AstraZeneca’s Imfinzi plus Imjudo has cautiously challenged Roche’s Tecentriq plus Avastin in front-line liver cancer, and today the UK firm upped the ante: Emerald-1, testing Imfinzi plus transarterial chemoembolisation (TACE) and Avastin, has been toplined positive for progression-free survival versus TACE alone. Of course, nothing is yet known about the absolute benefit seen, and it's unclear whether Astra would file based on these data alone; the group says Emerald-1 is continuing to its secondary OS readout. And nothing has been said about the study’s third cohort, Imfinzi plus TACE alone, hinting at a lack of success here. Imfinzi plus Imjudo is approved for first-line liver cancer based on results from the Himalaya study, which on a cross-trial basis failed to match Roche’s Imbrave-150. In the second-line setting Keytruda is approved, but Opdivo’s accelerated nod was pulled in 2021, two years after the failure of the front-line Checkmate-459 study. Meanwhile, Keytruda’s own first-line filing, in combination with Eisai’s Lenvima, got a US complete response letter because the uncontrolled Keynote-524 trial gave it insufficient backing. That FDA decision turned out to be well founded when the same combo then failed to beat Lenvima in the phase 3 Leap-002 study. Selected first-line liver cancer trialsStudyRegimenResultCheckmate-459Opdivo monotherapyFailed to beat Nexavar on mOS: 16.4mth vs 14.7mth (HR=0.85, p=0.075)Leap-002Keytruda + Lenvima vs LenvimaFailed to beat Lenvima on mOS: 21.2mth vs 19.0mth (HR=0.84, p=0.023)Imbrave-150Tecentriq + AvastinmOS: NE vs 13.2mth for Nexavar (HR=0.58, p=0.0006); US approved Jun 2020HimalayaImfinzi + ImjudomOS: 16.4mth vs 13.8mth for Nexavar (HR=0.78, p=0.0035); US approved Oct 2022Imfinzi monotherapymOS: 16.6mth vs 13.8mth for Nexavar (HR=0.86)Emerald-1Imfinzi + TACE +/- AvastinToplined positive for PFS vs TACE alone; continuing to OSEmerald-3Imfinzi + Imjudo + TACE +/- LenvimaPrimary endpoint PFS vs TACE alone; ends Dec 2025Source: OncologyPipeline, Lancet, ESMO & prescribing information.
AstraZeneca’s Imfinzi plus Imjudo has cautiously challenged Roche’s Tecentriq plus Avastin in front-line liver cancer, and today the UK firm upped the ante: Emerald-1, testing Imfinzi plus transarterial chemoembolisation (TACE) and Avastin, has been toplined positive for progression-free survival versus TACE alone. Of course, nothing is yet known about the absolute benefit seen, and it's unclear whether Astra would file based on these data alone; the group says Emerald-1 is continuing to its secondary OS readout. And nothing has been said about the study’s third cohort, Imfinzi plus TACE alone, hinting at a lack of success here. Imfinzi plus Imjudo is approved for first-line liver cancer based on results from the Himalaya study, which on a cross-trial basis failed to match Roche’s Imbrave-150. In the second-line setting Keytruda is approved, but Opdivo’s accelerated nod was pulled in 2021, two years after the failure of the front-line Checkmate-459 study. Meanwhile, Keytruda’s own first-line filing, in combination with Eisai’s Lenvima, got a US complete response letter because the uncontrolled Keynote-524 trial gave it insufficient backing. That FDA decision turned out to be well founded when the same combo then failed to beat Lenvima in the phase 3 Leap-002 study.
Selected first-line liver cancer trials
| Study | Regimen | Result |
|---|
| Checkmate-459 | Opdivo monotherapy | Failed to beat Nexavar on mOS: 16.4mth vs 14.7mth (HR=0.85, p=0.075) |
| Leap-002 | Keytruda + Lenvima vs Lenvima | Failed to beat Lenvima on mOS: 21.2mth vs 19.0mth (HR=0.84, p=0.023) |
| Imbrave-150 | Tecentriq + Avastin | mOS: NE vs 13.2mth for Nexavar (HR=0.58, p=0.0006); US approved Jun 2020 |
| Himalaya | Imfinzi + Imjudo | mOS: 16.4mth vs 13.8mth for Nexavar (HR=0.78, p=0.0035); US approved Oct 2022 |
| Imfinzi monotherapy | mOS: 16.6mth vs 13.8mth for Nexavar (HR=0.86) |
| Emerald-1 | Imfinzi + TACE +/- Avastin | Toplined positive for PFS vs TACE alone; continuing to OS |
| Emerald-3 | Imfinzi + Imjudo + TACE +/- Lenvima | Primary endpoint PFS vs TACE alone; ends Dec 2025 |
