Dialing In On Individualized Patient Care
Innovative Approaches & Research Tailor Treatment – Now More than Ever
Neratinib-Based Regimen Promising for HR+ HER2-Mutant Breast Cancer
Oncodermatology – Treating the Skin Needs of Cancer Patients
Groundbreaking Robotic Surgeries in Breast, Pancreatic Cancers
BREAKTHROUGHS IN PATIENT CARE AND CANCER DISCOVERY
During the last several years, cancer treatment has evolved from a one-size-fits-all approach to individualized patient care, based on the informed decision of the patient, the biology of the cancer, and the right time for delivery.
Major advances in research have further informed the potential of precision oncology and genomics. Large genomic datasets – and the computational power to effectively manage them – have given us more insights into human health than ever before. The internet connected patients and their champions, helping shine a light on rare diseases and find solutions.
Thankfully, patient care has become more individualized and precise. As you can see in this issue of CancerAnswers@Simmons, many of these discoveries have been translated to patient care.
Meet faculty member Suzanne Cole, M.D., on page 4, as she shares her passion for bringing oncology care to community-based centers with a commitment to excellence and access to clinical trials, which are mainly available on primary campuses of academic medical centers. Increasingly, patient-centered care means bringing cancer treatment closer to patients.
On page 6, read about a novel drug combination for HER2-mutant breast cancer, a subtype of the disease for which targeted therapies were unknown. Based on the results of a multicenter study, the three-drug combination has been added to the treatment guidelines by the National Comprehensive Cancer Network.
Our newly established Oncodermatology Clinic aims to address the skincare needs of cancer patients. Get to know its leader, Meghan Heberton, M.D., on page 8, and read about her team’s expertise in the assessment and management of skin rashes from cancer treatments, post-surgery or radiation-related skin complications, and more.
Cancer clinical trials always try to improve the approved standards of patient care and, many times, the right clinical trial is the best approach for the individualized care of the patient. Learn about William Marks on page 12 and his experience finding remission for his chronic lymphocytic leukemia after treatment in a clinical trial.
It’s encouraging to pause and remember how far we’ve come. Thank you for joining me in celebrating our progress with this issue of CancerAnswers@Simmons
Sincerely,
CARLOS L. ARTEAGA, M.D. Director, Harold C. Simmons Comprehensive Cancer Center Associate Dean of Oncology Programs X: @carlosarteagamd
4 Bringing Academic Oncology to the Community
Suzanne Cole, M.D., Medical Director of Community Oncology, raises the standard of care, including access to clinical trials, for cancer patients who live in the areas that surround Dallas.
6 Promising Targeted Combination for HR+ HER2-Mutant Breast Cancer
New research supports the use of a triplet regimen – the HER2 inhibitor neratinib, the antiestrogen fulvestrant, and the HER2 antibody trastuzumab – for this breast cancer subtype.
8 Meeting the Specialized Skincare Needs of Cancer Patients
Oncodermatology is dedicated to improving patient outcomes through collaborative, integrated care. An increasing number of patients can benefit from its advances.
9 Wendy & Emery Reves International Breast Cancer Symposium
Leading interdisciplinary experts shared the latest developments in breast cancer research and clinical care at UT Southwestern in Dallas.
10 Shaping the Future of Robotic Surgery
Simmons Cancer Center is building on a proven reputation for innovation in robotic surgery, especially in breast and GI cancers, as well as technical education for surgeons worldwide.
12 Chronic Lymphocytic Leukemia Case Study
Meet the patient who achieved a complete remission of his cancer in a clinical trial involving a targeted therapy with obinutuzumab and ibrutinib – remaining on maintenance treatment for several years.
14 The 30-Year Journey of Belzutifan
The novel drug was discovered and developed at UT Southwestern. It is used for familial kidney cancer with mutations in the von Hippel-Lindau gene and has now been approved to treat all types of metastatic clear cell renal cell carcinoma.
16 News, Honors & Awards
Simmons Cancer Center spotlights people doing great work.
A champion of community-based cancer care, Suzanne Cole, M.D., shares her passion for innovation and clinical research.
“If a patient has cancer, they should not be denied access to a potentially lifesaving clinical trial just because they live two hours away.”
— SUZANNE COLE, M.D.
As Medical Director of Community Oncology at UT Southwestern Harold C. Simmons Comprehensive Cancer Center, Suzanne Cole, M.D., is responsible for providing cancer patients who live in the areas that surround Dallas with the unmatched level of care for which UT Southwestern is known, but in a location that’s convenient to them.
“I have a strong passion for bringing academic oncology closer to the community,” Dr. Cole says. “The significance of this work is not lost on me. It is a matter of life and death for those under my care.”
Before joining the UT Southwestern faculty in 2018, Dr. Cole spent eight years caring for patients in rural communities. She is passionate about bringing the UT Southwestern standard of care to patients near regional locations in Richardson/Plano, southwest Dallas County, and beyond.
Dr. Cole has dedicated her career to treating patients with cancers and blood disorders. In addition to her clinical expertise, she emphasizes the importance of building a trusting relationship between patients and their physicians.
“Effective communication requires awareness of the patient’s values, needs, and desired outcomes,” she says. “At our clinics, we strive to include patients and their families in the decision-making process, giving them realistic expectations about prognosis and treatment.”
According to Dr. Cole, the latest and most promising therapies, often made available through clinical trials,
have been shown to significantly improve survival rates across most cancer types.
However, participation in cancer trials remains low nationwide. “I was shocked to learn that in the United States, less than 5% of cancer patients enroll in clinical trials,” Dr. Cole says.
One of the reasons so few patients participate is that clinical trials are often conducted at large medical centers in urban areas, while a large fraction of cancer patients receive their care close to home in smaller hospital or clinic settings without access to the latest and most promising research, she says.
“If a patient has cancer, they should not be denied access to a potentially lifesaving clinical trial just because they live two hours away,” she explains.
Throughout her career, Dr. Cole has consistently led the way in designing and operationalizing programs that allow patients to easily join clinical trials in community settings. Leveraging her strong background in research, she and her team have made cutting-edge trials accessible to more patients in local communities.
That means overhauling clinical processes and workflows as well as streamlining policies and procedures pertaining to clinical trial enrollment. Dr. Cole has also succeeded in patient recruitment by securing buy-in from all staff members.
“Every member of the team, including laboratory personnel and infusion nurses, is committed to making clinical trials in the community setting a success,” she says. “Our patients have reported that our environment feels personal, as they have the chance to interact with the same nurse or front desk staff member during each of their visits.”
Suzanne Cole, M.D., is Assistant Professor of Internal Medicine in the Division of Hematology and Oncology at UT Southwestern. She is Medical Director of the Simmons Cancer Center clinic in Richardson, Medical Director of Community Oncology for Simmons Cancer Center, and a member of the Experimental Therapeutics Research Program.
New research supports the use of a triplet regimen that includes the HER2 inhibitor neratinib for a relatively uncommon molecular subtype of breast cancer.
UT Southwestern Harold C. Simmons Comprehensive Cancer Center is home to a diverse array of exciting translational research programs in breast cancer and developmental therapeutics.
A recent multicenter study co-led by researchers at UT Southwestern found that using the HER2 inhibitor neratinib, the antiestrogen fulvestrant, and the HER2 antibody trastuzumab together delayed progression and extended survival in patients with hormone receptor (HR)-positive metastatic breast cancer harboring activating HER2 mutations. The study’s findings were reported in the journal Annals of Oncology
“This novel combination therapy showed very encouraging results, even in patients who progressed after several other lines of treatment,” says co-lead author Carlos L. Arteaga, M.D., Director of Simmons Cancer Center and Associate Dean of Oncology Programs at UT Southwestern. Nisha Unni, M.D., Associate Professor of Internal Medicine in the Division of Hematology and Oncology, and Ariella Hanker, Ph.D., Assistant Professor of Internal Medicine, were co-authors on the research.
Based on the results of this study, the National Comprehensive Cancer Network (NCCN) has added this three-drug combination to its treatment guidelines. This marks a significant achievement in clinical research and a new patient option in clinical practice nationwide.
Somatic-activating mutations in the HER2 gene without gene amplification or overexpression are present in approximately 10% of advanced breast cancers, according to Dr. Unni.
“We hypothesized that dual HER2 targeting, through addition of trastuzumab to neratinib and fulvestrant, would prolong responses observed with the doublet,” Dr. Unni says. “It turns out we were right. The triplet showed superior efficacy across all parameters, including progression-free survival.”
Overall, 57 patients received a combination of neratinib, fulvestrant, and trastuzumab. Seven patients received only fulvestrant and trastuzumab, and seven received just fulvestrant. The 14 patients in the latter groups had the option to cross over to the triple-drug therapy if they didn’t respond to the therapies they received.
The study’s efficacy end points were overall response rate (ORR), duration of response (DOR), and progression-free survival (PFS). The researchers also evaluated safety and performed a biomarker analysis via central next-generation sequencing.
After analysis, the researchers found that the ORR was 39%, which included one complete response and 21 partial responses. In addition, treatment with the trio of drugs yielded a median DOR of 14.4 months and a median PFS of 8.3 months.
A total of four patients who experienced disease progression while on fulvestrant plus trastuzumab crossed over to treatment with the triplet regimen; one of these patients had a partial response.
“Neratinib appears to be a critical component of this triplet regimen, as demonstrated by lack of response in the small cohorts of patients treated with fulvestrant alone or fulvestrant plus trastuzumab and subsequent response in a patient who crossed over after progression on fulvestrant alone or fulvestrant plus trastuzumab,” Dr. Unni explains.
With respect to safety, diarrhea occurred in 93% of patients receiving the triplet and 29% of those receiving fulvestrant plus trastuzumab. Among patients receiving the triplet, 53% experienced grade 3 diarrhea. Overall, these side effects were manageable with dose interruptions and dose reductions.
Following circulating tumor DNA analysis, the researchers found that some patients developed secondary mutations in HER2 while on neratinib treatment. A recent study led by Dr. Hanker, published in Cancer Research, showed that these mutations were acquired during treatment and caused patients to stop responding to treatment.
“Circulating tumor DNA is emerging as a key component in assessing tumor evolution and informing mechanisms of acquired drug resistance, thus providing insights for tailored treatment,” Dr. Arteaga says.
Based in part on these results, the researchers are planning a first-in-class multi-institutional neoadjuvant trial of neratinib and the antiestrogen letrozole in patients with newly diagnosed invasive lobular breast cancer harboring HER2 mutations.
The trial began enrolling patients in early 2024. Dr. Unni hopes it will provide new insight into the treatment of early stage HER2-mutant invasive lobular breast cancers.
“Overall, the number of trials for invasive lobular cancers is low,” Dr. Unni says. “The goal of this phase two open-label study is to target and provide highly specific treatment to these patients at an early stage in the neoadjuvant setting.”
Carlos L. Arteaga, M.D., is the Director of Simmons Cancer Center and Associate Dean of Oncology Programs at UT Southwestern. He holds the Annette Simmons Distinguished University Chair in Breast Cancer Research. He is an internationally recognized expert in breast cancer with more than 350 publications in the areas of oncogenes and breast tumor initiation and progression, targeted therapies and biomarkers of drug action and resistance, and investigator-initiated clinical trials. Dr. Arteaga is also a member of the Cellular Networks in Cancer Research Program at Simmons Cancer Center.
Nisha Unni, M.D., is Associate Professor of Internal Medicine in the Division of Hematology and Oncology at UT Southwestern. She specializes in the treatment of breast cancer, and her research focuses on HER2/neu positive breast cancer and triple negative breast cancer. She is a member of the Experimental Therapeutics Research Program at Simmons Cancer Center.
Ariella Hanker, Ph.D., is Assistant Professor of Internal Medicine at UT Southwestern. Her work is focused on therapeutic targeting of breast cancer-associated alterations and delineating mechanisms of resistance to breast cancer-targeted therapies, including HER2 inhibitors, antiestrogens, PI3K/ AKT inhibitors, and CDK4/6 inhibitors. Dr. Hanker is a member of the Experimental Therapeutics Research Program at Simmons Cancer Center.
How an innovative program is expanding access to specialized skincare needs.
UT Southwestern Harold C. Simmons Comprehensive Cancer Center’s Oncodermatology Clinic focuses on meeting the specialized skincare needs of cancer patients. As dermatological morbidity in oncology continues to rise, oncodermatology has emerged as a field dedicated to improving patient outcomes through collaborative and integrated care.
“Cancer care is changing rapidly, and some providers don’t associate skin conditions with delivery of oncology drugs,” says Meghan Heberton, M.D., Director of the Oncodermatology Clinic at Simmons Cancer Center. “An increasing number of cancer patients can benefit from dermatologyspecialized, evidence-based interventions.”
Dr. Heberton joined UT Southwestern in 2022 with the goal of building a state-of-the-art oncodermatology program from the ground up. Simmons Cancer Center is one of the few locations in Texas with a dedicated oncodermatology service.
The oncodermatology team has expertise in the assessment and management of skin rashes from cancer treatments, post-surgery or radiation-related
skin complications, metastatic disease to the skin, pre- and post-stem cell transplant care, including graft-versus-host disease, and general dermatologic care of patients living with cancer.
In addition to a robust clinical practice, outpatient procedures such as skin biopsies, cryosurgery, intralesional injections, and excisions are available.
“The field is highly interdisciplinary,” Dr. Heberton says. “While unique and distinct disciplines, oncology and dermatology are integrated in many ways.”
Dr. Heberton and her team work closely with referring providers to deliver the specialized care patients need before, during, and after cancer treatment.
While the program just started, Dr. Heberton hopes to increase clinical capacity and develop standardized educational resources for oncodermatology trainees. She is also passionate about making a real-world impact on patient care.
“The potential for clinical and translational research is endless,” Dr. Heberton explains. “We are making this area a top priority as we expand the program.”
Meghan Heberton, M.D., is Assistant Professor of Dermatology at UT Southwestern and the Director of the Oncodermatology Clinic at Simmons Cancer Center.
Leading interdisciplinary experts shared the latest developments in breast cancer research and clinical care at UT Southwestern in Dallas.
Featuring international expertise and thoughtprovoking discussions, the Wendy & Emery Reves International Breast Cancer Symposium provided a comprehensive update on recent progress in research discoveries and clinical care of patients with breast cancer.
“UT Southwestern attracted some of the brightest minds in breast cancer research from around the country to engage at this symposium,” says Heather McArthur, M.D., M.P.H., Clinical Director of the Breast Cancer Program at UT Southwestern Harold C. Simmons Comprehensive Cancer Center. “It was a phenomenal opportunity to share findings in this exciting era of discovery.”
Dr. McArthur co-chaired the Reves Symposium along with Deborah Farr, M.D., Associate Professor of Surgery and Section Chief, Breast and Soft Tissue Surgery at UT Southwestern, and Carlos L. Arteaga, M.D., Director of Simmons Cancer Center and Associate Dean of Oncology Programs at UT Southwestern
Held in early May, the symposium hosted on campus at UT Southwestern in Dallas featured keynote addresses by Elizabeth Mittendorf, M.D., Ph.D., M.H.C.M., of Dana-Farber/Harvard Cancer Center, on promising new immunotherapy clinical protocols, and by Joan Massagué, Ph.D., of the Sloan Kettering Institute, on basic research on signaling pathways that regulate normal cell behavior and cancer metastasis. Breakout sessions throughout the symposium covered genomics, local therapy, pathology/imaging, cell cycle and CDK4/6 inhibitors, drug development, endocrine therapy, and immunology.
“This symposium convened a range of professionals in the breast cancer space. As a surgeon, I value
opportunities like this to engage with my peers and to meet others who touch so many complementary areas in the field,” Dr. Farr says.
Symposium attendees included breast cancer care providers, nursing professionals, basic and translational scientists, physician-scientists, clinical trialists, laboratory-based postdoctoral and clinical fellows, graduate students, patient advocates, and interested individuals from industry and the community.
In 1990, a multimillion-dollar donation was made to endow the Wendy & Emery Reves International Breast Cancer Symposium and to support other breast cancer initiatives at UT Southwestern Wendy Reves, a native of Marshall, Texas, became a leading New York runway model before meeting distinguished Hungarian author and publisher Emery Reves in 1945 while he was living in New York. Mrs. Reves, who died in 2007, received the Komen Award for Philanthropy, the National Arts Club Award for Philanthropy (New York), and the Silver Cup Award from Transforming Lives through the Arts (TACA) in Dallas. She was an honorary trustee of the International Churchill Society.
“Wendy Reves’ generosity and concern for humanity continues to help us advance and disseminate a growing body of scientific knowledge for the benefit of patients with cancer and those at risk of the disease,” Dr. Arteaga says. “We at the Simmons Cancer Center are proud of hosting this excellent forum and the outstanding presentations and exchange of ideas.”
Deborah Farr, M.D., is Associate Professor of Surgery in the Division of Surgical Oncology and Section Chief, Breast and Soft Tissue Surgery, at UT Southwestern. She is a member of the Experimental Therapeutics Research Program at Simmons Cancer Center.
Heather McArthur, M.D., is Associate Professor of Internal Medicine in the Division of Hematology and Oncology and Clinical Director of the Breast Cancer Program at Simmons Cancer Center. She holds the Komen Distinguished Chair in Clinical Breast Cancer Research.
From breast cancer to gastrointestinal tumors, Simmons faculty are shaping the future with new procedures.
UT Southwestern Harold C. Simmons
Comprehensive Cancer Center is solidifying its reputation as a global leader in robotic surgery as faculty members build on the institution’s proven track record of success in breast and gastrointestinal cancers as well as surgical education.
“Through years of practice, we have been pioneers in developing and advancing robotic surgery for many indications,” says Adam Yopp, M.D., Professor of Surgery and Chief of the Division of Surgical Oncology at UT Southwestern.
“In addition, our state-of-the-art Simulation Center has helped position us as a global leader in surgical education.”
For years, Dr. Yopp and his team of surgical oncologists, including Deborah E. Farr, M.D., and Patricio Polanco, M.D., both Associate Professors of Surgery in the Division of Surgical Oncology, among others, have consistently been at the forefront of advancing robotic surgical technology and imparting their knowledge to surgeons worldwide.
Surgical oncologist Adam Yopp, M.D., right, is one of the leading forces behind innovations in robotic surgery procedures and education at UT Southwestern.
“Through years of practice, we have been pioneers in developing and advancing robotic surgery for many indications. In addition, our state-of-theart Simulation Center has helped position us as a global leader in surgical education.” — ADAM YOPP, M.D.
UT Southwestern stands out as one of the few centers in the world that performs robotic mastectomy surgeries. In 2020, Dr. Farr, in collaboration with plastic surgeon Nicholas Haddock, M.D., performed the first single-port robotic nipple-sparing mastectomy (or rNSM) in the country.
They introduced the novel procedure to their North Texas patient population with the goal of effectively removing the cancer and reconstructing the breast tissue without the negative long-term repercussions of traditional mastectomy. After receiving Institutional Review Board approval, they began enrolling patients into a clinical trial to evaluate the technique.
“When I presented our outcomes data nationally for the first time, many surgical oncologists were baffled that we could perform a thorough mastectomy through such a small incision,” Dr. Farr says.
A study published in January 2024 in the journal JAMA Surgery reported excellent results among the first 20 patients who underwent the procedure using the new robotic techniques at UT Southwestern.
“We have achieved the original goals of the procedure – better teaching visualization and more aesthetic outcomes,” Dr. Farr notes.
The team also discovered another outcome they hadn’t anticipated using the new procedure.
“While modern mastectomy and breast reconstruction have made great strides, most approaches still result in loss of full sensation in the nipple and breast due to nerve damage from stretching and cutting the breast tissue,” Dr. Farr says, adding that was not the case with rNSM. “Almost all patients in the initial study retained sensitivity in their breasts.”
After more than 60 rNSM procedures at UT Southwestern, 88% of patients have reported still having sensation, which is key for maintaining their quality of life after treatment.
In addition to breast cancer, UT Southwestern is renowned for its groundbreaking work in robotic surgery for pancreatic cancer.
According to Dr. Polanco, the Whipple procedure has traditionally been performed to attempt to remove a pancreas cancer through a large incision in the abdomen, requiring an extended hospital stay and long recovery.
At UT Southwestern, he and his team have specialized training in robotic-assisted pancreas surgery, a more precise approach through smaller incisions that has been shown to benefit patients with faster recovery times and less pain. It has also been shown to have comparable outcomes with fewer complications than open surgery.
Led by robotic pancreas surgery pioneer Herbert Zeh III, M.D., Professor and Chair of Surgery at UT Southwestern, the gastrointestinal surgery program has become one of the few international centers of excellence for this approach. Patients travel from throughout the U.S. to receive the robotic pancreaticoduodenectomy (also known as the Whipple procedure) at UT Southwestern.
Besides the pancreaticoduodenectomy, several other robotic pancreatic surgeries are routinely performed at the institution, including distal pancreatectomies, tumor enucleations, and bypass procedures for chronic pancreatitis, among others.
In March 2022, the surgical oncologists organized a symposium and invited surgeons from around the world to observe UT Southwestern’s robot-assisted procedures: robotic Whipple for pancreatic cancer, robotic hepatectomy for liver cancer, and rNSM.
In addition, visiting international surgeons regularly spend time at the UT Southwestern Simulation Center to immerse themselves in hands-on training rather than just observing procedures and techniques. UT Southwestern surgeons, including Dr. Polanco, have also visited those surgeons’ hospitals to provide additional guidance and skill refinement in robotic-assisted techniques.
Adam Yopp, M.D., is Professor of Surgery, Chief of the Division of Surgical Oncology, and Surgical Director of the Liver Tumor Program. He specializes in cancer surgeries for the GI tract, liver, pancreas, stomach, and bile duct. Dr. Yopp holds The Occidental Chemical Chair in Cancer Research and is a member of the Experimental Therapeutics Research Program at Simmons Cancer Center.
Patricio Polanco, M.D., is Associate Professor of Surgery in the Division of Surgical Oncology and Director of Robotic Surgery Training, Co-Director of the Pancreatic Cancer Program, and Co-Director of the Pancreatic Cancer Prevention Clinic. Dr. Polanco is an affiliate member of the Population Science and Cancer Control Research Program at Simmons Cancer Center.
Farrukh Awan, M.D., and his team are uniquely positioned to help chronic lymphocytic leukemia patients.
After undergoing a routine physical in September 2015, William Marks was diagnosed with chronic lymphocytic leukemia (CLL). Following an initial consultation with an oncologist, Mr. Marks left feeling more bewildered and distressed than when he first received his diagnosis.
“Both my wife and I were distraught that chemotherapy may be our only option,” Mr. Marks says. He accepted a friend’s suggestion and sought a second opinion from Farrukh Awan, M.D., a Professor of Internal Medicine in the Division of Hematology and Oncology at UT Southwestern. Dr. Awan is highly skilled in the treatment of CLL as well as other types of leukemia and lymphoma.
Much to the couple’s surprise, chemotherapy was not the only treatment option. A number of clinical trials were available at UT Southwestern. After enrolling in the cooperative group ECOG9161 clinical trial offering a combined targeted drug therapy with obinutuzumab and ibrutinib, Mr. Marks achieved a complete remission of his cancer. He
has been in complete remission for several years while being on maintenance treatment.
“I’ll never forget sitting with Dr. Awan. His comforting words reassured me that it wasn’t the end at all. I knew he was our doctor,” Mr. Marks says. “Having witnessed my father’s battle with myeloma, I wanted to spare my family from watching me go through chemotherapy.”
According to Dr. Awan, the landscape of CLL treatment is rapidly evolving due to novel targeted therapies that show effectiveness, improved safety, patient tolerability, and the potential for improving overall survival. He notes that these agents also improve outcomes for patients with high-risk and relapsed disease.
“The goal of therapy has evolved from achieving a clinical complete remission to eliminating minimal residual disease,” Dr. Awan explains. With many options available, treatment for CLL is becoming more individualized, he adds.
Over the past decade, researchers have established that chemotherapy has no role for the management of patients with CLL. In addition, they’ve discovered that smart targeted therapies like Bruton tyrosine kinase (BTK) and B-cell lymphoma 2 (Bcl-2) inhibitors are the drugs of choice for most patients who require treatment.
With respect to the efficacy of BTK inhibitors, three agents – acalabrutinib, zanubrutinib, and ibrutinib – are closely matched. Bcl-2 inhibitors in combination with an anti-CD20 monoclonal antibody (obinutuzumab) are also considered a promising option for select patients. These are distinct approaches currently utilized for the treatment of CLL. However, it is possible that the field may shift toward a combination approach, incorporating targeted antibody treatments like obinutuzumab and bcl-2 inhibitors to BTK-inhibitor based treatments.
“When deciding on a treatment, it is essential to carefully evaluate the risks and benefits of each drug and take into account the patient’s unique needs and preferences,” Dr. Awan says. “This is a critical factor in maximizing efficacy and minimizing unwanted side effects of therapy.”
“When deciding on a treatment, it is essential to carefully evaluate the risks and benefits of each drug and take into account the patient’s unique needs and preferences. This is a critical factor in maximizing efficacy and minimizing unwanted side effects of therapy.”
— FARRUKH AWAN, M.D.
“A number of promising new treatments for CLL are currently in clinical trials,” Dr. Awan adds. “We’re hoping that further combinations of therapies delivered early will allow us to eventually achieve a cure.”
Simmons Cancer Center is actively launching cutting-edge trials for CLL across all risk groups. “Our goal is to turn CLL into a chronic illness with good quality of life rather than a death sentence and potentially cure a percentage of patients within the next few years,” Dr. Awan explains.
In Mr. Marks’ case, he not only found an alternative to chemotherapy but also a treatment that was effective for his disease.
“My story could have been written in an entirely different way,” Mr. Marks says. “Having completed a 35-year career in health care, I can confidently say that UT Southwestern is one of the most exceptional cancer centers I’ve had the privilege to be a part of. I owe my life to my hero, Dr. Awan.”
Farrukh Awan, M.D., is Professor of Internal Medicine in the Division of Hematology and Oncology at UT Southwestern. He specializes in stem cell transplantation, cellular therapies, and treatments for leukemia and lymphoma. Dr. Awan is a member of the Experimental Therapeutics Research Program at Simmons Cancer Center.
FDA’s expanded use for belzutifan culminates decades-long journey from gene discovery to first-in-class drug.
The U.S. Food & Drug Administration (FDA) has expanded the approved use of belzutifan for treatment of metastatic kidney cancer, marking another milestone for the novel, first-in-class hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor initially discovered at UT Southwestern.
“This remarkable journey exemplifies UT Southwestern’s dedication to converting important scientific discoveries into improvements in patient care and underscores the power of innovation and team science in advancing health care,” says James Brugarolas, M.D., Ph.D., Professor of Internal Medicine in the Division of Hematology and Oncology and founding Director of the Kidney Cancer Program at Harold C. Simmons Comprehensive Cancer Center. “With the FDA’s approval, thousands of patients in need will gain access to this important new treatment.”
Belzutifan was initially approved by the FDA in 2021 for adult patients with familial kidney cancer with mutations in the von Hippel-Lindau (VHL) gene. The latest approval broadens the drug’s label to anyone with metastatic clear cell renal cell carcinoma (ccRCC).
“This remarkable journey exemplifies UT Southwestern’s dedication to converting important scientific discoveries into improvements in patient care and underscores the power of innovation and team science in advancing health care.”
— JAMES BRUGAROLAS, M.D., PH.D.
HIF-2α was discovered in the late 1990s by Steven McKnight, Ph.D., Professor of Biochemistry, and David Russell, Ph.D., Professor Emeritus of Molecular Genetics, at UT Southwestern. Research elsewhere subsequently showed that it played a key role in the growth of kidney cancer.
Kevin Gardner, Ph.D., and Richard Bruick, Ph.D., both former
James Brugarolas, M.D., Ph.D., is Professor of Internal Medicine in the Division of Hematology and Oncology at UT Southwestern. He is founding Director of the Kidney Cancer Program at Simmons Cancer Center. He also holds the Sherry Wigley Crow Cancer Research Endowed Chair in Honor of Robert Lewis Kirby, M.D, and is a member of the Cellular Networks in Cancer Research Program at Simmons Cancer Center.
UTSW professors, then studied the protein, identifying an unusual cavity within the HIF-2α molecule. They speculated that this cavity may provide a foothold for a drug and performed a screen of UT Southwestern’s chemical library to identify specific compounds that could bind to and thus block HIF-2α function. In 2010, UT Southwestern started Peloton Therapeutics with the purpose of clinically developing HIF-2α inhibitors as an anti-cancer targeted therapy.
Lead compounds developed by Peloton were evaluated in the Brugarolas Lab, where they were tested for activity against human kidney tumors transplanted in mice. These studies provided the first evidence that the compounds had activity against human kidney cancer.
Kevin Courtney, M.D., Ph.D., Associate Professor of Internal Medicine, Division of Hematology and Oncology, conducted a clinical trial along with Dr. Brugarolas and several other investigators from other institutions. Their study showed for the first time that HIF-2α inhibitors were safe and may be effective in patients.
Pharmaceutical giant Merck acquired Peloton in 2019 and now markets belzutifan under the brand name Welireg.
In 2023, results evaluating belzutifan for treatment of metastatic ccRCC showed a statistically significant and clinically meaningful delay in tumor progression compared with everolimus, the former standard of care. The results led to the expanded FDA approval.
“Imagine being stage 4 and then getting a restart,” says Texas businessman Mark Hilz, who was initially diagnosed with kidney cancer in 2011 and started taking belzutifan last year after transferring to UT Southwestern and Dr. Brugarolas’ care. “I’m also able to maintain a great quality of life on this treatment.”
The Kidney Cancer Program within UT Southwestern’s Simmons Cancer Center is one of only two National Cancer Institute-designated Specialized Programs of Research Excellence (SPORE) in kidney cancer. Established in 2013, the program has become a leader worldwide.
Disclosures: UT Southwestern and some of its researchers will receive financial compensation, through prior agreements with Peloton, based on belzutifan’s FDA approval.
UT Southwestern Harold C. Simmons Comprehensive Cancer Center is among the first in the nation and the first in Texas to offer radiation treatments using a new technology that combines positron emission tomography (PET) imaging with radiotherapy to precisely treat bone and lung cancers.
SCINTIX biology-guided radiotherapy (BgRT), delivered by the RefleXion X1 unit, is an option for patients with primary and metastatic bone and lung cancers. Using a radioactive tracer that interacts with cancer cells to produce photonic signals from emissions, the system targets tumors by using cancer’s acquired activity to specifically target diseased tissue.
“In essence, we are now able to assess the exact location of one or multiple tumors as well as their individual biological signatures,” said Aurelie Garant, M.D., Assistant Professor of Radiation Oncology and member of the Simmons Cancer Center who leads the Brachytherapy Program.
“Given that not all tumors are created equal, biology-guided radiotherapy provides us with the unique opportunity to target the areas that are most biologically active, while sparing normal tissues.”
SCINTIX’s novel technology uses each cancer’s biologic processes to determine how much radiation to deliver, even if the target moves. The X1 continuously constructs a map from emissions data to target the locations for beamlets of radiation, delivered
Moncrief Cancer Institute, a nonprofit, communitybased early detection and support center and part of the UT Southwestern Harold
C. Simmons Comprehensive Cancer Center, debuted its new Mobile Screening Clinic in March. The second in its fleet, the $1 million, 36-foot
with subsecond speed. At the same time, SCINTIX tracks tumor motion generated by internal processes such as breathing and digestion as well as movement by patients.
The technology received Breakthrough Device designation in 2021 from the FDA and clearance to use the therapy for lung and bone cancer treatment in 2023. UT Southwestern, which led a study on its efficacy, was only the second institution in the country to install it.
cancer screening clinic doubles Moncrief’s capacity to provide free cancer screening services to underinsured and uninsured populations in Tarrant County.
Eligible residents in Tarrant County can receive free breast cancer and prostate cancer screenings on the new Mobile Screening Clinic, which is ADA-accessible and equipped with the latest medical technologies, including digital 3D mammography and highspeed telemedicine links to cancer experts.
Since 2010, Moncrief has provided free screenings for a variety of cancers to more
than 100,000 people in rural and underserved populations across 67 counties in Texas. To reach the public, the institute’s community outreach team preaches a simple message: Early cancer detection saves lives.
“The earlier you diagnose a cancer, the simpler and less expensive it is to treat,” says Keith Argenbright, M.D., Director of Moncrief Cancer Institute and Professor at the Simmons Cancer Center. “By detecting cancers earlier, we estimate that between $5 and $6 is saved (by individuals and health systems) for every dollar invested into our program.”
Tian Zhang, M.D., has been appointed Associate Director of Clinical Research for Simmons Cancer Center. She will oversee all clinical research activities. Dr. Zhang joined UT Southwestern in 2021 as an Associate Professor in the Division of Hematology and Oncology in the Department of Internal Medicine after being on the faculty at Duke University Medical Center.
Zhijian “James” Chen, Ph.D., Professor of Molecular Biology, has been awarded the 2023 Louisa Gross Horwitz Prize from Columbia University in recognition of his groundbreaking work on innate immunity – the body’s response to pathogens that quickly identifies and destroys cells and tissues that have been attacked. Nearly half of the scientists who have received the Horwitz Prize over the past 56 years subsequently were awarded the Nobel Prize.
Dr. Chen is a member of the Cellular Networks in Cancer Research Program at Simmons Cancer Center.
Vincent Tagliabracci, Ph.D., Associate Professor of Molecular Biology, received the 2024 Edith and Peter O’Donnell Award in Biological Sciences from the Texas Academy of Medicine, Engineering, Science and Technology (TAMEST) for broadening the understanding of pseudokinases, a family of enzymes that play key roles in many physiological and pathological processes.
Dr. Tagliabracci is a member of the Cellular Networks in Cancer Research Program at Simmons Cancer Center.
Todd Aguilera, M.D., Ph.D., Assistant Professor of Radiation Oncology, has been named one of 11 inaugural Cancer Moonshot Scholars as part of the Unity Agenda sponsored by President Biden and the National Institutes of Health.
Dr. Aguilera, a radiation oncologist with expertise in molecular engineering, molecular imaging, and tumor immunology, will receive nearly $3.3 million from the National Cancer Institute (NCI) over five years to fund research seeking new treatments for rectal cancer.
Dr. Aguilera is a member of the Experimental Therapeutics Research Program at Simmons Cancer Center.
Jason B. Fleming, M.D., FACS, former Chair of Gastrointestinal Oncology at Moffitt Cancer Center in Tampa, Fla., has rejoined UT Southwestern as Deputy Director for Clinical Affairs of the Harold C. Simmons Comprehensive Cancer Center.
Dr. Fleming was a faculty member in the Department of Surgery at UT Southwestern from 1999 to 2005.
Dr. Fleming is an internationally recognized surgical oncologist specializing in the treatment of pancreatic cancer and a prolific academician with over 300 peer-reviewed publications. He will direct all clinical operations at Simmons Cancer Center and drive strategies to advance innovative, patient-centered cancer care across the UT Southwestern Health System, including its regional locations. He will also promote and further establish the center as a national leader in multidisciplinary, evidence-based patient care, cancer clinical trials, and novel treatment approaches.
The following list features grants awarded to Harold C. Simmons Comprehensive Cancer Center members from August 2023 to January 2024 for research that is entirely cancer-specific:
Todd Aguilera, M.D., Ph.D. Early Response to Radiotherapy and Immunotherapy in Rectal Cancer: An Integrated Molecular, Cellular, and Spatial Approach
National Cancer Institute
Kiyoshi Ariizumi, Ph.D. Tumor Extravasation in Zebrafish as a Prognostic Marker and a Therapeutic Target for Metastasis of Kidney Cancer U.S. Department of Defense
Carlos Arteaga, M.D., in Collaboration With Vanderbilt University Medical Center Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancer
National Cancer Institute
James Brugarolas, M.D., Ph.D.
PET Imaging of HIF-2a in Renal Cancer U.S. Department of Defense
Isaac Chan, M.D., Ph.D. Using Natural Killer Cells to Prevent Breast Cancer Metastases
National Cancer Institute
Using Natural Killer Cells to Treat Metastatic Breast Cancer
Mary Kay Ash Foundation
Kenneth Chen, M.D. DROSHA Regulates Mesenchymal Expression and Chemosensitivity in Wilms Tumor U.S. Department of Defense
Stephen Chung, M.D. Regulation of Protein Synthesis in Leukemia Stem Cells
National Cancer Institute
Nicholas Conrad, Ph.D. Targeting MTAP-Deficient Cancers by Inhibiting MAT2A Induction
American Cancer Society
Suzanne Conzen, M.D. Fellowship (Predoc: M.E. Hofstad) Elucidating Mechanisms of Therapy Response in BRCA2 Mutant Prostate Cancers
National Cancer Institute
Ian Corbin, Ph.D. Leveraging SCARB1 Overexpression for the Treatment of ccRCC With Low-Density Lipoprotein Nanocarriers U.S. Department of Defense
Lindsay Cowell, Ph.D. i-AKC: Integrated AIRR Knowledge Commons
National Institute of Allergy and Infectious Diseases
Lindsay Cowell, Ph.D., and Raquibul Hannan, M.D., Ph.D. Leveraging Biophysicochemical Motifs in T Cell Receptor Antigen Binding Regions and Antigen Co-Occurrence to Predict Response to Immune Checkpoint Inhibitors
U.S. Department of Defense
Gaudenz Danuser, Ph.D. Fellowship (Instructor: D. Segal) The Context-Dependent Role of Caveolin-1 as a Driver of Cellular Adaptation in Ewing Sarcoma National Cancer Institute
Anthony Davis, Ph.D. Evaluation of the Cellular and Molecular Responses of Lung and Liver Cells Derived From iPSCs With Varying Intrinsic Radiosensitivity to Space Radiation National Aeronautics and Space Administration Johnson Space Center
Arthur Hong, M.D. Actionable Categories of Avoidable Hospital Care Among Adults With Cancer National Cancer Institute
Yujin Hoshida, M.D., Ph.D., in Collaboration With Duke University & Massachusetts General Hospital Therapeutic Modulation of a Proteomic HCC Risk Signature With Statins in Patients With Liver Cirrhosis National Cancer Institute
Mamta Jain, M.D. STOP-HCC-HCV: Screen, Treat, or Prevent Hepatocellular Cancer-Hepatitis C: Expansion to All Adults Cancer Prevention and Research Institute of Texas
Jane Johnson, Ph.D. Mechanisms Controlling the Progression of Prostate Adenocarcinoma to Neuroendocrine Cancer
U.S. Department of Defense
Payal Kapur, M.D., and James Brugarolas, M.D., Ph.D. Leveraging Biophysicochemical Motifs in T Cell Receptor Antigen Binding Regions and Antigen Co-Occurrence to Predict Response to Immune Checkpoint Inhibitors
U.S. Department of Defense
Matteo Ligorio, M.D., Ph.D. Fellowship (Postdoc: G. Pontecorvi) Shifting the Paradigm of Pancreatic Cancer Progression: Unveiling the Role of Pancreatic Enzymes
American-Italian Cancer Foundation
Weibo Luo, Ph.D. Characterization of Epigenetic and Metabolic Vulnerability in VHL-Deficient ccRCC and its Therapeutic Potential
U.S. Department of Defense
Peter Ly, Ph.D. Fellowship (Predoc: E. Maurais) Non-Cell Autonomous Consequences of Cytoplasmic DNA
National Cancer Institute
Ravikanth Maddipati, M.D. Optogenetic Engineering of Tumor Topography in Native Tissue Environments
National Cancer Institute
Ananth Madhuranthakam, Ph.D.
Novel 3D DWI for Detection and Characterization of Prostate Cancer in Men With Pelvic Metal Implants National Cancer Institute
Next-Generation WholeBody MRI for Detection and Assessment of Therapy Response in Bone Lesions National Institute of Arthritis and Musculoskeletal and Skin Diseases
Srinivas Malladi, Ph.D. Delineate Tumor Immune Contexture That Shapes ccRCC Metastatic Progression and Response to Immunotherapy
U.S. Department of Defense
Samuel McBrayer, Ph.D. Fellowship (Resident: J. Traylor) Investigating Acquired Resistance to DHODH Inhibition in IDH Mutant Glioma Neurosurgery Research & Education Foundation
David McFadden, M.D., Ph.D. Identifying Metabolic Dependencies in Hurthle Cell Carcinoma of the Thyroid National Cancer Institute
Joshua Mendell, M.D., Ph.D. Fellowship (Postdoc: M.L. Norris) Regulation and Function of Subcellular RNA Localization in Neural Crest Cells and Their Derivatives
Eunice Kennedy Shriver
National Institute of Child Health and Human Development
Deepak Nijhawan, M.D., Ph.D.; Jef Karel De Brabander, Ph.D.; Joseph Martin Ready, Ph.D.; and Tian Qin, Ph.D. A Platform for the Rapid Discovery of Novel Small Molecules for Chemical Biology
Robert A. Welch Foundation
Kathryn O’Donnell-Mendell, Ph.D.
The Role of Translation
Initiation Factor eIF5B in Lung Cancer Pathogenesis National Cancer Institute
Venuprasad Poojary, Ph.D. Znf740 in the Regulation of CD8+T Cell Exhaustion National Cancer Institute
Xiaofeng Qi, Ph.D. Recruitment of First-Time Tenure-Track Faculty Members Cancer Prevention and Research Institute of Texas
Luke Rice, Ph.D. Conformation and Recognition in Microtubule Dynamics
National Institute of General Medical Sciences
Single-Molecule Interrogation of Microtubule Dynamics Mechanisms
National Institute of General Medical Sciences
Amit Singal, M.D., M.S., and Yujin Hoshida, M.D., Ph.D. Precision Risk Stratification and Screening for Hepatocellular Carcinoma, HCC Among Patients With Indeterminate Liver Nodules
National Cancer Institute
Epigallocatechin Gallate for Prevention of Lethal Cirrhosis Complications
National Cancer Institute
Daniel Siegwart, Ph.D. Genetic Drug Engineering Program at UTSW Medical Center Pfizer
Joseph Su, Ph.D., M.P.H. Modulation Effect of Folate on the Association Between Inorganic Arsenic and Aggressive Prostate Cancer U.S. Department of Defense
Xiankai Sun, Ph.D. PET Imaging of HIF-2a in Renal Cancer U.S. Department of Defense
Richard Wang, M.D., Ph.D. Regulation and Function of Viral and Endogenous Circular RNA in Cancer National Cancer Institute
Chen Yao, Ph.D. Targeting Stem-Like CD8 T Cells in Immunotherapy Against Kidney Cancer U.S. Department of Defense
Qing Zhang, Ph.D.
Identification of DCLK2-TBK1 Signaling Axis as a Potential Therapeutic Target in Kidney Cancer National Cancer Institute
You Zhang, Ph.D. High-Precision Proton Therapy for Liver Cancer: Developing an End-to-End Strategy With Real-Time Liver Tumor Localization and On-theFly Plan Delivery Adaptation
National Institute of Biomedical Imaging and Bioengineering
Yanbin Zheng, Ph.D. Ectopic PLAG1 Plus Loss of p53 Drives Rhabdomyosarcoma Rally Foundation for Childhood Cancer Research
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Refer a Patient
Our team welcomes the opportunity to partner with physicians in the care of patients with cancer.
If you would like to refer a patient to Simmons Cancer Center, please call 214-645-HOPE (4673) or 866-460-HOPE (4673)
Insurance and medical records information are requested with new patients, and we will schedule an appointment within a few days of referral. Once we have been able to schedule a time convenient for your patient, we will notify you.
WHY REFER TO SIMMONS CANCER CENTER
UT Southwestern respects the relationship you have with your patients, and we are committed to open communication throughout the course of treatment. We look forward to collaborating with referring physicians to provide the highest quality of care to your patients.