Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data
15 Jul 2024
Dive Brief:
An experimental cancer drug developed by Revolution Medicines shrank pancreatic tumors in about one-quarter of participants who had been followed for at least five months after treatment in an early-stage study.
The update, which Revolution Medicines shared with investors Monday, is the latest cut of data from the trial, which has tested the company’s targeted therapy RMC-6236 in people with lung or pancreatic tumors that are driven to growth by mutations in a cancer gene known as RAS.
Among study participants who previously received one or more prior drug regimens for their cancer and have a “KRAS G12X” mutation, treatment with RMC-6236 led to a median progression-free survival of 8.1 months. Revolution claims this is higher than typically seen with other regimens and is advancing its drug into a Phase 3 pancreatic cancer trial later this year.
Dive Insight:
Revolution Medicines is one of a handful of biotechnology and pharmaceutical firms looking to exploit drug research advances that have made RAS mutations easier to target. Mutations in the gene are frequently a trigger for cancers of the lungs, pancreas or colon.
Pancreatic cancer, which is considered among the hardest tumor types to treat, is particularly dependent on RAS mutations, according to Revolution Medicines. Currently, however, standard treatment is chemotherapy-based regimens that have limited effectiveness.
RMC-6236 is designed to inhibit RAS signaling by binding to the mutant protein in its “on” state. The company’s first-in-human study, which has enrolled nearly 400 patients with RAS-driven solid tumors, has so far evaluated nine different doses of the drug. Results were last presented in October.
Monday’s data are from 127 study participants with pancreatic ductal carcinoma who received between 160 milligram and 300 milligram doses of RMC-6236. Nearly all experienced side effects, most commonly rash, diarrhea, mouth sores and vomiting. Those adverse events were considered severe or medically significant in 22% of participants and in 28% required dose modification.
Median progression-free survival, a measure of how long treatment staves off disease progression or death, was a median of 8.1 months in people who specifically have the KRAS G12X mutation, and 7.6 months in those who broadly have RAS mutant tumors, including those with KRAS G12X changes. According to Revolution Medicines, the benchmark median progression-free survival for chemotherapy regimens in this setting ranges from 2 months to 3.5 months.
Among participants who had at least three prior treatment regimens, the median progression-free survival was 4.2 months.
Revolution Medicines said it plans to advance the 300 milligram dose of RMC-6236 into a Phase 3 study comparing it to investigator’s choice of standard chemo among previously treated people with pancreatic cancer. The company anticipates starting the study in the second half of the year, with progression-free survival data coming in the first half of 2026.
Along with Revolution Medicines, a range of other companies are advancing RAS inhibitorsRAS inhibitors in solid tumors, including BridgeBio Oncology Therapeutics, Frontier Medicines and Eli Lilly. Two drugs specifically targeted to KRAS mutations, Amgen’s Lumakras and Bristol Myers Squibb’s Krazati, are currently approved for lung cancer.
Revolution Medicines recently absorbed EQRx via an all-stock deal, swelling its cash balance to $1.7 billion as of March 31. Shares in the company fell in early Monday morning trading before bouncing back to trade up by more than 2%.
'
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.