Merck gets positive EU CHMP opinions for Keytruda regimens for patients with two types of Gynecologic cancers
Rahway: Merck, known as MSD outside of the United States and Canada, has 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 gynecologic 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 Gynecology 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.
“At Merck, we are deeply committed to expanding the role of KEYTRUDA to improve outcomes for more patients facing difficult-to-treat gynecologic 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.”
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) tumors. In June 2024 , KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, was approved in the U.S. for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
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 U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.
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