EU CHMP Recommends Approval of Merck’s Keytruda Regimens for Gynaecologic Cancer

EU CHMP Recommends Approval of Merck’s Keytruda Regimens for Gynaecologic Cancer

By, Admin 24 September 2024

EU CHMP recommends approval of Merck’s Keytruda regimens as treatment for patients with two types of gynaecologic cancers

Overview

Merck, known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending approval of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for two indications in gynaecologic cancers. The first opinion recommends the approval of Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy. The second positive opinion recommends the approval of Keytruda in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynaecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and final decisions are expected in the fourth quarter of 2024.

Statement from Merck Research Laboratories

  • At Merck, we are deeply committed to expanding the role of Keytruda to improve outcomes for more patients facing difficult-to-treat gynaecologic cancers as we work to address the impact of women’s cancers around the world,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. 
  • These positive CHMP opinions bring us one step closer to providing new immunotherapy-based regimens to more patients with endometrial and cervical cancer in the European Union who may benefit. We look forward to the European Commission’s decisions.

KEYNOTE-868 for Keytruda+ Carboplatin and Paclitaxel

  • The recommendation in primary advanced or recurrent endometrial carcinoma is based on the NRG-GY018 trial, also known as KEYNOTE-868, evaluating Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent. 
  • In this study, the Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus carboplatin and paclitaxel. 
  • If approved, this would mark the third indication for Keytruda in endometrial cancer in Europe. 
  • Keytruda plus Lenvima (lenvatinib) was approved in November 2021 for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation, and Keytruda monotherapy was approved in April 2022 for these patients who have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumours. 
  • In June 2024, Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, was approved in the US for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

KEYNOTE-A18 Trial: Behind Use in Cervical Cancer

  • The recommendation in newly diagnosed patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer is based on the KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, in which Keytruda in combination with concurrent CRT demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and PFS versus CRT alone. 
  • If approved, this would mark the second indication for Keytruda in cervical cancer in Europe. 
  • Keytruda plus chemotherapy, with or without bevacizumab, was approved in April 2022 for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] =1). 
  • In January 2024, Keytruda in combination with CRT was approved in the US for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.

About Endometrial Carcinoma

  • Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. 
  • Globally, endometrial cancer is the sixth most common cancer in women and 15th most common cancer overall. 
  • Worldwide, it is estimated there were approximately 420,368 patients diagnosed with endometrial cancer and 97,723 patient deaths from the disease in 2022. 
  • In Europe, it is estimated there were approximately 124,874 patients diagnosed with endometrial cancer and 30,272 patient deaths from the disease in 2022.

About Cervical Cancer

  • Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. 
  • All women are at risk for cervical cancer, and it is most frequently diagnosed between the ages of 35 and 44. 
  • While screenings and prevention have resulted in declining cervical cancer rates, the disease continues to affect many people in the US and around the world. 
  • Cervical cancer is the fourth most common cancer in women globally. 
  • Worldwide, it is estimated there were approximately 662,301 patients diagnosed with cervical cancer and 348,874 patient deaths from the disease in 2022. 
  • In Europe, it is estimated there were approximately 58,219 new cases of cervical cancer diagnosed and 26,950 patient deaths from the disease in 2022.

Merck Research for Breast and Gynaecologic Cancer 

  • Merck is advancing research aimed at expanding treatment options for certain breast and gynaecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. 
  • Breast cancer and gynaecological cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to give patients facing these devastating diseases options. 
  • With more than 20 clinical trials in more than 18,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. 
  • Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. 
  • Merck is working to develop a portfolio and pipeline to address the impact of women’s cancers on patients, their families and communities globally.

Keytruda: PD-1 Therapy

  • Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. 
  • Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.

Merck’s immuno-oncology research

  • Merck has the industry’s largest immuno-oncology clinical research program. 
  • There are currently more than 1,600 trials studying Keytruda across a wide variety of cancers and treatment settings. 
  • The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers. 

About Lenvima

  • Lenvima, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). 
  • Lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumour growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRa), KIT, and RET. 
  • In syngeneic mouse tumour models, Lenvima decreased tumour-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!