Title:
DCGI approves MSD’s Keytruda for additional indications of cervical and esophageal cancers
Excerpt:US-based pharma major MSD (tradename of Merck & Co., Inc) announced that the Drugs Controller General of India (DCGI) has approved its anti cancer drug Keytruda (pembrolizumab), for additional indications of cervical cancer and esophageal cancer. The company said that the anti-programmed death receptor-1 (PD-1), has received approval for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS =1, and for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD-L1 with a CPS = 10.
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)
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)...
Excerpt:The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland....In a phase III study, the addition of pembrolizumab to chemotherapy with or without bevacizumab was associated with a significant improvement in progression-free survival and overall survival in patients with persistent, recurrent or metastatic cervical cancer with PD-L1 CPS≥1.
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)...for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test...
Evidence Level:Sensitive: A2 - Guideline
Title:
NICE Backs Merck's Keytruda for PD-L1-Expressing Cervical Cancer
Excerpt:The UK's National Institute for Health and Care Excellence on Wednesday recommended that the National Health Service provide Merck's Keytruda (pembrolizumab) plus chemotherapy with or without Genentech's Avastin (bevacizumab) as treatment for cervical cancer patients in England whose cancers express PD-L1 with a combined positive score of at least 1.
Evidence Level:Sensitive: A2 - Guideline
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
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.
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:cisplatin + paclitaxel; carboplatin
DOI:10.1200/JCO.2023.41.16_suppl.5500
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.
Excerpt:Eligible adults with persistent, recurrent, or metastatic cervical cancer...Pembro + chemo significantly improved OS and PFS in the CPS ≥1, all-comer, and CPS ≥10 populations...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.
DOI:10.1200/JCO.2023.41.16_suppl.5500
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)
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)...
Evidence Level:Sensitive: B - Late Trials
Title:
Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer
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.
DOI:10.1056/NEJMoa2112435
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
Excerpt:...PD-L1 expression`Assess percentage of subjects who respond to treatment who are HPV positive compared to percentage of subjects who respond to treatment who are HPV negative.`...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Study on Carboplatin-Paclitaxel-Pembrolizumab in treatment of locally advanced cervical cancer Studio su Carboplatino-Paclitaxel-Pembrolizumab nel trattamento neoadiuvante del carcinoma cervicale localmente avanzato.
Excerpt:...>1% di cellule tumorali positive per PD-L1, valutato attraverso IHC;3. ...
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
Pembrolizumab treatment of advanced cervical cancer: Updated results from the phase II KEYNOTE-158 study
Excerpt:All 14 responses were in pts with PD-L1–positive tumors, resulting in an ORR of 17.1% (95% CI, 9.7% to 27.0%) in the PD-L1–positive cohort (N=82)…
Evidence Level:Sensitive: C3 – Early Trials
Title:
57P - The efficacy and safety of pembrolizumab in advanced cervical cancer: A real-world treatment study
Excerpt:Patients received Pembrolizumab 200mg IV once every three weeks….The ORR was 25% with a DCR of 30%. All responses were in patients with PDL1+ or of unknown PDL1 status. mOS was 8.9months in total population (11.2months in PDL1+), and mPFS was 6.4months (8.3months in PDL1+)....pembrolizumab should be considered as a standard option for those with advanced PDL1+ cervical cancer.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study
Excerpt:Patients received pembrolizumab 200 mg every 3 weeks for 2 years....ORR was 12.2% (95% CI, 6.5% to 20.4%), with three complete and nine partial responses. All 12 responses were in patients with PD-L1–positive tumors.