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Poster display session

1824 - A Phase I/II Safety Study of Tisotumab Vedotin (HuMax®-TF-ADC) in Patients With Solid Tumors

Date

10 Sep 2017

Session

Poster display session

Presenters

Maxime Chenard-Poirier

Citation

Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376

Authors

M. Chenard-Poirier1, D.S. Hong2, R. Coleman3, J. de Bono1, M. Mau-Sorensen4, D. Collins5, S. Lisby6, L. Basse6, U. Lassen7

Author affiliations

  • 1 Oncology, Institute of Cancer Research Royal Marsden Hospital, SM2 5PT - Sutton/GB
  • 2 Phase I Unit, The University of Texas M. D. Anderson Cancer Center, 77035 - Houston/US
  • 3 Oncology, MD Anderson Cancer Center, 77030-3721 - Houston/US
  • 4 Phase I Unit, Copenhagen University Hospital, 2100 - Copenhagen/DK
  • 5 Oncology, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 6 Medical Department, Genmab, 1260 - Copenhagen/DK
  • 7 Dept. Of Oncology, Phase 1 Unit, Rigshospitalet, 2100   - Copenhagen/DK
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Resources

Abstract 1824

Background

Tisotumab vedotin (Tv) is an antibody-drug conjugate composed of a Tissue Factor (TF) specific human IgG1 monoclonal antibody conjugated to a microtubule disrupting agent Monomethyl Auristatin E (MMAE). Tv is being tested in an ongoing Ph I/II dose-escalation study (NCT02001623) in patients (pts) with locally advanced and/or metastatic solid tumors known to express TF. Preliminary data were presented at ASCO 2015, abstract #2570; here, we present the full data set from the dose-escalation part.

Methods

Key eligibility criteria include PS 0-1, normal organ function and no bleeding disorder or invasion of large vessels. Pts were treated with a classic 3 + 3 dose escalation regimen of Tv once every 3 weeks (q3Wk). The primary study objective was to assess tolerability of Tv. Safety was reported according to CTCAE 4.03. Responses were evaluated according to RECIST 1.1.

Results

Twenty-seven pts were enrolled across 8 dose cohorts (0.3-2.2 mg/kg). Demography: mean age 61 yrs (range 43-73); gender 9 males and 18 females; median number of prior lines of therapy 3 (range 1-14). Three dose-limiting toxicities (diabetes mellitus type II, mucositis and neutropenic fever, all Gr 3) were seen in 3 pts in the 2.2 mg/kg dose cohort. The most common AEs seen in ≥ 20%: epistaxis (48%), fatigue (48%), anemia (41%), alopecia (30%), constipation (30%), nausea (30%), pyrexia (30%), decreased appetite (26%), abdominal pain (22%) and diarrhea (22%). SAEs (all pts): 29 events in 15 pts (56%), 1 SCCHN pt in the 0.6 mg/kg cohort died from tumor related bleeding. AEs Gr ≥ 3: 19 pts (70%) experienced 41 events. Efficacy: 14 pts (52%) achieved SD or better; 1 cervical cancer pt dosed 1.2 mg/kg with 2 prior treatment lines before trial entry achieved and maintained PR during entire study period. After study period, the pt was transferred to named patient use. Immunohistochemistry (IHC): Samples from 25 pts were evaluable. TF expression was present in 20 (80%) samples.

Conclusions

Tisotumab vedotin demonstrated a manageable toxicity profile. Recommended Ph II dose was identified as 2.0 mg/kg q3Wk. Biological activity included SD in 13 pts and 1 pt with prolonged PR (cervical cancer).TF was found widely expressed across investigated indications by IHC. Data warrant further exploration in solid tumors.

Clinical trial identification

NCT02001623, release date November 14, 2013

Legal entity responsible for the study

Genmab A/S

Funding

Genmab A/S

Disclosure

D.S. Hong: Research/Grant Funding: Bayer, Lilly, Genentech, LOXO, Pfizer, Amgen, Mirati, Ignyta, Merck, Daichi-Sanko, Eisai Travel, Accommodations, Expenses: MiRNA, LOXO Consulting Role: Bayer, Baxter, Guidepoint Global Other: Oncoreseponse (founder). R. Coleman: Member of Genmab\'s Advisory Board for Tisotumab vedotin. J. de Bono: Employee of The institute of Cancer Research, Served on Genmab Advisory Board, have served as advisor on advisory boards for multiple industry partners incl. AstraZeneca, Daiichi-Sankyo, Genentech, GSK, Merck, Pfizer, Sanofi, Taiho a.o. S. Lisby, L. Basse: Employee of Genmab and hold stocks in the company. All other authors have declared no conflicts of interest.

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