European Medicines Agency Validates Marketing Authorization Application for Tisotumab Vedotin in Treating Recurrent or Metastatic Cervical Cancer

Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) have announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tisotumab vedotin, an antibody-drug conjugate (ADC), intended for the treatment of adult patients with recurrent or metastatic cervical cancer showing disease progression on or after systemic therapy. If approved, tisotumab vedotin would be the first ADC granted European Union (EU) marketing authorization for people with cervical cancer.

The MAA is grounded in data from the global, randomized, Phase 3 innovaTV 301 trial (NCT04697628), wherein tisotumab vedotin exhibited superior overall survival (OS), progression-free survival (PFS), and a confirmed objective response rate (ORR) in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. Data from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK as monotherapy in patients with previously treated recurrent or metastatic cervical cancer was also included in the MAA. The safety profile of tisotumab vedotin in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information.

Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab, stated, “The validation of our application is an important milestone supporting our commitment to bringing a new therapeutic option for recurring or metastatic cervical cancer to more patients. There continues to be a need for therapeutic options for these patients, and we’re dedicated to delivering potential improved outcomes to women diagnosed with this devastating disease.”

Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer, commented, “Today’s milestone signifies our progress in exploring the availability of tisotumab vedotin for more patients with recurrent or metastatic cervical cancer. We remain dedicated to collaborating closely with regulatory authorities while we navigate the process to potentially deliver a new therapeutic option to people facing this debilitating disease.”

Cervical cancer is a disease with high unmet needs despite advances in vaccination and screening practices. It ranks as the fourth leading cause of cancer death in women globally, with approximately 570,000 new cases and 311,000 new deaths of women annually. Recurrent and/or metastatic cervical cancer is particularly devastating and mostly incurable. In the European Union, cervical cancer ranks 11th among the most frequently occurring cancers in women and 12th among the most frequent causes of cancer death in them.

The innovaTV 301 trial (NCT04697628) is a global, randomized, open-label Phase 3 trial evaluating tisotumab vedotin versus investigator’s choice of chemotherapy alone in 502 patients with recurrent or metastatic cervical cancer who received no more than two prior systemic regimens in the recurrent or metastatic setting. The primary endpoint is overall survival, with main secondary outcomes including progression-free survival, confirmed objective response rate, time to response, and duration of response, as assessed by the investigator, as well as safety and quality of life outcomes.

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