Tag: Antibody Drug Conjugate

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

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

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

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

… 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

DS-6000a Displays Early Clinical Activity in Ovarian Cancer and RCC

August 24, 2022 2:20 pm

In an interview with Targeted Oncology, Erika P. Hamilton, MD, discussed the early clinical activity seen with DS-6000a in patients with advanced ovarian cancer or renal cell carcinoma with disease progression following standard of care treatment.

Interim data from a … Read more

ADCs Begin to Carve a Place in the Treatment Landscape for Ovarian Cancer

July 26, 2022 2:39 pm

by Brittany Lovely

Patients with recurrent, platinum-resistant ovarian cancer have limited effective treatment options available, but a class of targeted antibody-drug conjugates (ADCs) represent a promising development for this population.1

The treatment landscape for patients who experience disease progression

… Read more

Farletuzumab Ecteribulin Shows Early Activity in Platinum-Resistant Ovarian Cancer

June 21, 2022 11:03 am

by Chris Ryan

The antibody-drug conjugate farletuzumab ecteribulin demonstrated notable antitumor activity with a manageable safety profile in patients with platinum-resistant ovarian cancer.

The antibody-drug conjugate (ADC) farletuzumab ecteribulin (MORab-202) demonstrated notable antitumor activity with a manageable safety profile in

… Read more

SORAYA Trial: Antibody-Drug Conjugate Produces Remissions in One-Third of Patients With Drug-Resistant Ovarian Cancer

March 22, 2022 10:22 am

by the ASCO Post Staff

In a clinical trial involving patients with ovarian cancer previously treated with platinum-based chemotherapy, a novel antibody-drug conjugate therapy produced a substantially better response than standard treatments, investigators from Dana-Farber Cancer Institute reported at the … Read more

STRO-002 Produces Deep Responses in Heavily Pretreated Advanced Ovarian Cancer

January 7, 2022 11:18 am

by Kristi Rosa

The FolRα-targeted antibody-drug conjugate STRO-002 was found to elicit encouraging responses in heavily pretreated patients with advanced ovarian cancer.

The FolRα-targeted antibody-drug conjugate (ADC) STRO-002 was found to elicit encouraging responses in heavily pretreated patients with advanced

… Read more

Mirvetuximab Elicits Responses in More Than 31% of Patients With FRalpha-High Platinum-Resistant Ovarian Cancer

November 30, 2021 12:10 pm

by Nichole Tucker

Top-line results from the phase 3 SORAYA study show promise for mirvetuximab in patients with FRα-high platinum-resistant ovarian cancer.

Single-agent mirvetuximab soravtansine (mirvetuximab; IMGN853) has demonstrated clinically meaningful benefit in patients with late receptor alpha (FRα)-high platinum-resistant

… Read more

Phase 1 Study of Novel Drug for Ovarian Cancer Shows Positive Results

December 5, 2020 6:00 pm

One patient had a complete response and the majority of patients achieved disease control at 12 weeks.

A phase 1 trial of an anti-folate receptor alpha (FolRα) human immunoglobulin G1 (IgG1) antibody for women with advanced ovarian cancer showed responses

… Read more

Phase I Data of XMT-1536 Supports Continued Development in Ovarian Cancer

September 17, 2020 1:00 pm

Updated interim safety, tolerability, and efficacy data for the ovarian cancer cohort of the ongoing expansion portion of the Phase I study evaluating XMT-1536 show a 34% objective response rate (ORR) and 79% disease control rate, including two complete responses. … Read more

Mirvetuximab Soravtansine Plus Bevacizumab in FRα-Overexpressing Advanced Epithelial Ovarian Cancer

May 30, 2020 5:00 pm

By Susan Moench, PhD, PA-C

This study evaluated the combination of bevacizumab with an antibody drug conjugate targeted to the folate receptor alpha in the setting of epithelial ovarian cancer.

Early results from a single-arm phase 1b study conducted in … Read more