FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option

On May 23, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA)’s Medical Devices Advisory Committee has strongly recommended FDA approval of the company’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease (Press release, Guardant Health, MAY 23, 2024, View Source [SID1234643674]).

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The recommendation signals the advisory committee panel’s consensus on Shield’s safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks. The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions. The FDA is expected to decide whether to approve Shield later this year.

"The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk," said AmirAli Talasaz, co-CEO of Guardant Health. "Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths."

The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication. They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S.2 yet has a 91% five-year survival rate when caught at stage I (localized).3 Despite this, one out of three eligible Americans – 50 million people – are not being screened for CRC.4 Current primary non-invasive screening options include stool-based tests which have proven efficacy in detecting CRC; however, studies have consistently found that barriers such as handling stool and challenges performing the test impact adherence.5,6,7,8 Shield offers patients a choice that can be completed with a simple blood draw during a routine office visit.

"Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,"9 said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. "Clinical evidence and CRC screening guidelines acknowledge the value of offering choice to individuals at average risk for CRC and highlight the role of patient preference in test selection and CRC screening completion."

The panel’s recommendation is based on Guardant’s premarket approval (PMA) application for Shield, including the results of the pivotal ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study, published in the March 2024 issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of existing stool-based tests used as primary CRC screening options, in which overall sensitivity ranges from 67% to 92%.10

For more information about Shield for CRC screening, visit BloodBasedScreening.com.

About the Shield test

The Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. Shield is intended for colorectal cancer screening in individuals at average risk of the disease, age 45 years or older. Patients with an "Abnormal Signal Detected" may have colorectal cancer or advanced adenomas and should be referred for colonoscopy evaluation. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. The test is performed at Guardant Health, Inc.

Natera Announces New MRD Data in Multiple Tumor Types, to be Presented at ASCO Annual Meeting

On May 23, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that the company, along with its collaborators, will present new data at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4, 2024 (Press release, Natera, MAY 23, 2024, View Source [SID1234643668]).

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The presentations feature data across a variety of indications, including breast cancer, colorectal cancer (CRC), lung cancer, melanoma, esophageal cancer, and urothelial cancer, with one oral presentation and 12 poster presentations on Signatera, Natera’s personalized and tumor-informed molecular residual disease test, as well as one poster with data on Empower, Natera’s test for hereditary cancer.

Minetta Liu, MD, chief medical officer of oncology at Natera, said, "We look forward to sharing new data across cancer types, reflecting Natera’s deep clinical pipeline in MRD with results from randomized trials as well as real-world studies. This includes promising new findings from the CIRCULATE-Japan GALAXY study demonstrating the prognostic and predictive utility of Signatera and actionable biomarkers in colorectal cancer."

GALAXY is part of the CIRCULATE-Japan trial platform, which also includes ALTAIR, a first-of-its-kind, "treat on molecular recurrence" study evaluating the utility of Signatera in CRC. Natera expects to announce topline results for this phase III randomized trial in August 2024.

Below is the full list of presentations featuring Signatera and Empower at ASCO (Free ASCO Whitepaper):

Poster Presentation | Abstract # 3609 | Presenter: Yoshiaki Nakamura, MD, PhD | CRC
Prognostic and predictive value of ctDNA-based MRD and actionable biomarkers in patients with resectable CRC: CIRCULATE-Japan GALAXY
Oral Presentation | Abstract # LBA507 | Presenter: Sherene Loi, MD, PhD | Breast Cancer
Prognostic utility of ctDNA dynamics in the monarchE trial of adjuvant abemaciclib plus endocrine therapy (ET) in HR+, HER2-, node-positive, high-risk early breast cancer (EBC)
Poster Presentation | Abstract # 3586 | Presenter: Eric Lander, MD | CRC
Genomic alterations in early-onset versus average-onset stage IV CRC
Poster Presentation | Abstract # 5034 | Presenter: Rebecca Hassoun, MD | Testicular Cancer
Longitudinal Evaluation of ctDNA as a Prognostic Biomarker to Detect Minimal Residual Disease (MRD) in Testicular Cancer
Poster Presentation | Abstract # 4587 | Presenter: Adanma Ayanambakkam, MD | Urothelial Cancer
Longitudinal analysis of ctDNA in localised and metastatic urothelial cancer
Poster Presentation | Abstract # 4028 | Presenter: Aziz Zaanan, MD | Esophageal Cancer
Longitudinal ctDNA analysis during treatment (Tx) of locally advanced resectable (LAR) gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ADENOCA): the PLAGAST prospective biomarker study
Poster Presentation | Abstract # 9564 | Presenter: Michael LaPelusa, MD | Melanoma
Association between ctDNA and Recurrence-Free Survival (RFS) in Patients (pts) with Resected Stage III Melanoma – an Exploratory Analysis of SWOG S1404
Poster Presentation | Abstract # 6056 | Presenter: Glenn Hanna, MD | Head and Neck Squamous Cell Carcinoma
Personalized ctDNA for monitoring disease status in HPV-negative head and neck squamous cell carcinoma
Poster Presentation | Abstract # TPS8659 | Presenter: Yasushi Goto, MD, PhD | Lung Cancer
Randomized phase III study comparing suspension or continuation of PD- 1 Pathway Blockade for patients with advanced non-small-cell lung cancer (SAVE study: JCOG1701)
Poster Presentation | Abstract # 569 | Presenter: Mridula George, MD | Breast Cancer
Predicting response to neoadjuvant therapy (NAT) in patients (pts) with early-stage breast cancer (BC) using ctDNA testing
Poster Presentation | Abstract # 549 | Presenter: Marla Lipsyc-Sharf, MD | Breast Cancer
Impact of ctDNA surveillance on clinical care for patients with stage I-III breast cancer: Findings from a multi-institutional study.
Poster Presentation | Abstract # 518 | Presenter: Yoichi Naito, MD | Breast Cancer
ctDNA monitoring for breast cancer at high risk of recurrence: Interim analysis of JCOG1204A1
Poster Presentation | Abstract # 10596 | Presenter: Sarah Lee, MD | Pan-Cancer (Empower)
A targeted panel of actionable high risk hereditary cancer predisposition genes can identify patients with pathogenic/likely pathogenic variants (PVs) irrespective of meeting established NCCN testing criteria
About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers.

Indapta Therapeutics to Highlight its g-NK Cell Platform for the Treatment of Cancer and Autoimmune Disease in a Plenary Session at New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference

On May 23, 2024 Indapta Therapeutics, Inc., a privately held biotechnology company developing differentiated cell therapies for the treatment of cancer and autoimmune diseases, reported that CEO Mark Frohlich, MD, will be giving a plenary talk today titled, "g-NK cells for the treatment of cancer and autoimmune disease" at the New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (Press release, Indapta Therapeutics, MAY 23, 2024, View Source [SID1234643667]).

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In his talk, Dr. Frohlich will summarize the differentiated mechanisms of target cell killing for Indapta’s lead clinical program, IDP-023, a g-NK cell therapy product. These mechanisms include highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells. Indapta is currently applying g-NK cells to hematologic cancers in an ongoing Phase 1 trial enrolling patients with non-Hodgkin’s lymphoma, multiple myeloma and acute myelogenous leukemia.

Dr. Frohlich will also describe Indapta’s expanded focus on autoimmune disease, including its plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration for a clinical trial of IDP-023 in multiple sclerosis.

"Based on published evidence that endogenous g-NK cells are not only protective against the development of multiple sclerosis, but also slow the progression of the disease, we plan on filing an IND in mid-2024 to initiate a clinical trial of g-NK cells for this indication," said Dr. Frohlich. "In addition to being able to achieve B cell depletion by combining with a B cell directed monoclonal antibody, g-NK cells have additional mechanisms not shared by conventional NK cells or CAR-T cells, namely their ability to kill HLA-E expressing autoreactive T and B cells as well as address the Epstein Barr Virus reservoir that may contribute to the disease pathogenesis."

Indapta’s Differentiated g-NK Cell Therapy

Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as "g minus" NK cells, or "g-NK" cells. G‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability.

Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, View Source)

Abdera Therapeutics Announces FDA Clearance of IND Application for ABD-147

On May 23, 2024 Abdera Therapeutics Inc., a biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable, precision radiopharmaceuticals for cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for ABD-147, the first delta-like ligand 3 (DLL3) targeting radiopharmaceutical for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) (Press release, Abdera Therapeutics, MAY 23, 2024, View Source [SID1234643666]). Abdera plans to initiate a Phase 1 clinical trial in the second half of 2024.

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ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing DLL3. DLL3 is a protein found on the surface of neuroendocrine tumors, but rarely expressed on the surface of normal cells or tissues.

"ABD-147 represents a potential best-in-class treatment for SCLC and other aggressive neuroendocrine tumors," said Philippe Bishop, M.D., chief medical officer. "Leveraging our ROVEr platform, we custom-engineered ABD-147 with optimized pharmacokinetic properties and tumor penetration to destroy tumor cells while limiting radiation toxicity to the body. We are hopeful this highly potent next generation radiotherapeutic will provide a potential breakthrough addressing a critical medical need for the treatment of SCLC and other high-grade neuroendocrine cancers. We look forward to initiating a Phase 1 clinical trial of ABD-147 later this year."

The Phase 1, first-in-human, open-label clinical study aims to evaluate the safety and preliminary efficacy of 225Ac-ABD-147 in patients with SCLC or LCNEC who previously received platinum-based therapy. The study will determine the recommended dose regimen for future development.

"FDA clearance of our first IND marks a major milestone for Abdera as we transition into a clinical-stage radiopharmaceutical company," said Lori Lyons-Williams, president and chief executive officer. "We believe our ROVEr platform uniquely enables a new wave of innovation in targeted radiotherapeutics, with ABD-147 representing the first in a robust pipeline of custom-engineered programs we are advancing to the clinic."

About Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

The global incidence for SCLC and LCNEC has been reported to represent approximately 325,000 patients and is expected to increase 4% annually through 2029. In the U.S., the incidence has been reported to be approximately 35,000 new cases annually. Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers. These cancers have the most aggressive clinical course of any type of pulmonary tumor and often metastasize to other parts of the body, including the brain, liver and bone. Without treatment, the median survival from diagnosis has been reported to be only two to four months. With treatment, the overall survival at five years is 5% to 10% for SCLC, and 15% to 25% for LCNEC. SCLC and LCNEC generally carry a poor prognosis and new treatment options are urgently needed.

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

About the ROVEr Platform

Abdera’s Radio Optimized Vector Engineering (ROVEr) platform enables the company to custom-engineer targeted radiopharmaceuticals with tunable pharmacokinetic (PK) properties to achieve high tumor uptake while minimizing renal exposure and mitigating other systemic radiotoxicities such as myelosuppression. Abdera can optimize the delivery and therapeutic index of potent radioisotopes capable of emitting powerful alpha or beta particles to selectively destroy tumor cells while sparing healthy cells, providing patients with potentially transformative new cancer treatments.

Abdera’s approach offers the ability to design radiotherapeutics against virtually any cancer target expressed on the cell surface. Coupled with a highly potent mechanism of cell killing, the ROVEr platform is uniquely poised to exploit both high- and low-expressing targets to selectively deliver therapeutic levels of radioisotope to cancer cells.

City of Hope Researchers to Present Investigational Treatments for Colorectal, Kidney and Blood Cancers at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 23, 2024 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that it will present new data and offer expert perspectives on leading-edge cancer research and treatments in development at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, which will take place in Chicago from May 31 to June 4 (Press release, City of Hope, MAY 23, 2024, View Source [SID1234643665]). Highlights include the following:

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2024 Best of ASCO (Free ASCO Whitepaper) program: New data on mismatched unrelated donor peripheral blood stem cell transplantation
Late-breaking data on the phase 3 CodeBreaK 300 trial
Glofitamab monotherapy for patients with advanced mantle cell lymphoma
An oral inhibitor monotherapy for people with advanced kidney cancer
Interventions for older adults with cancer who traditionally have not had access to supportive care treatments that could improve quality of life
About 40,000 oncology professionals will attend the meeting, themed "The Art and Science of Cancer Care: From Comfort to Cure." City of Hope experts will have 64 presentations, including oral sessions, clinical science symposiums, education discussions and the following late-breaking abstract:

Overall survival (OS) of phase 3 CodeBreaK 300 study of sotorasib plus panitumumab (soto+pani) versus investigator’s choice of therapy for KRAS G12C-mutated metastatic colorectal cancer (mCRC)

Presenter: Marwan G. Fakih, M.D., City of Hope medical oncologist
Presentation Time and Location: Monday, June 3, 1:21 p.m. CT, Arie Crown Theater
Other noteworthy City of Hope abstracts:

Expanding access to stem cell transplants: Not a perfect match, yet perhaps just as good
Presentation Time and Location: Friday, May 31, 3:45 p.m. CT, S100bc

Access to potentially lifesaving stem cell transplants traditionally has been limited due to the need for a donor whose stem cells match the recipient’s genes. However, Monzr M. Al Malki, M.D., City of Hope hematologist-oncologist, co-led a multicenter phase 2 trial (NCT04904588) sponsored by NMDP and conducted via CIBMTR (Center for International Blood and Marrow Transplant Research) that demonstrates encouraging overall survival one year after older patients with advanced blood cancers received "HLA-mismatched unrelated donor peripheral blood stem cell transplantation," meaning the donor stem cells originated from someone who was not a relative and not a complete HLA match.

While the 13-site ongoing trial includes adults and children, this interim analysis that will be presented as an oral abstract presentation evaluated the first 70 older adult patients with advanced blood cancers who received this type of transplant and underwent both reduced intensity conditioning and post-transplant cyclophosphamide, which is a method used to prevent a potentially life-threatening side effect called graft-versus-host disease (GVHD). City of Hope has performed over 19,000 transplants, is one of the nation’s leading transplant programs and is at the forefront of using transplants to treat older adults with blood cancers.

Overall survival at one year post-stem cell transplant was 79%. Rates of GVHD and other complications were comparable to those of recipients who received HLA-matched donor stem cells, suggesting HLA-mismatched unrelated donor peripheral blood stem cell transplantation may one day be used more widely, expanding access to the lifesaving therapy.

"This data, supported by the National Marrow Donor Program, is promising and is the reason why I continue to work to expand access to stem cell transplantation for older patients, underrepresented people and patients with blood cancers," Dr. Al Malki said.

The adult cohorts of this trial recruitment have closed with more than 200 patients in follow-up. The pediatric arm of the trial is ongoing.

Bispecific antibody demonstrates sustained response rates in lymphoma patients who received and rejected previous treatments
Presentation Time and Location: Saturday, June 1, 5:24 p.m. CT, S100bc

In an updated efficacy and safety phase 1/2 trial (NCT03075696), bispecific antibody glofitamab continues to demonstrate compelling response rates with a fixed-duration treatment among a group of mantle cell lymphoma patients who have nearly exhausted approved treatment options due to aggressive disease.

The researchers evaluated close to 60 participants who had received two or more previous treatments — the majority of which had stopped responding to treatment before they enrolled in this study. Patients received about 7.4 months of glofitamab. Landmark analyses indicated that most patients with a complete response at the end of treatment were alive without disease progression 15 months after the end of treatment. The median duration of complete response was 12.6 months, and median progression-free survival was 8.6 months.

"People with mantle cell lymphoma have a rare form of non-Hodgkin lymphoma that is currently incurable, so it is encouraging to see people who were told by others that there is not much more to be done live months and even years longer with this treatment," said Tycel Phillips, M.D., City of Hope hematologist-oncologist and presenting author. "We at City of Hope continuously develop leading-edge treatments for people diagnosed with lymphoma and other blood cancers."

Early safety and clinical efficacy data on monotherapy DFF332 in advanced kidney cancer patients
Presentation Time and Location: Saturday, June 1, from 8:30 a.m. CT, S100bc

People with an advanced kidney cancer called clear cell renal cell carcinoma (ccRCC) appeared to experience positive medicinal effects from the targeted therapy pill DFF332 while encountering manageable side effects in an ongoing first-in-human phase 1/1B multicenter trial (CDFF332A12101, NCT04895748).

Sumanta "Monty" Pal, M.D., a City of Hope medical oncologist, will share preliminary data on 40 advanced kidney cancer patients who took DFF332, an oral hypoxia-inducible factor (HIF)-2α inhibitor that has been shown in preclinical models to be effective in reducing ccRCC tumors. All study participants had received at least one other type of therapy before joining the clinical trial. At data cutoff, 16 patients continued to be treated, while 19 patients (48%) stopped receiving the treatment due to disease progression. The most common side effects were fatigue (33%), anemia (30%), increased blood cholesterol and constipation (15%). No extreme adverse effects have been observed so far. At cutoff, 18 patients (45%) had stable disease and two patients (5%) achieved partial response.

"While the study is still in process, so far, we have seen a promising safety profile for monotherapy DFF332 with indications of clinical activity," Dr. Pal said. "We are conducting analysis on how the medicine moves within the body as well as collecting biomarker data that will be shared at our ASCO (Free ASCO Whitepaper) presentation."

Using telehealth to improve access to supportive care services for older adults with cancer living in lower-resourced communities
Presentation Time and Location: Saturday, June 1, at 1:39 p.m. CT, S102

A study at City of Hope | Antelope Valley found that telehealth can be leveraged to offer older adults living in high-poverty, lower resourced communities with a specialized evaluation developed at City of Hope called a geriatric assessment, which identifies supportive care services older adults with cancer need to manage vulnerabilities, better define care goals and improve quality of life.

This quality improvement study included 251 participants who were 65 years or older with newly diagnosed or advanced cancer. These patients underwent a baseline geriatric assessment and most had initial visits with a geriatric nurse practitioner – 197 via televideo and 45 via telephone. The assessment identified vulnerabilities in 209 patients and, after review, the nurse practitioner made 460 necessary referrals for supportive care services – 86% of which were implemented. The most common referrals were to pharmacy (177), social work (142), occupational therapy (76) and physical therapy (48). More than 92% of patients reported they were satisfied with the telehealth services that resulted in supportive care interventions for older adults.

"In my experience, if you don’t do a geriatric assessment, the patient pays for it later," said Tanyanika Phillips, M.D., M.P.H., presenting author and City of Hope medical oncologist and hematologist in Antelope Valley, California. Phillips noted that if care is prescribed without accurate health information, the result could be serious side effects or even hospitalization, which could lead not only to more costly care but also cancer treatment outcomes that are not the best for patients.

"In a general visit, patients often will say they feel well and are fine because they’re incentivized to answer in the affirmative and move forward with treatment," Phillips added. "Place this same patient in a different environment where they are answering geriatric assessment questions, and they may be more forthcoming and detailed about their lifestyle and abilities. This candor will help physicians prescribe the most appropriate care for that individual based on their circumstances."

Providing supportive care interventions via telehealth based on a geriatric assessment is shown to improve daily functioning, happiness and quality of life
Presentation Time and Location: Sunday, June 2, from 11:54 a.m. CT, S100bc

A randomized trial at a Brazilian cancer center and under the guidance of City of Hope’s internationally renowned cancer and aging expert William Dale, M.D., Ph.D., found that older adults with metastatic cancer reported experiencing significant improvements in the performance of daily activities, emotional well-being and quality of life after receiving a telehealth-based geriatric assessment (GA) that resulted in supportive care interventions. This data extends City of Hope’s prior work in GA-guided supportive care beyond the borders of the United States.

"Our studies continue to prove that patients and families win when care teams ask older adults with cancer the right questions at the outset to guide care. This is true even when telehealth is used in a low-resource environment. Guidance from a GA can change care choices and improve outcomes — all without making cancer therapy less effective. It’s a form of precision medicine: more appropriate supportive care interventions, better daily functioning, higher quality of life and the same great cancer care results. It’s a winning formula for patients, families, providers and the health system," said Dr. Dale, senior author of the study, City of Hope’s George Tsai Family Chair in Geriatric Oncology and director of City of Hope’s Center for Cancer and Aging. Dr. Dale is the recipient of this year’s B.J. Kennedy Geriatric Oncology Award, which honors geriatric oncologists who have demonstrated outstanding leadership and achievement in the field of geriatric oncology.

Additional highlights include the following award-winning poster abstract and three education sessions:

"A phase I/II trial of palbociclib, pembrolizumab, and endocrine therapy for patients with HR+/HER2- locally advanced or metastatic breast cancer (MBC): Clinical outcomes and stool microbial profiling"*
Presentation Time: Sunday, June 2, from 9 a.m. to noon CT
Presenter: Alexis LeVee, M.D., City of Hope Hematology & Medical Oncology Chief Fellow
*Conquer Cancer, the ASCO (Free ASCO Whitepaper) Foundation, awarded Dr. LeVee a 2024 ASCO (Free ASCO Whitepaper) Annual Meeting Merit Award, which supports students and trainees who are first authors on abstracts selected for presentation.
"Evidence Evaluating Cannabis’ Efficacy Across the Cancer Care Continuum"
Monday, June 3, 8:30 a.m. CT
Session title: Evidence-Based Integrative Oncology: Guideline Insights for Comprehensive Care
Presenter: Richard T. Lee, M.D., City of Hope clinical professor, Supportive and Integrative Medicine Program; Cherng Family Director’s Chair for the Center for Integrative Oncology
"Tissue-Based Molecular Testing and the Role of Artificial Intelligence"
Monday, June 3, 10 a.m. CT
Session title: Should I Order the Test? Expanding the Array of Emerging Diagnostics in Breast Cancer
Presenter: Daniel Schmolze, M.D., City of Hope associate clinical professor, Department of Pathology
"What Is Variant Histology Renal Cell Cancer and What Are the Available Treatment Options?"
Monday, June 3, 3:15 p.m. CT
Session title: Managing Variant Histologies in Urothelial and Renal Cell Cancers
Presenter: Sumanta Kumar Pal, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research