Nov 2021: Pembrolizumab (Keytruda, Merck) in conjunction with chemotherapy, with or without bevacizumab, has been approved by the Food and Drug Administration for patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 (CPS 1), as determined by an FDA-approved test.
Pembrolizumab ને એફડીએ દ્વારા વારંવાર અથવા મેટાસ્ટેટિક સર્વાઇકલ કેન્સર ધરાવતા દર્દીઓ માટે સિંગલ ટ્રીટમેન્ટ તરીકે પણ નિયમિત મંજૂરી આપવામાં આવી હતી જેમને કીમોથેરાપી પર અથવા પછી રોગની પ્રગતિ થાય છે અને જેમની ગાંઠો PD-L1 (CPS 1) વ્યક્ત કરે છે, જેમ કે FDA-મંજૂર પરીક્ષા દ્વારા સ્થાપિત કરવામાં આવે છે. FDA એ જૂન 2018 માં, PD-L1 IHC 22C3 pharmDx (Dako North America Inc.) સાથે, આ સંકેતને ઝડપી મંજૂરી આપી હતી.
Pembrolizumab with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab, was studied in KEYNOTE-826 (NCT03635567), a multicenter, randomised, double-blind, placebo-controlled trial. The experiment involved 617 patients who had not been treated with chemotherapy and had chronic, recurring, or first-line metastatic સર્વિકલ કેન્સર. Patients were enrolled regardless of whether or whether they had PD-L1 expression. Pembrolizumab 200 mg with chemotherapy with or without bevacizumab or placebo plus chemotherapy with or without bevacizumab were randomly assigned (1:1) to one of two treatment groups. Pembrolizumab was given until disease progression, intolerable toxicity, or 24 months had passed from the start of the study.
Overall survival (OS) and progression-free survival (PFS) were the key efficacy outcome measures, which were assessed by the investigator using RECIST v1.1, which was adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR and reaction length were also used as additional outcome measures (DoR). The median OS in the pembrolizumab arm was not reached (95 percent CI: 19.8, NR) and was 16.3 months (95 percent CI: 14.5, 19.4) in the placebo arm (HR 0.64; 95 percent CI: 0.50, 0.81; 1-sided p-value = 0.0001) for patients with tumours expressing PD-L1 (CPS 1, N=548). The median PFS in the pembrolizumab arm was 10.4 months (95 percent CI: 9.7, 12.3), while the placebo arm was 8.2 months (95 percent CI: 6.3, 8.5) (HR 0.62; 95 percent CI: 0.50, 0.77; 1-sided p-value 0.0001). In the pembrolizumab and placebo arms, the objective response rates were 68 percent (95 percent CI: 62, 74) and 50 percent (95 percent CI: 44, 56), respectively, with median DoRs of 18.0 and 10.4 months.
Pembrolizumab, chemotherapy, and bevacizumab were associated with peripheral neuropathy, alopecia, anaemia, fatigue/asthenia, nausea, neutropenia, diarrhoea, hypertension, thrombocytopenia, constipation, arthralgia, vomiting, urinary tract infection, rash, leukopenia, hypothyroidism, and decreased appetite in 20 percent of patients.
પેમ્બ્રોલિઝુમાબને દર 200 અઠવાડિયે 3 મિલિગ્રામ અથવા દર 400 અઠવાડિયે 6 મિલિગ્રામની માત્રામાં આપવામાં આવે છે જ્યાં સુધી રોગની પ્રગતિ અથવા અસ્વીકાર્ય ઝેરી અસર થાય છે, જે 24 મહિના સુધી ટકી શકે છે.
