The big one - PDAC
Revolution Medicine got the limelight in the plenary session with their potential new therapy, daraxonrasib (da-rax-on-rasib).
This product is not yet FDA approved; however, may be permitted as part of the Expanded Access Program (EAP) as of May 2026, allowing eligible patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) to access the drug outside of clinical trials. It already received Breakthrough Therapy and Orphan Drug designations and even selected for the Commissioner's National Priority Voucher (CNPV) pilot program, which accelerates the standard review timeline.
Daraxonrasib has been tested in metastatic disease after at least one prior therapy. PDAC unfortunately is often in later stages, even at presentation. Only about 15% ultimately resectable so this impacts a lot of people as you can imagine. Currently, the available 2L therapies offer very limited benefit, roughly 3-4 months of median progression free survival (mPFS) and 6-7 months overall survival (mOS).
PDAC is one of the cancers that has a strong influence from RAS (identified in more than 90% of cases) so having a product that targets this is key. Daraxonrasib is an oral, RAS(ON) multi-selective, tri-complex inhibitor of the active, GTP-bound state of mutant and wild type RAS.
Trial Design
So what were the outcomes of this trial?
OS 13.2 months with da-rax vs. 6.6 months with chemo in specifically the RAS12 population (again the majority of patients had this) with very similar results with the overall population translating that the broader population will benefit as well.
mPFS of 7.3 months vs. 3.5 for chemo
ORR 33.2% vs. 11.8%
Needless to say, this product is going to make a difference… I know of 2 people who died of pancreatic cancer. Fortunately, not close to me but it was clear the journey I witnessed others going through was not pretty. It is quick and it is deadly.
In quoting a few patient stories available online (see here)…
“I was told I had three to six months to live. I was devastated.”
“My oncologist warned me that chemo was going to be a challenge.”
And here:
“My surgeon told me that they cut me open and, contrary to what they thought, found a tumor on the head of my pancreas that had spread outside of the pancreas. Metastatic pancreatic cancer is considered inoperable so when they saw that, they closed me up.”
“Later that day, he introduced me to my oncologist. He was not as confident. When pressed, he said, “With treatment, you might have 1 to 3 good years left, but that’s it.”
“Like a lot of other people with metastatic pancreatic cancer, I was given FOLFIRINOX, which is five different drugs. It’s awful. Chemo combinations are all awful, but FOLFIRINOX was really, really abrasive.”
The need is big. Very big.
“Out of suffering have emerged the strongest souls; the most massive characters are seared with scars.” —Khalil Gibran