The Canadian Cancer Trials Group’s Adjuvant BR.31 study that failed today might have been an academic-sponsored effort, but it represented what looks like AstraZeneca’s last shot at getting Imfinzi approved for treating NSCLC in the adjuvant setting. Adjuvant BR.31 enrolled 1,415 all-comers with stage IB-IIIA disease, but tested its primary endpoint, disease-free survival versus placebo, only in those whose tumours expressed PD-L1 at 25% or greater; that was said to have drawn a blank. The setback comes after the low-key failures of two other phase 3 adjuvant NSCLC trials, Mermaid-1 and 2, which tested Imfinzi with or without chemo respectively, in stage II-III disease; both had their recruitment targets slashed in mid-2022, and were quietly removed from Astra’s pipeline later that year. Imfinzi is awaiting US approval for neoadjuvant NSCLC, with an imminent PDUFA date based on the Aegean study, a use for which Opdivo has an 8 October action date on the back of Checkmate-77T. For now the purely adjuvant NSCLC space remains largely controlled by Keytruda, with a supporting role from Tecentriq. Selected trials in adjuvant NSCLC Stage IStage II-IIIOpdivo (Bristol Myers Squibb)Anvil/Checkmate-427Ends 2025Keytruda (Merck & Co)Keynote-091 (Pearls)FDA approved in IB-IIIA all-comers, even though DFS was not significant in ≥50% PD-L1 expressersTecentriq (Roche)–Impower-010FDA approved in PD-L1 ≥1% expressersImfinzi (AstraZeneca)Adjuvant BR.31 (academic sponsored)Failed for DFS in ≥25% PD-L1 expressers (primary endpoint)–Mermaid-1Recruitment stopped, enrolment cut from 332 to 86, removed from pipeline Nov 2022Mermaid-2Recruitment stopped, enrolment cut from 284 to 22, removed from pipeline Nov 2022Source: OncologyPipeline.
The Canadian Cancer Trials Group’s Adjuvant BR.31 study that failed today might have been an academic-sponsored effort, but it represented what looks like AstraZeneca’s last shot at getting Imfinzi approved for treating NSCLC in the adjuvant setting. Adjuvant BR.31 enrolled 1,415 all-comers with stage IB-IIIA disease, but tested its primary endpoint, disease-free survival versus placebo, only in those whose tumours expressed PD-L1 at 25% or greater; that was said to have drawn a blank. The setback comes after the low-key failures of two other phase 3 adjuvant NSCLC trials, Mermaid-1 and 2, which tested Imfinzi with or without chemo respectively, in stage II-III disease; both had their recruitment targets slashed in mid-2022, and were quietly removed from Astra’s pipeline later that year. Imfinzi is awaiting US approval for neoadjuvant NSCLC, with an imminent PDUFA date based on the Aegean study, a use for which Opdivo has an 8 October action date on the back of Checkmate-77T. For now the purely adjuvant NSCLC space remains largely controlled by Keytruda, with a supporting role from Tecentriq.
Selected trials in adjuvant NSCLC
| Stage I | Stage II-III |
|---|
| Opdivo (Bristol Myers Squibb) | Anvil/Checkmate-427 |
| Ends 2025 |
| Keytruda (Merck & Co) | Keynote-091 (Pearls) |
| FDA approved in IB-IIIA all-comers, even though DFS was not significant in ≥50% PD-L1 expressers |
| Tecentriq (Roche) | – | Impower-010 |
| FDA approved in PD-L1 ≥1% expressers |
| Imfinzi (AstraZeneca) | Adjuvant BR.31 (academic sponsored) |
| Failed for DFS in ≥25% PD-L1 expressers (primary endpoint) |
| – | Mermaid-1 |
| Recruitment stopped, enrolment cut from 332 to 86, removed from pipeline Nov 2022 |
| Mermaid-2 |
| Recruitment stopped, enrolment cut from 284 to 22, removed from pipeline Nov 2022 |
