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SystImmune spreads into first-line lung

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

TrialSettingRegimenPrimary endpointStart datePrimary completion
BL-B01D1-3012nd-line EGFRm NSCLC (post-TKI)Monotherapy, vs chemoPFSMay 2024May 2026
BL-B01D1-3022nd-line EGFRwt NSCLC (post-PD-(L)1 + chemo)Monotherapy, vs docetaxelOSMay 2024May 2026
BL-B01D1-3033rd-line nasopharyngeal carcinomaMonotherapy, vs chemoORR, OSDec 2024Dec 2025
BL-B01D1-3042nd-line SCLCMonotherapy, vs chemoOSAug 2024Jul 2026
BL-B01D1-3052nd-line oesophageal squamous cell carcinomaMonotherapy, vs chemoPFS, OSMar 2024May 2026
BL-B01D1-3062nd-line ER+/HER2- breast cancerMonotherapy, vs chemoPFSApr 2024May 2026
BL-B01D1-3072nd-line TNBCMonotherapy, vs chemoPFS, OSJun 2024Jun 2026
BL-B01D1-3081st-line EGFRm NSCLC+ Tagrisso, vs TagrissoPFSMar 2025Dec 2028

Source: OncologyPipeline & clinicaltrials.gov.

Tags

Molecular Drug Targets