Astra’s phase 3 is the encore to Merck’s $700m deal
When Merck & Co last week handed across $700m up front to China’s Curon Biopharmaceutical for rights to CN201 it put anti-CD19 T-cell engagers back on the map. Now just days later it’s AstraZeneca that’s jumped ahead in this space, taking its contender AZD0486 straight into a phase 3 study, a new listing on the clinicaltrials.gov registry reveals. Astra gained rights to AZD0486 (formerly known as TNB-486) in its 2022 acquisition of the private company Teneotwo for $100m up front. The latest human data on this are from a phase 1 trial presented at EHA in June, where a 92% ORR was cited in 24 follicular lymphoma patients, while a cut of four patients in the more aggressive DLBCL setting showed three responses, according to ASH 2022. AZD0486 has also been studied in relapsed/refractory ALL, but no data appear to have been released here, and phase 2 in DLBCL has yet to get under way. The phase 3 study will see the bispecific molecule combined with Rituxan in first-line follicular lymphoma, with two combo regimens being compared against investigator’s choice of three Rituxan/chemo combos; amazingly, the study aims to enrol over 1,000 patients.
Clinical studies of AZD0486/TNB-486
| Trial | Setting | Result |
|---|---|---|
| Phase 1 | r/r B-cell non-Hodgkin’s lymphoma | 2 CRs & 1 PR in 4 DLBCL pts, per ASH 2022; 19 CRs & 3 PRs in 24 follicular lymphoma pts dosed at ≥0.8mg, per EHA 2024 |
| Phase 1/2 | r/r B-cell ALL | None released |
| Phase 2 | r/r B-cell non-Hodgkin’s lymphoma | None – trial starts in Oct 2024 |
| Phase 3 | 1st-line follicular lymphoma, Rituxan combo | None – trial started Aug 2024; primary endpoints are safety & recommended ph3 dose in safety run-in, then PFS vs Rituxan + chemo in ph3 stage (n=1,005) |
Source: OncologyPipeline.
This story has been updated to add follicular lymphoma data presented at EHA.
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