Latest news with #JyotiMayadev
Medscape
2 days ago
- Business
- Medscape
Could Liquid Biopsy Guide Treatment in Cervical Cancer?
Circulating tumor DNA (ctDNA) levels in patients with cervical cancer before and during treatment were prognostic of disease progression and survival in a post hoc analysis of the phase 3 CALLA trial. The findings 'support the future utility of…ctDNA analysis to help guide treatment decisions for locally advanced cervical cancer,' said lead study author Jyoti Mayadev, MD, a radiation oncologist at Moores NCI-Designated Comprehensive Cancer Center and professor of radiation medicine and applied sciences at the University of California, San Diego School of Medicine in La Jolla, California. Mayadev reported the results at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. They were published simultaneously in the Annals of Oncology . The previously published CALLA trial showed that patients receiving adjuvant chemoradiotherapy (CRT) for locally advanced cervical cancer did not have improved progression-free survival (PFS) with the addition of concurrent durvalumab compared with placebo. The trial included 770 patients with previously untreated stage IB2-IIB node-positive or IIIA-IVA any node-status locally advanced cervical cancer who were randomly assigned to receive durvalumab (1500 mg intravenously once every 4 weeks) plus CRT (n = 385) or CRT alone (n = 385). CRT, consisting of external beam radiotherapy with intravenous cisplatin or carboplatin, was delivered once weekly for 5 weeks, followed by image-guided brachytherapy. Exploratory Analysis Methods and Results A preplanned exploratory analysis sampled ctDNA levels in a subset of 186 patients to determine if ctDNA could serve as a biomarker for treatment response. The study used an ultrasensitive tumor-informed ctDNA assay, personalized for each patient, to test plasma at baseline, cycle 3 day 1 (immediately post-CRT), and cycle 6 day 1 (3 months post-CRT), explained Mayadev during her presentation at the meeting. ctDNA was detected in 99% of baseline samples, with no difference across the treatment arms, she reported. Immediately after treatment, detectable levels decreased to 35.5% in the durvalumab/CRT arm and 39.8% in the CRT-only arm. By 3 months after treatment, levels declined further to 23.4% and 36.4%, respectively, demonstrating a 13% lower rate of detectable ctDNA in the durvalumab/CRT arm at this timepoint. The study showed that ctDNA levels were prognostic of both PFS and overall survival (OS), regardless of treatment arm. Among patients in whom ctDNA was detectable immediately posttreatment, 68% subsequently progressed, and among those without detectable ctDNA, 83% had not progressed by the time of data cutoff, for a positive predictive value of 61%, a negative predictive value of 83%, and a sensitivity and specificity of 68% and 78%, respectively. ctDNA Detected 5.5 Months Before Radiographic Progression The median lead time from ctDNA detection on the ultrasensitive assay until radiographic or clinical evidence of progression was 5.5 months, ranging from 1.5 to 16.5 months. Looking specifically at PFS and OS, patients with ctDNA levels were prognostic of PFS and OS for patients in both treatment arms at all timepoints measured. In the durvalumab/CRT arm, low vs high ctDNA at baseline conferred a hazard ratio of 0.60 for PFS and of 0.63 for OS. In the CRT-only arm, low vs high ctDNA conferred hazard ratios of 0.62 and 0.85 for PFS and OS, respectively. Similarly, detectable ctDNA levels immediately posttreatment compared with undetectable levels identified patients at a higher risk for progression and death, regardless of treatment arm. With detectable ctDNA as the reference, PFS and OS hazard ratios were 0.23 and 0.20 in the durvalumab/CRT arm and 0.15 and 0.18 in the CRT-only arm, respectively. Having no ctDNA detected 3 months after treatment cessation reduced the risks for progression and death by at least 95% for patients in both treatment arms, Mayadev said during her presentation. Multivariate analysis showed that detection of ctDNA immediately posttreatment conferred a hazard ratio of 5.27 ( P < .001) for PFS, independent of disease stage at baseline or treatment allocation, she said. 'Our study found that persistent ctDNA levels posttreatment strongly correlated with an increased risk of relapse and were likely reflective of residual disease that, in some instances, went undetected by other means,' wrote Mayadev and co-authors in their paper. 'On average, ctDNA was detected 5.5 months before radiographic progression. In clinical practice, this could allow for proactive treatment management to potentially improve patient outcomes — for example, earlier consideration of adjuvant therapies, such as immunotherapy or systemic therapy, or a switch to a novel therapeutic regimen. In cases of recurrence, tracking ctDNA levels in real-time could also help assess response to salvage therapy, providing a dynamic tool for optimizing therapeutic decisions.' 'This really is a good analysis showing how ctDNA is definitely a better prognostic marker than standard poor prognostic clinical factors such as nodal status and even updated FIGO staging for cervical cancer,' said Mark Einstein, MD, the discussant for the paper, who is professor and chair of the Department of Obstetrics and Gynecology and Women's Health at Montefiore Medical Center/Albert Einstein College of Medicine, New York City. However, he said the positive predictive value and sensitivity 'are good, but they're not great. The negative predictive value, though, is excellent, and this would reveal that the test might have some value as a negative predictive marker of recurrence rather than a positive predictive marker of recurrence.' But, the bigger question, he said, is 'what are we going to do with that information? If we actually do know that someone has a positive ctDNA, are we going to get into the situation that we are in with ovary cancer, with CA125 without measurable disease, where it just creates a lot of anxiety without necessarily restarting treatment? This could identify central disease before it actually becomes distant, which could lead to potentially curative surgical options, and it might put someone on increased surveillance in imaging, but I think we need to really look at this prospectively.' Also commenting on the study, Sarah Kim, MD, a gynecologic surgeon specializing in the treatment of ovarian, endometrial, cervical, vulvar, and vaginal cancer at the Memorial Sloan Kettering Cancer Center in New York City, pointed out what she found useful and what additional questions need to be answered. 'Further studies need to be done to validate these results and determine the clinical utility in the setting of adjuvant therapy or recurrence,' she said in an interview with Medscape Medical News . 'I think these are important findings and potentially clinically impactful for patients with locally advanced cervical cancer,' said Kim. 'They support the use of ctDNA to detect minimal residual disease and/or the use of ctDNA as a prognostic marker, which is lacking in cervical cancer. We have seen similar results in patients with endometrial cancer, where the ctDNA increases prior to any detection of disease on imaging.' The trial was sponsored by AstraZeneca. Mayadev disclosed leadership roles with the American Brachytherapy Society and NRG Oncology; honoraria from AstraZeneca; consulting or advisory roles with Agenus, AstraZeneca/MedImmune, Merck, Primmune Therapeutics, and Varian Medical Systems; research funding from Varian Medical Systems; and travel, accommodations, and other expenses from Merck. Einstein disclosed a consulting or advisory role with Antiva Biosciences, Asieris Pharmaceuticals, and Merck, and research funding from Johnson & Johnson, Merck, and PapiVax Biotech, Inc. Kim had no disclosures.
Yahoo
3 days ago
- Business
- Yahoo
Personalis' NeXT Personal® Predicts Cervical Cancer Recurrence Risk in New CALLA Phase 3 Study Analysis Presented at ASCO
FREMONT, Calif., June 03, 2025--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced the presentation of new results from the CALLA phase 3 study showing for the first time its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test detected cervical cancer progression, up to 16 months ahead of imaging. The results demonstrate the potential of NeXT Personal to enable earlier detection in a cancer with high recurrence rates. The results were presented yesterday by Jyoti Mayadev, MD, from the University of California San Diego, at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago in an oral presentation titled "Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses." The results from this study were also simultaneously published in the journal Annals of Oncology. Samples were analyzed from patients with cervical cancer who had enrolled in the original CALLA clinical trial. In this new study analysis, NeXT Personal was used to look for small traces of ctDNA in blood samples from a cohort of 186 patients with locally advanced cervical cancer. Dr. Mayadev's team found that overall ctDNA levels after chemoradiotherapy (CRT) treatment were strongly predictive of risk of cervical cancer progression. "Despite standard chemoradiotherapy, up to half of patients with locally advanced cervical cancer relapse, underscoring the urgent need for better prognostic tools. In the CALLA phase 3 study, ultrasensitive, tumor-informed ctDNA analysis emerged as a powerful predictor of progression and survival—detecting relapse up to ~16 months before imaging. These findings highlight ctDNA's potential to guide treatment decisions and personalize care in high-risk cervical cancer," said Dr. Mayadev. Key findings presented: Detection of ctDNA following CRT was independently prognostic of patient outcomes. Risk of progression and death were at least 95% lower for patients where ctDNA was not detected ~3 months after completing CRT. Detection of ctDNA after CRT was associated with high subsequent risk of disease progression, and was detected a median of ~5 months and up to ~16 months earlier than by imaging scans. High ctDNA levels (≥ median) at baseline was associated with higher risk of progression and death. "We are excited to see the results presented for NeXT Personal in this large phase 3 study in cervical cancer," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "Cervical cancer is the fourth most common cancer for women globally, resulting in hundreds of thousands of deaths each year. The new results show the strong potential for an ultrasensitive MRD test like NeXT Personal to inform treatment for cervical cancer patients." About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit and connect with us on LinkedIn and X (Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity, clinical relevance or importance of the NeXT Personal test. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect small traces of ctDNA, detect residual or recurrent cancer early (including detection earlier than standard of care imaging), monitor or predict a patient's response to therapy or risk of cancer recurrence, accurately predict clinical outcomes for cancer patients, or impact cancer care or management (including for escalation or de-escalation of treatment), or to the clinical adoption or use of, or the ability of Personalis to obtain Medicare coverage or reimbursement for, the NeXT Personal test, or to the sufficiency of the publication and study results described in this press release to support such adoption, use, coverage or reimbursement. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Personalis' Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 6, 2025. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law. Not affiliated with or endorsed by ASCO. View source version on Contacts Investors: Caroline Cornerinvestors@ 415-202-5678 Media Contact pr@
Business Wire
4 days ago
- Business
- Business Wire
Personalis' NeXT Personal ® Predicts Cervical Cancer Recurrence Risk in New CALLA Phase 3 Study Analysis Presented at ASCO
FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced the presentation of new results from the CALLA phase 3 study showing for the first time its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test detected cervical cancer progression, up to 16 months ahead of imaging. The results demonstrate the potential of NeXT Personal to enable earlier detection in a cancer with high recurrence rates. The results were presented yesterday by Jyoti Mayadev, MD, from the University of California San Diego, at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago in an oral presentation titled 'Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.' The results from this study were also simultaneously published in the journal Annals of Oncology. Samples were analyzed from patients with cervical cancer who had enrolled in the original CALLA clinical trial. In this new study analysis, NeXT Personal was used to look for small traces of ctDNA in blood samples from a cohort of 186 patients with locally advanced cervical cancer. Dr. Mayadev's team found that overall ctDNA levels after chemoradiotherapy (CRT) treatment were strongly predictive of risk of cervical cancer progression. 'Despite standard chemoradiotherapy, up to half of patients with locally advanced cervical cancer relapse, underscoring the urgent need for better prognostic tools. In the CALLA phase 3 study, ultrasensitive, tumor-informed ctDNA analysis emerged as a powerful predictor of progression and survival—detecting relapse up to ~16 months before imaging. These findings highlight ctDNA's potential to guide treatment decisions and personalize care in high-risk cervical cancer,' said Dr. Mayadev. Key findings presented: Detection of ctDNA following CRT was independently prognostic of patient outcomes. Risk of progression and death were at least 95% lower for patients where ctDNA was not detected ~3 months after completing CRT. Detection of ctDNA after CRT was associated with high subsequent risk of disease progression, and was detected a median of ~5 months and up to ~16 months earlier than by imaging scans. High ctDNA levels (≥ median) at baseline was associated with higher risk of progression and death. 'We are excited to see the results presented for NeXT Personal in this large phase 3 study in cervical cancer,' said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. 'Cervical cancer is the fourth most common cancer for women globally, resulting in hundreds of thousands of deaths each year. The new results show the strong potential for an ultrasensitive MRD test like NeXT Personal to inform treatment for cervical cancer patients.' About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit and connect with us on LinkedIn and X (Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are 'forward-looking statements' within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity, clinical relevance or importance of the NeXT Personal test. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect small traces of ctDNA, detect residual or recurrent cancer early (including detection earlier than standard of care imaging), monitor or predict a patient's response to therapy or risk of cancer recurrence, accurately predict clinical outcomes for cancer patients, or impact cancer care or management (including for escalation or de-escalation of treatment), or to the clinical adoption or use of, or the ability of Personalis to obtain Medicare coverage or reimbursement for, the NeXT Personal test, or to the sufficiency of the publication and study results described in this press release to support such adoption, use, coverage or reimbursement. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in Personalis' Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 6, 2025. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law. Not affiliated with or endorsed by ASCO.
