Philadelphia, PA, USA, September 21, 2021, The GOG Foundation, Inc. and GOG Partners is pleased to share information from Seagen, Inc and Genmab A/S as they announce FDA Accelerated Approval for TIVDAK™ (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer.
GOG-3023 (InnovaTV 204): A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMAX®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer. On September 20, 2021, Seagen and Genmab announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK™ (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. 1
“This is a historic time for our patients. Effective new options for care are desperately needed and today, with the approval of tisotumab vedotin, we have cleared another hurdle in providing a meaningful intervention to our patients. This action today also represents the first approved antibody drug conjugate for women with gynecologic malignancies and is a testament to committed collaboration between GOG Partners, ENGOT, the global investigative community and our pharmaceutical partners Seagen, Inc. and Genmab A/S to improve the lives patients with cervix cancer” noted Robert Coleman, MD, Chief Scientific Officer for the US Oncology Network in Houston, Texas. Dr. Larry Copeland, GOG Foundation President and Professor at The James Cancer Center at The Ohio State University adds, “This recent FDA approval continues to demonstrate the value GOG Foundation and GOG Partners brings to patients with cervical cancer. Through collaboration and hard work, we provide new, effective therapies to our patients. Ultimately, this exciting approval is another step to help achieve the GOG Mission of conducting clinical research that positively impacts patients with cervical cancer. We are transforming the standard of care.”
In the innovaTV 204 (GOG-3023 (InnovaTV 204): A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMAX®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer clinical trial, TIVDAK was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Results from the trial showed a 24 percent confirmed objective response rate (ORR) (95% CI; 15.9-33.3), as assessed by an independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The median duration of response (DOR) was 8.3 months (95% CI; 4.2 to not reached). The prescribing information for TIVDAK includes a BOXED WARNING for ocular toxicity, and warnings for peripheral neuropathy, hemorrhage, pneumonitis, and embryo-fetal toxicity. The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), peripheral neuropathy (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%), leukocytes decreased (30%), creatinine increased (29%), dry eye (29%), prothrombin international normalized ratio increased
(26%), activated partial thromboplastin time prolonged (26%), diarrhea (25%), and rash (25%). Please
see Important Safety Information below.1
About the GOG-3023 (InnovaTV 204) Trial
A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.
Few effective second-line treatments exist for women with recurrent or metastatic cervical cancer. Accordingly, we aimed to evaluate the efficacy and safety of tisotumab vedotin, a tissue factor-directed antibody-drug conjugate, in this patient population.2 Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of tumors including cervical cancer. Preliminary safety and efficacy data observed in a cohort of previously treated patients with cervical cancer suggest a positive benefit risk profile for this population of high unmet need. This trial was made available to patients 18 years or older with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progression on standard of care chemotherapy in combination with bevacizumab, if eligible. Measurable disease according to RECIST v1.1. as assed by IRC. Patients were required to have acceptable renal function, liver function and hematological status.
About Cervical Cancers
Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Almost all cases are caused by the human papillomavirus (HPV) infection, with approximately 80% classified as squamous cell carcinoma (arising from cells lining the bottom of the cervix) and the remainder largely adenocarcinomas (arising from glandular cells in the upper cervix).
Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages. In 2020, it was estimated that there are approximately over 600,000 new diagnoses of cervical cancer worldwide each year. In the U.S. it is estimated that there will be 14,480 new diagnoses of cervical cancer annually and approximately 4,290 deaths.
About The GOG Foundation, Inc. (www.gog.org)
The GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel.
About GOG Partners
Supported by industry, GOG Partners has been structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.
To view the full Seagen, Inc. and Genmab Press release, September 20, 2021
References:
1 TIVDAK [package insert]. Bothell, WA: Seagen, Inc.
2 Lancet Oncol 2021, Published Online April 9, 2021 https://doi.org/10.1016/ S1470-2045(21)00056-5
Corporate & Media Contact:
GOG Partners – Staff Contact
Jenna Cummins, CMP, Director of Communications & Industry Relations
773-750-5753
jcummins@gog.org
Method of Research
Randomized controlled/clinical trial
Subject of Research
People