3:42 PM
Dec 05, 2018
 |  BC Extra  |  Clinical News

AbbVie's Rova-T suffers another setback in SCLC

AbbVie Inc. (NYSE:ABBV) said late Wednesday that it will stop enrollment in the Phase III TAHOE trial of Rova-T rovalpituzumab tesirine as second-line treatment of advanced or metastatic small cell lung cancer after the product led to a lower improvement on the primary endpoint of overall survival (OS) vs. topotecan.

The failure is the second setback this year for the product, which was the centerpiece of AbbVie's 2016 acquisition of Stemcentrx Inc. for $5.8 billion up front and up to $4 billion in milestones.

In March, AbbVie said it would not seek accelerated approval of Rova-T as third-line treatment of relapsed or refractory SCLC. The company based that decision on the "magnitude of effect across multiple parameters" in the Phase II TRINITY trial of Rova-T in the third-line indication. Buysiders who spoke to BioCentury at the time said the Rova-T setback raises questions about AbbVie’s ability to grow its pipeline (see "Rova-T Roadblock").

The open-label, international TAHOE trial was slated to enroll about 600 SCLC patients with high delta like canonical Notch ligand 3 (DLL3) expression and who have first disease progression during or following first-line platinum-based chemotherapy. For patients who are on treatment with Rova-T in TAHOE, AbbVie said the trial's IDMC recommended that investigators and patients make individual decisions about whether or not to continue treatment.

AbbVie said the TAHOE setback does not affect other clinical trials of the antibody-drug conjugate (ADC) composed of a humanized mAb against DLL3 and a pyrrolobenzodiazepine (PBD) dimer toxin.

Rova-T is in the Phase III MERU trial as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage SCLC. According to ClinicalTrials.gov, the estimated primary completion date for MERU is in November 2019.

Also on Wednesday, FDA accepted and granted Priority Review to an sBLA from Genentech Inc. for anti-PD-L1 mAb Tecentriq atezolizumab as first-line treatment of extensive-stage SCLC. Its PDUFA date is March 18, 2019 (see “Tecentriq Could be First Front-line SCLC Therapy Approved in Two Decades”).

In August, FDA granted accelerated approval to anti-PD-1 mAb Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat SCLC in a third-line setting (see "Opdivo Gets Accelerated Approval in SCLC Population").

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