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 2

“As we advance our clinical development program for tisotumab vedotin into earlier lines of therapy in cervical cancer, we’re encouraged by these interim results of the combination cohorts with tisotumab vedotin,” said Roger Dansey, M.D., Chief Medical Officer, Seagen. “Based on these results from the innovaTV 205 study, we also plan to evaluate tisotumab vedotin further in various combinations in first-line metastatic or recurrent cervical cancer.”

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 2 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 ≥3 adverse events (AE) occurred in 78.8% of patients (n=26/33), with 57.6% (n=19/33) of patients experiencing Grade ≥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 ≥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 2 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).