Pembrolizumab Immunotherapy Receives FDA Approval for Cervical Cancer

On 12 June 2018, the United States Food and Drug Administration FDA approved, for tumors with PD-L1 positivity of %1 or more in recurrent or metastatic cervical cancer during or after chemotherapy, the immunotherapy pembrolizumab (Keytruda).

• Cervical cancer symptoms, stages and treatment (detailed)

Pembrolizumab was tested in KEYNOTE 158, a multicenter, nonrandomized, open-label trial, in recurrent or metastatic cervical cancer involving 98 patients. They received treatment every 3 weeks at 200 mg intravenously until unacceptable toxicity or documented progression. Of 98 patients, approval relied on PD-L1-positive patients previously receiving at least 1 chemotherapy cycle for metastatic disease, totaling 77.

Results of KEYNOTE-158;

• With median follow-up of 11.7 months, these 77 patients receiving pemrolizumab immunotherapy had an objective response rate of %14.3.
• Among responses, %2.6 were complete responses and % 11.7 partial.
• In the 11 meaningful responders, estimated median response duration had not been reached because immunotherapy was still effective (some continued responding beyond 18 months).
• Among responders, %91 had response durations of 6 months or longer.
• No immunotherapy response was observed in cervical cancer patients with PD-L1-negative tumors.

In KEYNOTE-158 cervical cancer patients, occurring in at least %10, the commonest side effects; fatigue, pain, fever, peripheral edema (swelling of hands and feet), musculoskeletal pain, diarrhea / colitis, abdominal pain, nausea, vomiting, constipation, decreased appetite, bleeding, urinary tract infection (UTI), rash, hypothyroidism, headache and dyspnea. Pembrolizumab was stopped for adverse effects in %8. Severe side effects (grade 3 or higher) occurred in %39. The commonest severe effects were anemia (% 7), fistula (% 4.1), bleeding (% 4.1) and infections excluding UTI (% 4.1).

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The recommended pembrolizumab dose for cervical cancer is every 3 weeks at 200 mg.

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