Dr. Monk discusses the significance of the FDA approval of tisotumab vedotin and notable research that was presented at the 2021 ESMO Congress in cervical cancer.
Welcome to OncLive On Air®! I’m your host today, Jessica Hergert.
OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.
In today’s episode, we had the pleasure of speaking with Bradley J. Monk, MD, FACS, FACOG, professor, Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph’s Hospital, medical director, Gynecologic Program, US Oncology Research Network, and co-director, GOG Partners, to contextualize recent breakthroughs in cervical cancer, including a newly FDA-approved agent and practice-changing research that was presented at the 2021 ESMO Congress.
On September 20, 2021, the FDA granted an accelerated approval to tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
The regulatory decision is based on data from phase 2 innovaTV 204 trial (NCT03438396), in which the antibody-drug conjugate (ADC) led to an objective response rate of 24% (95% CI, 15.9%-33.3%) per independent review committee using RECIST v1.1 criteria in patients with recurrent or metastatic cervical cancer who received prior doublet chemotherapy and bevacizumab (Avastin).
Among those who responded to treatment, 7% experienced a complete response and 17% had a partial response. The median duration of response with tisotumab vedotin was 8.3 months (95% CI, 4.2–not reached). The median time to response with the ADC was 1.4 months (range, 1.1-5.1), and activity was reported within the first 2 treatment cycles.
At the 2021 ESMO Congress, interim findings from the phase 3 KEYNOTE-826 trial (NCT03635567) demonstrated that the addition of pembrolizumab (Keytruda) to chemotherapy with or without bevacizumab (Avastin) significantly improved survival and response rates in patients with persistent, recurrent, or metastatic cervical cancer.
In the subset of patients with a PD-L1 combined positive score (CPS) of 1 or higher, the median progression-free survival (PFS) in the investigative and control arms was 10.4 months (95% CI, 9.7-12.3) vs 8.2 months (95% CI, 6.3-8.5), respectively (HR, 0.62; 95% CI, 0.50-0.77; P < .001). In this group, the median overall survival (OS) was not reached (NR) at the time of the data cutoff in the investigative arm (95% CI, 19.8–NR) vs 16.3 months (95% CI, 14.5-19.4) in the control arm (HR, 0.64; 95% CI, 0.50-0.81; P < .001).
In the all-comer population, the median PFS was 10.4 months (95% CI, 9.1-12.1) in the investigative arm vs 8.2 months (95% CI, 6.4-8.4) in the control arm (HR, 0.65; 95% CI, 0.53-0.79; P < .001). The median OS in this population was 24.4 months (19.2–NR) with pembrolizumab vs 16.5 months (95% CI, 14.5-19.4) with placebo (HR, 0.67; 95% CI, 0.54-0.84; P < .001).
In the group of patients who had a PD-L1 CPS of 10 or higher, the median PFS with pembrolizumab plus chemotherapy with or without bevacizumab was 10.4 months (95% CI, 8.9-15.1) vs 8.1 months (95% CI, 6.2-8.8) with chemotherapy with or without bevacizumab (HR, 0.58; 95% CI, 0.44-0.77; P < .001). The median OS was also NR (95% CI, 19.1-NR) in the investigative arm vs 16.4 months (95% CI, 14.0-25.0) in the control arm (HR, 0.61; 95% CI, 0.44-0.84; P = .001).
In our exclusive interview, Monk discussed the significance of the FDA approval of tisotumab vedotin and notable research that was presented at the 2021 ESMO Congress in cervical cancer.
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