Mansoor Raza Mirza, MD, chief oncologist at Copenhagen University Hospital in Denmark speaks about the FDA Approves Pembrolizumab Plus Chemo as First-Line Therapy for Advanced, Recurrent Cervical Cancer.
Link to Article:
https://www.medscape.com/viewarticle/960819?src=
Pembrolizumab (Keytruda, Merck) and conventional chemotherapy " with or without bevacizumab " have been approved by the US Food and Drug Administration (FDA) as first-line therapy for patients with persistent, recurrent, or metastatic PD-L1-expressing cervical cancer.
The first-line approval comes on the heels of the KEYNOTE-826 trial’s phase 3 data, which were reported at the European Society for Medical Oncology (ESMO) Congress 2021 last month.
The FDA also announced the regular approval of pembrolizumab alone for patients with recurrent or metastatic cervical cancer who are experiencing disease progression during or after treatment in the same press release. In June 2018, the FDA granted rapid approval for this indication, along with the approval of a companion diagnostic test, PD-L1 IHC 22C3 pharmDx, which can detect PD-L1 expression in malignancies.
In patients with recurrent, persistent, or metastatic cervical cancer, adding pembrolizumab to platinum-based chemotherapy with or without bevacizumab resulted in significant improvements in overall and progression-free survival, according to the latest KEYNOTE-826 study, presented at ESMO last month.
The combination has been dubbed “the new standard of care” for cervical cancer by Raza Mirza, MD, chief oncologist at Copenhagen University Hospital in Denmark, who presented the findings at ESMO.
Pembrolizumab 200 mg intravenously every 3 weeks in conjunction with conventional chemotherapy and bevacizumab, at the investigator’s discretion, or placebo for up to 35 cycles were given to 617 patients with chronic, recurring, or metastatic cervical cancer.
The median progression-free survival was 10.4 months in the pembrolizumab group and 8.2 months in the placebo group for patients with a PD-L1 combination positive score of 1 or more. At 12 months, the pembrolizumab group had a 45.5 percent progression-free survival rate compared to 34.1 percent in the placebo group (hazard ratio [HR], 0.62; P.001).
The researchers also stated that the median overall survival in the pembrolizumab group was not reached, while the placebo group had a median overall survival of 16.3 months. At 12 and 24 months, the pembrolizumab group had higher overall survival rates (75.3 percent and 53 percent, respectively) than the placebo group (63.1 percent and 41.7 percent, respectively) (HR, 0.61; P.001).
Pembrolizumab improved progression-free survival and overall survival in patients with a PD-L1 combination positive score of 10 or more. Overall survival with pembrolizumab was 75.7 percent at 12 months and 54.4 percent at 24 months, compared to 61.5 percent and 44.6 percent with placebo (HR, 0.61; P.001). Patients with PD-L1-negative tumors, on the other hand, did not benefit from the addition of pembrolizumab.
Peripheral neuropathy, alopecia, anemia, fatigue, nausea, neutropenia, diarrhea, and hypertension were the most common adverse effects in the pembrolizumab group, according to the study, which occurred in more than one in five participants.