Dr. Hong on the Design of the InnovaTV 201 Trial in Cervical Cancer

David S. Hong, MD
Published: Wednesday, May 22, 2019



David S. Hong, MD, deputy director of the Department of investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the design of the InnovaTV 201 trial in cervical cancer.

The phase I/II InnovaTV 201 trial was a multi-cohort study that examined the use of the antibody–drug conjugate (ADC) tisotumab vedotin (HuMax-TF-ADC) in patients with cervical cancer, bladder cancer, head and neck cancer, and non–small cell lung cancer. Investigators hypothesized that the ADC could show a clinical benefit in these tumor types.

In the phase I part of the trial, a recommended phase II dose of 2 mg/kg every 3 weeks was established. Investigators noted activity across several different histologies, says Hong. According to independent radiology review, the confirmed and unconfirmed response rate was 35% in the cervical cohort. Moreover, the progression-free survival (PFS) was approximately 4.1 months. This stands in contrast to second-line pembrolizumab (Keytruda), which showed a 14% response rate in PD-L1–positive patients and a more modest improvement in PFS of 2.1 months. Investigators are encouraged by these results relative to other available treatments in this difficult-to-treat patient population, concludes Hong.
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David S. Hong, MD, deputy director of the Department of investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the design of the InnovaTV 201 trial in cervical cancer.

The phase I/II InnovaTV 201 trial was a multi-cohort study that examined the use of the antibody–drug conjugate (ADC) tisotumab vedotin (HuMax-TF-ADC) in patients with cervical cancer, bladder cancer, head and neck cancer, and non–small cell lung cancer. Investigators hypothesized that the ADC could show a clinical benefit in these tumor types.

In the phase I part of the trial, a recommended phase II dose of 2 mg/kg every 3 weeks was established. Investigators noted activity across several different histologies, says Hong. According to independent radiology review, the confirmed and unconfirmed response rate was 35% in the cervical cohort. Moreover, the progression-free survival (PFS) was approximately 4.1 months. This stands in contrast to second-line pembrolizumab (Keytruda), which showed a 14% response rate in PD-L1–positive patients and a more modest improvement in PFS of 2.1 months. Investigators are encouraged by these results relative to other available treatments in this difficult-to-treat patient population, concludes Hong.



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