FDA Approves Tivdak for Metastatic Cervical Cancer

The Food and Drug Administration (FDA) approved Tivdak (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy, according to the agency.

“Today marks a great day for patients, especially adults battling advanced cervical cancer,” said Tamika Felder, cervical cancer patient advocate and Founder and Chief Visionary Officer, Cervivor, Inc, in a press release from Genmab and Pfizer, the manufacturers of the agent. “This full approval opens up new treatment paths for this patient community who have long faced limited options.”

The approval is based on findings from the innovaTV 301 trial, which included 502 patients with recurrent or metastatic cervical cancer who previously received at least two other systemic treatments — including chemotherapy with or without Avastin (bevacizumab) or an anti-PD1/PD-L1 agent.

READ MORE: Second-Line Tivdak ‘Very Beneficial’ in Cervical Cancer

Patients in the trial were randomly assigned to one of two groups. Half of the patients received intravenous Tivdak every three weeks, while the other half received the investigator’s choice of chemotherapy. The investigators chose from chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed. Patients all continued this therapy until disease progression or unacceptable side effects.

The main goal of the trial was to see if Tivdak led to better overall survival, which is the time patients live before death of any cause. Investigators on the study also noted progression-free survival (time from treatment until death or disease worsening) and confirmed objective response rate (percentage of patients whose disease shrinks or disappears).

The median overall survival was 11.5 months in the Tivdak group, compared with 9.5 months in the chemotherapy group. That's a 30% reduction in the risk of death. Tivdak also outperformed chemotherapy in progression-free survival, too, with medians of 4.2 months and 2.9 months, respectively. The confirmed objective response rate was 17.8% in the Tivdak group, and 5.2% in the chemotherapy group.

“As a treating physician, it is encouraging to see overall survival data among these patients and a manageable safety profile with [Tivdak],” Dr. Brian Slomovitz, director of Gynecologic Oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center, Miami Beach, said in the press release. “Treatment options for patients with advanced or recurrent cervical cancer are limited. The five-year survival rate for patients who have metastatic disease at diagnosis is less than 20% in the U.S. There is a high unmet need for more treatment options that have demonstrated survival benefit in the contemporary treatment landscape. The approval of [Tivdak] brings us a step closer to fulfilling that need.”

The most common side effects (including laboratory abnormalities) that occurred in 25% or more of patients were decreased hemoglobin, peripheral neuropathy (pain and tingling in the hands and feet), conjunctival adverse reactions, increased aspartate aminotransferase (which could indicate liver issues), fatigue, decreased sodium, nosebleed and constipation.
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