The FDA has given enfortumab vedotin-ejfv approval for the treatment of locally advanced or metastatic urothelial carcinoma

Share This Post

August 2021: Enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor combination, has been approved by the Food and Drug Administration for adult patients with locally advanced or metastatic urothelial carcinoma.

have previously received a programmed death receptor-1 (PD-1) or programmed death ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or have previously had one or more prior lines of therapy and are ineligible for cisplatin-containing chemotherapy
In December 2019, the FDA granted enfortumab vedotin-ejfv accelerated approval for patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

The open-label, randomised, multicenter trial EV-301 (NCT03474107) was necessary to confirm the clinical benefit of the 2019 accelerated authorisation. 608 individuals with locally advanced or metastatic urothelial carcinoma who had previously undergone a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy were enrolled in this study. On days 1, 8, and 15 of a 28-day cycle, patients were randomised (1:1) to receive either enfortumab vedotin-ejfv (EV) 1.25 mg/kg or the investigator’s choice of single-agent chemotherapy (docetaxel, paclitaxel, or vinflunine).

Overall survival (OS) was the primary effectiveness outcome, with progression-free survival (PFS) and overall response rate (ORR) being critical secondary efficacy endpoints assessed by investigators using RECIST 1.1. Patients on the EV arm (n=301) had a median OS of 12.9 months (95 percent CI: 10.6, 15.2) compared to 9.0 months (95 percent CI: 8.1, 10.7) in the chemotherapy arm (n=307) (HR 0.70; 95 percent CI: 0.56, 0.89; p=0.0014). The median PFS was 5.6 months (95 percent confidence interval: 5.3, 5.8) versus 3.7 months (95 percent confidence interval: 3.5, 3.9), respectively (HR 0.62; 95 percent confidence interval: 0.51, 0.75; p0.0001). The ORR was 40.6 percent (95 percent confidence interval: 34.9, 46.5) versus 17.9 percent (95 percent confidence interval: 13.7, 22.8) (p0.0001).

Efficacy in 89 patients with locally advanced or metastatic urothelial cancer who had previously received a PD-1 or PD-L1 inhibitor and were ineligible for cisplatin-containing chemotherapy was evaluated in Cohort 2 of EV-201 (NCT03219333), a single-arm, multi-cohort, international trial in 89 patients with locally advanced or metastatic urothelial cancer who had previously received a PD-1 or PD-L The primary efficacy outcome was confirmed ORR, which was assessed by a blinded independent central review, and response length was a key secondary efficacy endpoint. The confirmed ORR was 51% (95 percent CI: 39.8, 61.3), with 22% of replies being complete, and the median response time was 13.8 months (95 percent CI: 6.4, not estimable).

Rashes, aspartate aminotransferase increased, glucose increased, creatinine increased, fatigue, peripheral neuropathy, lymphocytes decreased, alopecia, decreased appetite, haemoglobin decreased, diarrhoea, sodium decreased, nausea, pruritus, phosphate decreased, dysgeusia, alanine aminotransferase increased, anaemia, anaemia, anaemia, anaemia, anaemia, ane

The USPI now includes a boxed warning for significant skin reactions, such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, as well as a warning for pneumonitis.

 

Enfortumab vedotin-ejfv is given as an intravenous infusion lasting 30 minutes on days 1, 8, and 15 of a 28-day cycle until disease progression or intolerable toxicity.

Reference: https://www.fda.gov/

Check details here.

 

Take second opinion on urothelial cancer treatment


Send Details

Website |  + posts

Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.

Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.

Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.

Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.

These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.

Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Advancements in adoptive CAR immune cell immunotherapy synergistically combined with multimodal approaches for tumor treatment
CAR T-Cell therapy

Advancements in adoptive CAR immune cell immunotherapy synergistically combined with multimodal approaches for tumor treatment

CAR T cell therapy has transformed cancer treatment, especially in hematological malignancies. Treatment of solid tumors remains challenging due to their immunosuppressive tumor microenvironment. Combination with chemotherapy, immune checkpoint inhibitors, oncolytic viruses, and improved genetic engineering holds promise. Multimodal approaches enhance immune cell infiltration and persistence, raising efficacy. Evolving personalized methods will be instrumental in overcoming solid tumor resistance and improving patient outcomes.

How to prevent infections in patients receiving CD19-targeted chimeric antigen receptor T cells for B-cell malignancies
CAR T-Cell therapy

How to prevent infections in patients receiving CD19-targeted chimeric antigen receptor T cells for B-cell malignancies?

CAR T-cell therapy revolutionized cancer therapy, offering incredible success in the management of B-cell malignancies, but it is associated with severe infection risks secondary to immunosuppression. Preventive measures are pre-infusion screening, vaccination, and antimicrobial prophylaxis. Post-infusion, close surveillance for infection and cytokine release syndrome management are key. Long-term care includes the treatment of hypogammaglobulinemia, revaccination, and patient education. The approach ensures improved outcomes and reduces infection-related complications in patients receiving CD19-targeted CAR T-cell therapy.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

CancerFax is the most trusted online platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies.

Send your medical reports and get a free analysis.

🌟 Join us in the fight against cancer! 🌟

Привет,

CancerFax — это самая надежная онлайн-платформа, призванная предоставить людям, столкнувшимся с раком на поздних стадиях, доступ к революционным клеточным методам лечения.

Отправьте свои медицинские заключения и получите бесплатный анализ.

🌟 Присоединяйтесь к нам в борьбе с раком! 🌟