FDA Approves Therapy for Metastatic Cervical Cancer

The US Food and Drug Administration recently granted approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.  [now a part of Pfizer Inc.])  for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The traditional approval comes after tisotumab vedotin-tftv was given accelerated approval for this indication.

The efficacy of this therapy was assessed in the innovaTV 301 study,  an open-label, active-controlled, multicenter, randomized trial comprising 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens, including chemotherapy with or without bevacizumab and/or an anti-PD-(L)-1 agent. Exclusion criteria was defined as any patients with active ocular surface disease, any prior episode of cicatricial conjunctivitis or ocular Stevens-Johnson syndrome, Grade ≥2 peripheral neuropathy, or clinically significant bleeding issues or risks.

The population of interest were randomized (1:1) to receive either tisotumab vedotin 2 mg/kg intravenously every 3 weeks or by investigator’s choice or a chemotherapy regimen consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed, until unacceptable toxicity or disease progression. The key efficacy end point was overall survival (OS). Secondary end points were progression free survival (PFS) and confirmed objective response rate (ORR).

The results of the analysis showed that the median OS was 11.5 months (95% CI: 9.8, 14.9) in the tisotumab vedotin arm and 9.5 months (95% CI: 7.9, 10.7) in the chemotherapy arm (Hazard Ratio [HR] 0.70 [95% CI: 0.54, 0.89] p-value 0.0038). The median PFS was 4.2 months (95% CI: 4.0, 4.4) in the tisotumab vedotin arm and 2.9 months (95% CI: 2.6, 3.1) for those treated with chemotherapy (HR 0.67 [95% CI: 0.54, 0.82] p-value <0.0001), while ORR was 17.8% (95% CI: 13.3, 23.1) and 5.2% (95% CI: 2.8, 8.8) in the respective arms (p-value <0.0001).

The most common adverse reactions (≥25%) in innovaTV  decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation

The FDA noted that the results “fulfill the post-marketing requirement of the previous accelerated approval.”

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