Tag: Precision Medicine

Enhertu Gets Tumor-Agnostic FDA Approval for HER2-Positive Cancers

— About half of patients responded, duration of response as long as 19 months in three trials

April 5, 2024 9:00 am

By Charles Bankhead

The FDA granted tumor-agnostic accelerated approval to trastuzumab deruxtecan (Enhertu) for previously treated unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid cancers.

The action represents the first tumor-agnostic approval for an antibody-drug conjugate targeting HER2-positive tumors. According … Read more

Combining Avutometinib With Defactinib Yields High Response Rates in LGSOC

March 22, 2024 9:00 am

By Ryan Scott

Patients who are heavily pretreated with recurrent low-grade serous ovarian cancer (LGSOC) had high response rates, regardless of the number of prior lines of therapy received, when treated with avutometinib (previously VS-6766) plus defactinib, according to data … Read more

ctDNA Offers Potential Biomarker for PARP Inhibitor Maintenance Therapy in Epithelial Ovarian Cancer

March 20, 2024 9:00 am

Clearity’s Perspective: At the SGO meeting several presentations described how circulating tumor DNA (ctDNA) may be a new, personalized, sensitive tool to help evaluate treatment de-escalation, monitor minimal residual disease (MRD), and track treatment response in ovarian cancer. The application … Read more

Rezatapopt Shows Preliminary Efficacy in TP53 Y220C–Mutated Advanced Ovarian Cancer

March 19, 2024 9:00 am

By Kristi Rosa

Rezatapopt (PC14586) elicited responses with a favorable toxicity profile in heavily pretreated patients with advanced ovarian cancer harboring TP53 Y220C mutations, according to data from the phase 1/2 PYNNACLE study (NCT04585750) presented at the 2024 SGO Annual … Read more

New microbiome insights could help boost immunotherapy for a range of rare cancers

March 1, 2024 9:00 am

Clearity’s Perspective: Previous research in different types of cancer has suggested that there is a relationship between a cancer patient’s gut microbiota (microorganisms that live in the digestive tract) composition and the response to immune checkpoint inhibitor therapy; however,

… Read more

Priority Review Granted for Trastuzumab Deruxtecan; Would Be First Tumor-Agnostic ADC

A tumor-agnostic approval would be a significant development in the advance of antibody-drug conjugates (ADCs), which are designed to deliver a potent, cancer-fighting payload into a tumor while sparing nearby tissues.

January 30, 2024 9:00 am

Clearity’s Perspective: Most drugs are tested and approved to treat cancers based on where in the body the cancer started and the type of tissue from which it developed. Enhertu (Trastuzumab Deruxtecan, T-Dxd), a HER2-targeted antibody drug conjugate (ADC), already … Read more

Real-World Data Confirm the Incidence of ADC-Related Ocular Toxicities in Ovarian Cancer

January 26, 2024 9:00 am

By Ashling Wahner

Although the antibody-drug conjugate (ADC) mirvetuximab soravtansine-gynx (Elahere) is associated with a high rate of ocular toxicity in patients with folate receptor α (FRα)-positive, platinum-resistant ovarian cancer, the real-world incidence of this adverse effect (AE) in this … Read more

NCCN Guidelines Update Adds Mirvetuximab Soravtansine Plus Bevacizumab for FRα-Expressing, Platinum-Sensitive Ovarian Cancer

January 19, 2024 9:00 am

Clearity’s Perspective: In the January 17, 2024 update to the National Comprehensive Cancer Network (NCCN) guidelines for ovarian cancer, several new therapies have been added to the list of acceptable regimens for recurrent platinum-resistant ovarian cancer. For example, trastuzumab deruxtecan … Read more

What Comes after NCI-MATCH? NCI’s New Precision Medicine Cancer Trials

December 6, 2023 9:00 am

By James H. Doroshow, M.D.

More than 8 years ago, NCI launched NCI-MATCH, a first-of-its-kind precision medicine cancer clinical trial. NCI-MATCH tested different targeted therapies in people with cancer whose tumors had specific genetic changes. This year, three second-generation precision

… Read more

PC14586 Targets Previously “Undruggable” p53 in Treatment of Solid Tumors

Despite previous unsuccessful attempts to target p53, investigators have continued to try to develop novel therapeutics directed at the tumor suppressor gene with the goal of restoring p53 wild-type activity.

November 27, 2023 9:00 am

By Kyle Doherty

Despite previous unsuccessful attempts to target p53, investigators have continued to try to develop novel therapeutics directed at the tumor suppressor gene with the goal of restoring p53 wild-type activity. With the initiation of the phase … Read more

Artificial Intelligence May Predict Ovarian Cancer Therapy Outcomes

November 21, 2023 9:00 am

By Rylan DeStefano

An artificial intelligence model called IRON (Integrated Radiogenomics for Ovarian Neoadjuvant therapy) shows an 80% accuracy rate in the prediction of therapy outcomes for patients with ovarian cancer. The artificial intelligence model focuses specifically on the volumetric … Read more

Raludotatug Deruxtecan Elicits Early Efficacy and Safety in Platinum-Resistant Ovarian Cancer

November 17, 2023 9:00 am

Clearity’s Perspective: A phase I clinical trial studying the antibody-drug conjugate (ADC) raludotatug deruxtecan (DS-6000a, R-DXd) shows early encouraging activity in heavily pretreated ovarian cancer. The antibody portion of raludotatug deruxtecan targets CDH6 (found in about 65-85% of ovarian cancers) … Read more

Scientists Piece Together DNA Repair Pathway Implicated in Breast, Ovarian, and Prostate Cancers

November 15, 2023 9:00 am

Clearity’s Perspective: Cancer cells that have mutations in BRCA or that are HRD-positive are not able to use the so-called homologous recombination repair pathway to fix mistakes in the cancer cell. These cancer cells become reliant on other repair pathways. … Read more

Tumor Testing May Be Increasingly Useful in Ovarian Cancer

May 8, 2023 3:00 pm

Testing tumors with next-generation sequencing in patients with ovarian cancer can provide teams insight into targetable mutations that may affect treatment decisions, although this approach is not the current standard of care for all patients, an expert said.

Among 1,092 patients with ovarian cancer, 27.5% underwent next-generation sequencing; 96.1% had one or more genetic alteration; 25.9% had an alteration that aligned with targeted treatment

In an

… Read more

Dual Inhibition of PARP and ATR Feasible, Early Trials Suggest

April 19, 2023 12:40 pm

by Leah Lawrence

Early-phase trials testing the safety and efficacy of PARP inhibition plus ataxia telangiectasia- and Rad3-related kinase (ATR) inhibition in biomarker-selected patients show intriguing results, researchers reported at the AACR Annual Meeting 2023.

“ATR inhibition prevents recovery from … Read more

Genetic Test Identifies Ovarian Cancer Patients Likely To Benefit From PARP Inhibitors

January 12, 2023 9:58 am

A genetic test developed in a study at the University of Helsinki and Helsinki University Hospital identifies ovarian cancer patients who benefit from PARP inhibitors, a treatment option.

Since the therapy is associated with potential serious side-effects, it is important … Read more

FDA Grants First Tumor-Agnostic Approval for RET Fusion-Positive Cancers

September 22, 2022 9:49 am

by Mike Bassett

— Selpercatinib approved for advanced or metastatic solid tumors that progress on systemic therapy

The FDA granted accelerated approval to selpercatinib (Retevmo) for adults with locally advanced or metastatic solid tumors associated with RET gene fusions, the

… Read more

FDA Approves Tafinlar Plus Mekinist for Patients With BRAF V600-Mutant Solid Cancers

June 23, 2022 10:56 am

by Brielle Benyon

Tafinlar plus Mekinist is now approved by the Food and Drug Administration to treat adults and children over the age of 6 who have BRAF V600-mutant advanced solid cancers.

The Food and Drug Administration (FDA) approved Tafinlar

… Read more

MD Anderson Researchers Present Encouraging Results of Early-Stage Clinical Trials at 2022 ASCO Annual Meeting

June 7, 2022 10:45 am

by University of Texas M.D. Anderson Cancer Center

Newswise — CHICAGO ― Results from three early-stage clinical trials led by researchers at The University of Texas MD Anderson Cancer Center show promising activity with novel immunotherapies and targeted therapies for … Read more

Biomarkers May Identify Ovarian Cancer Patients Who Benefit From AstraZeneca WEE1 Inhibitor

June 5, 2022 9:55 am

by Caroline Hopkins

CHICAGO – AstraZeneca’s investigational WEE1 inhibitor adavosertib showed potential in biomarker-selected advanced ovarian cancer populations in two studies presented during the American Society of Clinical Oncology’s annual meeting Saturday.

The drug, which AstraZeneca licensed from Merck in … Read more