Tony Berberabe

Nubeqa/ADT treatment led to positive impacts on HRQoL vs placebo in mHSPC: © stock.adobe.com.

Among patients with with metastatic hormone-sensitive prostate cancer (mHSPC), Nubeqa (darolutamide) and androgen deprivation therapy (ADT) treatment led to positive impacts on health-related quality of life (HRQoL) when compared with placebo and ADT, according to patient-reported outcome data from the phase 3 ARANOTE trial.

Notably, these data, which were shared at the

, also highlighted clinically meaningful delays in pain progression with the investigative treatment.

Furthermore, on June 3rd, 2025, just days after the data was presented at the meeting, the United States Food and Drug Administration 

(FDA) granted approval to Nubeqa for the treatment of patients

 with mHSPC based on data from the ARANOTE study.

“[This] is the first and only androgen receptor antagonist to demonstrate clinically meaningful delays in pain progression and overall well-being, including those specific areas of social and family well-being, functional well-being, and urinary symptoms. Health-related quality of life benefits may be greatest in patients treated with Nubeqa who had ultralow [prostate-specific antigen (PSA)] levels,” explained Dr. Alicia Morgans, in a presentation of the study

Morgans, a genitourinary medical oncologist who serves as the director of the Survivorship Program at Dana-Farber Cancer Center and associate professor of Medicine at Harvard Medical School, in Boston.

In this analysis, multiple patient-reported outcome measures were used to assess patient experience during treatment. They included the Brief Pain Inventory Short Form (BPI-SF), used to assess pain, specifically the worst pain in the past 24 hours, and the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, a questionnaire evaluating overall quality of life in patients with prostate cancer. The FACT-P includes domains such as physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer-specific assessments, including bowel and urinary difficulties.

The analysis showed that Nubeqa was associated with a delay in pain progression, defined as the time from randomization to a confirmed increase of at least 2 points in worst pain over the nadir or the initiation of opioid treatment for at least 7 days versus placebo. When assessing time to pain progression by PSA response, patients who reached a PSA of less than 0.02 or 0.2 nanograms per millilitre (ng/mL) at any time had a longer time to pain progression than patients with a PSA greater than or equal to 0.2 ng/mL.

“I think this is a critical thing for us to recognize that our patients’ quality of life, intuitively, of course, is associated with disease control. But this is also helpful for us in clinical practice so that we can encourage patients as their cancer appears to be better controlled; we expect them to feel better,” Morgans explained during the presentation.

Regarding time to FACT-P deterioration, Nubeqa was associated with an extension in median time to deterioration, defined as the first decrease of 10 or more points in the total score, by 5.1 months versus placebo. Improvements were most prominent in the areas of social and family well-being, functional well-being, and prostate cancer concerns, including urinary symptoms. Similarly with the BPI-SF, patients with a PSA of 0.02 or 0.2 ng/mL at any time had a longer time to HRQoL deterioration versus a PSA of 0.2 ng/mL or greater.

The phase 3 ARANOTE trial assessed Nubeqa plus ADT versus placebo and ADT for the treatment of mHSPC. 

2024 European Society of Medical Oncology (ESMO) Congress

 showed that the combination reduced the risk of radiographical progression or death by 46% and demonstrated a favorable safety profile.

 for the study combination in patients with mHSPC in November, 2024.

the 2025 ASCO Genitourinary Cancers Symposium

A total of 669 patients enrolled globally were randomly assigned on a 2:1 basis to receive Nubeqa 600 mg twice daily plus ADT (446 patients) or placebo plus ADT (223 patients). The primary end point was radiographic progression-free survival by central blinded review, with secondary end points including overall survival, time to PSA progression, and safety.

At a data cutoff of June 7, 2024, the median follow-up was 25.3 months for the Nubeqa group and 25.0 months for the placebo group. The median radiographic progression-free survival for Nubeqa plus ADT was not reached compared with 25.0 months for placebo plus. At 24 months, the rate of radiographic progression-free survival was 70.3% for the Nubeqa group versus 52.1% for the placebo group.

The median treatment duration was 24.2 months in the Nubeqa group compared with 17.3 months for the placebo group. Incidence of treatment-emergent side effects was similar between the arms, with 91.0% any-grade and 30.8% grade 3 (severe) or 4 (life-threatening) treatment-emergent side effects with Nubeqa plus ADT and 90.0% any-grade and 30.3% grade 3 or 4 with ADT plus placebo.

“Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial” by Dr. Moregans, et al. 

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Articles

Nubeqa (darolutamide) combined with androgen deprivation therapy (ADT) significantly improved health-related quality of life (HRQoL) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo and ADT, as demonstrated in the phase 3 ARANOTE trial. The treatment delayed pain progression and was associated with better social, family, and functional well-being. Following these findings, the FDA approved Nubeqa for mHSPC. The trial also showed a 46% reduction in radiographic progression or death risk, with a favorable safety profile and extended radiographic progression-free survival.

Nubeqa and ADT treatment led to positive impacts on health-related quality of life vs placebo in metastatic hormone-sensitive prostate cancer. 

Nubeqa Combo Positively Impacts HRQoL vs Placebo in Prostate Cancer Subgroup 

Tecentriq/chemo combo reduces the risk of death vs chemo alone in dMMR, stage 3 CRC: © stock.adobe.com.

Among patients with deficient mismatch repair, stage 3 colorectal cancer and resistance to chemotherapy, Tecentriq (atezolizumab) plus chemotherapy treatment reduced the risk of recurrence or death by 50% compared with chemotherapy treatment alone, according to data from the phase 3 ATOMIC trial which were shared in a press briefing at the 

The trial sought to determine if adding an immune checkpoint inhibitor to standard care would improve outcomes after surgical resection in this population.

“These data establish this combination as a new standard treatment for patients with stage III colon cancer and deficient mismatch repair,” said lead author Dr. Frank A. Sinicrope, coleader, Gastrointestinal Cancer Program, and clinical investigator, Mayo Foundation, both in Rochester, Minnesota, during the press briefing.

ATOMIC enrolled 712 patients across more than 300 sites in the National Clinical Trials Network. Patients were eligible if they had resected stage III colon cancer, deficient mismatch repair determined by immunohistochemistry, no prior chemotherapy or radiation, and an ECOG performances status of 2 or less.

After undergoing surgery, patients were randomly assigned to receive Tecentriq plus the standard mFOLFOX6 chemotherapy regimen of oxaliplatin, leucovorin calcium, and fluorouracil, followed by 6 months of Tecentriq in the treatment arm versus mFOLFOX6 alone in the control arm. The primary end point was disease-free survival and secondary end points were overall survival and side effect profile.

At the data cutoff of February 4, 2025, the median follow-up was 37.2 months. At the second interim analysis at 75% of disease-free survival events, it was determined that the study met the protocol-specified boundary for efficacy and the data were released.

At 3 years, the combination resulted in a disease-free survival rate of 86.4% versus 76.6% for chemotherapy alone. “This is a substantial…benefit achieved,” Sinicrope said. Referring to the disease-free survival curves, Sinicrope added that “the [disease-free survival] curve is plateauing, indicating that we’re not seeing any more recurrences or death with the immunotherapy and chemotherapy combination.”

Subgroup analysis also demonstrated a positive disease-free survival benefit across subpopulations defined by age, sex, race, tumor location, and risk group for patients in the mFOLFOX plus Tecentriq arm. In particular, proximal and distal tumor location, T-stage, and risk group demonstrated disease-free survival that favored the treatment versus the control arm.

“No matter the patient’s age, their sex, their race, their location, T-stage, or N-stage, patients are doing better with the addition of immunotherapy to chemotherapy,” Sinicrope said.

The safety of mFOLFOX6 plus Tecentriq was in line with the known safety profiles of each, with a manageable increase in nonfebrile neutropenia.

“We regard [these findings] as a highly impactful study that will change clinical practice, and it actually represents the first immunotherapy adjuvant study in colon cancer,” Sinicrope concluded.

“The most important thing about this study is that it involves a real-world population that I will see in my clinic,” Joel Saltzman, MD, medical oncologist, Taussig Cancer Center, Cleveland Clinic, in Ohio, said during the commentary section of the press briefing. “We have seen patients in whom we thought immunotherapy would be helpful, but we weren’t sure if we could integrate it into their care,” Saltzman continued.

He further noted that “this was a study that took 5 years to accrue patients at more than 300 sites, and it would not have been feasible without the support of federal funding from the National Cancer Institute and our cooperative group network.”

The ATOMIC trial demonstrated that adding Tecentriq (atezolizumab) to chemotherapy significantly reduced the risk of recurrence or death by 50% in patients with stage III colorectal cancer and deficient mismatch repair. This combination therapy showed a 3-year disease-free survival rate of 86.4% compared to 76.6% with chemotherapy alone. The trial enrolled 712 patients and confirmed the efficacy of the combination across various subpopulations. The safety profile was consistent with known data, and the study is expected to change clinical practice by establishing a new standard treatment.

Tecentriq and chemotherapy combination reduces the risk of death versus chemotherapy alone in deficient mismatch repair, stage 3 colorectal cancer.

Tecentriq Plus Chemo Reduced Risk of Death vs Chemo Alone in dMMR Colon Cancer 

CURE sat down with Marcia K. Horn CEO of International Cancer Advocacy Network (ICAN), and ICAN's Physicians Advisory Council chairman, Robert H. Tamis, MD, co-inventors of ICAN's Remission Coach to discuss the organization's clinical trials search engine that is in development.

Please explain the objectives of Remission Coach. Who is its primary user audience—physicians, patients, caregivers?

:  Remission Coach, once launched when we receive the remaining funding to complete its development, will be used by patients, families, physicians and essentially everyone who is part of the clinical trials enterprise. It was developed by ICAN, a 501(c)(3) charity, based on our experience serving patients in the U.S. and abroad. After working closely with patients on clinical trials enrollment, we saw the need for a clinical trials search engine that would better connect patients with the most appropriate trials, as well as empower and educate patients during their cancer journey.

:  Remission Coach is revolutionary because, as Bob Tamis has designed it, it reverses the status quo. Currently, patients have to search for the right trial. Remission Coach will allow the most knowledgeable, highly motivated clinical trial experts to use our search engine to find the right patients.

How should it be used in relation to a patient's current treatment regimen?

  Remission Coach is a complement to current treatment. As data are entered, patients become aware of tests (such as molecular profiling) and procedures that were possibly not explored by their oncology team. When the record is complete (with personal, identifiable information removed), clinical trial recruiters can then search these anonymous records for eligible patients.

How does this differ from ClinicalTrials.gov?

:  ClinicalTrials.gov and similar services require patients to search for relevant clinical trials by searching for their particular cancer, by reading and attempting to understand the inclusions and exclusions written in complex terminology (often unfathomable to a layperson), and finally by contacting the clinical trial, hoping to qualify. When patients do not qualify, they must repeat this time consuming and frustrating process for another trial for which they might qualify—all while the clock is ticking.

:  Remission Coach will reverse this situation by supplying data that are searchable 24/7/365 by multiple clinical trials, and having those trials find the right patients. The still-anonymous patient will then be notified through the “matchmaker” service of Remission Coach and will have the option to accept, reject or ask for more information about the trial.

How are patients matched to potentially life-saving clinical trials? What criteria need to be entered?

:  Each clinical trial has different criteria for the patients it wants to recruit, so we would be collecting all appropriate information from the patient (or physician or caregiver). When patients consistently update their records, clinical trials using Remission Coach can securely search that anonymized data and connect the patient to the appropriate trial at the most convenient location.

How is the product updated with regard to new clinical trials?

:  Instead of Remission Coach being updated with new clinical trials, the patient’s medical record is updated so that clinical trial experts and recruiters can locate the most appropriate prospective candidates. That is a major difference between Remission Coach and other clinical trial search engines.

:  A unique feature of Remission Coach is that when a new patient enters data into the program, the record is immediately accessible to any clinical trial permitted to search our database. Thus, Remission Coach is a dynamic system, continually updated by new patients desiring to enter a clinical trial. If a clinical trial searched Remission Coach and found only a certain number of eligible patients, they might find another batch the very next day.

:  At this stage, we hope to secure funding from angel investors and/or philanthropic funding from the general public as well as from biopharmaceutical companies and contract research organizations (CROs). This will let us finalize the development of Remission Coach and cover the costs of the patient database. In the future, the ongoing funding of Remission Coach would come from a subscription model paid for by the companies and organizations that use the service.

If patient information is entered by the physician, does the physician only have access, or can the patient have access?

:  The patient is in complete control and can give permission for a physician, family member or caregiver to have access to Remission Coach to enter data, or assist in any way. Also, Remission Coach is designed to accept Electronic Data Transfer (EDT) into the patient’s record so that laboratory results, imaging studies, and physician records can be encrypted and downloaded (only with the patient’s consent), making it easy to have patient data entered into our system. Remission Coach is not only HIPAA compliant, it is beyond HIPAA compliant. We consider protecting the privacy of patients to be a sacred trust.

What will the next version of Remission Coach look like?

:  Our focus now is cancer—to make sure patients have the latest information and technology available. Soon after we launch the cancer version of Remission Coach, we will be expanding to all chronic and lethal diseases, making it possible for more patients to access an appropriate clinical trial in their disease area which will hopefully extend their survival and improve their quality of life.

Remission Coach: New Search Engine Aims to Revolutionize Clinical Trials Recruitment

At the core of any movement, whether it’s political, economic, religious, or societal, is the grassroots efforts of a few individuals who are united by a common goal. Fostered by a spirit of outreach, volunteers at Debbie’s Dream Foundation (DDF): Curing Stomach Cancer have devoted their time and efforts to the stomach cancer community.

Christy and Tony Leonard of North Carolina were initially on the receiving end of one member’s time, consideration and support. Tony received a telephone call from the Maryland chapter’s founder, Gae Rogers, after Christy contacted the group and poured out their story. Rogers is a stomach cancer survivor herself.

“Gae has made a huge difference — from providing support, giving me hope and by answering a lot of our questions. She was a resource that is just not available anywhere else,” Leonard told 

 magazine. Tony was initially diagnosed in 2012 on his 39

 birthday with a very serious and rare form of gastric cancer called linitis plastica.

It was one of many telephone calls that spurred the couple’s further involvement with the group. Sharing their common experiences of going through a difficult treatment regimen, surgery, recovery and complications, “was the best part of our involvement with Debbie’s Dream Foundation,” says Tony. 

The couple’s involvement has grown over the years and has ranged from participating in DDF’s Annual Advocacy Day in which legislators in Congress were asked to include stomach cancer research in their budgets to holding barbecue cookouts at their home and inviting other patient members and their families.

“Our involvement has come full circle,” says Christy. “We’ve done a lot to give back to the organization on a legislative front and research front that we were recently honored with the inaugural Volunteer of the Year Award for Debbie’s Dream Foundation. It felt good to be recognized, although that’s not why we do it. We do it because of what the organization has done for us and what it has done for our kids.”

As a mother of five, Christy’s focus on how stomach cancer affects the whole family, especially the children, fuels her involvement.

“People need to understand that when you survive the disease, there needs to be a focus on the survivorship of the entire family, for the caregivers and the children. You need to know that you’re not alone. And I cannot emphasize that enough,” she says.

Patients with gastric cancer face complex abdominal surgeries and heavy regimens of toxic chemotherapy and radiation. According to the foundation, gastric cancers—those that begin in the stomach, esophagus, or the junctions of these two organs &mdash; account for 37,600 new cancer cases in the United States each year and 25,150 deaths. Of these, 21,000 are stomach cancers resulting in 10,600 deaths each year.

Because it is relatively uncommon in the United States compared to other cancers, stomach cancer does not get nearly as much funding. The group is compelled to petition lawmakers to increase funding for stomach cancer to change the landscape of the disease and for those affected, says Debbie Zelman, the founder and president of DDF. Through its efforts on advocacy days, in which group members meet, train and strategize, members descend on Capitol Hill to educate members of Congress about how stomach cancer affects their respective states and local districts.

“By our second Advocacy Day in 2014, we were successful in adding stomach cancer research funding to the Department of Defense’s Peer Reviewed Cancer Research Program (PRCRP),” says Zelman. The result was that stomach cancer is now included as one of the 11 cancer research areas eligible for funding under the PRCRP. “We told lawmakers two years ago that we weren’t looking for money right now, but we would like a seat at the table,” she says.

The group got a lot more than a seat, with an initial line item of $25 million earmarked for research in 2014, which has grown to $50 million this past February 2015.

“It’s a significant step but there is still a lack of awareness and a lack of screening for the disease,” Zelman says. “People don’t always think of stomach cancer, so we have to be our own best advocate, both individually and as a collective group.”

Debbie's Dream Foundation: Curing Stomach Cancer is a 501(c)(3) non-profit organization dedicated to raising awareness about stomach cancer, advancing funding for research, and providing education and support internationally to patients, families and caregivers. DDF seeks as its ultimate goal to make the cure for stomach cancer a reality. More information about Debbie’s Dream and how you can get involved can be found at their 

From petitioning national lawmakers to provide more funding for stomach cancer to holding survivor banquets in their backyards, volunteers at Debbie's Dream Foundation are dedicated to ending the disease.

Tony Berberabe

Nubeqa Combo Positively Impacts HRQoL vs Placebo in Prostate Cancer Subgroup

Tecentriq Plus Chemo Reduced Risk of Death vs Chemo Alone in dMMR Colon Cancer

Remission Coach: New Search Engine Aims to Revolutionize Clinical Trials Recruitment

Turning the Tables on Stomach Cancer Through Outreach and Advocacy

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