FDA Approves Antibody-drug Conjugate TIVDAK™ for Recurrent or Metastatic Cervical Cancer

Genmab A/S and Seagen Inc. revealed that the first and only approved antibody-drug conjugate (ADC) known as TIVDAK™ (tisotumab vedotin-tftv), has been granted regulatory authorisation from the US Food and Drug Administration (FDA) as a patented novel therapy for women with recurrent or metastatic cervical cancer with progression of the disease on or after chemotherapy.

Novel therapy for women with recurrent or metastatic cervical cancer

Cervical cancer is still one of the top causes of cancer mortality in women throughout the world, with more than 311,000 women dying from it in 2018.

TIVDAK was approved by the FDA under the Accelerated Approval Program focused on both tumor response and response durability. Further validation and evaluation of clinical benefit in confirmatory trials may be required for continued licensure.

Robert L. Coleman, M.D., Chief Scientific Officer, US Oncology Research and lead investigator of the innovaTV 204 clinical trial stated:

“Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients. This is an important development for patients with recurrent or metastatic cervical cancer.”

Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab commented:

“TIVDAK’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they are in need of a new treatment option and we look forward to making it available to them. The journey towards the approval of TIVDAK started nearly two decades ago with innovative research by scientists at Genmab and Seagen and reflects on our purpose of making an impact in the lives of cancer patients and their families. Today’s announcement marks Genmab’s evolution into a fully integrated biotechnology company and we would like to thank patients, caregivers, investigators and our collaborators for their participation in our clinical studies.”

Roger Dansey, M.D., Chief Medical Officer, Seagen stated:

“We are pleased with the accelerated approval of TIVDAK, Seagen’s third FDA-approved antibody-drug conjugate, and fourth approved medicine. Our mission at Seagen is to develop medicines that make a difference for people impacted by cancer.”

TIVDAK’s Biologics License Application (BLA) was filed in February 2021 and was cleared in April 2021 with Priority Review. The results of the innovaTV 204 study were included to construct the submission. If a drug addresses an unmet medical need for a severe illness, the FDA’s Accelerated Approval Program allows for approval based on a surrogate endpoint that is fairly likely to predict therapeutic benefit. A randomized phase 3 clinical study (innovaTV 301) is now being conducted throughout the world to enable worldwide registrations.

Moreover, as a part of the innovaTV 204 clinical study, TIVDAK was tested in 101 individuals with relapsed or metastatic cervical cancer who had undergone no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy treatment. According to an independent review committee (IRC) by using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, the study had a 24% confirmed objective response rate (ORR) (95% CI; 15.9-33.3). The DOR (duration of response) was 8.3 months on average (95 % CI; 4.2 to not reached).

About the innovaTV 204 Trial

The innovaTV 204 trial (NCT03438396/GOG-3023/ENGOT-cx6) was an open-label, multicenter, single-arm Phase 2 trial that assessed tisotumab vedotin in 101 women with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, and with at least one platinum-based chemotherapy regimen.

Active ocular surface illness, any past episode of cicatricial conjunctivitis or Stevens-Johnson syndrome, Grade 2 peripheral neuropathy, or known coagulation abnormalities leading to an increased risk of bleeding were all deemed exclusion criteria. Confirmed ORR per RECIST v1.1, as determined by an IRC and DOR, was the primary effectiveness outcome measure.

The study was conducted by Genmab in collaboration with Seagen, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the GOG Foundation, Inc. (GOG). For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About TIVDAK (tisotumab vedotin-tftv)

TIVDAK™ (tisotumab vedotin-tftv) for injection 40 mg (Photo: Business Wire)

TIVDAK (tisotumab vedotin-tftv) is an ADC comprised of a human monoclonal antibody directed to tissue factor (TF) developed by Genmab and a protease-cleavable linker that covalently binds the microtubule-disrupting chemical monomethyl auristatin E (MMAE) to the antibody, which is an ADC technology engineered by Seagen. TIVDAK’s anticancer efficacy is thought to be due to the ADC binding to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and of MMAE release via proteolytic cleavage.

MMAE causes cell cycle arrest and apoptotic cell death by disrupting the microtubule network of actively dividing cells. Furthermore, TIVDAK induces both antibody-dependent cellular phagocytosis and antibody dependent cellular cytotoxicity in vitro.

The prescribing information for TIVDAK includes a BOXED WARNING for ocular toxicity, and Warnings for peripheral neuropathy, hemorrhage, pneumonitis, and embryo-fetal toxicity.


Original Source: Press Release – Genmab and Seagen Announce FDA Accelerated Approval for TIVDAK™ (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer


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