Tag: Targeted Therapies

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

Patients and Doctors Push Back Against the Harsh Side Effects of Cancer Drugs

— “If the patients are not taking the drug, then it’s not going to work”

February 6, 2024 10:30 am

By Associated Press.

For cancer patients, the harsh side effects of powerful drugs have long been the trade-off for living longer. Now, patients and doctors are questioning whether all that suffering is necessary.

They’ve ignited a movement to radically change … 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

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

RAF/MEK and FAK Inhibitor Combo Effective in Low-Grade Serous Ovarian Cancer

November 5, 2023 9:00 am

Clearity’s Perspective: The combination of avutometinib and defactinib has shown encouraging activity in Low-Grade Serous Ovarian Cancer. Updated results from the RAMP 201 trial suggest that the combination is active regardless of the number of prior therapies patients have received. … Read more

Personalized cancer vaccine and adoptive T cell therapy benefits patients with advanced ovarian cancer: Study

September 21, 2023 9:00 am

By Andrea S. Blevins Primeau, PhD, MBA

A Ludwig Cancer Research study has shown that combining adoptive T cell therapy (ACT) with an innovative, personalized cancer vaccine under development at the Lausanne Branch of the Ludwig Institute for Cancer Research … Read more

Elahere for Ovarian Cancer: How to Manage Side Effects

August 15, 2023 9:00 am

A new drug approval is providing hope for many people living with ovarian cancer.

Some women have what is known as “platinum-resistant” cancer, that means the disease is no longer responding to platinum-based chemotherapy, the most common chemo drug used … Read more

Mirvetuximab Soravtansine Continues to Outperform Chemo in FRα-High Ovarian Cancer

May 3, 2023 9:19 am

by Jordan Sava

Impressive efficacy data and consistent safety data continue to be seen with mirvetuximab soravtansine for the treatment of patients with platinum-resistant ovarian cancer, according to data from the confirmatory MIRASOL trial.

Mirvetuximab sorvtansine-gynx (Elahere) demonstrated statistically significant

… 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

Preclinical Study Reveals New Target for Drug-Resistant Ovarian Cancer

April 18, 2023 1:04 pm

There are currently three antibody drug conjugates (ADC) targeting B7-H4 being tested in clinical trials: AZD8205 (NCT05123482), SGN-B7-H4V (NCT05194072) and XMT-1660 (NCT05377996). You can use Clearity’s clinical trial finder to find more information about these trials.

As part of the … Read more

Targeting FRα Enters a New Era in Ovarian Cancer and Beyond

January 16, 2023 9:41 am

by Anita T. Shaffer

Efforts to target the folate metabolism network have entered a new stage, with the approval of a novel therapy directed at folate receptor–α and the potential for additional agents aimed at that target in solid tumors.… Read more

FDA Approves Mirvetuximab Soravtansine-gynx for FRα+ Platinum-resistant Ovarian Cancer

November 14, 2022 12:21 pm

By Kristi Rosa

The FDA has granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for the treatment of adult patients with folate receptor α (Frα)–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior … Read more

Mirvetuximab Soravtansine Generates Improvement in PROs Vs Chemotherapy in Advanced Ovarian Cancer

October 13, 2022 2:03 pm

by Chris Ryan

Treatment with mirvetuximab soravtansine elicited a statistically significant benefit vs investigator’s choice of chemotherapy for the OV28 abdominal/gastrointestinal symptom subscale in patients with folate receptor alpha–positive, advanced ovarian cancer.

Treatment with mirvetuximab soravtansine elicited a statistically significant

… 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

Phase 1 Success of Targeting MUC16 in Patients With Recurrent Ovarian Cancer

September 14, 2022 1:11 pm

by Jordyn Sava

In an interview with Targeted Oncology during the EMSO Annual Congress, David O’Malley, MD, discussed the phase 1 study of ubamatamab in ovarian cancer.

Ubamatamab, a novel MUC16 antibody, demonstrated evidence of durable responses in patients with … Read more