Genmab + Seagen present interim results from the innovaTV 205 study.

Initial results from these two dose expansion cohorts of the study showed encouraging and durable anti-tumor activity with tisotumab vedotin in combination with carboplatin (Cohort D) as first-line therapy for patients with advanced cervical cancer who had not received prior systemic therapy, with a 55% objective response rate (ORR) and with tisotumab vedotin in combination with pembrolizumab (Cohort F) for patients with advanced cervical cancer who experienced disease progression after 1-2 lines of prior systemic therapy, with a 38% ORR. Both combinations demonstrated a manageable and acceptable safety profile, with no new safety signals identified.

“For patients diagnosed with recurrent or metastatic cervical cancer, there is a need for additional treatment options in the first-, second- and third-line settings,” said Ignace B. Vergote, M.D., Ph.D., co-founder of European Network of Gynaecological Oncological Trial groups (ENGOT), and lead investigator on the innovaTV 205/ENGOT-cx8/GOG-3024 clinical trial. “Interim results from the innovaTV 205 study show the potential for tisotumab vedotin to treat these patients, with encouraging response rates in combination with carboplatin and also in combination with pembrolizumab.”

Tisotumab Vedotin (TV) + Carboplatin (Carbo) in First-line (1L) or + Pembrolizumab (Pembro) in Previously Treated (2L/3L) Recurrent or Metastatic Cervical Cancer (r/mCC): Interim Results of ENGOT-cx8/GOG-3024/innovaTV 205 Study (Presentation #723MO, mini oral presentation on Sunday, September 19): 1L TV + Carbo Dose Expansion Cohort Interim Results:Within this cohort, recurrent or metastatic cervical cancer patients who had not received any prior systemic therapy were given the recommended Phase II dose of tisotumab vedotin 2.0 mg/kg plus carboplatin AUC 5 Q3W. Efficacy : The primary endpoint of ORR was 55% (n= 18/33 patients), with four patients achieving complete responses and 14 patients achieving partial responses. Median time to response was 1.4 months (range 1.1-4.4), with median follow up of 7.9 months and median duration of response of 8.3 months (95% CI: 4.2-NR). Median progression-free survival (PFS) was 9.5 months (95% CI: 4.0-NR).

Safety : Grade greater than 3 adverse events (AE) occurred in 78.8% of patients (n=26/33), with 57.6% (n=19/33) of patients experiencing Grade greater than 3 AEs related to treatment with tisotumab vedotin.Adverse events of special interest (AESI) included ocular events (Grade 1-2: 57.6%; Grade ?3: 9.1%), bleeding (Grade 1-2: 51.5%; Grade ?3: 6.1%) and peripheral neuropathy (Grade 1-2: 48.5; Grade greater than 3: 12.1%).

2L/3L TV + Pembro Dose Expansion Cohort Results Interim Results : Within this cohort, recurrent or metastatic cervical cancer patients who had received 1-2 prior systemic therapies were given the recommended Phase II dose of tisotumab vedotin 2.0 mg/kg plus pembrolizumab 200 mg Q3W. Efficacy : The primary endpoint of ORR was 38% (n=13/34 patients), with two patients achieving complete responses and 11 patients achieving partial responses. Median time to response was 1.4 months (range 1.3-5.8), with median follow-up of 13.0 months and a median duration of response of 13.8 months (95% CI: 2.8-NR).Median PFS was 5.6 months (95% CI: 2.7-13.7).

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