The GALAXY Study has provided compelling data that highlights the predictive value of circulating tumor DNA (ctDNA) status in colorectal cancer outcomes. Using Natera’s Signatera test, this study offers oncologists key insights into how ctDNA can be used to monitor disease recurrence, guide therapy decisions, and potentially redefine patient management strategies. Study Design and Participants This large-scale study involved 2,240 patients with stage 2 to stage 4 colorectal cancer (CRC). The median follow-up period was 23 months, and the study focused on the predictive role of ctDNA status in assessing disease-free survival (DFS) and overall survival (OS). The Signatera test,…
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The FDA has approved pembrolizumab (Keytruda) combined with platinum-based chemotherapy for the treatment of patients with unresectable, advanced, or metastatic malignant pleural mesothelioma (download slides below). This marks the first new treatment for mesothelioma in over 15 years, providing a new option for patients battling this aggressive disease. Key Results from the KEYNOTE-483 Trial The approval was based on findings from the KEYNOTE-483 trial, a randomized, open-label, phase 3 study involving patients with unresectable, advanced, or metastatic malignant pleural mesothelioma who had not received prior systemic therapy. Participants were randomized to receive either pembrolizumab with pemetrexed and platinum-based chemotherapy for…
The FDA has recently approved Kisqali (ribociclib) in combination with a non-steroidal aromatase inhibitor (NSAI) for the treatment of early-stage HR+/HER2- breast cancer in patients at high risk of recurrence (download slides below). This approval provides a new treatment option for patients, aiming to reduce the likelihood of cancer recurrence during the early stages of the disease. Key Findings from the NATALEE Trial The NATALEE trial was a randomized, open-label, multicenter phase 3 trial that included 5,101 adults with HR-positive, HER2-negative early breast cancer. Patients were selected based on lymph node involvement or tumor size and grade, ensuring a diverse…
iTeos Therapeutics and GSK revealed promising results from their phase 2 TIGIT trial at the 2024 European Society for Medical Oncology (ESMO) conference in Barcelona. The mid-stage trial, known as GALAXIES Lung-201, evaluated the combination of belrestotug, an anti-TIGIT antibody, and dostarlimab (Jemperli), GSK’s anti-PD-1 treatment, in patients with previously untreated, unresectable, or metastatic PD-L1-high non-small cell lung cancer (NSCLC). The results demonstrated a 30% improvement in tumor shrinkage with the combination therapy compared to dostarlimab monotherapy. The overall response rate (ORR) was impressive across all dosing cohorts: These results stand in contrast to the 37.5% ORR for patients who…
On September 12, 2024, the U.S. Food and Drug Administration (FDA) approved Tecentriq Hybreza, the first subcutaneous (SC) formulation of a PD-(L)1 inhibitor for cancer treatment. Developed by Genentech, Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) allows for a 7-minute subcutaneous injection, significantly reducing the 30 to 60 minutes typically required for intravenous (IV) administration of Tecentriq. This new formulation provides an alternative treatment option for patients with cancers such as non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), and others. New Administration Option for Cancer Patients Tecentriq Hybreza is expected to offer patients and healthcare providers…
Dr. Nathalie M. Johnson, MD, a breast cancer specialist with Legacy Health Partners, delves into the evolving role of circulating tumor DNA (ctDNA) in the management of breast cancer. As the field of oncology continues to advance, Dr. Johnson emphasizes the importance of adopting ctDNA testing more widely to improve patient outcomes, particularly for those with high-risk breast cancer types. The Role of ctDNA in Breast Cancer Management Dr. Johnson begins by highlighting how ctDNA is becoming a crucial tool in her practice. Although there aren’t standardized guidelines for its use just yet, she stresses that ctDNA testing can be…
Introduction Dr. Kevin Hughes, MD, from MUSC Health, sheds light on a critical issue in the field of oncology: the underutilization of genetic testing among patients who could significantly benefit from it. Despite the availability of commercial genetic testing for the past 25 years, an astonishing 90% of patients with genetic mutations remain unaware of their status. This lack of awareness often leads to missed opportunities for early intervention and cancer prevention. The Problem with Current Genetic Testing Practices Dr. Hughes points out that many patients with mutations that could predispose them to cancer are diagnosed late because they were…
Introduction On August 2, 2024, the FDA granted accelerated approval to afamitresgene autoleucel (TECELRA) for treating adults with unresectable or metastatic synovial sarcoma. This approval marks a significant advancement in immunotherapy for synovial sarcoma, a rare and aggressive cancer type. TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy. This treatment is specifically for patients who have previously undergone chemotherapy and whose tumors express the MAGE-A4 antigen. Clinical Trial and Efficacy The approval was based on the results from the SPEARHEAD-1 trial, a multicenter, single-arm, open-label study. This trial included patients with inoperable or metastatic synovial…
On August 1, 2024, the U.S. Food and Drug Administration (FDA) approved an expanded indication for dostarlimab-gxly (Jemperli), in combination with carboplatin and paclitaxel, for adult patients with primary advanced or recurrent endometrial cancer. This new approval allows the use of dostarlimab-gxly not only in mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) patients but also in the broader population of those with primary advanced or recurrent endometrial cancer. Clinical Trial Evidence The approval was based on the results of the RUBY trial (NCT03981796), a randomized, multicenter, double-blind, placebo-controlled study involving 494 patients. Participants were randomized to receive either dostarlimab-gxly…
Introduction ASCO 2024 Head & Neck Cancer developments brought forth several groundbreaking studies in the field of head and neck cancer, showcasing advancements that could potentially change clinical practices. Dr. Shlomo Koyfman, MD, highlighted three pivotal studies that stood out during the conference. These studies delve into proton therapy, biomarker trials, and the role of immunotherapy, offering new insights and potential changes in treatment approaches for head and neck cancer patients. 1. IMRT vs. IMPT Proton Therapy Study The much-anticipated IMRT (Intensity-Modulated Radiation Therapy) versus IMPT (Intensity-Modulated Proton Therapy) phase three study finally provided data after a decade of research.…
Genetic Testing Cancer In recent years, the field of oncology has witnessed significant advancements, particularly in the realm of genetic testing. One such advancement is the use of circulating tumor DNA (ctDNA) monitoring, which has the potential to revolutionize cancer treatment and management. Dr. Erica Giblin, MD, from Ascension Medical Group, shares her insights and experiences with ctDNA testing, highlighting its impact on the detection and treatment of breast cancer recurrences. The Role of ctDNA in Early Detection Dr. Giblin emphasizes the importance of ctDNA monitoring, noting that it has been integrated into her practice for over a year. This…
Author: Dr. Shubham Pant, MD – MD Anderson Overview: At the ASCO 2024 conference, Dr. Shubham Pant, MD – MD Anderson shared exciting updates from the Phase 2 trial of zanidatamab, a bispecific HER2 antibody, in patients with HER2-positive biliary tract cancer (BTC). This trial highlights the potential of zanidatamab to improve treatment outcomes for this challenging cancer type. Mechanism of Action: Zanidatamab targets two domains on the HER2 protein (ECD2 and ECD4), which enhances receptor internalization and HER2 downregulation. This dual targeting mechanism leads to a more effective antitumor response compared to traditional HER2-targeted therapies. Study Design: Key Findings:…
Author: Dr. Zandra Klippel, Global Product Head, Multiple Myeloma, Sanofi At the ASCO 2024 conference, Dr. Zandra Klippel the Global Product Head, Multiple Myeloma, Sanofi summarizes the promising Phase 3 results from the IMROZ study. This study evaluated the combination of Sarclisa (isatuximab) with VRd (bortezomib, lenalidomide, and dexamethasone) in patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for transplant. Key Findings: Future Research Directions: Ongoing research aims to optimize dosing, reduce side effects, and expand the use of Isa-VRd to other myeloma populations, including those eligible for transplant. Future trials will explore different dosing schedules and delivery…
Author: Dr. Alexis LeVee, City of Hope At the ASCO 2024 conference, Dr. Alexis LeVee from City of Hope presented a pivotal Phase 1b clinical trial that explores the combination of CDK4/6 inhibitors and PD-1 inhibitors with endocrine therapy in patients with hormone receptor-positive, HER2-negative metastatic breast cancer (HR+/HER2- mBC). This study investigates how these combinations can enhance anti-tumor responses and improve clinical outcomes. Study Details: Results: Conclusion: The combination therapy shows promising results in enhancing immune response and improving clinical outcomes in HR+/HER2- mBC patients. Further evaluation in prospective trials is needed to confirm these findings. Abstract: A phase…
Author: Dr. Regina Barragan-Carillo, City of Hope Overview: At ASCO 2024, Dr. Regina Barragan-Carillo from City of Hope Cancer Center shared her pioneering research on how Latino ethnicity influences the gut microbiome composition in patients with metastatic renal cell carcinoma (mRCC). This study sheds light on the crucial link between ethnicity, gut microbiome, and treatment outcomes with immune checkpoint inhibitors. Study Highlights: Implications: This study emphasizes the importance of considering ethnic diversity in medical research and treatment strategies. Understanding the unique gut microbiome profiles of different ethnic groups can lead to more personalized and effective cancer treatments. Conclusion: Dr. Barragan-Carillo’s…
Presented by Dr. Hedyeh Ebrahimi, City of Hope Overview: At the ASCO 2024 conference, Dr. Hedyeh Ebrahimi of City of Hope presented an impactful study led by Dr. Alex Chehrazi Rafel. The study investigated the effectiveness of high-dose chemotherapy regimens in patients with recurrent germ cell tumors. This collaborative effort included contributions from four leading referral centers: City of Hope, UCSF, UC Davis, and UCLA. Study Details: Key Findings: Implications: The results highlight the potential benefits of the TICE regimen for improving overall survival in patients with recurrent germ cell tumors. Additionally, the identification of beta HCG as a prognostic…
Introduction During a comprehensive presentation by Dr. Catherine Coombs at UC Irvine, insights into the unique challenges and opportunities of using CAR T-cell therapies in Chronic Lymphocytic Leukemia (CLL) were discussed. Despite CLL being a malignancy with numerous effective treatment options, CAR T-cell therapy has been relatively slow to gain approval. This detailed exploration highlights the potential and hurdles of integrating CAR T into CLL management, including a review of Lysacel and other significant treatments. The State of CAR T in CLL Challenges in CLL Dr. Coombs pointed out that CLL is characterized by immune dysfunction, which can impair the…
Introduction At a recent conference, Dr. Anjali Advani of the Cleveland Clinic discussed the transformative role of Chimeric Antigen Receptor T-cell (CAR-T) therapy in the treatment of acute lymphoblastic leukemia (ALL), especially in conjunction with bispecific antibodies and antibody-drug conjugates. Her talk offered a comprehensive overview of current therapies and explored the future of CAR-T in ALL treatment, providing crucial insights for oncologists. The Evolution of ALL Treatment Current Landscape Historically, adults with relapsed refractory ALL had dismal prognoses, but the landscape has shifted dramatically with the introduction of innovative therapies. Dr. Advani highlighted four pivotal agents currently approved for…
Introduction During the CAR-T & Bispecifics Conference, Dr. Brian Sworder, MD, from UCI Irvine, shared compelling insights on the utility of circulating tumor DNA (ctDNA) in the context of CAR-T cell therapy, particularly for relapsed refractory large B-cell lymphoma. This summary highlights the critical aspects of his presentation, emphasizing the revolutionary potential of ctDNA in predicting therapy outcomes and understanding resistance mechanisms. The Significance of Circulating Tumor DNA in Oncology Understanding ctDNA Circulating tumor DNA consists of small fragments of DNA shed by tumor cells into the bloodstream. It serves as a non-invasive biomarker that can be analyzed to detect…
Introduction During the recent CAR-T & Bispecifics conference, Dr. Nitin Jain, MD, from MD Anderson Cancer Center in Houston, Texas, presented a challenging case involving advanced B-cell lymphoblastic leukemia (BLL). This discussion offered profound insights into the nuanced decision-making processes in oncology, particularly in cases involving genetic complexities and multiple treatment failures. The session highlighted the evolving landscape of oncological treatment where genetic insights drive personalized medicine approaches. … Detailed Case Review and Genetic Implications Patient Background The focus was on a 25-year-old Hispanic male patient initially diagnosed with BLL in 2016. This patient’s medical journey has been significantly complicated…
Introduction The recent findings from the DESTINY-Breast06 Phase III trial signify a potential shift in the treatment landscape for HR-positive, HER2-low metastatic breast cancer. This landmark study evaluates the efficacy of Enhertu (trastuzumab deruxtecan), a specifically engineered antibody drug conjugate, marking significant strides in targeted cancer therapy. These results demonstrate substantial improvements in progression-free survival (PFS) compared to standard chemotherapy, offering new hope for patients with limited treatment options. Trial Design and Methodology Overview DESTINY-Breast06 is a global, randomized, open-label, Phase III trial that compares the effectiveness and safety of Enhertu against the investigator’s choice of standard chemotherapy, which includes…
Introduction The US Food and Drug Administration (FDA) recently approved nogapendekin alfa inbakicept-pmln (Anktiva), used in conjunction with bacillus Calmette-Guérin (BCG), marking a significant advancement in the treatment of non–muscle-invasive bladder cancer (NMIBC) unresponsive to BCG alone. This groundbreaking approval addresses a substantial unmet need within the high-risk bladder cancer population, offering new hope for thousands of patients across the United States. Background and Rationale Bladder cancer ranks as the sixth most prevalent cancer in the United States, with approximately 81,000 new cases annually and 17,000 deaths. NMIBC represents about 70% of all bladder cancer cases and is typically managed…
… Gabriel Mannis, MD Associate Professor of Medicine in the Division of Hematology at Stanford University School of Medicine provides an in-depth analysis of Notable Lab’s Predictive Precision Medicine Platform. Dr. Mannis discusses the pivotal role of PPMP in advancing the treatment of Acute Myeloid Leukemia (AML), focusing on how its rapid and personalized approach can significantly enhance patient outcomes by tailoring therapies to individual needs. For more information visit www.NotableLabs.com For More Information Visit Notable Lab’s Predictive Precision Medicine Platform