It is possible that today will be Penny's last immunotherapy treatment and that she will begin a new trial in a few weeks.
The new trial is for a drug (with the catchy name MRTX1133) that was designed to target cancer cells with a specific genetic mutation (KRAS G12D) that Penny's cancer has. Recently the FDA approved a similar drug that targets the KRAS G12C mutation. That drug has shown itself to be quite effective, so this is a much anticipated trial. The KRAS gene has long been known to play a role in cancer cells' ability to reproduce, but until the recently FDA-approved drug, there had not been any successful drugs to target this gene.
We've known about this trial for awhile, and the hope has been to continue on the current immunotherapy trial long enough for the KRAS-targeting drug trial (a) to have progressed in its dose escalation and (b) to have demonstrated a good combination of tolerance and effectiveness.
But a few things have changed in the last month
Penny hasn't tolerated the immunotherapy as well the last two times (especially last time, when it wiped her out for most of 5 days after treatment).
The most recent scan suggests some progression of the cancer. (You may recall we had to sign a form to allow "continuation post-progression").
Last week Monday Penny spent some time in the ER with a bowel obstruction. After waiting things out for 36 hours at home, the obstruction resolved on its own after about 5 hours in the ER.
There are some other indicators that the cancer may again be progressing (slowly for now).
There is a Grand Rapids opening in the new trial. There may be other openings in the future, but it is hard to know just when they will occur and whether they will mesh well with other things related to Penny's treatment.
We've initiated the screening phase of the new trial. If Penny qualifies, the new treatments would begin in a few weeks. (No sooner than two weeks because we need to wait at least two weeks after today's treatment.). MRTX1133 is an oral medication, so we would not have infusion days, but especially early in the trial there would be multiple visits for bloodwork and other testing.
Penny would be the first person in Grand Rapids to receive the drug, which will be given at the second lowest dose level in the dose escalation phase of the trial. According to the consent form, 3-12 people in the country have received the lower dose without major complications, and according to Dr. Lakhani, the pharmaceutical company anticipates that the drug should begin to demonstrate effectiveness at the dose Penny would be receiving. The study allows for intra-subject dose escalation, so if higher doses work well in other subjects, Penny could receive higher doses in the future while remaining in the study.
That's a long way of saying that today's infusion will proceed as scheduled, but the treatment plan may be changing after today. In the meantime, we are hoping the treatment goes more smoothly this time than it did three weeks ago and that Penny qualifies for the new trial. While the study team determines that, we will do our research on the study and read the 26-page consent form...
Comments
Kimberley Carlos Belez: Hi, Randy and Penny, We are keeping you in our prayers and are asking the Lord to open the way He has for the next steps. We love you! -- Carlos & Kimberley B
Marie VanderLinde : Praying for physical comfort and hope!
Pamela Plantinga: I am praying that Penny doesn't feel so tired and miserable after today's treatment, and I'm very much hoping and praying that she qualifies for this new drug.
Jane Warners: Thanks for the info, Randy. I’m praying for discernment for all involved with Penny’s care. Also, I’m thankful for hope and healing and will pray for minimal side effects following today’s infusion.
Herm De Vries: Thank you for this update. Strength and encouragement to you as you process this combination of worry and hope ...
Susan Langeland: Thanks for todays update, Randy. Lifting you both to the Lord for all your needs to be met.
Chriss Pruim: This is exciting. I will be praying that the side effects won't be so bad this time and that Penny will be accepted into this promising new trial!!!
Glen Boer: Keeping you both in my prayers