FDA Approves Pluvicto™ for Eligible Patients with Metastatic Castration-Resistant Prostate Cancer
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Dr. Oliver Sartor, co-principal investigator on the VISION Trial which led to FDA approval of PluvictoTM, explains how it could change the landscape of treatment options for patients with advanced prostate cancer.
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The U.S. Food and Drug Administration (FDA) has approved Pluvicto™ (PSMA-617 Lutetium-177) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) who have previously been treated with other anticancer therapies (androgen receptor pathway inhibition and taxane-based chemotherapy).
“The approval of Pluvicto™ is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options,” said Oliver Sartor, MD, medical director at Tulane Cancer Center and co-principal investigator on the international clinical trial (VISION) that led to FDA approval. “Pluvicto™ is a step forward in the evolution of precision medicine for prostate cancer.”
Tulane Cancer Center was one of the leading sites in the U.S. in terms of patient accrual to VISION, thanks to a team of prostate-focused oncologists including Drs. Sartor, Pedro Barata, Jodi Layton and Brian Lewis. Dr. Kendra Harris, chief of Radiation Oncology, was an essential part of the team handling isotope delivery, expert care and more.
Pluvicto™ is a radioligand therapy that combines a targeting compound that binds to a cell surface protein expressed by tumors and a radioactive isotope, thereby causing DNA damage that inhibits tumor growth. This approach enables targeted delivery of radiation to the tumor, while limiting damage to the surrounding normal tissue. Pluvicto™ is expected to be available to physicians and patients within weeks.
FDA approval of Pluvicto™ is based on the results of the Phase III VISION trial, which demonstrated that PSMA-positive mCRPC patients previously treated with androgen receptor pathway inhibition (such as abiraterone or enzalutamide) and taxane-based chemotherapy who received Pluvicto™ plus standard of care (SOC) had improved overall survival compared to SOC alone.
Participants treated with Pluvicto™ plus SOC had a 38% reduction in risk of death and a statistically significant reduction in the risk of radiographic disease progression or death compared to SOC alone. The most common adverse events in the Pluvicto™ arm of the study were fatigue (43%), dry mouth (39%), nausea (35%), anemia (low red blood cell counts) (32%), decreased appetite (21%), and constipation (20%).
PSMA is highly expressed in more than 90 percent of patients with prostate cancer, making it an important phenotypic biomarker for assessing disease status. To be eligible for Pluvicto™ treatment, patients should have PSMA PET scan positive disease as assessed by a PSMA-11 Galium-68 scan (with certain limitations and caveats).
Two late-stage studies evaluating Pluvicto™ in earlier lines of treatment for metastatic prostate cancer are currently underway.
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Vanue Lacour – a VISION Trial participant – describes his experiences with mCRPC and Pluvicto™.
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New Findings May Lead to Personalized Treatments for
Non-Clear Cell Renal Cell Carcinoma
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There has been an emergence of novel treatment regimens for the treatment of metastatic renal cell carcinoma – most commonly for the clear cell (ccRCC) type rather than non-clear cell (nccRCC), which is more rare.
"With the emergence of these novel treatment options or combinations of options, we started to look for a rationale to decide who should get what," said Pedro Barata, MD, MSc, assistant professor of medicine. "Until now, we used clinical factors to make our decisions – things like performance status, lab values, the overall fitness of the patient, where the disease is located, pathology, etc. But we need to go beyond that and find biomarkers to select the best therapies for patients because not everyone responds in the same way."
With that in mind, Barata and his team headed up a large multi-institutional collaboration with colleagues from several other academic institutions who are all members of the genitourinary research group at Caris Life Sciences, a molecular profiling company dedicated to providing physicians and patients with the benefits of precision medicine – personalizing treatment plans based on the genetics of a patient's particular cancer.
The results of their study received a second-place merit award and were orally presented by Dr. Barata at the recent North American Kidney Cancer Symposium in Austin.
His team genetically sequenced 657 nccRCC biopsy samples stored at Caris in an effort to identify seven genomic expression clusters which have been shown to predict responses to particular therapies. They focused on non-clear cell histologies for this project because they had examined clear cell before and wanted to put the results side by side to see where there were differences.
"Gene expression profiling reveals that these tumors have a different expression of molecular signatures compared with clear cell histologies, which means there is the potential to optimize treatment selection for nccRCC," said Barata. "This is the first and largest study I've ever seen dedicated to revealing non-clear cell genomic signature data, and it opens the door to using genomic signatures to identify therapies that are most likely to be effective in these patients. That's the ultimate goal."
The next step according to Barata is to validate the data in clinical trials. "First, we will use tumor samples from patients currently enrolled in kidney cancer trials to validate the genomic signatures, and then we will design trials using these signatures to select patients."
In addition to kidney cancer, Dr. Barata treats bladder and prostate cancer. Since his arrival at Tulane, he has focused on expanding our Genitourinary Cancer Program by opening new clinical trials, collaborating with colleagues around the world and publishing the results of their work in academic publications, as well as planning and hosting several community outreach and CME activities in association with the International Kidney Cancer Association and other organizations. To book an appointment with Dr. Barata, please call 504-988-6300.
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"One Man Can Make a Difference"
at the One Man Shoot Sporting Clays Event
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Saturday, April 2
Riverside Sporting Clays
52400 Hwy. 16, Denham Springs, LA 70706
1st Flight Begins Competition - 8 AM
2nd Flight Begins Competition - 11 AM
Lunch - 10:30 'til
Live Auction - 3 PM
Awards - 4 PM
Silent Auction & Raffle Drawings - 4:30 PM
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This event, which has raised over $1.27 million since 2011, was founded by the late Connie Mack Boykin – a former patient of Dr. Oliver Sartor, head of Tulane's Prostate Cancer Research Program – and it continues to be inspired by his memory.
When an unexpected diagnosis of prostate cancer changed his life, Connie Mack not only resolved to fight his disease, but he also wanted to raise awareness among as many men as possible to be proactive when it comes to their health and that early detection of prostate cancer is key. He, along with his brother, Michael, and friends, Randy Hays and Cyril LeJeune, thought the best way to do this was to wrap the message around an activity that men enjoy - sporting clays - and the One Man Shoot was born.
"Connie Mack wanted folks to know that one man can make a difference in the fight against prostate cancer," said Michael Boykin. "His courage inspired everyone involved in the Shoot, and through his inspiration we have become passionate about supporting the search for a cure."
Four-man teams will compete in the sporting clays tournament. Each participant in the clays competition will receive an event shirt and shells, plus food, drinks and live entertainment. Additional guests may attend the festivities for $25 per person. The event will also include free PSA testing, additional shooting games, raffles, and live and silent auctions. Multiple team awards will be presented in each of three classes, along with top individual shooters in several categories.
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March is Colorectal Cancer Awareness Month
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The American Cancer Society reminds you that colorectal cancer is one of the most common types of cancer and is a leading cause of cancer-related deaths in the United States.
If all adults 45 and older were screened for colorectal cancer, we could avoid thousands of deaths each year and prevent many people from ever getting the disease.
The infographic below focuses on the benefits of getting tested. Whether you or a loved one are worried about getting colorectal cancer, have just been diagnosed, are going through treatment, or are trying to stay well after treatment, the American Cancer Society offers detailed information to help you find the answers you need.
To learn more, visit their website.
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Gunning for a Cure Sets Record -
$340K Raised for Prostate Cancer Research
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The 9th Annual Gunning for a Cure Sporting Clays Fundraiser – held Saturday, March 12, at Stella Events and Adventures in Plaquemines Parish – set a new event record, raising approximately $340,000 for Tulane Cancer Center's Prostate Cancer Research Fund, and $1.7 million cumulatively since the event began in 2013!
Approximately 70 four-man teams participated in the competitive sporting clays event, which also included live and silent auctions, live entertainment, a luncheon, fun activities for the kids, and on-site PSA testing.
"It was an amazing day filled with lots of fun and friendly competition, all benefiting our mission to find a cure for prostate cancer," said Chalyn Perez, head of the event's organizing committee. "The gratitude and appreciation we have for each and every person who was part of this day is huge. Thank you all so much."
"The funds raised through this event are incredibly important to continue the momentum of research progress," said Oliver Sartor, MD, head of Tulane's Prostate Cancer Research Program. "We’ve come far – especially in recent months – in our attempts to better understand and treat advanced disease, but we have much more ground to cover. Thanks to the generosity of everyone involved in the Gunning event, we have the resources to continue our march forward toward more effective prevention, earlier diagnosis and innovative treatment options. We are tremendously grateful to have so many advocates in this fight."
Plans are already underway for Gunning for a Cure 2023, taking place Saturday, March 11. Please mark your calendars and join the fun at Stella!
Photo Caption - Chalyn Perez (left) presents Dr. Oliver Sartor with a check representing a portion of the total proceeds from this year's event.
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Dr. Sartor (far left) congratulates a top performing team in the competitive sporting clays event.
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Karen Palmisano accepts the Warrior's Cup honor on behalf of her husband, Gary Palmisano, Sr., who bravely fought but recently lost his battle with prostate cancer.
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or visit
To make a tax-deductible donation to Tulane Cancer Center
(Federal Tax ID# 72-0423889) please click here.
Thank you for your generosity and support!
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