As the Federal Trade Commission (FTC) scrutinizes Pfizer’s $43 billion Seagen buyout, the antibody-drug conjugate (ADC) specialist has notched a phase 3 win that could broaden its cervical cancer ambitions.
In a phase 3 trial in people with recurrent or metastatic cervical cancer who had disease progression on or after a prior therapy, Seagen’s Genmab-partnered Tivdak helped patients survive longer compared with chemotherapy.
The study, called innovaTV 301, tested the drug in 502 patients with the cancer who have been on no more than two prior systemic regimens in the recurrent or metastatic setting.
Tivdak also proved its worth in progression-free survival and objective response rate, the companies said.
The partners plan to discuss the results with regulatory authorities, they said in a statement. The companies hope to secure a full FDA approval after the med won its accelerated FDA nod in 2021.
The ADC was first approved in 2021 to treat recurrent or metastatic cervical cancer in patients whose diseases progresses during or after chemotherapy. Since then, the National Comprehensive Cancer Network has deemed the drug a preferred second-line treatment in its guidelines.
“Demonstrating a survival benefit with the results of innovaTV 301 is a critical milestone in our efforts to ensure more adults living with advanced cervical cancer have an approved treatment option," Seagen’s R&D head Roger Dansey, M.D, said in a statement.
The data are likely to be practice-changing and have positive implications for the drug’s potential role in front-line cervical cancer and other tissue-factor-expressing tumors, analysts at William Blair wrote in a note to clients.
Meanwhile, the results come as Pfizer works to close its $43 billion buyout of Seagen. Seagen expects the deal to close by late 2023 or early 2024, it said in a recent FTC filing.