Astra polishes up a second Emerald
AstraZeneca has added to the partial success of the Emerald-1 study with another partial win, in the related Emerald-3 trial. Both concern first-line hepatocellular carcinoma patients eligible for TACE (transarterial chemoembolisation), and test various combinations of Imfinzi. On Thursday Astra toplined Emerald-3 as positive for its primary endpoint of PFS for a cohort comprising Imfinzi, Imjudo, TACE and Lenvima, but said the second active treatment arm, Imfinzi/Imjudo/TACE alone, showed only “strong trends towards improved PFS and OS”; any effect here wasn’t formally tested, and the study will continue. That’s somewhat similar to the Emerald-1 result, which showed statistical significance against TACE alone only for a triplet containing Avastin, while in this trial Imfinzi and TACE alone were a clear statistical bust. Astra said it would share the Emerald-3 data with regulators, but there’s still no news on any filing based on Emerald-1, over two years after those data were presented at ASCO-GI. Meanwhile the results of Emerald-2, a third study, testing Imfinzi with or without Avastin in the adjuvant setting, were once expected in 2023, but have been delayed to the second half of this year.
Selected AstraZeneca studies in hepatocellular carcinoma
| Trial | Setting | Active cohort 1 | Active cohort 2 | Control cohort | Status |
|---|---|---|---|---|---|
| Emerald-1 | 1st-line | Imfinzi + TACE + Avastin | Imfinzi + TACE | TACE alone | Positive for PFS for cohort 1 (15.0mth vs 8.2mth, HR=0.77); cohort 2 data not stat sig (10.0mth vs 8.2mth, HR=0.94); continuing to OS |
| Emerald-2 | Adjuvant | Imfinzi + Avastin | Imfinzi | Placebo | Data expected H2 2026 (earlier H2 2023) |
| Emerald-3 | 1st-line | Imfinzi + Imjudo + TACE + Lenvima | Imfinzi + Imjudo + TACE | TACE alone | Toplined positive for PFS for cohort 1; continuing to follow cohort 2 & OS |
Source: OncologyPipeline.
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