New drug for cervical cancer! TF Targeted Antibody Drug Couple (ADC) tisotumab vedotin is showing strong results and will be available on the market!

!--, 2020 // -- Seattle Genetics and Genmab A/S recently presented positive results of a critical Phase II innovaTV study on antibody drug adversary (ADC) tisotumab vedotin for cervical cancer at the 2020 European Society of Medical Oncology (ESMO) virtual conference.
women with relapsed or metastatic cervical cancer who developed the condition after first-line chemotherapy had limited available treatment options and there was a significant unseeled demand for new treatment options.
results published at the conference showed that tisotumab vedotin, as a single drug therapy, has significant efficacy and provides objective relief with clinical significance and long-lasting: total remission rate (ORR) of 24%, medium remission duration (DOR) of 8.3 months, and controlled safety.
tisotumab vedotin is an antibody drug couple (ADC) that targets tissue factors (TF), which is expressed on cervical cancer cells and promotes tumor growth, angiogenesis and metastasis.
Recurrences and/or metastatic cervical cancers previously treated usually show a very limited objective remission rate for standard therapies, usually less than 15%, with a medium total survival (OS) of only 6.0-9.4 months.
based on the results of the innovaTV 204 study, the two companies plan to submit a Biological Products Licensing Application (BLA) to the FDA to support accelerated approval of tisotumab vedotin.
approved, the drug will provide an important treatment option for the female population of women with relapsed or metastatic cervical cancer.
innovaTV 204 is an ongoing one-arm, global, multi-center study in 101 patients with relapsed or metastatic cervical cancer who have previously received double chemotherapy (combination or non-combination of bevadan) but have progressed, or have received at least 2 therapies to treat relapse and/or metastatic diseases.
study assessed the efficacy and safety of tisotumab vedotin (given every 3 weeks).
primary endpoint is the Objective Mitigation Rate (ORR) assessed by the Independent Center for Blind Law Review (BICR), and key secondary endpoints include mitigation duration (DOR), progress-free lifetime (PFS), total lifetime (OS), safety, and tolerance.
results showed that the ORR treated with tisotumab vedotin was 24% (95% CI: 15.9-33.3%), of which the total remission rate (CR) was 7% (7 cases) and the partial remission rate (PR) was 17% (17 cases).
10 months of follow-up or 8.3 months of medium DOR (95% CI: 4.2- not reached).
1.4 months (range: 1.1-5.1) from the start of treatment to the time of remission, the treatment response was generally observed during the first 2 treatment cycles.
subgroup analysis showed that the remission rates were generally consistent across subgroups, regardless of tumor histology, the number of previously received treatments, the response to previous systemic programmes, and the combination of double chemotherapy and beva monotherapy as first-line therapy.
PFS was 4.2 months (95% CI: 3.0-4.4) and 30% (95% CI: 20.8-40.1).
OS was 12.1 months (95% CI: 9.6-13.9) and 79% (95% CI: 69.3-85.6).
study, the most common treatment-related adverse events (-20%) included hair loss, nosebleeds, nausea, conjunctivitis, fatigue, and dry eyes.
. Robert L. Coleman, M.D., chief scientific officer of us Oncology Research, lead investigator of the
innovaTV 204 study, said, "With the treatment of first-line standard care therapy resistance or progression, current treatment options for metastatic cervical cancer are limited.
the current treatment of the disease objective mitigation rate is low, the prognosis is very poor.
results from Phase 2 clinical trials are encouraging, and the data confirm that tisotumab vedotin provides clinically significant, long-lasting relief with controlled side effects.
"tisotumab vedotin mechanism of action (Photo: immunopaedia.org.za) Cervical cancer originated in cervical cells and remains one of the leading causes of cancer death among women worldwide, resulting in more than 311,000 female deaths each year, the vast majority of them in developing countries.
in developed countries, routine medical examinations and human papillomavirus (HPV) vaccination have reduced the incidence of cervical cancer.
despite these advances, many women are still diagnosed with cervical cancer, which often relapses or metases and can have devastating effects.
cervical cancer originated in cervical cells and is one of the leading causes of cancer death in women worldwide.
estimated that in 2018, about 13,000 women in the United States will be diagnosed with cervical cancer and about 4,000 will die.
, more than 311,000 women die each year from cervical cancer, the vast majority of them in developing countries.
in developed countries, routine medical examinations and human papillomavirus (HPV) vaccines have reduced the incidence of cervical cancer.
despite these advances, many women are still diagnosed with cervical cancer, which can have devastating effects, especially in relapses and/or metastatic diseases.
tisotumab vedotin is a research ADC drug that targets tissue factors (TFs), combined with Genmab's TF-targeted single anti-tisotumab and Seattle Genetics' ADC technology, which targets TF antigens on cancer cells and delivers the cytotoxic agent MMAE (monomethyl auristatin E) directly to cancer cells.
In cancer biology, TF is a protein involved in tumor signaling and angiogenesis that is overexpressed in the vast majority of cervical cancer patients and many other solid tumors, including ovarian, lung, pancreas, colorectal and head and neck cancers.
high expression and rapid internalization of TF-based factors in many solid tumors, TF is an ideal target for the development of ADC drugs.
!--/ewebeditor:page--!--ewebeditor:page-title"--Currently, tisotumab vedotin is being developed by Seattle Genetics and Genmab as a monotherapy or combination of other therapies to treat relapsed and/or metastatic cervical cancer, ovarian cancer, and other solid tumors.
addition, both parties are evaluating the drug's weekly or weekly dosing program.
() Original source: Seattle Genetics and Genmab Present Data from Tisotumab Vedotin innovaTV 204 Pivotal Trial in Recurrent or Metastatic Vical Cancer at ESMO Virtual Congress 2020/!--/ewebeditor:page-page.