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SystImmune spreads into first-line lung
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SystImmune’s Bristol Myers Squibb-partnered ADC izalontamab brengitecan is already in a raft of Chinese phase 3 trials, and now first-line NSCLC is joining the roster, a recent listing on clinicaltrials.gov reveals. Iza-can, which hits both EGFR and HER3, will be tested alongside AstraZeneca’s Tagrisso, versus Tagrisso alone, in EGFR-mutated NSCLC patients in the BL-B01D1-308 study. This adds to two second-line trials, one in EGFRm and the other in EGFRwt NSCLC, following a tyrosine kinase inhibitor or PD-(L)1 plus chemo respectively. Still, more eagerly awaited is Bristol’s global phase 1/2 solid tumour study, which had been slated to begin in December but now has a February 2025 start date. That uncontrolled trial will test iza-can in combination with Tagrisso and Keytruda, with lung cancer a particular focus. Bristol paid $800m to license iza-can in late 2023, since when interest in Chinese assets has exploded. Within the EGFR x HER3 ADC space Avenzo recently picked up a preclinical project from DualityBio, AVZO-1418; phase 1 is planned to start this year. Even so, Bristol and SystImmune (a subsidiary of China’s Biokin/Baili) are well ahead of the chasing pack.
China phase 3 trials of izalontamab brengitecan
Trial | Setting | Regimen | Primary endpoint | Start date | Primary completion |
---|---|---|---|---|---|
BL-B01D1-301 | 2nd-line EGFRm NSCLC (post-TKI) | Monotherapy, vs chemo | PFS | May 2024 | May 2026 |
BL-B01D1-302 | 2nd-line EGFRwt NSCLC (post-PD-(L)1 + chemo) | Monotherapy, vs docetaxel | OS | May 2024 | May 2026 |
BL-B01D1-303 | 3rd-line nasopharyngeal carcinoma | Monotherapy, vs chemo | ORR, OS | Dec 2024 | Dec 2025 |
BL-B01D1-304 | 2nd-line SCLC | Monotherapy, vs chemo | OS | Aug 2024 | Jul 2026 |
BL-B01D1-305 | 2nd-line oesophageal squamous cell carcinoma | Monotherapy, vs chemo | PFS, OS | Mar 2024 | May 2026 |
BL-B01D1-306 | 2nd-line ER+/HER2- breast cancer | Monotherapy, vs chemo | PFS | Apr 2024 | May 2026 |
BL-B01D1-307 | 2nd-line TNBC | Monotherapy, vs chemo | PFS, OS | Jun 2024 | Jun 2026 |
BL-B01D1-308 | 1st-line EGFRm NSCLC | + Tagrisso, vs Tagrisso | PFS | Mar 2025 | Dec 2028 |
Source: OncologyPipeline & clinicaltrials.gov.
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