Tecentriq surprises in adjuvant liver cancer

Given the mixed track record of Roche’s Tecentriq in perioperative cancer uses, today’s apparent success of the Imbrave-050 trial comes as a pleasant surprise. The study tested Tecentriq plus Avastin in adjuvant liver cancer, and the combo is said to have beaten active surveillance alone on its primary endpoint of relapse-free survival. The precise contribution of Avastin to this result is unknown, but the success comes after the same combo was approved three years ago for first-line inoperable liver cancer on the basis of Imbrave-150. Tecentriq’s other perioperative success was in adjuvant NSCLC, where the drug is approved in ≥1% PD-L1 expressers on the basis of Impower-010, and an Abraxane combo read out positively in the perioperative triple-negative breast cancer (TNBC) trial Impassion-031, albeit on pathological complete response, likely not an approvable endpoint. Apart from that Tecentriq monotherapy and combos have failed several pivotal perioperative trials, including Imvigor-010, Imagyn-050, Impassion-050 and Immotion-010; the next big readout, from Impassion-030 in adjuvant TNBC, is expected soon. Specifically in adjuvant liver cancer this year could also see data from three other anti-PD-(L)1 drugs: Shanghai Junshi’s toripalimab, Astrazeneca’s Imfinzi and Innovent’s sintilimab.

Phase 3 studies in adjuvant hepatocellular carcinoma
Drug Trial Setting Primary endpoint & status
Tecentriq (Roche) Imbrave-050 + Avastin, vs active surveillance RFS, toplined positive Jan 2023
Toripalimab (Shanghai Junshi) Jupiter-04* MonoRx, vs placebo RFS, ends Apr 2023
Imfinzi (Astrazeneca) Emerald-2 +/- Avastin, vs placebo RFS, ends May 2023
Sintilimab (Innovent) Dadali* + Avastin, vs active surveillance RFS, ends Dec 2023
Camrelizumab (Jiangsu Hengrui) SHR-1210-III-325* + apatinib, vs active surveillance RFS, ends Jul 2024
Opdivo (Bristol/Ono) Checkmate-9DX MonoRx, vs placebo RFS, ends Dec 2024
Tislelizumab (Beigene) NCT05564338 +/- sitravatinib, vs placebo RFS, ends Sep 2026
Keytruda (Merck & Co) Keynote-937 MonoRx, vs placebo RFS & OS, ends Oct 2027
Notes: RFS=relapse-free survival; *China study. Source: clinicaltrials.gov.

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