Bladder Cancer Breakthrough Dramatically Extends Survival
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From the Duke Cancer Institute archives. Content may be out of date.
People with advanced urothelial cancers — most of whom have bladder cancer — now have a new first-line treatment that will extend their survival for the first time in almost 40 years. The new treatment, approved by the Food and Drug Administration (FDA) on December 15, combines pembrolizumab, an immunotherapy agent, with enfortumab vedotin, an antibody drug conjugate.
The FDA had previously approved the drug combination in April for people who are ineligible for cisplatin-containing chemotherapy, a much smaller group of people. Bladder cancer is the fifth most common cancer.
Data from a phase three clinical trial, presented at the European Society of Medical Oncologists in October, showed that the experimental therapy nearly doubled the median survival to 31.5 months, compared to an average survival of just 16.5 months in the standard chemotherapy arm. Progression-free survival also doubled.
Furthermore, a slowing of the progression rate after 18 months in almost 40% of the experimental arm suggests that some people may live much longer. Historically, only 5% of advanced bladder cancer patients survived five years.
Some People Already Receiving the New Drug Combination
Because the FDA previously approved this new treatment for use later in the course of metastatic bladder cancer, oncologists at the Duke Cancer Institute said that they have already been using the combination.
Christopher Hoimes, DO, a medical oncologist in the DCI Center for Prostate and Urologic Cancers, said that people with urothelial cancer should visit a comprehensive cancer center to see if the treatment is right for them and to develop a guidance plan on dosing and management.
A Role in the Drug’s Early Development
Hoimes has been studying this breakthrough treatment combination since 2017, when he was part of a team developing the idea for the combination.
Hoimes' reasons for believing that the two agents would work well together were complex, but he boiled down his thinking to this: targeting the cancer’s surface adhesion receptors could potentially enhance the immune response.
Despite having a sound scientific rationale for how the combination would work, he understood that the odds were against him in a field where hundreds of cancer therapies and combinations had been tested and failed for this intractable disease.
Convincing Two Companies to Work Together
Another matter threatening to hinder progress was that the drugs Hoimes wanted to study were owned by two different companies — pembrolizumab by Merck, and enfortumab vedotin by Seattle Genetics (now Seagen Inc.).
Companies are typically reluctant to combine an investigational product to other treatments because they can limit their indications and increase side effects, according to medical oncologist Daniel George, MD, director of the DCI Center for Prostate and Urologic Cancers, who was not involved in the trial. To do so, they must be convinced that a collaboration is worth the risk, extra time, and resources, said George.
What motivated Hoimes to push for the two companies to study the combination, he said, was his passion for studying bladder cancer and generating similar enthusiasm amongst the pharmaceutical teams to work together to improve outcomes for patients.
Hoimes felt frustrated after years of watching patients suffer through months of grueling chemotherapy and life-altering surgery that rewarded them with only a small increase in survival. And too many of his patients weren’t even eligible to get the chemotherapy, he said.
Hoimes and the team of investigators convinced the two companies to work together on a phase one study, for which he served as principal investigator (PI). Positive data from that trial led to a phase two study, which Hoimes also led, and an FDA accelerated approval for the combination for a select population in April of 2023.
Outlook for Advanced Bladder Cancer May Improve Even More
The outlook for people with aggressive bladder cancer may improve even more in the future, after completion of an ongoing phase three study of this same drug combination in the perioperative setting — before and after people undergo surgery — to try and stop the cancer from spreading.
Hoimes is a lead PI and on the scientific committee for the international study, called Keynote-B15, which has recently fully enrolled.
“This trial raises the stakes even more. This is the curative-intent setting, where a greater proportion of patients with urothelial cancer who are candidates for surgery . . . may be cured of their disease. I’m certainly hopeful for similarly stunning results as what we just had for patients who are metastatic, but we need to wait for the data to guide us in this earlier-stage surgical setting,” he said.
Alexandra Thomas, MD, Associate Director of Translational Research for the Duke Cancer Institute (DCI), and Andrew Armstrong MD, George Barth Geller Distinguished Professor for Research in Cancer, have received continued National Cancer Institute (NCI) funding to support DCI’s participation as a Lead Academic Participating Site (LAPS) in the National Clinical Trials Network (NCTN).The competitively renewed $4.58 million, 6-year award will help expand access to NCI-sponsored clinical trials, support Duke investigators’ leadership in the development and conduct of multicenter cancer studies and strengthen infrastructure that advances practice-changing cancer research. Dr. Thomas serves as contact PI and Dr. Armstrong serves as co-PI of this important award.The award supports Duke’s enrollment efforts across the NCTN trial portfolio which includes a broad range of cancer types and treatment approaches. It also provides resources to mentor future clinical trial leaders and fosters multidisciplinary collaboration across DCI.Thomas will work alongside Dr. Armstrong, who serves also as Director of Research for the DCI Center for Prostate and Urologic Cancers, to help guide Duke’s contributions to this national research network, advancing innovative clinical trials, and bringing new treatment opportunities to patients throughout the region.Duke has been a LAPS since the initiation of this program in 2014. From 2014-2025, the work at Duke was led by Jeffrey Crawford, MD, who has recently retired.Dr. Thomas shared what this award will mean for DCI and its clinical trials work: “This award places DCI in an elite group of cancer centers recognized by the NCI as vital to advancing the clinical trials that improve outcomes for our patients with cancer. It reflects the extraordinary dedication of our investigators, research teams, and, most importantly, the patients who partner with us in this research. We are excited to build on this momentum, expand access to innovative trials across our region, and mentor the next generation of clinical trial leaders.”
Duke Cancer Institute kicked off its first signature fundraising event with a powerful show of support for cancer research, innovation, and patient care. Duke Rides, held on October 3 in Wilson Gym, united more than 1,100 donors, sponsors, volunteers, and supporters in a shared mission to improve the lives of people affected by cancer.Duke-blue strobe lights and high-energy music like Taylor Swift’s “Shake It Off” and Britney Spears “Hit Me Baby One More Time” kept everyone energized while they took turns cycling on stationary bikes. During rider changes, cancer survivors told their stories, with members of their care teams at their sides.“Raising more than $675k in our first year is nothing short of extraordinary,” said Diane Reidy-Lagunes, MD, physician vice president of cancer services, Duke University Health System.“What makes this event so special is the way it brings together the entire Duke community—our patients and families, physicians, nurses, researchers, staff, students, alumni, and friends. We are united by a shared commitment to beating cancer and being part of something bigger than any one of us,” said Reidy-Lagunes."We have wanted a signature event for many years," said Debbie Taylor, assistant vice president, Duke Cancer Institute and Duke Children’s Development. "But we don't have a big events team, which makes getting something like this off the ground incredibly difficult. We are so grateful for the colleagues and donors who stepped up and helped us turn an idea into a reality."Among the event’s top fundraisers was a team led by Tony and Teddie Brown, which raised an impressive $233, 859.For Tony Brown, supporting Duke Rides is deeply personal. A Professor of the Practice Emeritus in Duke’s Sanford School of Public Policy, where he taught for 28 years, Brown has experienced firsthand the impact of exceptional care. His treatment under Hope Uronis, MD, a gastrointestinal medical oncologist, and his broader care team inspired him to help ensure that other patients receive the same support.“The care I’ve received from Dr. Uronis and my entire team has been remarkable,” Brown said. “The combination of competence, compassion, and collaboration has meant more to me than words can express,” said Brown.Lenny Santoro, another survivor, echoed that sentiment. "I'm here today because of the excellent care that I received more than eight years ago for my prostate cancer. And because of three clinical trials that Dr. Dan George and Duke gave me the opportunity to join," he said.Other top fundraising teams included the Duke Alumni for Cancer Survival and those supporting the following disease groups: pancreatic cancer, breast cancer, gastrointestinal cancer, genitourinary cancers (prostate and urologic), and pediatric cancers.The funds raised will provide much needed support for research aimed at improving treatment options and outcomes for cancer patients."Next time," said Taylor, "our goal is to raise over a million."
Alexandra Thomas, MD, Associate Director of Translational Research for the Duke Cancer Institute (DCI), and Andrew Armstrong MD, George Barth Geller Distinguished Professor for Research in Cancer, have received continued National Cancer Institute (NCI) funding to support DCI’s participation as a Lead Academic Participating Site (LAPS) in the National Clinical Trials Network (NCTN).The competitively renewed $4.58 million, 6-year award will help expand access to NCI-sponsored clinical trials, support Duke investigators’ leadership in the development and conduct of multicenter cancer studies and strengthen infrastructure that advances practice-changing cancer research. Dr. Thomas serves as contact PI and Dr. Armstrong serves as co-PI of this important award.The award supports Duke’s enrollment efforts across the NCTN trial portfolio which includes a broad range of cancer types and treatment approaches. It also provides resources to mentor future clinical trial leaders and fosters multidisciplinary collaboration across DCI.Thomas will work alongside Dr. Armstrong, who serves also as Director of Research for the DCI Center for Prostate and Urologic Cancers, to help guide Duke’s contributions to this national research network, advancing innovative clinical trials, and bringing new treatment opportunities to patients throughout the region.Duke has been a LAPS since the initiation of this program in 2014. From 2014-2025, the work at Duke was led by Jeffrey Crawford, MD, who has recently retired.Dr. Thomas shared what this award will mean for DCI and its clinical trials work: “This award places DCI in an elite group of cancer centers recognized by the NCI as vital to advancing the clinical trials that improve outcomes for our patients with cancer. It reflects the extraordinary dedication of our investigators, research teams, and, most importantly, the patients who partner with us in this research. We are excited to build on this momentum, expand access to innovative trials across our region, and mentor the next generation of clinical trial leaders.”
Duke Cancer Institute kicked off its first signature fundraising event with a powerful show of support for cancer research, innovation, and patient care. Duke Rides, held on October 3 in Wilson Gym, united more than 1,100 donors, sponsors, volunteers, and supporters in a shared mission to improve the lives of people affected by cancer.Duke-blue strobe lights and high-energy music like Taylor Swift’s “Shake It Off” and Britney Spears “Hit Me Baby One More Time” kept everyone energized while they took turns cycling on stationary bikes. During rider changes, cancer survivors told their stories, with members of their care teams at their sides.“Raising more than $675k in our first year is nothing short of extraordinary,” said Diane Reidy-Lagunes, MD, physician vice president of cancer services, Duke University Health System.“What makes this event so special is the way it brings together the entire Duke community—our patients and families, physicians, nurses, researchers, staff, students, alumni, and friends. We are united by a shared commitment to beating cancer and being part of something bigger than any one of us,” said Reidy-Lagunes."We have wanted a signature event for many years," said Debbie Taylor, assistant vice president, Duke Cancer Institute and Duke Children’s Development. "But we don't have a big events team, which makes getting something like this off the ground incredibly difficult. We are so grateful for the colleagues and donors who stepped up and helped us turn an idea into a reality."Among the event’s top fundraisers was a team led by Tony and Teddie Brown, which raised an impressive $233, 859.For Tony Brown, supporting Duke Rides is deeply personal. A Professor of the Practice Emeritus in Duke’s Sanford School of Public Policy, where he taught for 28 years, Brown has experienced firsthand the impact of exceptional care. His treatment under Hope Uronis, MD, a gastrointestinal medical oncologist, and his broader care team inspired him to help ensure that other patients receive the same support.“The care I’ve received from Dr. Uronis and my entire team has been remarkable,” Brown said. “The combination of competence, compassion, and collaboration has meant more to me than words can express,” said Brown.Lenny Santoro, another survivor, echoed that sentiment. "I'm here today because of the excellent care that I received more than eight years ago for my prostate cancer. And because of three clinical trials that Dr. Dan George and Duke gave me the opportunity to join," he said.Other top fundraising teams included the Duke Alumni for Cancer Survival and those supporting the following disease groups: pancreatic cancer, breast cancer, gastrointestinal cancer, genitourinary cancers (prostate and urologic), and pediatric cancers.The funds raised will provide much needed support for research aimed at improving treatment options and outcomes for cancer patients."Next time," said Taylor, "our goal is to raise over a million."
