KEY TAKEAWAYS
- The innovaTV 301 trial aimed to compare the efficacy and safety of TV and chemotherapy in recurrent cervical cancer.
- The primary endpoint was to determine OS.
- Researchers noticed TV showed a statistically significant and clinically meaningful improvement in OS, with a safety profile in pts with 2L/3L r/mCC.
Tisotumab vedotin (TV), an investigational antibody-drug conjugate, has gained accelerated approval for monotherapy in recurrent or metastatic cervical cancer (r/mCC) post-c hemotherapy progression.
Seagen Inc and his team spearheaded the study that aimed to compare TV to the investigator’s choice of chemotherapy in r/mCC patients after first-line therapy.
The study enrolled r/mCC patients progressing after standard chemotherapy, doublet ± bevacizumab ± anti-PD-(L)1 therapy, measurable disease per RECIST v1.1, and ECOG PS 0-1. Randomized 1:1 to TV or investigator’s choice chemotherapy, with the primary endpoint of overall survival (OS).
About 502 patients were randomized into two arms (TV: 253; chemotherapy: 249). The median follow-up for survival was 10.8 months (95% CI, 10.3-11.6). The overall median age of participants was 50 years, ranging from 26 to 80 years, and the demographic and disease characteristics were well-balanced between the two arms.
Of the enrolled patients, 63.9% had prior exposure to bevacizumab, and 27.5% had previously received anti-PD-(L)1 therapy. The TV arm exhibited a 30% reduction in the risk of death compared to the chemotherapy arm, as indicated by a hazard ratio (HR 0.70; 95% CI 0.54-0.89; P=0.0038). The median overall survival (OS) was significantly longer in the TV arm, measuring 11.5 months (95% CI 9.8-14.9), in contrast to the chemotherapy arm with a median OS of 9.5 months (95% CI 7.9-10.7).
Furthermore, progression-free survival (PFS) favored the TV arm, showing a HR of 0.67 (95% CI, 0.54-0.82; P<0.0001). The therapeutic vaccine demonstrated a superior confirmed objective response rate (ORR) at 17.8%, compared to 5.2% in the chemotherapy arm (OR: 4.0; 95% CI, 2.1-7.6; P<0.0001).
The safety analysis revealed that most patients experienced at least one treatment-related adverse event (AE), with 87.6% in the TV arm (grade ≥3: 29.2%) and 85.4% in the chemotherapy arm (grade ≥3: 45.2%).
The study establishes tisotumab vedotin (TV) as a promising treatment in the second or third line for patients with r/mCC. TV demonstrated statistically significant and clinically meaningful improvements in OS, PFS, and ORR compared to chemotherapy, in pts with 2L/3L r/mCC. The study is sponsored by Seagen Inc.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/28
Clinical Trial: https://clinicaltrials.gov/study/NCT04697628
Fujiwara K, Slomovitz B.M, Martin A.G et al. (2023). “MO – InnovaTV 301/ENGOT-cx12/GOG-3057: A global, randomized, open-label, phase III study of tisotumab vedotin vs investigator’s choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer”. Presented at ESMO ASIA 2023 (Abstract 288)
