The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, recommending the approval of Merck’s Keytruda (pembrolizumab) for two indications in gynecologic cancers. These recommendations aim to expand treatment options for endometrial and cervical cancer patients within the European Union. The CHMP's decision is a step towards providing new immunotherapy-based regimens to patients with these difficult-to-treat cancers.
The first recommendation supports 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 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), with final decisions expected in the fourth quarter of 2024.
Supporting Clinical Trials
The recommendation for endometrial carcinoma is based on the NRG-GY018 trial, also known as KEYNOTE-868, which evaluated Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent. This study demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus carboplatin and paclitaxel.
In June 2024, the U.S. Food and Drug Administration (FDA) approved Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
The recommendation for 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.
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.
Impact on Women's Cancers
Endometrial carcinoma, beginning in the inner lining of the uterus, is the most common type of uterine cancer. Cervical cancer forms in the cells lining the cervix. According to Merck, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall. Worldwide, there were approximately 420,368 patients diagnosed with endometrial cancer and 97,723 deaths in 2022. In Europe, there were approximately 124,874 patients diagnosed with endometrial cancer and 30,272 deaths in 2022.
Cervical cancer is the fourth most common cancer in women globally, with approximately 662,301 patients diagnosed and 348,874 deaths worldwide in 2022. In Europe, there were approximately 58,219 new cases of cervical cancer diagnosed and 26,950 deaths in 2022.
Merck's Commitment
Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, stated, “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. 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.”
Merck is advancing research to expand treatment options for breast and gynecologic cancers, aiming to improve outcomes for patients. With over 20 clinical trials involving more than 18,000 patients, Merck is focused on advancing standards of care in women’s cancers.
