Health systems across the U.S. have experienced an uptake in patient demand for the pancreatic cancer drug daraxonrasib in the weeks since the FDA granted expanded access to the drug through a May 1 “safe to proceed” letter.
Demand heightened following news the Revolution Medicines drug extended survival among stage 4 pancreatic cancer patients who participated in a clinical trial. Of the 168 patients enrolled in the trial, 35% responded to the drug. Among trial participants, the median progression-free survival time was 8.5 months and the median overall survival was 13.1 months.
While pancreatic cancer represents only 3.2% of new cancer cases, it is the cause of 8.4% of cancer deaths — making it the third-leading cause of cancer death in the U.S., according to the National Cancer Institute.
The District of Columbia and Delaware have the highest rates of pancreatic cancer incidence and mortality, respectively, according to the most recent data published by the American Cancer Society.
Becker’s asked 19 health system leaders if their organizations are experiencing an increased interest in the pancreatic cancer drug and how they are preparing to meet patient demand.
Editor’s note: Responses have been lightly edited for clarity and length.
Hani Babiker, MD. Associate Director of Clinical Research Operations at Mayo Clinic Comprehensive Cancer Center (Jacksonville, Fla.): Pancreatic cancer is a disease with poor prognosis and increasing incidence, and we have been trying to find a therapeutic breakthrough for decades. A breakthrough was announced on April 13.
This is good news not only for us pancreatic cancer oncologists but most importantly for our patients who are in dire need of such an advancement. This year also a one-of-its-kind noninvasive device has been approved in the treatment of locally advanced pancreatic cancer that increases efficacy with new therapies in pancreatic cancer.
Yes, demand is high, and metrics to facilitate access is our priority here at the Mayo Clinic. We as oncologists at our three NIH sites are actively educating patients about daraxonrasib, developing metrics of facilitating expanded access that will take some time, meeting regularly to discuss ways of removing obstacles, and developing collaborative efforts to initiate new trials with the drug. We also are in close communications with our partners in community practices to provide them with any updates. Moreover, we are actively studying daraxonrasib with other drug combinations in the lab to inform potential future investigator-initiated trials to further advance efficacy.
Gregory Botta, MD, PhD. Medical Oncologist and Associate Professor of Medicine at University of California San Diego Health: Daraxonrasib has not yet been FDA-approved for metastatic pancreatic cancer patients after first-line chemotherapy. Currently, an expanded access program has been announced and UC San Diego Health has submitted an application. We are actively processing the application with the manufacturer and determining the next steps for obtaining and distributing daraxonrasib. Per overall guidance, the EAP provides a pathway for access to investigational medicines for patients with a serious or life-threatening condition, who have no comparable or satisfactory alternative treatment options, have exhausted approved treatment options, and are not able to join a clinical trial.
Mitesh Borad, MD. Oncologist, Professor of Medicine and Leader of the Novel Therapeutics and Therapeutic Modalities Program at Mayo Clinic Comprehensive Cancer Center (Phoenix): Our approach has been multi-pronged and proactive instead of being reactive. We foresee that access issues will persist even after FDA approval given the narrow setting the drug may garner for its initial approval — second line and beyond metastatic patients.
The RASolute 302 study will pave the way for use in the refractory, metastatic setting. We are opening multiple front-line metastatic trials, adjuvant therapy trials, combination therapy trials and also planning for trials for next generation drugs that can overcome daraxonrasib resistance. We are also developing investigator-initiated trials using daraxonrasib that address locally advanced pancreatic cancer patients which represents about 40 percent of pancreatic cancer diagnoses.
Our role as the leading medical center is to be at the forefront of this “revolution.”
Michael Cecchini, MD. Co-Director of the Colorectal Program in the Center for Gastrointestinal Cancers at Smilow Cancer Hospital; Director of GI Clinical Research Team, Yale Center for GI Cancers; and Associate Professor of Medicine at Yale School of Medicine (New Haven, Conn.): Yale Smilow Cancer Hospital is participating in the daraxonrasib expanded access program. We have a high volume of patients interested in this therapy. Once activated, in addition to clinical support (physician, nursing, pharmacy, etc.) the expanded access program will require appropriate research staffing (research coordinators, regulatory support, data managers, etc.). We have the necessary clinical support in place for our patient population, and we have allocated the necessary research support to the program to meet the needs of our patient population.
Christopher Chen, MD. Assistant Professor in the Division of Oncology in the Department of Medicine at Stanford (Calif.) University: Many of our patients have been carefully tracking the development of daraxonrasib as well as other KRAS inhibitors for many years, including participating in clinical trials of such drugs at Stanford. We are striving to establish expanded access to these drugs as soon as possible as well as preparing for the anticipated commercial launch.
Andrew Chapman, DO. Director of the Sidney Kimmel Comprehensive Cancer Center and Executive Vice President of Cancer Research and Oncology Services at Jefferson Health (Philadelphia): As expected, there has been significant patient interest in daraxonrasib. In efforts to meet patient’s needs, we are working with Revolution Medicines to develop an expanded access program as quickly as possible.
Deirdre Cohen, MD. Director GI Oncology and Associate Professor of Medicine at Mount Sinai (New York City): Our cancer center has received a growing number of requests from both patients and providers regarding access to daraxonrasib following the recent FDA approval of the expanded access program. There is definitely increased interest from patients with advanced pancreatic cancer who are looking for additional treatment options.
To prepare for this demand, our oncology, pharmacy and research teams have been working together to review eligibility criteria, access pathways, and operational workflows so we can help manage referrals, prior authorizations, and treatment coordination as efficiently as possible. We are also educating providers and nursing staff on dosing considerations, toxicity monitoring and management of potential side effects to ensure patients can be monitored closely and treated safely once therapy is initiated.
At the same time, we are making sure patients and referring providers have clear, up-to-date information about the process and expectations for treatment. Our goal is to provide timely access while ensuring patients receive the appropriate education, monitoring and support throughout therapy.
Samir Dalia, MD. Oncologist and Physician Leader for Oncology Pharmacy and Therapeutics at Mercy (Chesterfield, Mo.): This drug looks like it may be the next best option for an otherwise dismal disease. We’re seeing increasing interest from our patients and from our clinicians. Our focus is on being ready. We’ve already started building a plan for the medication in our electronic medical record and we are making sure the right clinical and approval processes are in place so we can offer the drug through the current access program. If the treatment is right for a patient, we want to be able to offer it without delay. At Mercy, we make every effort to provide new, effective therapies available as quickly and safely as possible.
W. Jeffery Edenfield, MD. Executive Director of Medical Oncology at Prisma Health (Greenville, S.C.): The response to the survival data associated with daraxonrasib has been brisk and constant. We have placed many patients on the compassionate use list in keeping with the process forwarded by the FDA and Revolution Medicines. I am not aware at present that any of these patients have received the drug through this program, but we are hopeful. There are few human cancers less touched by progress than pancreas cancer and we are all excited to be able to discuss this with patients.
Vikram Gorantla, MD. Medical Oncologist at UPMC Hillman Cancer Center (Pittsburgh): There is incredible excitement about daraxonrasib and its benefits in advance stage 4 pancreas cancer in patients with KRAS biomarker mutation. It has been a while since we have seen a drug which doubled overall survival benefit in pancreatic cancer. Pancreatic cancer has been a wasteland for clinical trials. Numerous promising agents have failed in phase 3 data however the RASolute 302 Phase 3 data is expected to be positive with drug approval in Q3 this year. We at UPMC Hillman Cancer Center have been able to work with Revolution Medicines to provide expanded access programs for patients who cannot wait. We expect to open clinical trials using this in the early stage, adjuvant setting to reduce the risk of recurrence. We are also planning on working with Revolution Medicine on quality initiatives to make sure biomarker testing is being done for all patients with advanced pancreatic cancer, which will help patients identify where this drug will work. Our pathology department is working on expedited liquid biopsy KRAS testing with turnaround in a matter of days versus weeks. We have already started working with our dermatology colleagues to deal with the skin toxicity that is seen in 90% of patients on this drug.
Tri Le, MD. Medical Oncologist at UVA Health (Charlottesville, Va.): Our cancer center is working with the team from Revolution Medicines to set up the early access program to allow eligible patients at UVA Comprehensive Cancer Center access to treatment with daraxonrasib. We have received queries from patients both inside and outside our health system but do not yet have this medication available for patient use.
Christopher Lieu, MD. Associate Director of Clinical Research at the University of Colorado Anschutz Cancer Center (Aurora): Our health system has received a surge in inquiries regarding daraxonrasib for patients with advanced pancreatic cancer. Given the significant unmet need in pancreatic cancer and the compelling clinical data that has been reported, this high level of patient interest is understandable. To handle this demand, our cancer clinical research teams are actively collaborating with Revolution Medicines to utilize their expanded access protocol. Because of the extraordinary nationwide demand for this therapy, the administrative processes are taking some time to navigate as Revolution Medicines manages an unprecedented volume of requests on their end. We are dedicating all necessary resources and working every day to advance the daraxonrasib protocol to deliver this promising new treatment to the patients as quickly as possible.
Rosario Ligresti, MD. Director of Pancreas Center at Hackensack Meridian Health Hackensack (N.J.) University Medical Center: The John Thuerer Cancer Center at Hackensack University Medical Center is experiencing a substantial interest in this new drug, especially since it really represents the most significant change and success in pancreatic cancer chemotherapy in 20 years! That said, obtaining it through the new FDA program will take substantial effort and expended resources.
Thankfully, John Thuerer Cancer Center has a very robust phase 1 new drug program and we are quite used to implementing new, cutting-edge therapies seamlessly. Hopefully this is the first of many targeted and precision therapies for pancreatic cancer. It certainly offers patients hope where there really wasn’t much hope before.
Jonathan Mizrahi, MD. Gastrointestinal Medical Oncologist, Ochsner MD Anderson Cancer Center (New Orleans): Our pancreatic cancer patients are understandably excited and eager to have another option that could improve their survival. Unlike IV chemotherapy which can include longer clinic appointments, daraxonrasib is an oral medication that conveniently keeps patients at home for treatment. We have experienced a substantial increase in inquiries about daraxonrasib in the last month, particularly since the FDA announced that the drug would be available through an early access program. Those who have inquired have either exhausted standard of care therapies for their pancreatic cancer or are not tolerating chemotherapy well. We have begun setting up the early access infrastructure at Ochsner to efficiently procure daraxonrasib for eligible pancreatic cancer patients. While we have not yet had any patients obtain the medication, we have identified clinically appropriate patients and will be ready to prescribe daraxonrasib as soon as possible.
Vaibhav Sahai, MD. Associate Professor of Internal Medicine in Hematology/Oncology at University of Michigan Health (Ann Arbor): The University of Michigan Health has been experiencing an increased patient interest in the pancreatic cancer drug daraxonrasib. We have instituted several access possibilities, including working with Revolution Medicines to open the expanded access study at our site. On the patient side, we have been discussing access with all existing pancreas cancer patients that either meet or do not meet expanded access criteria. We have been increasing access to new patients and encouraging both patients, through the cancer answer line, and physicians, through M-line, to reach out to us. In addition, the Rogel Cancer Center has other KRAS inhibitor trials open and several others opening for our patients with pancreatic cancer in the community.
Ardaman Shergill, MD. Oncologist and Assistant Professor of Medicine at UChicago Medicine: Patients are keenly interested in having an opportunity to benefit from daraxonrasib. We participated in the RASolute 302 study and have experience with the drug. We are working as quickly as possible to be able to open the expanded access protocol at the University of Chicago Medicine. Our UChicago Medicine Comprehensive Cancer Center leadership is very supportive. They’re prioritizing this for our patients and sharing resources and support to move quickly. Furthermore, the Revolution Medicines team has been responsive in understanding, mitigating and/or removing delays. A lot of centers are trying to open and a lot of patients are seeking the drug, so this systematic approach to avoid delays and unnecessary steps is key. It is important to keep sharing the feedback and patient input as well as stories to make progress — and to do so in time so the patients who need it most right now can get it.
Sara Moran Smith, PharmD. Oncology Pharmacy Program Manager at Allina Health (Minneapolis): We are seeing a significant increase in patient and provider interest in daraxonrasib, which reflects the excitement surrounding its promising clinical outcomes and the urgent need for new treatment options in pancreatic cancer. At Allina Health, we are proactively preparing by developing internal workflows, including EMR builds and prescribing pathways, to support safe and efficient use through the expanded access program. At the same time, access remains dependent on manufacturer processes and supply availability, and we are experiencing delays in receiving key information needed to operationalize the program. Our current focus is on building a scalable, compliant framework, by partnering closely with research, pharmacy and clinical teams so that once access is granted, we can rapidly and equitably deliver this therapy to eligible patients.
Ashwin Somasundaram, MD. GI Cancers Clinical Trial Lead at UNC Lineberger Comprehensive Cancer Center (Chapel Hill, N.C.): Our cancer center has experienced a surge of interest in access to daraxonrasib. From day one of the announcements, we have worked with the FDA and Revolution Medicines to set up one of the first expanded access programs in the country.
Robert Vonderheide, MD. Director of the Abramson Cancer Center at Penn Medicine (Philadelphia): The response from our patients, our physicians, and from patients and their families outside of our healthcare system seeking access to daraxonrasib has been massive. As a site for the Phase III RASolute 302 study and the Phase I GI-102 study, our clinicians have seen firsthand how daraxonrasib has impacted the lives of many patients with pancreatic cancer who were running out of options. There is real hope with this new approach. We have an all-hands-on-deck effort here to work with the manufacturer to secure access and safe deployment of the drug for our patients.
https://www.beckershospitalreview.com/pharmacy/the-most-significant-change-in-20-years-cancer-centers-prepare-for-daraxonrasib-demand/
