Dr. Hong on Results of the Phase II innovaTV 201 Study

David S. Hong, MD
Published: Tuesday, Mar 19, 2019



David S. Hong, MD, deputy director of the Department of investigational Cancer Therapeutics and associate vice president of clinical research at The University of Texas MD Anderson Cancer Center, discusses the promising results of the phase II innovaTV 201 study, in which the antibody-drug conjugate tisotumab vedotin was used to treat patients with previously treated recurrent or metastatic cervical cancer.

The biggest takeaway of this phase II trial is the fact that tisotumab vedotin is very active in this heavily pretreated, metastatic cervical cancer setting, Hong explains, adding that there are currently not a lot of data or therapy that have shown this level of clinical activity.

While the PD-1 inhibitor pembrolizumab (Keytruda) was approved by the FDA in the second-line and beyond setting in PD-L1–positive patients with cervical cancer, the agent elicited an objective response rate (ORR) of 14% in PD-L1–positive patients and was associated with a median progression-free survival (PFS) of 2.1 months in the KEYNOTE-158 trial, which was the basis for the FDA approval. Whereas, in the updated analysis of the phase II trial, tisotumab vedotin demonstrated an ORR of 22% and also a median PFS of 4 months, he adds. Hopefully, these data will set the field on a path toward regulatory approval, Hong concludes.

<<< 2019 SGO Annual Meeting


David S. Hong, MD, deputy director of the Department of investigational Cancer Therapeutics and associate vice president of clinical research at The University of Texas MD Anderson Cancer Center, discusses the promising results of the phase II innovaTV 201 study, in which the antibody-drug conjugate tisotumab vedotin was used to treat patients with previously treated recurrent or metastatic cervical cancer.

The biggest takeaway of this phase II trial is the fact that tisotumab vedotin is very active in this heavily pretreated, metastatic cervical cancer setting, Hong explains, adding that there are currently not a lot of data or therapy that have shown this level of clinical activity.

While the PD-1 inhibitor pembrolizumab (Keytruda) was approved by the FDA in the second-line and beyond setting in PD-L1–positive patients with cervical cancer, the agent elicited an objective response rate (ORR) of 14% in PD-L1–positive patients and was associated with a median progression-free survival (PFS) of 2.1 months in the KEYNOTE-158 trial, which was the basis for the FDA approval. Whereas, in the updated analysis of the phase II trial, tisotumab vedotin demonstrated an ORR of 22% and also a median PFS of 4 months, he adds. Hopefully, these data will set the field on a path toward regulatory approval, Hong concludes.

<<< 2019 SGO Annual Meeting



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