Tag Archives: TPX-0131

The necessity for compassionate use/expanded access

Posted on August 13, 2021 | 14 comments

My participation in this, my sixth phase I clinical trial, would not be possible without the concept of compassionate use/expanded access.

That is because I did not qualify–was precluded–from the actual trial. The reason? Because I’ve had too many previous therapies–specifically ALK inhibitors. Three to date. Well, until yesterday 🙂 Now four.

Fortunately, there was a back door. And I had a crew of people knocking on it for me. Colin Barton, who works so much magic behind the scenes at ALKPositive as chair of the Medical Committee. I talk a lot about goddesses; this man is a god of good. An ALK+ patient himself, he uses his smarts, personal resources and the fervor of a man on a mission to advocate for the other members of this club. He has initiated conversation with the decision makers at various pharmaceutical companies. I shared with him that at first I thought this might be a fool’s errand, but Colin is a visionary and he saw something I did not. And he has assembled an amazing team of fellow patients who work tirelessly to ferret out potential treatments that could benefit the ALK community.

My oncologist Dr. Jess Lin was also relentless on my behalf–contacting the sponsor almost daily. Jess presents as sweet and mild mannered, but she can be ferocious when it comes to her patients.

Of course, this was a time sensitive matter and some of my friends (talking about you Rob Densen) were not satisfied with the pace as I waited for drug. Where I was hesitant to reach out he was not and I am grateful.

So there we have it. Today I took my second tablet and then lay down for an hour so as to better visualize the cancer exploding like a mouthful of Pop Rocks. And, to continue with that metaphor, my mind continues to be blown by what a long, strange trip the last two months have been. I spent a whole lot of time thinking about dying all while hoping it wasn’t true.

Not natural bedfellows–these two thoughts. At least if you are hoping for a good nights sleep.

Therefore I am happy to report that I am still feeling good/better and that my dreams last night were sweet.

xo

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TPX-0131

Posted on August 12, 2021 | 18 comments
  • Heather, Linnea, Jess

A fourth generation ALK inhibitor provided to me by Turning Point Therapeutics through compassionate use.

At 1:30 pm today I took the first dose. Before handing me the tiny tablet (it is one mg), Dr. Lin and my nurse Heather performed a little ritual—a blessing of sorts. And then, down the hatch.

By Dr. Lin’s estimate I am the third person in the world to take this drug (it is in clinical trial in Australia) and therefore it is impossible tp predict side effects.

Truthfully, I am far more interested in efficacy. And the thing is, if this experimental therapeutic is going to be effective for me, I may know very soon. Likewise if there is no response.

After dosing I hung out at the hospital for an additional two hours of observation. I squeezed in my second nap of the day (I had been there since 7:30 am) and when I awakened I just had this sense that something was going on in my body. Something good.

So light some candles. Cross some fingers. Have a chat with the universe on my behalf.

xoxo

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Drained

Posted on August 5, 2021 | 3 comments

What a busy seven days it has been. Melinda and Sally, Jemesii, Peter and his girlfriend Caroline and my brother Bink and sister John have all visited over the past week. It has been great fun, much has been accomplished and I am exhausted.

However, I also have had more baseline energy. A function of restarting TNO155? Perhaps.

This morning I was scheduled for installation of a PleurX-cath–financial assistance approved. My breathing has also been some improved and I went to the appointment hopeful that I should be turned away again–but this time for lack of necessity.

And indeed a Pleur-x was deemed unnecessary at this junture. Instead I had another thoracentesis which yielded 150 ml of serosanguinous fluid.

Last night I learned that TPX-0131 would be at MGH no later than early next week. I know my oncologist has been working tirelessly on my behalf to forestall more delays, and my friend Rob Densen and his pals at Senator Markey’s office got involved as well. Moral of the story? Choose your oncologist’s, your friends, and their friends carefully.

To put a dot on that i, I shall take my final dose of TNO155 tonight—and my final dose of lorlatinib on Sunday as I begin washout. And then, next Thursday, my lead in dose of TPX-0131.

There have been moments (hours, days) in the preceding weeks where I felt I was down for the count. I don’t feel that way today. Raggedy and realistic about the fight that lies ahead, but confident that I’m going to get a shot at it.

xo

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Waiting.

Posted on August 1, 2021 | 4 comments
And (allow me some dark humor please) the suspense is killing me.

Unfortunately hurry up and wait can play an overarching role in the management of cancer. There are even rooms for this–Waiting Rooms. And I have spent far too much of my precious time in such.

At the moment my waiting is of a different sort. The expectation was that I should be starting on TPX-0131 this week. However, at my appointment last Thursday, I learned that lead in dose has been pushed back by another week. FDA and the IRB have both signed off but this holdup is in manufacturing and labelling. Whatever that means. At this stage, I am nervous that this won’t be the last delay and–between you and me–it’s getting more and more difficult to hold my breath in the interim.

What did happen last Thursday is that I started back on the SHP2 inhibitor TNO155.

Per my oncologist’s advice, I shall not be getting a pleurodesis, but rather a (déjà vu!) pleur-x catheter. Financial assistance has been applied for and the pulmonologist’s team spoken to. That will take place Thursday morning, after which a visiting nurse shall make two visits both to drain the catheter but also to teach someone else how to do so–it is not possible to do alone.

And then, hopefully, a week later I shall be taking a fourth generation ALK inhibitor.

It is early days–I shall be one of the first–but this is the best of my current options. One on which I am pinning a whole lot of hope.

In the meantime, I am laying low. Continuing to tie up ends with my committee of personal assistants (bless each of you) and also spending time with my two kids who live in Boston. Today we went through family photos and despite their trepidation (what all this preparation represents), had a wonderful day.

And I, of course, hope that there shall be many more.

Wonderful days.

xo

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Mis-Maligned

Posted on July 27, 2021 | 9 comments

After a pleural effusion, a cytology test is performed. The results of my first two were reassuring. No cancerous cells found. However, there was a note of caution: the left pleural fluid cellblock contained ‘rare groups of highly atypical epithelial cells, consistent with metastatic adenocarcinoma.’

My third cytology exam, following last week’s procedure, was unequivocal: malignant.

Acccording to Medscape, ‘Development of a malignant pleural effusion is associated with a very poor prognosis, with median survival of 4 months and mean survival of less than 1 year.‘

Any treatment is considered palliative.

Grim and grimmer. However, my first response was take that twelve months and double it. Unrealistic? Sure, hell, why not. However, little about my last sixteen years has been realistic. Surreal is certainly a better adjective.

On Thursday I will see both Jess Lin and Alice Shaw and we shall discuss a pleurodesis.

And, a week later, I will hopefully be taking my lead in dose of TPX-0131. In my wildest dreams, I shall respond and begin to feel better.

In the meantime, I am still adjusting to, well, limitations. Because of fatigue, I had pushed last Sunday’s date night to this evening. However, after showering in preparation, I immediately felt nauseous and vomited. This is likely a side effect of the pleural effusion.

I called my (very understanding) date, who was already enroute, and told him I would need to cancel. Again. And that, in all honesty, I was fooling both of us in thinking that I was well enough to socialize. As an enthusiast, I sometimes operate under the assumption that I can just power through. However, my body is making it increasingly clear that it is time to rest.

So I shall. Pace myself. But, with not just the hope, rather the expectation, that I shall rise (and date!) again.

xo

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But the show must go on

Posted on July 23, 2021 | 7 comments

I was to get a PleurX catheter installed on Tuesday. However, I thought my appointment was in the afternoon whereas it had been in the morning. It was rescheduled for the next day and I spent Tuesday sleeping–exhausted as the day before the rest of the contents of my studio had been moved by (I kid you not) the two slowest movers on the planet. They did a good job though so all’s well that ends well.

My appointment on Wednesday was of the bright and early variety but this time I was where I was supposed to be when I was supposed to be. Johnnied up, on the table, being prepped. And then the surgeon comes in and tells me that they won’t be installing the PleurX because my insurance covered the procedure but not the supplies ($1000 a month to maintain).

I was stunned. ‘Why could you have not told me this before I was on the table?’ I asked. No response. The surgeon then went on to explain my options–another thoracentesis or a talc procedure, which would require admission to the hospital. He also allowed that after two thoracentesis’ the risk becomes greater than the value.

Fabulous. I asked them to call my oncologist (they texted her). Explained that time was of the essence here–that I would be starting back on the same drug (TNO155) that almost certainly initiated my rapid onset plueral effusion. That the PleurX catheter was being installed so that if my lung started to fill with fluid again, it could be managed.

In the end, I had my third thoracentesis in a two week span. It hurt like hell. This time they were able to extact 250mm of very viscous fluid. The x-ray following the procedure reported ‘residual loculated left pleural effusion.’ So, in short, my left lung is a project.

Yesterday I met with Jess. The good news is that I may be able to start on TPX-0131 in two weeks. Having a horizon line is helpful in these circumstances and now my eyes are set on that. And my blood work looked great.

As for the aborted catheter, perhaps it shall be a non issue. I took my dose of TNO155 on Wednesday, but the way the trial cycle works, this week is my week ‘off’—no TNO155, just lorlatinib. So that alleviates my worries per another massive pleural effusion in the coming days. As it looks now, I may have to go back on TNO155 for only one week. There may be need for yet another thoracentesis, but a catheter may have been of limited usefulness anyway.

I remain exhausted and short of breath (but less so after I get my lung drained). However, this body of mine still wants to live.

I plan on honoring that. Much time has been devoted to getting my affairs in order–a great comfort. But now I need to get back to the good stuff. To that end, dinner out with Diane and her husband Dave last night, a meal with another friend on Saturday and a date on Sunday.

I’m alive I’m alive I’m alive.

xo

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And a few more salient details

Posted on July 15, 2021 | 28 comments

I am exhausted. Spent, if you will. Therefore today’s blog is a cut and paste–taken from a message I sent out to my siblings and some close friends.

Another update. Not the kind I like to give. I hadad scans and saw both of my oncologists today. In short, it is still a shitshow in my left lung. Pleural effusion, partial collapse, possible pneumonia and a super aggressive cancer (Alice compared scans that were eight days apart and it had grown). And, unfortunately, my fever returned today–still low grade but not a good sign.

 
Next week I shall have a drain installed in my left lung and on the same day, I shall start back on the same drug that likely caused the pleural effusion–TNO-155–at a lower dose and with the hope that if my lung blows up again, we can control it with the drain.


My oncologist applied for (and received) compassionate use for the 4th gen ALK inhibitor that I had been precluded from (due to too many prior treatments)–TPX-0131. This is a great scenario as she gets to write the protocol. However, with paperwork it will be four to five weeks until I can start. Our goal–bluntly put—is to try to keep me alive that long.

 
This is brutal, I know. However, I thought it best to let you all know. If things don’t change course, I am wrapping it all up and sooner than I expected.


Please know how much I love you all and also that I am going to continue to fight like hell. I just need a miracle 🙂 And–an ask–please look after my kids. They are having a really tough time–Peter told me tonight he is barely holding it together. In the end, it doesn’t matter how much time you’ve had to prepare. None of us are ready.

xo

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