Second trial miss leaves Rova-T’s future in doubt

With overall survival worse in the Rova-T arm than in the control arm of the Tahoe trial in second-line advanced or metastatic small cell lung cancer, Abbvie had little choice but to pull the plug on the study. It has halted enrolment in the trial on the recommendation of its independent data monitoring committee. With the failure of the Trinity trial in third-line SCLC having been confirmed in March, the antibody-drug conjugate is now in one final SCLC trial, Meru, in the first-line maintenance setting. Abbvie insisted that the misses in both Tahoe and Trinity were no reason to expect the failure of Meru data ought to emerge in the coming months and will be hoping for some shred of comfort, having spent $5.8bn to buy Rova-T’s originator, Stemcentrx, back in 2016. But even if Meru succeeds the writing could be on the wall for Rova-T from a commercial standpoint: Roche’s Tecentriq has just gained FDA priority review in SCLC, having shown a two-month overall survival benefit over chemo in first-line disease. If it is approved by its PDUFA date in March, Tecentriq will be the first new front-line therapy for this cancer approved in two decades.

Study  Setting Detail Trial ID  Results
Trinity  3L and later SCLC expressing DLL3 >1%  Rova-T (no comparator) NCT02674568  Failed, even in DLL3 "high" subgroup
Tahoe  High-DLL3 and chemo-progressed SCLC   Rova-T vs topotecan NCT03061812  Enrolment halted after survival found to be less than control
Meru  SCLC maintenance after 1L Pt chemo  Rova-T + dexamethasone, vs placebo NCT03033511  Trial concluded in November, no data yet

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