Tisotumab Vedotin Results ‘Encouraging’ For Recurrent, Metastatic Cervical Cancer

Author: By Lynda Williams, Senior medwireNews Reporter

medwireNews: The antibody–drug conjugate tisotumab vedotin may be a feasible treatment for women with recurrent or metastatic cervical cancer, indicate phase II trial findings reported at the ESMO Virtual Congress 2020.

“Tisotumab vedotin demonstrated compelling, rapid and durable antitumor activity with encouraging progression-free and overall survival in women with recurrent or metastatic [cervical] cancer previously treated with double chemotherapy, with bevacizumab, if eligible”, said presenting author Robert Coleman, from Texas Oncology–The Woodlands in Houston, USA.

“This study suggests that tisotumab vedotin has the potential to be a new treatment for patients with previously treated recurrent or metastatic cervical cancer”, he commented.

Tisotumab vedotin was given intravenously at a dose of 2.0 mg/kg every 3 weeks to 101 women with recurrent or extrapelvic metastasis who had progressed on or after up to two prior systemic regimens, including paclitaxel plus platinum or topotecan, with or without bevacizumab.

After a median 10 months of follow-up, the primary endpoint of objective response rate (ORR) was 24%, with a complete response in 7%, partial response in 17% and stable disease in 49%. The median duration of response was 8.3 months, prompting the presenter to describe the responses as being “clinically meaningful and durable”.

Moreover, the ORRs were “generally consistent” across subgroups of histology, Robert Coleman said, with especially “encouraging” ORRs noted for two groups with little prior data – 25% for patients with nonsquamous histology and 19% for those previously treated with first-line bevacizumab.

A waterfall plot of patients with at least one post-therapy scan indicated that 79% of patients had a target lesion reduction, with just five patients showing progression within 6 weeks of treatment, “highlighting the overall clinical impact of treatment”, the investigator said.

Responses were “rapid”, arising after a median of 1.4 months, he added, with 70% occurring within the first 6 weeks.

Progression-free survival was a median of 4.2 months and overall survival a median of 12.1 months, with corresponding 6-month rates of 30% and 79%.

Analysis of a subgroup of 76 participants who were assessed for both membrane tumour factor expression – the target of the tisotumab vedotin antibody – and RECIST ORR showed that response occurred regardless of expression level, but the presenter cautioned that the analysis is limited by the small sample size.

He described tisotumab vedotin as “well tolerated” and noted there were no new safety signals, with the majority of treatment-related adverse events (AEs) at grade 1–2, albeit with one treatment-related death from sepsis.

Analysis of the prespecified AEs of interest, namely ocular side effects, bleeding and peripheral neuropathy, showed that the majority of events were mild and manageable by dose adjustment and the recommended eye care plan.

“Tisotumab vedotin is a potential novel treatment for women with previously treated recurrent and/or metastatic cervical cancer”, Robert Coleman concluded.

Reference

Coleman RL, Lorusso D, Gennigens A, et al. Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer: Results from the phase II innovaTV 204/GOG-3023/ENGOT-cx6 study. Ann Oncol 2020; 31 (Suppl_4): S1142–S1215. DOI: 10.1016/annonc/annonc325