What You Need to Know
By Erin Post
A new therapy that targets RAS mutations present in more than 90% of patients with pancreatic adenocarcinoma — the most common type of pancreatic cancer — approximately doubles overall survival according to clinical trial results announced today.
Revolution Medicines shared Phase III clinical trial results
for a pill called daraxonrasib in patients with previously treated metastatic
pancreatic cancer. For decades, RAS was considered “undruggable,” meaning that
there was no effective way to target RAS. These results greatly expand the
potential benefit of targeted
therapies for patients with pancreatic cancer.
“We are standing at the threshold of groundbreaking
treatments for patients with pancreatic
cancer,” said PanCAN Chief Scientific and Medical
Officer Anna
Berkenblit, M.D., MMSc. “Today’s announcement represents a real opportunity
to bring new hope for people facing this disease: hope for more time with
family, hope for better quality of life and hope that ongoing and future
research may ultimately lead to a cure.”
Next, Revolution Medicines will need to take their data to the U.S. Food and Drug Administration (FDA). If the FDA grants approval for daraxonrasib, it will be made available as a treatment for patients with metastatic pancreatic adenocarcinoma who have been previously treated.
Revolution Medicines, a clinical oncology company, announced positive results from its Phase III clinical trial comparing their once-daily pill daraxonrasib with the current standard of care chemotherapy in patients with previously treated pancreatic adenocarcinoma that has spread beyond the pancreas (metastatic). It was a global, randomized trial, meaning that patients from more than 60 locations around the world were randomly assigned to one of these two treatment groups.
According to a press release from the company, daraxonrasib
demonstrated a median overall survival of 13.2 months versus 6.7 months for
chemotherapy. Overall survival measures the length of time from when treatment
begins until death from any cause.
What are the side effects?
In their press release, Revolution Medicines states that
“Daraxonrasib was generally well tolerated, with a manageable safety profile
and with no new safety signals.” Prior studies with daraxonrasib have shown
that rash is the most common side
effect, with mouth sores, diarrhea, nausea and vomiting also common.
Let’s talk more about RAS mutations. What are they and why
have they been a focus for researchers studying treatments for pancreatic
cancer?
RAS
mutations are changes in the RAS family of genes, which regulate cell
growth and division. Mutations in RAS can cause cancer cells to grow
uncontrollably, leading to cancer. RAS mutations, particularly in the KRAS
gene, are found in over 90% of pancreatic cancer cases. Mutations in KRAS can
“switch on” signals for constant cell growth, driving tumor formation and
progression. These mutations are typically somatic mutations, meaning they
occur in tumor cells during a person’s lifetime and are not passed down
genetically. Identifying a KRAS mutation can guide treatment strategies and
eligibility for clinical trials. It is one of the most studied genetic drivers
in pancreatic cancer. KRAS inhibitors like daraxonrasib work by stopping the
activity of RAS proteins, blocking signaling pathways that promote growth.
What’s the next step for this treatment?
Additional data from this trial is expected to be presented
at the American Society of Clinical Oncology (ASCO) Annual Meeting in late May
2026. Revolution Medicines has announced their intent to take their data to the
U.S. FDA for approval. The treatment has been granted a special status:
daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher
pilot program, which is intended to accelerate the review of therapies aligned
with U.S. national health priorities.
I am a patient with pancreatic cancer interested in this
treatment. What should I do?
The RASolute 302 clinical trial has closed and is no longer
enrolling patients. At this time, Revolution Medicines does not have a program
for expanded access/compassionate use. Daraxonrasib is being
studied in additional clinical trials in other patient populations. Trials of
other investigational therapies targeting RAS in pancreatic cancer are ongoing.
Biomarker testing of a patient’s tumor tissue is the first
step to determining eligibility for these trials and to help find the best
treatment options. Patients can learn whether they have a KRAS mutation through
biomarker testing. Biomarker testing will also tell patients the specific KRAS
mutation present.
Patient Services Case Managers can answer questions about biomarker testing and provide resources to enroll. Many major cancer centers offer biomarker testing. Also, our Know Your Tumor program provides free biomarker testing for eligible patients. Contact PanCAN Patient Services to learn more.
