Palbociclib + Binimetinib for Pancreatic Cancer

This trial tests a new combination of two drugs, palbociclib and binimetinib, to determine if they can slow the growth of pancreatic cancer and other RAS-mutated cancers. These drugs are kinase inhibitors, blocking proteins that signal cancer cells to multiply. The trial aims to extend the time before cancer resumes growing. It seeks patients with specific mutations in their cancer, particularly those who have progressed after previous treatments and lack effective standard options. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial requires that you stop taking any cancer-directed therapy at least 28 days before joining, except for hormonal therapy, which can be taken up to 14 days before. Additionally, you must stop taking strong CYP3A4 inhibitors or inducers and P-glycoprotein inhibitors or inducers 14 days before starting the trial.

Research shows that the combination of palbociclib and binimetinib can cause some side effects, but they are usually manageable. Common side effects of binimetinib include rash and nausea. When combined with palbociclib, some toxicity has been observed, a common occurrence in cancer treatments.

Other studies have shown that patients taking binimetinib with another drug generally experience a good safety profile, meaning many can handle the treatment without serious problems. However, there has been a rare report of pancreatitis (inflammation of the pancreas) with binimetinib when used with other drugs.

Researchers are excited about the combination of palbociclib and binimetinib for pancreatic cancer because this treatment targets cancer cells in a unique way compared to standard treatments like chemotherapy. Palbociclib is a CDK4/6 inhibitor that helps stop cancer cells from dividing, while binimetinib blocks the MEK pathway, which is often overactive in cancer cells. This dual approach aims to tackle the cancer more effectively by disrupting two critical pathways that fuel tumor growth. By using this combination, there's potential for a more targeted attack on the cancer, possibly leading to better outcomes with fewer side effects than traditional chemotherapy alone.

Research shows that binimetinib, which participants in this trial may receive as monotherapy, may help treat certain cancers, including pancreatic cancer. Studies have found that binimetinib can slow tumor growth in early tests, potentially delaying cancer progression. Additionally, palbociclib, part of the combination treatment arm in this trial, almost doubled the time patients lived without their cancer worsening, from 5.6 to 9.5 months. When used together in the combination cohort, these two drugs target different pathways of cancer cell growth, which might lead to better outcomes for patients with RAS-mutated cancers. Early studies in similar cancer types have shown some success with this combination, but more research is needed to confirm these results in pancreatic cancer.²⁶⁷⁸⁹