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

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

Ursula Matulonis, MD, on Concordance of CA-125 and Radiographic Progression in Ovarian Cancer

February 21, 2024 9:00 am

By Mark Fuerst

About half of patients with platinum-sensitive relapsed ovarian cancer (PSROC) on maintenance poly (ADP-ribose) polymerase inhibitor (PARPi) therapy who showed RECIST progression did not have cancer antigen-125 (CA-125) progression, challenging current guidelines, according to a new study.… 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

Trial Analyzing MEK Inhibitor Combo for Ovarian Cancer Subset Begins

December 21, 2023 9:00 am

By Ashley Chan

A treatment combination of avutometinib and defactinib is being evaluated in a new phase 3 trial for patients with low-grade serous ovarian cancer.

A phase 3 trial analyzing the treatment combination of avutometinib and defactinib compared with … 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

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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

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

Phase 3 Trial of TTFields and Paclitaxel Misses OS End Point in Ovarian Cancer

August 28, 2023 9:00 am

The primary end point was not met in the phase 3 ENGOT-ov50 / GOG-3029 / INNOVATE-3 clinical trial of tumor treating fields therapy plus paclitaxel in patients with platinum-resistant ovarian cancer.

Patients with platinum-resistant ovarian cancer given tumor treating fields

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Batiraxcept Plus Paclitaxel Misses PFS End Point in Platinum-Resistant Ovarian Cancer

August 3, 2023 9:00 am

The addition of batiraxcept to paclitaxel did not significantly improve progression-free survival compared with paclitaxel alone in a prespecified subset of patients with platinum-resistant ovarian cancer who were not previously exposed to bevacizumab, missing the primary end point of the Read more

Avutometinib Plus Defactinib Demonstrates Promising Activity in Recurrent LGSOC

June 6, 2023 7:03 am

Treatment with avutometinib plus defactinib elicited high responses among patients with recurrent low grade serous ovarian cancer compared with avutometinib monotherapy, supporting the use of the combination in this patient population regardless of KRAS status, according to data from the … Read more

Study shows efficacy and safety of novel FolRα-targeting antibody drug conjugate in recurrent epithelial ovarian cancer

June 4, 2023 6:58 am

Updated dose expansion data of the phase I STRO-002-GM1 study have been presented today by Ana Oaknin, Principal Investigator of the Vall d’Hebron Institute of Oncology’s (VHIO) Gynecological Malignancies Group, on the ground at the 2023 Annual Meeting of the … 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

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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

CDK4/6 Inhibition Active in Recurrent Low-Grade Serous Ovarian Cancer

March 27, 2023 9:52 am

by Charles Bankhead

TAMPA, Fla. — About a fourth of patients with recurrent low-grade serous ovarian cancer (LGSOC) obtained durable responses to the combination of CDK4/6 inhibitor ribociclib (Kisqali) and letrozole, a small single-arm trial showed.

Overall, 23% of 48 … Read more

Chemotherapy-resistant ovarian cancer cells protect their neighbors, shows study

March 3, 2023 10:10 am

by University of Pittsburgh

Certain chemotherapy-resistant ovarian cancer cells protect neighboring cancer cells by sending signals that induce resistance, according to a new study from University of Pittsburgh and UPMC researchers that may help explain why ovarian cancer patients respond … Read more