Chinese-American biopharmaceutical company Zai Lab has announced positive topline results from the China-specific arm in its Phase III innovaTV-301 study examining its antibody-drug conjugate (ADC) TIVDAK or tisotumab vedotin.
As per results from the Chinese subpopulation arm of the study, cervical cancer patients who received TIVDAK, had a 45% reduction in the risk of death compared to chemotherapy. The study enrolled patients with recurrent or metastatic cervical cancer who had received prior standard systemic therapies. While the median overall survival (OS)—the Phase III trial’s (NCT04697628) primary endpoint—was 10.7 months with chemotherapy, it was not yet reached on the TIVDAK arm.
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At the same time, secondary endpoints examining progression-free survival and objective response rates favoured TIVDAK.
Rafael Amado, head of global research and development at Zai Lab, said: ““The consistent and positive results in the China subpopulation of the global Phase III study reinforce the potential for TIVDAK, the only ADC therapy in this disease setting, to increase options in this therapeutically unmet clinical setting. If approved, we expect TIVDAK to add to ZEJULA and augment our commercial franchise in women’s tumours.” Zejula (niraparib) is a PARP inhibitor approved to treat several gynaecological cancers.
TIVDAK is approved in the US based on results from the same Phase III innovaTV 301 clinical trial. Results from the China subpopulation arm were said to be consistent with those seen in the global study.
Lingying Wu, professor of oncology at the Chinese Academy of Medical Science, said: “While the recent adoption of immunotherapy as a first-line treatment in China represents progress, there is a lack of effective options for patients following relapse. The promising results from TIVDAK, which demonstrated superior survival extension in patients whose disease progressed after initial treatments, including prior anti-PD(L)1 treatment, offer hope for addressing this critical unmet need.”
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By GlobalDataElsewhere in the field of cervical cancer trials, Transgene’s stock fell after a Phase II trial of its therapeutic vaccine candidate TG4001 (tipapkinogene sovacivec) failed to meet its primary endpoint of improvement in progression-free survival (PFS) in a cervical cancer study. Meanwhile, a trial led by Kings College London has found that self-sampling human papillomavirus (HPV) kits could boost the number of women screened in England by 400,000 each year.
