FDA Approves Keytruda To Treat Advanced, PD-L1-Positive Cervical Cancer

The Food and Drug Administration (FDA) granted accelerated approval to Keytruda (pembrolizumab) for the treatment of patients with advanced, PD-L1—positive cervical cancer with disease progression on or after chemotherapy.

The agency based its decision on data from the global, open-label, nonrandomized, multicohort, multicenter phase 2 KEYNOTE-158 trial — an ongoing study designed to evaluate the efficacy of Keytruda in more than 1,300 adults who have advanced solid tumors that progressed on chemotherapy. Data for the approval included 98 patients with recurrent or metastatic cervical cancer enrolled in a single cohort of the study.

Patients in the study intravenously received Keytruda at a dose of 200 mg every three weeks until unacceptable toxicity or documented disease progression.

At a median follow-up of 11.7 months, the overall response rate (ORR) was 14.3 percent in 77 patients, which included a complete response rate of 2.6 percent and a partial response rate of 11.7 percent among the cervical cancer cohort.

In total, 10 patients (12 percent) experienced grade 3/4 treatment-related side effects. The most common adverse reactions in at least 10 percent of patients with cervical cancer enrolled in KEYNOTE-158 were fatigue, pain, pyrexia, peripheral edema, musculoskeletal pain, diarrhea/colitis, abdominal pain, nausea, vomiting, constipation, decreased appetite, hemorrhage, UTI, infections, rash, hypothyroidism, headache and dyspnea. Keytruda was discontinued due to adverse reactions in 8 percent of patients. Serious adverse reactions occurred in 39 percent of patients. The most frequent serious adverse reactions reported included anemia (7 percent), fistula (4.1 percent), hemorrhage (4.1 percent), and infections (except UTIs) (4.1 percent).

Keytruda — the first checkpoint inhibitor to be approved in this space – is currently approved to treat metastatic non-small cell lung cancer (NSCLC), advanced melanoma, recurrent or metastatic head and neck squamous cell carcinoma, metastatic urothelial carcinoma, advanced gastric cancer, refractory or relapsed classical Hodgkin lymphoma and advanced microsatellite instability-high (MSI-H)/mismatch repair deficient cancers.

"This approval is welcome news for patients, who now have another option in their fight against cervical cancer, a very serious disease," said Tamika Felder, founder and chief visionary officer of Cervivor, in an interview with CURE.