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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS >=1)

Published date:
04/29/2022
Excerpt:
Merck...announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). This approval is based on results from the Phase 3 KEYNOTE-826 trial, in which KEYTRUDA plus chemotherapy with or without bevacizumab (the KEYTRUDA regimen) demonstrated a statistically significant improvement in overall survival (OS) (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS) (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001)...
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
10/13/2021
Excerpt:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...Cervical cancer...in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. (1.11, 2.1)
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
10/26/2021
Excerpt:
Cervical Cancer: First-line Combination Therapy...Preferred Regimens...First-line Combination Therapy; Preferred Regimens: The following were added...Pembrolizumab + cisplatin/paclitaxel ± bevacizumab for PD-L1–positive tumors
Secondary therapy:
cisplatin + paclitaxel
Evidence Level:
Sensitive: B - Late Trials
Title:

KEYNOTE-826: Final overall survival results from a randomized, double-blind, phase 3 study of pembrolizumab + chemotherapy vs placebo + chemotherapy for first-line treatment of persistent, recurrent, or metastatic cervical cancer.

Published date:
05/31/2023
Excerpt:
The addition of pembro to chemo ± bev significantly reduced the risk of death by 40% in the PD-L1 CPS ≥1 population, by 37% in the all-comer population, and by 42% in the CPS ≥10 population, and had a manageable safety profile. These data are consistent with the earlier results and provide further support for pembro + chemo ± bev as a new standard of care for first-line treatment of persistent, recurrent, or metastatic cervical cancer.
Secondary therapy:
carboplatin; cisplatin + paclitaxel
DOI:
10.1200/JCO.2023.41.16_suppl.5500
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Merck Receives Positive EU CHMP Opinion for 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)

Published date:
03/25/2022
Excerpt:
Merck...today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab (the KEYTRUDA regimen), for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1)....The recommendation is based on results from the Phase 3 KEYNOTE-826 trial, in which the KEYTRUDA regimen demonstrated a statistically significant improvement in overall survival (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001)...
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: B - Late Trials
Title:

Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer

Published date:
11/11/2021
Excerpt:
We assessed the relative benefit of adding pembrolizumab to chemotherapy with or without bevacizumab. In 317 patients with a PD-L1 combined positive score of 10 or more, progression-free survival was 10.4 months and 8.1 months, respectively (hazard ratio, 0.58; 95% CI, 0.44 to 0.77; P<0.001). Overall survival at 24 months was 53.0% in the pembrolizumab group and 41.7% in the placebo group (hazard ratio for death, 0.64; 95% CI, 0.50 to 0.81; P<0.001), 50.4% and 40.4% (hazard ratio, 0.67; 95% CI, 0.54 to 0.84; P<0.001), and 54.4% and 44.6% (hazard ratio, 0.61; 95% CI, 0.44 to 0.84; P=0.001), respectively. Progression-free and overall survival were significantly longer with pembrolizumab than with placebo among patients with persistent, recurrent, or metastatic cervical cancer who were also receiving chemotherapy with or without bevacizumab.
Secondary therapy:
Chemotherapy
DOI:
10.1056/NEJMoa2112435
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A Literature Review Of Recurrent Or Metastatic Cervical Cancer Disease Burden, Treatment Outcomes, And Unmet Needs

Published date:
04/12/2021
Excerpt:
In studies of second or later lines of therapy, mPFS was 4.1 months and mOS was 5.2 months with BEVA; mPFS was 2.0 months, mOS was 11.0 months, and ORR was 11% (17% in PD-L1–positive patients) with pembrolizumab; mPFS was 2.5 months, mOS was 6.4 and 7.3 months, and ORR was 0% with topotecan.