In a significant development, Genmab and Seagen have unveiled interim data from the Phase III innovaTV 301 trial, showcasing the remarkable potential of their antibody-drug conjugate, Tivdak (tisotumab vedotin-tftv), in treating metastatic cervical cancer. Although specific figures were not disclosed, the companies revealed that the Independent Data Monitoring Committee made a pivotal discovery—Tivdak not only met its primary endpoint but also demonstrated a substantial survival advantage, crossing the predefined efficacy boundary during interim analysis.
Crucially, key secondary measures, including the objective response rate and investigator-assessed progression-free survival, also achieved statistically significant outcomes.
Patients facing advanced cervical cancer and progressing after initial therapy have long had limited treatment options, especially those featuring novel mechanisms of action and proven survival benefits. Genmab’s CEO, Jan van de Winkel, expressed optimism, stating, “These results provide hope for patients with recurrent or metastatic cervical cancer.”
The innovaTV 301 trial, a randomized and open-label study, enrolled over 500 patients who had received a maximum of two prior systemic therapies in the recurrent or metastatic setting. These participants were treated with Tivdak or a choice of chemotherapy selected by the investigators, such as irinotecan, topotecan, or gemcitabine.
Beyond its efficacy, the study also scrutinized Tivdak’s safety profile in this context, revealing that adverse events aligned with previously established findings, with no emergence of new safety concerns.
Genmab and Seagen are set to unveil a comprehensive analysis of innovaTV 301 at an upcoming medical conference.
Tivdak stands as a groundbreaking antibody-drug conjugate, specifically targeting Tissue Factor, a protein commonly found on the surface of cervical cancer cells. It delivers a potent microtubule-disrupting agent, monomethyl auristatin E, directly to the tumor cell. Notably, Tivdak secured FDA accelerated approval in September 2021 for treating recurrent or metastatic cervical cancer post-chemotherapy.
However, it is worth noting that the treatment carries a boxed warning for ocular toxicities, including potential vision loss and corneal ulceration. Patients receiving Tivdak undergo ophthalmic examinations at baseline, before each dose, and as clinically indicated.
In June 2022, the collaboration between Seagen and Genmab reported Phase Ib/II data from the innovaTV 205 trial. The data highlighted that Tivdak, either as a monotherapy or in combination with other therapies, yielded an impressive confirmed objective response rate of 41%.
The Phase III innovaTV 301 trial serves as Tivdak’s confirmatory study, paving the way for its transition to traditional approval. Moreover, data from this pivotal trial will play a vital role in regulatory applications on a global scale.