Genmab and Seagen Report P-III Trial (innovaTV 301) Results of Tivdak (tisotumab vedotin-tftv) for Recurrent or Metastatic Cervical Cancer
Shots:
- The P-III trial evaluating Tivdak vs CT alone (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) in 502 patients. The study was conducted by Seagen in collaboration with Genmab, ENGOT & GOG Foundation
- The trial met its 1EPs of OS at predetermined, independent interim analysis & the 2EPs of investigator-assessed PFS & ORR also demonstrated statistical significance while the safety profile was consistent with the known safety profile of Tivdak & no new safety signals were reported. The results will be submitted at an upcoming medical congress & discussed with regulatory authorities
- Tivdak received accelerated approval from the US FDA for adult patients with recurrent or metastatic cervical cancer with disease progression on or after CT
Ref: Businesswire | Image: Seagen
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