Welcome, @askretka. Do you have pancreatic cancer? Are you looking into clinical trials?

Looks like a very small evaluation with just 3 patients. While interesting, I gather it is a very long way from Phase 1/2 clinical trials?

A clinical trial is to compare a new treatment or drug to an existing one if one currently exists. Or the trial can be a new class of drug for which no prior treatment exists. A trial is conducted in three phases with phase III more closely resembling real-world conditions. Conducting trials are costly and time consuming to collect the required amount of data for biostatistical analysis to determine if the new drug offers significant improvement and is as safe or safer.

There may be other companies testing a biosimilar compound. A case in point is the drug Olaparib (Lynparza) made by Astra Zeneca and the biosimilar compound Rucaparib (Rubraca) by Clovis Oncology. Astra Zeneca had a significant head start and is a much larger, cash-rich Pharma company. Their head start led to generating the required data and submitting it to the FDA which led to approved use for a number of cancers including pancreatic.

Clovis was a new entry and a small bio pharmaceutical company. They were testing their compound on Ovarian and breast cancers when it was learned there was potential for treating pancreatic cancer in what is a very small cohort.

With a well established Pharma company already having 100% of the available cohort to sell their Rx drug, a smaller company with the same drug is faced with trying to use critical funds to get approval for ovarian and breast which is a larger cohort for fighting to gain market share.

Now imagine if you are the head of a small bio Pharma with limited funding. Do you dilute critical resources and try to go after a tiny population of pancreatic cancer patients with mutations that may respond to a PARP inhibitor and jeopardize getting the drug through the breast cancer trials so application can be made to the FDA where approval could mean gaining a market share of a bigger patient cohort? It sometimes comes down to a make or break decision and whether a company survives. Bottom line-there is an FDAapproved PARP inhibitor available and helping pancreatic cancer patients with targetable mutations now. Another fact is it takes about 13 years from the discovery of a bio active compound to receive FDA approval.

To get a drug through FDA approval is also very expensive. Every time filings of documents are made to the FDA, it is not a one-time fee that covers the submission. It costs millions of dollars to cover those filings.

I am going for a trial screening at NCI in bethesda,md for a ATM gene mutation in june,I have been trying to get into one for almost a year.

I have only the KRAS mutation and was NED as of April 29 from stage IV 12/2021.
Does anyone know of a trial outside of the ones at Univ of PA?

@tra418 , I also have the ATM mutation with my pancreatic cancer. I understand it has similar impact on DNA Damage Repair (DDR) as other gene mutations like BRCA1, BRCA2, PALB2, and is sometimes treated with drugs (PARP Inhibitors?) targeting the DDR function.

@gamaryanne , I think the KRAS mutation is more common in PC. I've seen trials and stories specifically targeting KRAS, but the only link I have handy is this one: https://www.nbcnews.com/health/health-news/gene-therapy-pancreatic-cancer-experimental-approach-shrank-tumors-one-rcna31437 . That might be the same treatment / story originating from U of PA, but with another researcher working on it in Oregon.

I've heard oncologists refer to "tumor agnostic" treatments in the context of modern, targeted therapies. Instead of focusing so much on the organ where the primary tumor originated and the traditional "cancer type," they're focusing on the "cancer biology" -- specifically mutations in the DNA and drugs that will target those cancer cells wherever they may roam.

"May we live in interesting times!" 😉

@mamarina , Thanks for that very encouraging link! I had read a study from several years ago (Stanford, iirc) where they found intra-arterial delivery in mice with pancreatic cancer achieved the same effect as traditional chemo delivery with about 1/300th the typical dose, meaning very little in the way of side effects.

It's awesome to see this moving not only from mice to humans, but with the added pressure from the balloons helping the meds penetrate that nasty stroma in such a non-invasive way.

Unfortunately, that doesn't appear to be an option for distant/multiple metastases. CRS + HIPEC (Cyto-Reductive Surgery + Heated Intra-Peritoneal Chemotherapy) is "conceptually" similar in that it attempts to deliver chemo directly to the tumor(s), but from the outside-in. Pretty invasive/risky and somewhat controversial from what I hear. Hope someone w/ more knowledge about this can share.

PanCan will be announcing details of a new Phase 3 trial with Oncolytics for their drug Pelareorep Biotech and a Checkpoint Inhibitor
On around 20th of September.
Oncolytics Biotech was granted FastTrack approval in December of 2022. The Checkpoint Inhibitor hasn't been decided yet.

This is all overwhelming. My brother in law was just diagnosed after going to E.R. for something completely unrelated. So far it has looked like this:
1. Go to E.R. for something unrelated and they do a CT Scan which shows something unusual.
2. They go in to do a biopsy but when they get in there, they don't see it so they just pull back out and schedule an MRI to double check.
3. MRI indicates there is something there. They reschedule the biopsy and go back in to take the biopsy.
4. They think there is something going on with the biopsy but it wasn't clear so they send the results to the UW Wisconsin team to look.
5. The night of the biopsy, he develops painful pancreatitis and ends up in the hospital.
6. A day later they tell him while he's still in the hospital that he has pancreatic cancer. When asked about the stage, they say it's 2B.... but telling us it's very early on.

.It feels like he's been put into a cattle prodding line now. A port is going in on Thursday and he'll start Chemo. I don't feel like they have been thorough enough. So much uncertainty and now he's getting a port put in? Looking to get a second opinion. Spoke with insurance company today. The spot in him is about an inch and a half by an inch big. It's not near the blood vessels. Why don't they just take that out? Why waste the next 5 months shrinking it? I know this may sound ignorant but I'm trying to understand. Does everyone who receives this diagnosis go directly into chemo?
Please help.

I'm no expert on the possibility of surgery, as I don't qualify. However, if the CT and the MRI show a tumor and the biopsy confirms cancer, then yes, chemo is likely the next step. People on this board have said that typically, MDs want to shrink the main tumor as much as possible before attempting to remove it. Did they mention the possible procedure? All I've read about is the Whipple. Many people on this board have posted about that procedure, so you can likely do a search and find posts with more info.