Thanks for your continued interest and support for Linnea Olson.
I awaited this weekly update meeting with Linnea with some trepidation. Linnea had said she would know by the way she felt whether the first dose of her new drug (a Turning Point 4th generation ALK inhibitor, which she had received on Thursday, the day before our meeting) was working. And she said she felt it was melting the cancer!
For more, please see Linnea’s recent blog posts (below) and my notes from the discussion, and the session recording (20 minutes) (also below).
Here are Linnea’s two latest blog posts to provide more detail on her recent news and reflections on compassionate use — her ticket to access the Turning Point drug:
TPX-0131 Posted on August 12, 2021 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
The Necessity For Compassionate Use/Expanded Access Posted on August 13, 2021 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
Here are my notes from the weekly update discussion (beyond the information in Linnea’s blog posts above):
Linnea: I am prone to wishful thinking, but I woke up from a nap, and felt that the cancer was melting away. I asked Jess Lin how long it took for cancer cells to react to the drug. I thought of it like aspirin. That it starts to take effect right away.
Peggy Zuckerman: There are people who think that our directions to our bodies work. What you’re imagining may be influencing what’s happening.
Jeff Waldron: You started yesterday. For what duration?
Linnea: Until I have side effects that are not OK or it becomes clear there is no response. My concern remains that my left lung is a mess. The last draining of the pleural effusion was full of blood. It is going to be hard to recover. I know this is still a long shot. My body has been capable of fighting things, but it had gotten to the point where it needed some help. I hope this is the appropriate help. Going forward, the mysteries will be side effects. I’m the third person in the world so they know nothing about this yet. They’re just guessing.
Peggy: I serve on a scientific ethics advisory board for Roche, and we have heard there is about a 95% approval by the FDA for patients who were benefiting in a trial to continue to receive the drug.
Kimary: Do you know the dosage they’re giving you?
Linnea: One milligram.
Brad: I’ve heard that very few people aren taking advantage of compassionate use.
Kimary: If so, that’s because of the paperwork burden. And busy community practices. They have little time to jump through the hoops.
Peggy: And the community oncologist will be less capable of making the argument. It helps if the oncologist is in a center of excellence.
Kimary: Who has the time to keep up on what’s in everyone’s pipeline? And even if you do know, it’s hard. I reached out to Calithera, for example, to find out about access to their drug, and their products weren’t ready. I was just a citizen. Maybe a top notch clinician would be more persuasive.
Jeff: I moderated two panels on compassionate use and expanded access. There is a document on obtaining access in countries around the world. Naomi Litchfield of Bio Emass gets access for patients in the UK. The panel also included Christine McCracken who was at Janssen, and her job was to help patients get expanded access. It’s not like there is no one in pharma on the other side. One of the panelists was from the FDA and was concerned that expanded access might be a workaround that would enable patients to avoid clinical trials.
Brad: We spoke last week about capturing your own data on a patient-reported survey to feed back to the manufacturer.
Linnea: They will capture the data if they want to. One of the biggest issues with compassionate use is you have to have a life-threatening disease, and you have to have exhausted all other treatments. So you are likely very sick. I view it as a win-win. They will capture data they think will be useful.
Peggy: You can provide your own sense of side effects. If you have side effects, you need to know who to discuss them with, and that might be in addition to your current medical team, but those who are working on the drug.
Kimary: It’s probably too early for them to even have dose de-escalation plans. Expanded access is the big umbrella, and compassionate use is under that. Expanded access can raise concerns for pharmaceutical companies since they can mess up the end points of clinical trials, not only for the pharma company, but for competitors.
Linnea: What’s unusual about my situation was getting access before there was access through clinical trials. It’s available in Australia, but not at MGH. Jess gets to write and control the protocol.
Peggy: Is there another site in the U.S. that is also offering this trial?
Linnea: There is one at UC Davis.
Brad: What can we do to help?
Linnea: Stay tuned. In other news: my youngest son got a new job. He will be working for Mercy Bio Analytics as a cancer researcher. I’m hoping I’ll be even better next week.