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InnovaTV 205 Arm H — Tisotumab vedotin + carboplatin + pembrolizumab ± bevacizumab in 1L recurrent/metastatic cervical cancer

Abstract: Phase 2 cohort · Session: Monday April 13, 2026 (cervical Plenary V) · Simultaneous publication: TBD (Gynecologic Oncology)

Headline: Tisotumab vedotin (Tivdak) combined with carboplatin + pembrolizumab ± bevacizumab delivers ORR 66% with median DOR 13 months in 1L recurrent/metastatic cervical cancer — moving TV into the 1L combination space alongside chemo-IO.

At a glance

  • Sponsor: Pfizer / Seagen · Genmab (innovaTV / Tivdak program)
  • PI / presenter: Apr 13 Plenary V (presenter TBD)
  • NCT ID: NCT03786081 (InnovaTV 205)
  • Phase / arms / N: Phase 2 multi-cohort; Arm H = tisotumab vedotin + carboplatin + pembrolizumab ± bevacizumab in 1L recurrent/metastatic
  • Primary endpoint(s): ORR, DOR
  • Indication / line: 1L recurrent or metastatic cervical cancer
  • Comparator: None (single-arm cohort)
  • Session: Plenary V (Day 4, Apr 13)

Headline result

Confirmed ORR 66%, median DOR 13 months in Arm H. Safety profile manageable and consistent with the known TV ocular and peripheral neuropathy AE profile, plus expected chemo-IO toxicities. The result positions tisotumab vedotin in 1L combinations, ahead of the historical 2L+ approval setting.

Mechanism / class

Tisotumab vedotin (Tivdak) is an antibody-drug conjugate targeting tissue factor (TF, CD142) — a coagulation initiator broadly expressed on solid-tumor epithelium — conjugated to monomethyl auristatin E (MMAE) via a cleavable linker. FDA-approved 2024 (full approval) for recurrent/metastatic cervical cancer post-platinum/IO. InnovaTV 205 Arm H is the 1L move.

Trial design deep dive

Study architecture: Phase 2 multi-cohort (InnovaTV 205 / ENGOT-cx8 / GOG-3024), with Arm H specifically evaluating tisotumab vedotin 2.0 mg/kg Q3W + carboplatin AUC5 + pembrolizumab 200 mg Q3W ± bevacizumab 15 mg/kg Q3W in 1L recurrent/metastatic cervical cancer. Single-arm cohort design — no internal randomized comparator. Bevacizumab inclusion was investigator-elected per the ± design, allowing within-cohort exploratory comparison of TV+chemo-IO with and without anti-VEGF backbone.

Endpoint definitions: ORR (confirmed, RECIST 1.1, investigator-assessed) and median DOR as co-primary efficacy endpoints. Secondary endpoints include DCR, PFS, OS, safety per CTCAE v5 (with prospective ocular and peripheral-neuropathy surveillance given TV class profile), and PRO/QoL. The 66% ORR + 13-mo mDOR reported at SGO 2026 is the mature Arm H readout.

Key subgroup analyses: ± bevacizumab subgroup (within-cohort) is the most-watched analysis — informs the Phase 3 design choice of whether to retain anti-VEGF in the cervical 1L combination. Histology (squamous vs adenocarcinoma), PD-L1 CPS, and HPV status subgroups reserved for follow-up. Tissue factor expression-by-response correlation TBD in poster appendix.

Comparator context: KEYNOTE-826 (pembro + chemo ± bev) established 1L SOC with ORR ~65–68%. The 66% Arm H ORR is numerically competitive but cross-trial comparison is unreliable; the 13-mo mDOR is the durability differentiator if it holds. Phase 3 head-to-head is required.

FDA implications: Not registration-enabling on its own — Arm H informs a Phase 3 design moving TV into 1L. Accelerated-approval pathway possible if a single-arm 1L cohort with confirmatory Phase 3 is acceptable; more likely a confirmatory randomized Phase 3 is required.

Discussant takeaway

Plenary V framing: the 66% ORR + 13-mo DOR in 1L is competitive with chemo + bev + pembro alone (KEYNOTE-826), and supports a Ph3 head-to-head design that includes TV in the 1L cervical combination architecture. Anchors the cervical-cancer ADC class alongside sacituzumab tirumotecan (TroFuse-036) and IBI130 (anti-TROP2).

Practice-changing verdict

No (Ph2 cohort) — but combination-design-defining. InnovaTV 205 Arm H informs a registration-enabling Ph3 design moving tisotumab vedotin into 1L recurrent/metastatic cervical. NCCN cervical-cancer sequencing implications pending Ph3.

  • Other SGO 2026: KEYNOTE-A18 mature OS (pembro + CCRT in LACC); TroFuse-036 (sacituzumab tirumotecan post-CCRT maintenance); IBI130 (anti-TROP2 ADC cervical)
  • AACR 2026: Tissue factor + cervical ADC mechanism sessions
  • ASCO 2026: Expected Ph3 design unveil + biomarker correlates
  • ESMO 2026: European cervical ADC follow-up

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