Genmab and Seagen Present Interim Results From the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021 - Seite 3

Safety:

• Grade ≥3 AEs occurred in 74.3% of patients (n=26/35), with 45.7% (n=16/35) of patients experiencing Grade ≥3 AEs related to treatment with tisotumab vedotin.
• AESI included ocular events (Grade 1-2: 51.4%; Grade ≥3: 2.9%), bleeding (Grade 1-2: 57.1%; Grade ≥3: 8.6%) and peripheral neuropathy (Grade 1-2: 37.1%; Grade ≥3: 2.9%), with one patient experiencing a Grade 4 bleeding event.

Additionally, Genmab and Seagen presented data from dose-escalation cohorts of the innovaTV 205 study at the 2021 International Gynecologic Cancer Society (IGCS) Annual Meeting held August 30 – September 2, 2021.

About Cervical Cancer
Cervical cancer originates in the cells lining the cervix. In 2021, an estimated 14,480 new cases of invasive cervical cancer will be diagnosed in the U.S., and 4,290 women will die from the disease.¹ Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women are in the developing world.² Routine medical examinations and human papillomavirus (HPV) vaccines have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic. Current therapies for previously treated recurrent or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent, with median overall survival ranging from 6.0 to 9.4 months.^{3,4,5,6,7,8,9,10}

About the innovaTV 205 Trial
The innovaTV 205 trial (also known as ENGOT-cx8/GOG-3024) is a Phase 1b/2 open-label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in patients with recurrent or metastatic cervical cancer. The study consists of two parts: dose escalation (Cohorts A, B, and C) and dose expansion (Cohorts D, E, F and G). Patients enrolled in the dose escalation cohorts have progressed during or after standard of care therapy or are intolerant or ineligible to receive standard of care treatments. The primary objective is to identify and establish the maximum tolerated dose and Recommended Phase 2 Dose (RP2D) of tisotumab vedotin as combination therapy. Within the dose expansion cohorts, patients with recurrent or metastatic cervical cancer who have not previously received prior systemic therapy are treated in Cohorts D and E, with patients who have progressed on or after standard of care treatments evaluated in Cohorts F and G.