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Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Educated Patient Resource Guide

It’s been a busy few weeks here at CURE® and in the oncology space as a whole, as the last two weekends had back-to-back meetings: the American Society of Clinical Oncology’s 

Here are some highlights from the conference, but as always, you can find all of our coverage at curetoday.com.

Imfinzi, Avastin, TACE May ‘Set a New Standard of Care’ in Liver Cancer

For patients with liver cancer whose disease is not eligible to be removed via surgery, adding Imfinzi and Avastin to transarterial chemoembolization — also known as TACE — tended to lengthen the time patients lived before their disease got worse, according to findings from the EMRALD-1 trial. These improvements in progression-free survival over TACE alone could lead to a new standard of care for this patient population, according to the lead study author, Dr. Riccardo Lencioni.

More specifically, patients who received Imfinzi and Avastin plus TACE lived for a median of 15 months before death or disease worsening, compared to 8.2 months for patients who received TACE alone. This correlates to a 23% reduction in the risk of disease progression or death, and benefits were seen across different patient subgroups.

Notably, the researchers on EMRALD-1 are still monitoring how the addition of the two drugs impacts overall survival. Once those data become more clear, it is possible that the drug manufacturers could submit this regimen to the FDA for approval, thereby officially shaking up the standard of care of TACE, which has remained the main treatment in this setting for about two decades.

Cancer in Bloodstream May Predict CRC Outcomes

Circulating tumor DNA — also known as ctDNA — was another hot topic at the Gastrointestinal Cancers Symposium. So ctDNA measures little fragments of cancer that are found in the bloodstream after cancer treatment.

Now, findings from the BESPOKE trial highlight the fact that ctDNA may offer insight into the recurrence risk in patients with stage 2/3 colorectal cancer who underwent surgery and then chemotherapy. The researchers used ctDNA to help determine minimal residual disease, or MRD, status. Essentially, patients with disease still detected in the blood stream were MRD positive, while those without detectable cancer were MRD negative. Findings showed that those with MRD negativity tended to live longer without experiencing relapse or death compared to patients with MRD positivity.

Survival Benefits with Keytruda and Padcev in Advanced Urothelial Cancer

Back in December, the Food and Drug Administration approved Padcev plus Keytruda for patients with previously treated locally advanced or metastatic bladder cancer. The approval was based on primary findings from the EV-302 trial. Now, updated findings from that trial are showing that the drug duo continues to outperform chemotherapy when it comes to progression-free survival — that’s the time patients live before their disease gets worse — as well as overall survival, which is the time patients live before death of any cause.

Notably, these survival benefits were seen across patient subgroups, such as those with visceral metastases and lymph node-only disease. According to the lead study author, Dr. Michiel S. Van Der Heijden, this could result in a new standard of care in patients with locally advanced or metastatic urothelial carcinoma.

Many Patients Miss Out on Testing to Guide Prostate Cancer Treatment

On the prostate cancer front, a study found that many people with metastatic castration-resistant prostate cancer are not undergoing germline or somatic testing. Now this is really important because back in 2020, two PARP inhibitors were approved in this setting. These are targeted drugs approved for patients whose cancers have certain characteristics, which can be determined by these types of tests.

Rates of germline and somatic testing have increased since the FDA approvals, but according to the study — which looked at real-world evidence of patients being treated in community cancer and urology centers — about 40% of patients did not undergo standard-of-care testing.

Study author, Dr. Neal Shore, said that this indicates the need for improved education on the importance of germline and somatic testing.

For more news on cancer updates, research and education, don’t forget to 

Here are some of the top stories from the recent Gastrointestinal Cancers Symposium as well as the Genitourinary Cancers Symposium. 

Highlights from the Gastrointestinal and Genitourinary Cancer Conferences 

Last week, we saw some big headlines in the oncology space, from Dexter Scott King’s death from prostate cancer and MLB Hall-of-Famer Ryne Sandberg announcing that he was diagnosed with the disease.

The FDA also requested a label update for CAR-T cell therapies that would warn patients and providers about secondary malignancies that have been reported from the treatment. Also, we took a look at laughter therapy, and how it could help patients and caregivers.

We’ve also been busy covering two conferences — ASCO’s 

, so tune in later this week for a special podcast episode highlighting some major research from those events.

Dexter Scott King Dies of Prostate Cancer, Ryne Sandberg Diagnosed With the Disease

Last Monday, Jan. 22, we saw two big stories in the prostate cancer space. First, Dexter Scott King, the son of the Civil Rights activist, Martin Luther King, Jr., died of prostate cancer. He was 62 years old.

At the time of his death, King was the Chairman of the King Center, which is an organization focused on educating the world about the life and legacy of Dr. Martin Luther King Jr. Dexter Scott King was also the president of the King estate.

In a statement announcing King’s death, his wife, Leah Weber said, “He transitioned peacefully in his sleep at home with me in Malibu. He gave it everything and battled this terrible disease until the end.”

And on the same day Dexter Scott King died, Major League Baseball Hall-of-Famer, Ryne Sandberg, announced that he was diagnosed with metastatic prostate cancer.

The 64-year-old — who was a 10-time All Star during his tenure for the Chicago Cubs, which ran from 1982 to 1997 — announced his diagnosis on Instagram. He said that received the diagnosis a week earlier and has started treatment. He asked that fans keep him in their thoughts and prayers.

FDA Requests Warnings on CAR-T Cell Therapies, Citing Secondary Cancers

The investigation into CAR-T cell therapies continues. Recently, the Food and Drug Administration (FDA) requested that approved BCMA- or CD19-targeted CAR-T cell therapies update their labeling to include a warning of reports of T-cell malignancies, including CAR-positive lymphomas, which have been reported in patients who use this type of therapy.

Back in November, the FDA announced that it was investigating 

reports of secondary diseases in patients who underwent CAR-T cell therapy

. The available data shows that these diseases are extremely rare, and researchers are still looking into what, exactly, is causing them.

Now, the FDA wrote letters to the manufacturers of five CAR-T cell therapies, requesting that they include a Boxed Warning — which is the highest safety-related warning for drugs — outlining the potential risks of CAR-T cell products. The companies must respond to the FDA within 30 days of receiving the letters, which were sent out on Jan. 19.

Laughter Therapy May Improve Mood, Decrease Pain in Patients With Cancer

And on a much lighter note, we covered recent research showing that laughter therapy can decrease mood disturbances in patients receiving palliative care for late-stage cancer, as well as their loved ones. The findings, which were published in the journal, 

, also found that the laughter therapy reduced pain perception in patients and decreased levels of burnout in caregivers.

Laughter therapy refers to alternative and complementary therapy using humor to help relieve stress and pain, in addition to potentially improving a patient’s sense of well-being, according to the National Cancer Institute. In this instance, it consisted of five 20- to 30-minute sessions held over five consecutive days. The participants introduced themselves using funny tools to relieve tension, and moved their bodies in laughing rhythms.

“This indicates that our palliative care patients and family caregivers would have a positive view of the use of laughter or humor in their palliative circumstances,” the researchers wrote.

CURE® editors discuss last week’s biggest cancer headlines, from Dexter Scott King’s death to the potential of laughter therapy to boost quality of life.

Prostate Cancer Headlines, CAR-T Warnings and Laughter Therapy

This week in oncology news, we saw a few decisions from the Food and Drug Administration, ranging from the agency agreeing to review a drug and potentially grant it a full approval to their citing manufacturing concerns for a gastric cancer drug.

Additionally, a small study showed 100% disease control rate in a subtype of non-Hodgkin lymphoma, and a clinical evaluation of a new prostate cancer drug will continue to enroll patients.

FDA Accepts sBLA For Tivdak in Recurrent or Metastatic Cervical Cancer

The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to Tivdak for the treatment of patients with recurrent or metastatic cervical cancer that has progressed after first-line therapy. Tivdak, the first antibody-drug conjugate for this patient population, received accelerated approval in 2021. Now, the sBLA is for the continued approval, which is contingent upon clinical benefit verification in confirmatory trials.

Results from the phase 3 innovaTV 301 trial presented at the 2023 ESMO Congress demonstrated that Tivdak reduced the risk of death by 30% compared to chemotherapy as a second- or third-line treatment for this patient population. The trial also showed improvements in overall survival, progression-free survival, and confirmed objective response rate. Treatment-related side effects were observed in a majority of patients, with anemia and nausea being the most common.

The FDA plans on making a decision on the approval by May 9, 2024.

FDA Cites Manufacturing Concerns in Missed Gastric Cancer Drug Deadline

Also in FDA news from the week, the agency will not meet the Jan. 12, 2024, deadline for approving zolbetuximab, a drug designed for the treatment of unresectable or metastatic HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction adenocarcinoma.

The FDA attributed the delay to "unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility" and issued a complete response letter to Astellas, clarifying that no clinical concerns, including safety and efficacy, were identified.

Zolbetuximab, a monoclonal antibody targeting the CLDN 18.2 protein overexpressed in certain gastric cancers, has shown promise in preclinical studies by inducing cell death in cancer cells. The drug had received a priority review from the FDA based on positive outcomes in the phase 3 SPOTLIGHT clinical trial and the GLOW clinical trial. Astellas, the manufacturer of the drug, is now collaborating with the FDA and the third-party manufacturer to address the identified issues and establish a timeline for resolving them.

Enrollment Continues in Study Evaluating ONCT-534 For Advanced Prostate Cancer

Patients are still being enrolled in an assessment of the novel drug, ONCT-534, for the treatment of advanced prostate cancer that has relapsed or is refractory to approved androgen receptor pathway inhibitors (ARPIs).

The study's first two cohorts received daily oral doses of 40 mg and 80 mg of ONCT-534, while the third and fourth patients, part of the third cohort, will be administered a 160 mg daily oral dose.

The ongoing phase 1/2 ONCT-534-101 study aims to determine the drug's safety, tolerability and preliminary antitumor activity, with a total of 27 patients in the first phase and two cohorts of 16 patients each in the second phase.

The study is anticipated to conclude in January 2028.

Novel Drug Shows 100% Disease Control Rate in WM

And finally, a novel drug, iopofosine I 131, showed a 100% disease control rate in patients with Waldenstrom’s macroglobulinemia, according to topline findings from the CLOVER WaM study.

The CLOVER WaM trial investigated iopofosine I 131 in 50 WM patients who had undergone at least two prior lines of therapy, including a BTK inhibitor. In an efficacy evaluable population of 41 patients who received a total dose of 60 mCi 60 or more days ago, the trial met its primary endpoint with a major response rate of 61%. The overall response rate in evaluable patients was 75.6%, with 100% experiencing disease control and 76% not experiencing disease progression at an average follow-up of eight months. Notably, 8% of patients achieved a stringent complete remission.

Now we should note, however, that this is a small study sample size of only 50 patients, so we would expect to see future studies evaluating this drug in a larger patient population.

Last week, the FDA provided updates on two cancer therapies. In this episode, we discuss those decisions and more. 

FDA Gives Cancer Drug Updates, Prostate Cancer Trial Enrolls Patients 

Leanne Burnham, Ph.D., is a prostate cancer researcher with a goal of addressing health disparities in Black men and advancing treatment options. But Burnham’s story with cancer extends far beyond her inspiring work: her dad has prostate cancer and she herself is a survivor of stage 4 Hodgkin’s lymphoma.

® Talks Cancer” podcast, Burnham discusses the research she’s working on to address these health disparities, shares how she was inspired by her father’s diagnosis and details her own survival story.

“It does give me something to be able to relate to individuals when I am in the community,” said Burnham, who is a postdoctoral fellow in the City of Hope Division of Health Equities. “I can't tell you how many times I hear men say, ‘Well, I don't know that I need to be screened, I feel fine.’ And I let them know my dad felt totally fine. He found out he had prostate cancer on accident in the emergency room for something completely unrelated to prostate cancer. And even with myself, you know, it's not like you go to sleep one night and then you wake up the next morning with cancer. It’s something that happens over time.”

In this episode of the “CURE® Talks Cancer” podcast, Leanne Burnham, Ph.D., discusses the research she’s working on to address health disparities in Black men with prostate cancer after being inspired by her father’s diagnosis, and shares her own cancer survival story.

A Prostate Cancer Researcher’s Unique Perspective as A Cancer Survivor

After putting off a trip to the doctor, Grammy-winning songwriter and vocal producer Kuk Harrell was devastated to learn that he had prostate cancer, like his father before him.

However, with his characteristic positive attitude and the help of his family, friends, and health care team, Harrell is now cancer-free, and spreading a message of hope to others who may find themselves in a similar situation.

 Talks Cancer" podcast, we talk with Kuk about what it’s like to be “on the other side” of his diagnosis, and how he’s using his platform to shine a light on prostate cancer with the 

 campaign in partnership with City of Hope.

On this week’s episode of the CURE Talks Cancer podcast, we talk with Grammy-winning songwriter and vocal producer Kuk Harrell about what it’s like to be “on the other side” of his prostate cancer diagnosis, and how he’s using his platform to shine a light on the disease.

There's Always Hope in Prostate Cancer

Cancer is no longer the once thought “one-size-fits-all” approach when it comes to treatment, especially because genomic testing plays such a crucial role for certain patients.

This week, we spoke with Bryce, who was diagnosed with prostate cancer in 2014 and whose cancer journey was changed once he discovered what genomic testing could do for his treatment options. In addition, Dr. Marcia Brose, from the University of Pennsylvania, weighs in on what patients should know about genomic cancer testing.

In this week’s episode, we spoke with a patient and his doctor about genomic testing and how it can change treatment outcomes for patients with cancer.

What You Need to Know About Genomics

 Talks Cancer podcast, we spoke with Andy Steinfeldt, who looks at cancer “as a motivation rather than a destination." After taking up running at age 63, Andy was diagnosed with prostate cancer a few years later in 2013. But he didn’t let it slow him down.

Since his initial diagnosis, Andy has faced a host of other health challenges — as well as a recurrence he just finished radiation treatment for. But despite all this, Andy has completed two full marathons, earned numerous medals in the Senior Games, takes classes at a local college and has even taken up singing to prove that anything is possible – even with cancer.

One patient opted to focus on his interests instead of focusing on cancer.

Seeing Cancer as a Motivation, Not a Destination

Many sports fans probably know Ed Randall best for his work as a longtime radio and TV personality and published author. But, following his own journey with cancer, Randall now utilizes his sports connections to help men across the United States get screened for prostate cancer — all through his nonprofit organization Fans for the Cure, which has helped thousands of men over an 11-year span.

After his own journey with prostate cancer, radio and TV personality Ed Randall used his extensive connections throughout professional sports to spread awareness about prostate cancer through his nonprofit organization Fans for the Cure.

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