Tag: Clinical Trial

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

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

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

Gynecologic cancer clinical trial enrollment lower for certain underrepresented groups

December 29, 2023 9:00 am

By Erin T. Welsh, MA

Key takeaways:

  • Clinical trial enrollment was lower for Asian, Black and Hispanic women vs. white women.
  • Asian and Hispanic women were underrepresented in endometrial, cervical and ovarian cancer trials.

Asian, Black and Hispanic women with … 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

Psilocybin May Help Ease Depression in Cancer Patients

In small trial, half had early remission of depressive symptoms after psilocybin-assisted therapy

December 18, 2023 9:00 am

By Diana Swift

Psilocybin-assisted therapy in a group setting was safe and appeared effective in patients with cancer and depression, according to a small, phase II, open‐label trial.

After one dose of psilocybin among 30 patients, depression severity scores dropped … Read more

Virtual Mind–Body Fitness Classes Show Unexpected Benefit in People with Cancer

December 15, 2023 9:00 am

By Edward Winstead

For people being treated for cancer, participating in virtual mind–body fitness classes may have important benefits, such as reducing the risk of being hospitalized for treatment-related problems, according to results from a clinical trial.

In the trial, … 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

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

HIPEC Improves Long-Term Outcomes in Stage III Ovarian Cancer

September 25, 2023 9:00 am

By Andrea S. Blevins Primeau, PhD, MBA

Adding hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves long-term outcomes in patients with stage III epithelial ovarian cancer, according to updated trial results published in The Lancet Oncology.

These 10-year … 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

Clinical trial gives women with gene mutation power over disease

September 8, 2023 9:00 am

Shared by Norma Rabago

When Juana Padron, a 40-year-old mother of four, chose to have a genetic test, going against her friends and family’s advice was the last thing on her mind.

Padron’s aunt died from breast cancer, and she … Read more

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

Aerobic exercise may reduce chemotherapy-induced peripheral neuropathy in ovarian cancer

August 2, 2023 9:00 am

Key takeaways:

  • Women assigned a 6-month intervention reported decreased chemotherapy-induced peripheral neuropathy symptoms.
  • Women in the control group reported a slight increase in symptoms.

A 6-month aerobic exercise intervention significantly improved self-reported chemotherapy-induced peripheral neuropathy among women who underwent chemotherapy … Read more

DESTINY-PanTumor-02: Trastuzumab Deruxtecan Has Activity Against a Range of HER2-Expressing Solid Tumors

June 7, 2023 6:55 am

Key Points:

  • Interim results of the phase 2 trial DESTINY-PanTumor-02 show that T-DXd has broad activity across tumor types and a toxicity profile consistent with previous studies.
  • T-DXd had the lowest activity in pancreatic cancer, and this cohort was stopped
… 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

Olaparib-durvalumab regimen prolongs PFS for certain women with advanced ovarian cancer

June 3, 2023 7:02 am

Key takeaways:

  • Researchers reported statistically significant improvement in median PFS with the combination added to standard of care in non-BRCA-mutated disease.
  • The relative contribution of durvalumab requires further study.

 

CHICAGO — First-line chemotherapy plus bevacizumab and durvalumab … Read more