Tisotumab Vedotin Phase 2 Data Shows Promise in Recurrent or Metastatic HNSCC

June 3, 2024, Copenhagen, Denmark - Genmab A/S has published encouraging data from their ongoing Phase 2 innovaTV 207 trial evaluating the antibody-drug conjugate (ADC) tisotumab vedotin in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The results were shared during a rapid oral session at the 2024 ASCO Annual Meeting in Chicago.

Key Findings from innovaTV207 Trial

The study involved 40 patients who had experienced disease progression after first-line therapy. Administered as a monotherapy, tisotumab vedotin demonstrated a confirmed objective response rate (cORR) of 32.5%. This included one complete response (CR) and 12 partial responses (PR). The median duration of response (DOR) was noted to be 5.6 months, with a median time-to-response (TTR) of 1.4 months.

Patient Selection Criteria

All study participants had previously received a platinum-based chemotherapy regimen. Many were also treated with checkpoint inhibitors (CPI) and other systemic therapies. Specifically, 32 out of the 40 patients had undergone platinum-based therapy, and 19 had been treated with at least two prior lines of systemic therapy.

Significance of Findings

HNSCC is currently the sixth most common cancer globally, with its incidence expected to rise by 30% by 2030. Despite advancements in treatment, many patients with recurrent or metastatic HNSCC show progression after initial therapies, leaving limited treatment options. Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer at Genmab, highlighted the importance of these findings, emphasizing the potential for tisotumab vedotin to fulfill unmet medical needs.

Safety Profile

No new safety concerns were reported in this study. Grade 3 or higher treatment-emergent adverse events (TEAEs) were observed in 67.5% of patients, with peripheral neuropathy being the most common severe adverse event at 40%. Adverse events of particular interest included ocular issues, peripheral neuropathy, and bleeding events, occurring in 52.5%, 47.5%, and 40% of patients, respectively.

Mechanism of Action

Tisotumab vedotin combines Genmab’s human monoclonal antibody targeting tissue factor (TF) with Pfizer’s ADC technology. The drug works by binding to TF-expressing cancer cells, allowing the internalization of the ADC-TF complex and subsequent release of monomethyl auristatin E (MMAE), which disrupts the microtubule network within cancer cells, inducing cell cycle arrest and apoptosis.

Future Developments

Currently, tisotumab vedotin has full FDA approval for treating recurrent or metastatic cervical cancer but is not yet approved for HNSCC in any country. Further clinical trials and safety evaluations are necessary to establish its efficacy and safety profile for HNSCC.

Genmab’s Commitment

Genmab, a biotechnology company established in 1999, aims to transform cancer treatment through innovative antibody therapeutics. With a goal to significantly impact patients' lives by 2030, Genmab continues to develop cutting-edge technologies and therapeutics in collaboration with global partners like Pfizer.

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