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Pancreatic cancer drug achieves 90% disease control, heads to phase 3

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A new drug for pancreatic cancer shows promise in early tests.

Daraxonrasib is a daily pill designed to block cancer signals linked to the RAS gene. It has now completed an early-stage clinical trial (the first time it has been tested in humans) to evaluate both its safety and effectiveness.

In a clinical trial conducted by Dana-Farber Cancer Institute and published in The New England Journal of Medicine, the drug was tested in 168 patients with advanced pancreatic cancer whose tumors contained mutations in the RAS gene. All study participants had received at least one previous chemotherapy treatment.

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The drug is designed to block multiple active cancer signals that help tumor cells grow. This is especially important because more than 90 percent of pancreatic cancers carry these harmful mutations, the researchers said.

Current and older drugs that target RAS mutations only work on certain types, such as rare KRAS mutations in pancreatic cancer.

Daraxonrasib is a daily pill designed to block cancer signals linked to the RAS gene. It has now completed an early-stage clinical trial to evaluate its safety and effectiveness. (iStock)

Researchers stated that approximately 30% of patients responded positively to the 300-milligram dose, which will be used in larger phase 3 trials. Overall, about 90% of patients’ cancer either shrank or stopped getting worse.

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There were some side effects reported; most commonly rash, oral inflammation, nausea and diarrhea.

principal investigator Dr. D., director of the Hale Family Pancreatic Cancer Research Center at Dana-Farber. Brian Wolpin commented in a press release that this development could change the future of cancer care.

Young female scientist holding pills in laboratory environment

About 90% of patients treated with the drug achieved disease control, meaning their cancer was reduced or stabilized. (iStock)

“If supported by data from future clinical trials, daraxonrasib would be a targeted therapy relevant to almost all patients with advanced pancreatic cancer,” he said.

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“This trial provides the first published data demonstrating the safety and broad efficacy of a RAS(ON) polyselective inhibitor in pancreatic cancer,” Wolpin continued. “If proven effective in larger clinical trials, this would represent a significant change in the way this disease is treated.”

In an interview with Fox News Digital, the researcher claimed daraxonrasib represents “one of the most promising treatment advances we’ve seen in pancreatic cancer.”

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This is especially important because pancreatic cancer has historically had “very few effective treatments,” Wolpin said.

“The study also showed disease control in approximately 90% of metastatic pancreatic cancer patients, which is extremely exciting,” he added.

3D image of pancreatic cancer cells

The study did not prove that daraxonrasib was superior to standard chemotherapy treatment, the researchers noted. (iStock)

Wolpin noted that although side effects are common, most patients can tolerate the treatment “with supportive care measures” and very few patients need to discontinue treatment due to side effects.

Wolpin added that since this was a phase 1/2 study, it “does not conclusively prove” daraxonrasib’s superiority over chemotherapy.

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“The study did not include a randomized control arm comparing daraxonrasib directly to chemotherapy,” he said. “However, the results of daraxonrasib appeared to be significantly better than what we have seen in previous clinical trials of chemotherapy in patients with previously treated metastatic pancreatic cancer.”

It also remains unclear how the drug might perform earlier in the disease, as the trial involved patients who had previously been treated.

Senior woman sitting at home undergoing chemotherapy treatment

“Additional research is needed to determine how best to sequence or combine treatments to provide the most durable responses and cures,” said lead researcher Sid. (iStock)

For patients and families affected by pancreatic cancer, Wolpin noted that daraxonrasib signals “real momentum” toward effective treatments, but it is still in the research phase and is not a cure.

“Pancreatic cancer remains a challenging disease, and additional research is needed to determine how best to sequence or combine treatments to provide the most durable responses and cures,” he said.

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Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, applauded the development in a separate interview with Fox News Digital.

“We are anxiously awaiting the public presentation of RASolute 302 at the ASCO meeting later this month,” said the expert, who was not involved in the research. “More than 90% of pancreatic cancers have kRAS activation, which is an important factor in the development and progression of these cancers.”

“The doubling of survival in previously treated patients is unprecedented.”

“If the full data set results to be released later this month confirm what has been previously published, I believe this will be one of the most important breakthroughs in all solid tumors,” Slomovitz continued. “The doubling of survival in previously treated patients is unprecedented.”

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The “magnitude of the benefit” could “reshape the treatment landscape” and “establish a new standard of care,” the doctor added.

“We will need to evaluate the entire data set for efficacy and safety,” Slomovitz added. “I am beyond cautiously optimistic and truly excited for our patients and their families suffering from this terrible disease.”

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