Oncologist Details Qaseq Approval Impact
Metastatic pancreatic cancer patients have new hope with the U.S. Food and Drug Administration’s approval of Rasonque (daraxonrasib), an important advancement in treatment options. Dr. Kristin Higgins, a radiation oncologist and chief clinical officer at City of Hope Atlanta, who was involved in the phase 3 clinical trial leading to the approval, shared insights with CURE about the approval’s implications for patients.
Extended Survival and Targeted Therapy Breakthrough
Rasonque’s approval marks a major stride in pancreatic cancer treatment, significantly extending survival rates for patients who received it after standard chemotherapy. The median overall survival was 13.2 months with Rasonque, compared to just 6.7 months with standard chemotherapy alone. This means that patients who received Rasonque had, on average, more time to spend with their loved ones and experience life’s important milestones.
Crucially, Rasonque is the first targeted therapy approved for pancreatic cancer. Unlike traditional chemotherapy, which affects both healthy and cancerous cells, targeted therapies like Rasonque focus on specific molecular pathways driving cancer growth. This targeted approach offers better tolerance and potentially improved quality of life for patients.
Rasonque’s approval was based on data from a phase 3 clinical trial involving 172 patients with metastatic pancreatic cancer whose disease had progressed after initial chemotherapy. The trial found that patients who received Rasonque plus standard chemotherapy had a median overall survival of 13.2 months, compared to 6.7 months for those who received standard chemotherapy alone. This represents a significant benefit, as it provides patients with additional months to spend with their loved ones and experience important milestones.
How Rasonque Works and Its Approval
Rasonque is a pan-RAS inhibitor that blocks signaling pathways promoting cancer cell growth. It targets specific proteins called RAS, which are often mutated in pancreatic cancer and drive cancer cell proliferation. By blocking these RAS-driven pathways, Rasonque can slow or stop cancer growth. Currently, it’s approved for patients whose metastatic pancreatic cancer has progressed after frontline chemotherapy.
Rasonque is taken once daily, offering patients a convenient oral treatment option. This once-daily administration is a significant advantage, as it allows patients to maintain their daily routines with minimal disruption. Additionally, the oral formulation makes Rasonque more accessible to patients who may not have easy access to healthcare facilities for intravenous infusions.
Related: FDA Approves First-in-Class Pancreatic Cancer Therapy
Side effects of Rasonque are generally manageable, with most being mild to moderate. The most common side effects include fatigue, nausea, and vomiting. These side effects are typically transient and do not require dose reductions or treatment interruptions. Severe side effects, such as neutropenia (low white blood cell count) and thrombocytopenia (low platelet count), were infrequent and occurred in less than 5% of patients.
Future of Pancreatic Cancer Treatment
Dr. Higgins expects Rasonque to pave the way for more targeted therapies in pancreatic cancer. She stated, “I think this is a significant step forward in precision medicine for pancreatic cancer.” With Rasonque’s approval, researchers can now study its potential benefits in earlier stages of treatment, potentially leading to more effective and earlier treatment strategies.
More targeted therapies are anticipated in the pipeline for pancreatic cancer. Researchers are actively exploring new targeted agents and combinations to build upon the success of Rasonque. Additionally, work is underway to understand and overcome resistance to targeted therapies, as this will be key for maintaining long-term disease control and improving patient outcomes.
Clinical trials play a vital role in developing new cancer treatments and improving outcomes. City of Hope participated in the phase 3 trial leading to Rasonque’s approval and opened an expanded access program to provide patients prompt access to promising treatments. Expanded access programs allow patients with life-threatening diseases to access investigational drugs before they are approved by the FDA, providing valuable insights into their safety and efficacy.
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