AbbVie halts late-stage TAHOE study of Rova-T in small-cell lung cancer

AbbVie on Wednesday announced that it was stopping enrolment of the Phase III TAHOE study assessing rovalpituzumab tesirine, also known as Rova-T, as a second-line treatment for patients with advanced small-cell lung cancer. The company noted that an independent data monitoring committee (IDMC) recommended ending enrolment in the trial after an interim analysis revealed that overall survival was shorter in the Rova-T arm than in the topotecan arm.  

In the TAHOE study, patients with advanced or metastatic SCLC with high delta-like protein 3 levels who experienced disease progression during or following first-line platinum-based chemotherapy were randomised to treatment with Rova-T or topotecan. AbbVie noted that the recommendation from the IDMC to halt enrolment does not apply to any other clinical studies of the therapy. 

Meanwhile, the news comes after AbbVie announced in March that it would not seek accelerated FDA approval of the experimental drug for use in the third-line setting in patients with relapsed/refractory SCLC based on the results from the Phase II TRINITY study. 

AbbVie gained rights to Rova-T as part of its acquisition of Stemcentrx in 2016 for $5.8 billion. The company has additionally entered into a partnership with Bristol-Myers Squibb to assess the effects of Rova-T in combination with Opdivo (nivolumab), both alone and together with Yervoy (ipilimumab), in patients with relapsed extensive-stage SCLC. 

For related analysis, see ViewPoints: AbbVie’s hopes on Rova-T look increasingly like a Hail Mary.

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