). Think of it like Kadcyla but with a different toxic payload. Given you've had taxane after taxane, receiving a topoisomerase inhibitor (the payload of DS8201) could "shock" the cancer cells.
There's currently a trial combining DS8201 with a immunotherapy drug (nivolumab). ClinicalTrials.gov Identifier: NCT03523572. This is phase 1 so you won't end up on a placebo.
The other product which might be of interest if tucatinib (currently owned by Seattle Genetics). This is similar drug to lapatinib, but it's supposed to better access the brain and CNS, and have fewer side effects.
Unfortunately it's in late stage trials, so you might see about requesting "Expanded Access to Investigational Products" from a Seattle Genetics representative.
I'm aware of other trials, but they're outside California.
Whatever direction you take, sending positive vibes and well wishes.

[donocco]

The main difference with Tucatinib vs lapatanib is that Tucatinib inhibits Her 2 neu wihout inhibiting EGFR (Her-1). This means less diarrhea. It has good CNS penetration. May be worth trying.

[Laurel]

Flori.....?

[Shobha]

Flori,

Sending prayers and good wishes. Your humor, so perfectly and aptly describing our struggles has always amazed and inspired me! Hoping to hear from you soon...

-shobha

[Laurel]

Thinking of you and praying for a break through. You are ever on my mind and heart, dear Flori.

[jaykay]

Like everyone else you have touched - thinking of you, Flori. Hang in there!

[Lucy]

Hey Flori, Like many others, just checking in to see how you're doing. The general hope is that you're out there living your best life and are too busy to check in here but when you have a minute, please let us hear from you. Hugs.

[SoCalGal]

Hi Lovely people,

Sorry I’ve been so remiss in updating - my emotional state has been garbage. After so many years of coping with this beast of a disease, to wind up with LMD and CNS and not really know what is happening to my body has been my own personal nightmare.

Thanks for checking on me and I’ll do my best to update. Finished 5 days of zaps to spinal cord met at C2. Including was an extra zap to the small brain met. All 5 days were me wearing the smother mask and no Ativan so I could drive myself. That was 8 weeks ago.

I went back on herceptin, plus added in xeloda, tykerb, xgeva. It’s all in hopes of slowing down progression rate, and maybe buying some more time. My QOL is still reasonable. It’s been terribly frustrating trying to get my right to die with dignity up and running. Apparently, Cedars prefers to let the hospice doctors handle it - but I am not on hospice. Not sure I feel like spending my time fighting all these idiots right now.

I have an MRI on Thursday and brain surgeon follow up on Friday. Will see then how I’m really doing, and if this mild vertigo is a symptom of progression or “just” a side effect of chemo/meds or “just” some mild vertigo no reason. I also have an intermittent stabbing pain at the right side back of my head. Could be from neck which has a lot of stenosis and other non-cancers probs that could be acting up. Also could be inflammation after rads. Will find out soon enough.

Me and my family are trying to hold on to hope. But I am feeling extreme fear almost daily.

As someone mentioned the trial DS8201 - yes, I’m well aware of, but due to my Herceptin allergy it is a no. I tried nerantinib and also a no go due to grade3 diarrhea. And SeaGen is not providing any compassionate use for tucatinib. And dog worming pills is not going to fly with me. Ditto for celery juice and CBD and all other super-alternative things. Once cancer is in the Central nervous system, it is a different game. I’m just learning the rules. I am competitive so I’ll try to kick some ass. But I also know when to fold…

Much love <3

[Lucy]

Good to hear from you Flori. Silence on the board can be scary!

Glad the QOL is still reasonable and hope the drugs are kicking the disease.

Is perjeta a consideration? It looks like you had taken it for a while but it's not on your currently list.

We understand that you have more pressing things going on in your life than updating us on the board but when you can and you're up to it, please do keep us posted on how you're doing. Hugs

[Laurel]

Flori,

You know I have been checking in daily and sometimes, like today, more than daily, seeking an update. CNS mets is a game changer, no doubt. It sounds as though this week is D-Day in terms of seeing if the whack-a-mole is working. I am praying it is!

No matter how grim the reality appears, your toughness to fight or to accept is what will carry you through. I wish with all my heart this cup would pass from you, my friend. With all my heart. The one bit of happy news is that life is still doable. I am grateful for that.

Obviously you are on my mind and in my prayers. Please let us know what you hear on Friday.

Laurel

[SoCalGal]

My apologies for not responding sooner, it’s very difficult to find the words. I’ve been given an average lifespan of 6 mos. and I’m just trying to deal the best I can. Feel free to friend me on Facebook or follow me on Instagram: fpk_etc

[Pamelamary]

Flori,
I am so sorry to hear this news and remember that these prognoses don't necessarily tell the whole of your story. Wishing you peace and strength...... Pam

[Donna H]

You are in no way average! I am sending you strength, love and hugs.

[Laurel]

Flori,

I can only imagine how difficult things are for you presently. Lots to wade through and sort out. I think your story may have more chapters than it appears on the surface. You know that old adage: What's the difference between God and a doctor? God KNOWS he isn't a doctor!!!

I am on Facebook, barely, but will try to reach out. Instagram is beyond my techno-abilities! I know, pathetic old lady here!

It is good to hear from you here, though, tough as it for you to share. We laugh and cry together on this board; pray, rejoice and mourn together. Our hells and our heavens are what bind us, not our wins or losses, and certainly not this beast. We are a group of fighters and we fight as a band of warriors. We are Team Druther, Team Her2Support! We are Team Flori and we've got your back! We want to walk with you wherever it leads, if you will let us, because we love you.

Laurel

[Lucy]

Flori, I am so sorry to hear this. But doctors are wrong all the time. As they say, doctors are only practicing. And also, you know what they call the medical student to finishes last in their class? Doctor! So, there's always hope and hopefully the treatments you've been getting have been kicking the disease in its backside. As I said before, we understand that you have more pressing things going on right now and updating us here isn't your main concern but we do care and we hope you'll let us know what you can when you're up to it. As Laurel said, we've got your back and we're here for you. Hugs

[jra40]

I do not believe doctors when they give timelines. You are a strong warrior and I know you can defy the odds! All my love and prayers for you Flori - prove them wrong!

God Bless,

Jessica

[jaykay]

Dear Flori,

I'm with Jessica re: doctors and their timelines. Many of us would be speaking from the grave if their timelines were valid.

Thinking of you and sending positive thoughts

xoxo
janis

[tricia keegan]

Flori Flori morning glory, I agree about Dr's time lines and think we're connected on FB. The world has changed so much since Joe and Christine started this site and I'm sure treatments have too. Keep fighting and know your friends here are with you in spirit.

[Lani]

HEALTH NEWSSEPTEMBER 6, 2019 / 7:58 AM / UPDATED 4 HOURS AGO
Inside drugmakers' strategy to boost cancer medicines with 'Lazarus effect'
Julie Steenhuysen, Ludwig Burger
8 MIN READ
(Reuters) - In the halls of MD Anderson Cancer Center, the drug Vitrakvi is known for having a “Lazarus effect” in some patients because it can reverse late-stage cancer that has defied all other treatment options.


Developed by Eli Lilly and Co’s (LLY.N) Loxo Oncology and marketed by German drugmaker Bayer (BAYGn.DE), it fights a rare genetic mutation that appears in less than 1% of solid tumors, regardless of where they appear in the body.

Finding those patients will require widespread adoption of sophisticated tests that look for multiple genetic alterations that could be driving the cancer.

So far, progress has been slow.

Adoption of so-called next-generation sequencing (NGS) tests has been stalled by lack of reimbursement from insurers over concerns that the evidence is not there yet to support widescale use, according to more than a dozen interviews with oncologists and pharmaceutical and diagnostic industry executives.

As a result, pharma companies from small biotech Blueprint Medicines Corp (BPMC.O) to larger rivals Lilly and Roche Holding AG (ROG.S) are taking matters into their own hands, bulking up staff to increase patient and physician awareness about testing and building up a gene testing infrastructure that for many community hospitals still does not exist.

Bayer executives told Reuters it plans to spend $70 million to increase patient and physician awareness of testing for rare mutations and to encourage regulatory approval of more tests. They expect that budget to expand as Vitrakvi continues to win approval in other countries.

Lilly told Reuters the company has signed an agreement with Thermo Fisher Scientific (TMO.N) to develop a companion diagnostic test for its experimental drug, LOXO-292.




The deal adds RET mutations - the target of both Lilly’s and Blueprint’s drugs - to Thermo’s Oncomine Dx Target Test, which local pathology labs can use to identify multiple genes linked with non-small cell lung cancer.

The agreement is aimed to help identify more lung and thyroid cancer patients who may benefit from the Lilly or Blueprint therapies. The Thermo test is already approved by the U.S. Food and Drug Administration - a key standard for Medicare coverage, the companies said.

According to Dr. Brian Alexander, chief medical officer of Roche’s gene testing company Foundation Medicine, only about 15% of U.S. patients with advanced cancers get comprehensive genomic profiling. Another 25% get single-gene testing, he said, and a large proportion “are not getting any testing at all.”

At MD Anderson, which sees 100,000 new cancer patients a year, only around 10,000 eventually have their tumors sequenced.

For a rare few, the tests are lifesaving.

Xin Zheng, 47, a mother of three in Michigan who was referred to Reuters by Blueprint, was diagnosed with stage 4 lung cancer in 2016. After failing several treatments, she was out of options.

Her husband, Zhigang Wei, asked for genetic sequencing, and the test turned up a RET mutation. After contacting multiple lung cancer experts, Zhigang found an early-stage clinical trial treating patients with Blueprint’s experimental drug, BLU-677.

Now, Xin is nearly back to normal.





“My wife is lucky,” he said, adding her quality of life is much better and she has hope for the future.

Finding patients with such rare mutations is like “looking for the needle in the haystack,” said Stefan Oelrich, head of pharmaceuticals at Bayer.

Dr. David Hyman of Memorial Sloan Kettering Cancer Center, who tested Vitrakvi in clinical trials, said making these tests the norm for advanced cancer patients will require a huge shift in the way oncology is practiced.

“It’s painful to know there are patients out there with these alterations who are dying without knowing about it and without getting any treatments,” he said.

NOT GETTING TESTED

For Bayer’s Vitrakvi and Roche’s Rozlytrek, along with similar drugs in development, genomic testing is critical to finding patients who can benefit from them.

Cancer patients and drug companies alike got a boost last year when the federal Medicare health program for the elderly and disabled said it would cover FDA-approved tests for advanced cancer patients that can identify hundreds of genetic mutations at once. A Medicare endorsement is generally followed by widespread coverage decisions by private insurers.

But the final regulations dropped a requirement that testmakers prove the tests are cost-effective and improve patient care. That created an “evidence gap” that has allowed some insurers, also known as third-party payers, to withhold coverage or demand more proof that they benefit patients, said Jeff Schreier of Diaceutics PLC (DXRX.L), a data analytics company that works with drugmakers to improve diagnostic testing.

“More payers are coming around, but it’s slow,” he said.

FILE PHOTO: Xin Zheng and Zhigang Wei are pictured on a family trip to Crater Lake, Oregon, U.S. in this July 2018 handout photo obtained by Reuters August 30, 2019. Zhigang Wei/Handout via REUTERS
The most recent coverage policy from CVS Health Corp’s (CVS.N) Aetna approves many single-gene tests for specific cancers, but still largely considers multi-gene tests experimental. Anthem Inc’s (ANTM.N) policy limits testing to “medically necessary” use and states there’s “insufficient published evidence” to support widespread testing.

And while Foundation Medicine’s and Thermo Fisher’s tests are getting reimbursed from Medicare, many hospitals such as MD Anderson, which have developed their own tests, are not guaranteed payment. “Reimbursement is still a driving force,” MD Anderson’s Kenna Shaw said of genomic testing, which costs an average of $5,000 per patient globally.

Lilly bought Loxo in January for $8 billion to profit from its targeted drugs in early-stage development. Bayer secured the rights to Loxo’s two leading compounds in a 2017 alliance.

Dr. Anthony Sireci, Loxo’s senior medical director, said the company has been working to “democratize” testing in the United States by increasing its use in local pathology labs, where most cancer testing has traditionally been done. The Thermo Fisher agreement will support those goals and expand patients’ access to “high-quality genomic testing,” he said.

“TEST YOUR CANCER”

Bayer has hired diagnostic experts to help its medical and sales staff assess the barriers to genomic testing and ensure that local pathology labs are including the genetic alterations targeted by its drugs when they profile tumors, the company’s oncology strategic business chief Robert LaCaze said in an interview.

Bayer also launched a public awareness campaign called “Test Your Cancer” that urges patients to ask their doctors about genomic cancer testing. The company is working with testing providers to ensure test reports are easy to understand.

Blueprint, which has six genomically-targeted drugs in development, told Reuters it plans to hire six diagnostics experts to increase awareness of the mutations their drugs target, especially in community medical practices, where 70% of cancers are treated.

Bayer sees signs of progress. Based on internal data, the company estimates average sequencing rates across tumors neared 30% last year, and the company saw a two-fold increase in the number of labs offering tests that carry the mutation targeted by Vitrakvi.

Bayer has not released sales figures for Vitrakvi.

Asked for an update in the most recent earnings call in July, Bayer’s Oelrich said uptake is going “according to plan,” but declined to say how many patients are using the drug. LaCaze said with very rare cancers like the ones Vitrakvi targets, sales growth is “something that will build over time.”

Editing by Michele Gershberg and Edward Tobin

[Laurel]

What a post, Lani! Thank you!

[caya]

Sending positive thoughts your ways, dear Flori.
You are one brave warrior woman!


all the best
caya

[Margaret Eleanor]

Flori,
I usually just just follow quietly and admire you from afar. However, tonight I’ll step up and shout out...I think you are one of the strongest, most wise, and compassionate women I’ve ever come across, in person or electronically. I love you and I’m proud to be on your team.

[SoCalGal]

Good news on brain/cervical MRI—NOTHING NEW in head and spinal cord met has shrunk way down. Brain met also shrinking — no swelling in cerebellum and nothing to correlate or cause vertigo so with that news me and my dear friends all started to cry. Brain surgeon didn’t yet have report but he came bursting into the room saying “your scans look good” and showed us pics on his iPad. (Of course he did).

I feel like I’m breathing for the first time since this all began. Thinking that I have another three months of life until repeat scans. And remembering 12 years ago when I lived in 3 month bursts.

Thank you for all the support.
Much love and one love.
Flori

[DianaMK]

Great news! God is good.

[Lucy]

I'm glad the news was better than expected. Thanks so much for updating us with the information. Keeping you in my thoughts and prayers. Hugs

[caya]

Great news Flori, B.H.



all the best
caya

[Laurel]

Yea!!!! Whew! Hard to type through the tears of joy! Man, am I elated! Got your six, Flori-girl! Go live, breathe and dance!!!

[Donna H]

So great to hear!! Dance, dance, dance!

[Shobha]

Best news I have heard today!!! Sending you prayers and best wishes

[jacqueline1102]

Hi Flori,

This is wonderful news. So happy for you and your loved ones.

Jackie

[Becky]

Thinking about you 3000 miles away! Sending all my love and best best hugs.

[jaykay]

Great news, Flori!

[Bunty]

That's fantastic Flori! Such a roller coaster ride, but I reckon you ride that roller coaster with great attitude and strength.
Best wishes
Marie

[Catherine]

Flori, Flori Morning Glory, We are all so happy for this good news!

Lots of love and support coming your way!

[Catherine]

Lani, your medical and drug reports are the best. I am going to print your recent post about Bayer’s research and their new test. A friend with a serious cancer Dx can maybe take and show her oncologist.

Thank you!

[Lani]

Vantage Logo May 08, 2019
Astra and Daiichi lay out their plan for a better Herceptin


Jacob Plieth
The companies’ DS-8201 succeeds in breast cancer patients who had failed Kadcyla, and will go before the regulators later this year.

Breast cancer
There was a time, some years ago, when Roche’s Kadcyla was seen by the sellside as the pharma industry’s biggest upcoming launch. The bullish forecasts failed to materialise, but Kadcyla did spawn numerous other Her2-targeting projects seeking to become better versions of Herceptin.

Today one of these, Astrazeneca/Daiichi Sankyo’s DS-8201, succeeded in a phase II breast cancer trial that will serve as the basis for a second-half regulatory filing. More lucrative uses might follow, and the result could vindicate the UK company’s aggressive move to license DS-8201 from Daiichi.

That licensing deal had been roundly criticised both for its up-front element – $1.35bn seemed a huge amount for what was, ultimately, an early-stage project – and the fact that Astra raised equity to help finance it.

But the basis for the tie-up was phase I data that Astra called “unprecedented”, amounting to a 60% remission rate in Her2-positive breast cancer subjects who had failed on an average of seven therapies. The UK company highlighted DS-8201 on last week’s first-quarter financials call.

High-intensity conjugate

Like Kadcyla (trastuzumab emtansine) DS-8201 (trastuzumab deruxtecan) is an antibody-drug conjugate. What makes the Daiichi project unique, its makers argue, is a high-intensity payload and cell membrane permeability, which might enable it to target tumours that express Her2 at relatively low levels.

One line of thinking is that patients retain some degree of Her2 expression even after failing multiple anti-Her2 therapies, and the latest findings, from the Destiny-Breast01 study, suggest that DS-8201’s characteristics translate into a real clinical benefit.

Enrolees had failed two Her2-targeting drugs, Herceptin and Kadcyla, yet a 5.4mg/kg DS-8201 dose showed strong clinical activity in terms of overall remission, the trial’s primary efficacy measure, Astra said today.

Hard data are being held back for a scientific meeting. In addition to efficacy, safety will be closely scrutinised given the expression of Her2 on healthy as well as cancerous cells, the touted efficacy of DS-8201, and the off-tumour toxicity of some potent Her2-directed therapies like CAR-T.

Kadcyla was once thought by the sellside to be capable of bringing in 2020 sales of $4.5bn, but last year’s revenue only just breached $1bn, and the current 2024 forecast is $1.4bn, EvaluatePharma computes.

The main problem is that in Her2-positive breast cancer Kadcyla failed to broaden its approved reach beyond Herceptin-relapsed subjects. In the front-line Marianne study Kadcyla-containing regimens were non-inferior but failed to beat Herceptin.

Analysts at present see DS-8201 selling $1.8bn in 2024, but this will not come from Destiny-Breast01’s third-line use alone. For the drug to make its mark fully it must succeed in the second-line setting head-to-head against Kadcyla, and perhaps also in Her2-low subjects, a brand new use.

Selected trials of DS-8201 in breast cancer
Study Setting Detail Trial ID
DS8201-A-J101 ~8th line, Her2-positive 59.5% ORR NCT02564900
Destiny-Breast01 3rd-line, Her2-positive, post Herceptin & Kadcyla Clinically meaningful ORR NCT03248492
Destiny-Breast02 3rd-line, Her2-positive, phIII confirmatory trial Data in 2020+ NCT03523585
Destiny-Breast03 2nd-line, Her2-positive, post Herceptin, vs Kadcyla Data in 2020+ NCT03529110
Destiny-Breast04 Her2-low, vs physician's choice Data in 2020+ NCT03734029
While there are now several Her2-targeting antibody-drug conjugates in development the evolving situation will also be of great interest to Macrogenics, which is developing a naked anti-Her2 MAb, margetuximab, that has an optimised Fc region.

Margetuximab scored a surprising success in the Sophia trial in subjects who had all failed Herceptin and Roche’s Perjeta, and most of whom had also failed Kadcyla. The success was down to patients who carried the 158F allele, a genetic variant that promotes binding with Fc-optimised MAbs like margetuximab; full Sophia data are one of the big attractions of the upcoming Asco conference.

This subgroup-driven effect might not put margetuximab in direct competition with DS-8201, which Astra might now rely on, along with Tagrisso, to form the cornerstone of its oncology strategy. Given the travails of Imfinzi and tremelimumab in lung cancer the UK group needs all the breaks it can get.

Selected Her2-targeting industry projects
Product Company Pharmacology class
Marketed
Herceptin Roche Anti-Her2 MAb
Perjeta Roche Anti-Her2 MAb
Kadcyla Roche/Immunogen Anti-Her2 MAb-DM1 maytansinoid conjugate
Phase III
DS-8201 Daiichi Sankyo/Astrazeneca Anti-Her2 MAb-cytotoxic drug conjugate
Margetuximab Macrogenics Fc-optimised anti-Her2 MAb
BAT8001 Bio-Thera Solutions Anti-Her2 MAb-maytansinoid conjugate
Phase II
Tucatinib Array/Seattle Genetics Her2-selective TKI
TAS0728 Otsuka Holdings Her2-selective TKI
Phase I
RG6194 Roche Anti-Her2 bispecific MAb
PRS-343 Pieris Pharmaceuticals Anti-Her2 bispecific MAb
ARX788 Ambrx Anti-Her2 MAb-cytotoxic drug conjugate
FS102 F-star Anti-Her2 MAb
PF-06804103 Pfizer Anti-Her2 MAb-cytotoxic drug conjugate
MEN1309 Oxford Biotherapeutics/Menarini Anti-Her2 MAb-maytansinoid conjugate
Source: EvaluatePharma.

[Cathya]

Congratulations Flori. Wonderful news.

God bless,

Cathy

[Carol Ann]

Yay, wonderful news!!!

Carol

[Lucy]

Hey Flori,

I've been thinking about you and wondering how you were doing. I noticed you've updated your signature to show some stability but also some progression. How are you though? When you're up to us, please give us an update and let us know how you're doing. Hugs

[Lucy]

Checking in again . . . Any updates Flori? Thinking about you.

[ariana]

Lucy, I was wondering the same thing -----Flori, hope you are doing well.

[Laurel]

Me, too! I have not wanted to be bothersome, but I am thinking of Flori all the time. Hoping you will chime in soon, Flori!

[Laurel]

Flori, Flori Morning Glory?????