Express FDA today approved Keytruda combination therapy for first-line treatment of cervical cancer, reducing the risk of death by 36%

▎ WuXi AppTec content team editor On October 13, 2021, Merck (MSD) announced that the US FDA approved the PD-1 inhibitor pembrolizumab (pembrolizumab, English trade name Keytruda) in combination with platinum-containing chemotherapy.
With or without bevacizumab, the first-line treatment is for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS score ≥ 1)
.

The press release stated that this is the first anti-PD-1 antibody combination therapy approved for first-line treatment of these patients
.

The approval is based on the positive results of a pivotal, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial
.

The trial enrolled 617 adult patients with persistent, recurrent, or metastatic cervical cancer (regardless of PD-L1 status) who had not received systemic chemotherapy
.

The test results showed that for patients with PD-L1 expression (CPS≥1, n=548): Compared with chemotherapy, pembrolizumab + chemotherapy reduced the risk of death by 36% (HR=0.
64; 95% CI: 0.
50, 0.
81; p=0.
0001)
.

The median PFS of the pembrolizumab+chemotherapy group was 10.
4 months, and that of the chemotherapy group was 8.
2 months (HR=0.
62; 95% CI: 0.
50, 0.
77; p<0.
0001)
.

The objective response rates of pembrolizumab+chemotherapy group and chemotherapy group were 68% and 50%, respectively
.

The median duration of remission in the pembrolizumab+chemotherapy and chemotherapy groups were 18.
0 months and 10.
4 months, respectively
.

▲Pembrolizumab/chemotherapy combination significantly improves the overall survival and progression-free survival of patients (Image source: Merck’s official website) "Cervical cancer usually affects younger women, unfortunately, diagnosed with persistent, recurrent or Women with metastatic cervical cancer usually have a lower survival rate
.

" Dr.
Bradley Monk, an oncologist at the University of Arizona School of Medicine, said, "There has been no new first-line approved treatment for this disease in the past 7 years
.

I am very happy that the Keytruda combination therapy has been approved today .
, Bringing a new treatment option to suitable patients
.

"Reference: [1] FDA approves pembrolizumab combination for the first-line treatment of cervical cancer.
Retrieved October 13, 2021, from https:// approves-pembrolizumab-combination-first-line-treatment-cervical-cancer[2] FDA Approves Merck's KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD -L1 (CPS ≥1).
Retrieved October 13, 2021, from https:// Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
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