Merck's KEYTRUDA Gains European Approval for Two New Gynecologic Cancer Treatments

With these approvals, KEYTRUDA is now authorized for 30 indications in the EU, including five in gynecologic cancers, Merck said in a statement.;

Published On 2024-10-25 12:17 GMT | Update On 2024-10-26 04:52 GMT

RAHWAY: Merck, also known as MSD outside the US and Canada, announced that the European Commission (EC) has approved two new indications for KEYTRUDA (pembrolizumab), its anti-PD-1 therapy, in gynecologic cancers.

The first approval is for use with carboplatin and paclitaxel as a first-line treatment for adults with primary advanced or recurrent endometrial carcinoma who are eligible for systemic therapy. The second approval is for KEYTRUDA combined with chemoradiotherapy (CRT) for adults with FIGO 2014 Stage III-IVA locally advanced cervical cancer who have not undergone prior definitive therapy.

With these approvals, KEYTRUDA is now authorized for 30 indications in the EU, including five in gynecologic cancers—three for endometrial cancer and two for cervical cancer.

“These KEYTRUDA-based regimens have the potential to change the treatment paradigm for people with endometrial and cervical cancer, two of the most commonly diagnosed cancers among women in Europe,” said Dr Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.

“These approvals underscore the continued expansion of the use of KEYTRUDA in diverse patient populations and treatment settings with utility of KEYTRUDA ranging from earlier lines of therapy to treating advanced disease” the company stated.

Read also: Merck eyes more acquisitions for life science after USD 600M Mirus Bio deal

The EC approvals are based on results from the Phase 3 NRG-GY018 trial, also known as KEYNOTE-868, and the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, respectively, and follow positive recommendations from the Committee for Medicinal Products for Human Use received in September 2024.

In NRG-GY018/KEYNOTE-868, KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone.

In KEYNOTE-A18, KEYTRUDA in combination with concurrent CRT demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and PFS compared to concurrent CRT alone for newly diagnosed patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer.

These approvals allow marketing of these KEYTRUDA regimens for these indications in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland. Timing for commercial availability of KEYTRUDA for these indications in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.

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 based on PFS results from the NRG-GY018 trial. The KEYTRUDA regimen reduced the risk of disease progression or death by 70% (HR=0.30 [95% CI, 0.19-0.48]; p<0.0001) in patients whose cancer was mismatch repair deficient (dMMR) and by 40% (HR=0.60 [95% CI, 0.46-0.78]; p<0.0001) in patients whose cancer was mismatch repair proficient (pMMR) compared to placebo with carboplatin and paclitaxel followed by placebo 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 based on PFS results from the KEYNOTE-A18 trial. The KEYTRUDA regimen reduced the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) versus concurrent CRT alone for these patients.

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MD Bureau

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Merck's KEYTRUDA Gains European Approval for Two New Gynecologic Cancer Treatments

With these approvals, KEYTRUDA is now authorized for 30 indications in the EU, including five in gynecologic cancers, Merck said in a statement.;

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