Pembrolizumab and lenvatinib have been approved by the FDA for advanced endometrial cancer

Share This Post

August 2021: Pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) has been approved by the Food and Drug Administration for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression after prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

On September 17, 2019, the FDA awarded pembrolizumab plus lenvatinib expedited approval for advanced endometrial cancer. The multicenter, open-label, randomised, active-controlled study 309/KEYNOTE-775 (NCT03517449) was necessary to confirm the clinical benefit of this accelerated authorisation.

827 patients with advanced endometrial cancer were enrolled in Study 309/KEYNOTE-775, who had previously had at least one platinum-based chemotherapy regimen in any setting, including neoadjuvant and adjuvant treatments. Patients were randomly assigned (1:1) to receive pembrolizumab 200 mg intravenously every 3 weeks with lenvatinib 20 mg orally once daily, or doxorubicin or paclitaxel, as determined by the investigator.

Progression-free survival (PFS), as determined by blinded independent central review (BICR), and overall survival (OS) were the primary efficacy outcome measures. The objective response rate (ORR) and duration of response (DOR), both assessed by the BICR, were additional efficacy outcome measures.

The median PFS for patients with advanced endometrial cancer that was not MSI-H or dMMR was 6.6 months (95 percent CI: 5.6, 7.4) for those receiving pembrolizumab and lenvatinib and 3.8 months (95 percent CI: 3.6, 5.0) for those receiving investigator’s choice chemotherapy (HR 0.60; 95 percent CI: 0.50, 0.72; p0.0001) for those receiving investigator’s choice chemotherapy. The median OS was 17.4 months (95 percent confidence interval: 14.2, 19.9) for men and 12.0 months (95 percent confidence interval: 10.8, 13.3) for women (HR 0.68; 95 percent confidence interval: 0.56, 0.84; p=0.0001). ORRs were 30% (95 percent confidence interval: 26, 36) and 15% (95 percent confidence interval: 12, 19), respectively (p0.0001). 9.2 months (1.6+, 23.7+) and 5.7 months (0.0+, 24.2+) were the median DORs.

Hypothyroidism, hypertension, fatigue, diarrhoea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight loss, abdominal pain, urinary tract infection, proteinuria, constipation, headache, hemorrhagic events, palmar-plantar erythrodysestrophy, palmar-plantar erythrodysestrophy, palmar-plantar erythrodysestrophy, palmar-plantar erythro

Pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks with lenvatinib 20 mg orally once daily is the recommended dose for endometrial cancer.

Reference: https://www.fda.gov/

Check details here.

 

Take second opinion on advanced endometrial carcinoma treatment

Spread the love

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Development of CAR T Cell therapy in Korea
Cancer treatment in South Korea

Companies in Korea takes a step closer in developing home grown CAR T-Cell therapy

Due to high costs, treatments developed by multinational pharmaceutical corporations are difficult for Korean patients to access. As a result, Korean businesses have created and localised CAR-T treatments in an effort to address these issues. Many businesses have either begun developing CAR-T therapies or declared their intention to do so, including Curocell, Abclon, GC Cell, Ticaros, Helixmith, Toolgen, Cllengene, Eutilex, and Vaxcell Bio.

Spread the love
Polatuzumab
Blood cancer

Polatuzumab vedotin-piiq is approved by USFDA for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

For adult patients with high-grade B-cell lymphoma (HGBL), not otherwise specified (NOS), or diffuse large B-cell lymphoma (DLBCL) who have not previously received treatment and who have an International Prognostic Index (IPI) score of 2 or higher, the Food and Drug Administration has approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.).

Spread the love

Need help? Our team is ready to assist you.

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

درمان سرطان در تركيه

Enquiry Form

Start chat
Need help with cancer treatment?
Hello,

Welcome to CancerFax.

CancerFax is the most trusted international patient facilitator working with top cancer hospital's in the world like MD Anderson, Dana Farber, Asan, NCC Japan, Sheba, Beijing Cancer Institute and Apollo to bring you best of therapies and drugs.

let us know what services would you like to take?

1) Travel abroad for cancer treatment
2) CAR T-Cell therapy treatment
3) Cancer vaccine
4) Online video consultation
https://cancerfax.com/