IDMC recommends Phase III trial of Rova-T in SCLC be halted

6 December 2018

US pharma company AbbVie’s (NYSE: ABBV) $10 billion bet on a cancer drug candidate two years ago looks like it could be heading for disappointment.

AbbVie said yesterday that it will stop enrollment for the TAHOE trial, a Phase III study evaluating rovalpituzumab tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). With stock markets in the USA closed yesterday

An Independent Data Monitoring Committee (IDMC) recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. For patients currently on treatment with Rova-T in TAHOE, the IDMC recommended that investigators and patients make individual decisions as to whether or not to continue treatment based on patient level response. The recommendation from the IDMC to halt enrollment applies only to the TAHOE study and does not impact other Rova-T clinical studies.

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