Dr Vergote on the Efficacy of Tisotumab Vedotin in Recurrent/Metastatic Cervical Cancer

Ignace B. Vergote, MD, PhD, chairman, Leuven Cancer Institute, head, Department of Obstetrics and Gynecology and Gynecologic Oncology, the Catholic University of Leuven, Belgium, discusses the efficacy of tisotumab vedotin-tftv (Tivdak) in patients with recurrent or metastatic cervical cancer, according to data from the phase 3 innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628).

The single-arm trial enrolled patients with recurrent or metastatic cervical cancer and documented disease progression on or after doublet chemotherapy with or without bevacizumab and an anti–PD(L)1 agent, if eligible and available. Patients were randomly assigned 1:1 to receive either intravenous tisotumab vedotin (n = 253) or investigator’s choice of either topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed (n = 249).

Previously reported data from this trial supported 

the FDA's accelerated approval of tisotumab vedotin

 in 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, Vergote notes. 

Results from a planned interim analysis of the trial were 

, and showed that patients treated with tisotumab vedotin experienced a 30% reduction in the risk of death vs investigator’s choice of chemotherapy as second- or third-line therapy. At a median follow-up of 10.8 months (95% CI, 10.3-11.6), tisotumab vedotin produced a statistically significant and clinically meaningful improvement in median OS of 11.5 months (95% CI, 9.8-14.9) vs 9.5 months (95% CI, 7.9-10.7) with chemotherapy (HR, 0.70, 95% CI, 0.54-0.89; 

 = .0038). The 12-month OS rates were 48.7% with tisotumab vedotin and 35.3% with chemotherapy.

Additionally, tisotumab vedotin produced a median progression-free survival (PFS) of 4.2 months (95% CI, 4.0-4.4) compared with 2.9 months (95% CI, 2.6-3.1) with chemotherapy (HR, 0.67; 95% CI, 0.54-0.82; 

 < .0001). The 6-month PFS rates were 30.4% and 18.9% with tisotumab vedotin and chemotherapy, respectively.

These updated data further support the use of tisotumab vedotin as a standard of care for patients in this population who have historically had limited treatment options, Vergote concludes.

Videos

Ignace B. Vergote, MD, PhD, discusses the efficacy of tisotumab vedotin-tftv in patients with recurrent or metastatic cervical cancer, according to data from the phase 3 innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628).

Caroline Seymour is your initial point of contact for the 

™. She joined the company in 2018 as an assistant editor, with expertise in video production and print/digital publication. Email: cseymour@onclive.com​ 

We are reporting from the 2023 ESMO Congress!

Get ready for highlights of some of the top news presented each day during the meeting—and soon we’ll speak with Dr Ignace Vergote to discuss some new data in gynecologic cancer, Dr Yelena Janjigian to highlight exciting developments in gastrointestinal cancer, Dr Jacob Sands to share key advances in lung cancer, and Drs Paolo Tarantino and Aditya Bardia to provide perspective on practice-changing data in breast cancer.

Welcome to OncLive News Network! I’m Caroline Seymour.

Findings from the phase 3 TROPION-Lung01 trial (NCT04656652) showed that the TROP-2-directed antibody-drug conjugate datopotamab deruxtecan produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs docetaxel in pretreated patients with advanced or metastatic non–small cell lung cancer (NSCLC) with or without actionable genomic alterations. Notably, longer median PFS was reported in the subgroup of patients with nonsquamous histology.

Moreover, datopotamab deruxtecan produced a statistically significant and clinically meaningful improvement in PFS vs investigator’s choice chemotherapy in patients with inoperable or metastatic hormone receptor–positive, HER2-negative breast cancer following 1 to 2 prior lines of chemotherapy in the phase 3 TROPION-Breast01 trial (NCT05104866).

In the phase 3 innovaTV 301 trial (NCT04697628), tisotumab vedotin-tftv (Tivdak) led to a 30% reduction in the risk of death vs investigator’s choice of chemotherapy as second- or third-line therapy in patients with recurrent or metastatic cervical cancer with disease progression on doublet chemotherapy. The results showed that at a median follow-up of 10.8 months (95% CI, 10.3-11.6), the median overall survival (OS) was 11.5 months (95% CI, 9.8-14.9) with tisotumab vedotin vs 9.5 months (95% CI, 7.9-10.7) with chemotherapy. 

Finally, in results from the phase 3 RUBY trial (NCT03981796), the addition of dostarlimab-gxly (Jemperli) to carboplatin and paclitaxel was associated with improved PFS and OS in subgroups of patients with mismatch repair–deficient and microsatellite instability–high disease, patients with no specific molecular profile, and those with 

mutations, providing prognostic value in primary advanced or recurrent endometrial cancer.

Please be sure to check out more of our coverage from the 2023 ESMO Congress at OncLive.com.

Thank you for watching OncLive News Network: On Location, I’m Caroline Seymour.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ESMO Congress. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

Breaking Ground in Breast, Lung, Gynecologic, and Gastrointestinal Cancers From ESMO 2023: Drs Tarantino, Sands, Vergote, and Janjigian

Ignace B. Vergote, MD, PhD, head of the Department of Obstetrics and Gynecology and Gynecologic Oncology, Catholic University of Leuven, Belgium, discusses the need to develop novel therapies in endometrial cancer.

Endometrial cancer is the most frequent gynecologic malignancy among women in the United States, says Vergote. Additionally, endometrial cancer has a high mortality and morbidity rate.

The current standard of care for patients with endometrial cancer is platinum-based chemotherapy in combination with a taxane, explains Vergote.

However, there are no established treatment options for patients who recur after first-line therapy, Vergote adds.

As such, developing novel therapies to treat patients who recur, maintaining remissions after first-line therapy, and extending the time patients are not on chemotherapy remain unmet clinical needs in endometrial cancer, concludes Vergote. 

Ignace B. Vergote, MD, PhD, discusses the need to develop novel therapies in endometrial cancer.



Ignace B. Vergote, MD, PhD

Articles

Dr Vergote on the Efficacy of Tisotumab Vedotin in Recurrent/Metastatic Cervical Cancer

Breaking Ground in Breast, Lung, Gynecologic, and Gastrointestinal Cancers From ESMO 2023: Drs Tarantino, Sands, Vergote, and Janjigian

Dr. Vergote on the Need to Develop Novel Therapies in Endometrial Cancer