Bristol takes its bispecific conjugate into lung cancer
A second global pivotal trial will test iza-can in the same NSCLC setting where patri-dxd failed.
A second global pivotal trial will test iza-can in the same NSCLC setting where patri-dxd failed.
Bristol Myers Squibb has already taken its SystImmune-originated ADC izalontamab brengitecan into one pivotal trial, and it will soon begin another, according to a recent listing on clinicaltrials.gov. The phase 2/3 Izabright-Lung01 trial, set to start in October, will enrol EGFR-mutant NSCLC patients who have progressed on EGFR TKI therapy.
However, in this use the Bristol anti-HER3 x EGFR ADC faces an uncomfortable precedent: Merck & Co's monospecific anti-HER3 ADC, patritumab deruxtecan, recently flunked the Herthena-Lung02 in the same setting, forcing that group to withdraw its filing here.
US vs Chinese
Izabright-Lung01 is similar to a Chinese trial already being carried out by SystImmune. That group has various late-stage lung cancer efforts under way, including a first-line Tagrisso combo study.
Izalontamab brengitecan pivotal lung cancer trials
| Trial | Sponsor | Setting | Regimen | Note |
|---|---|---|---|---|
| Izabright-Lung01 (ph2/3) | Bristol Myers Squibb | 2nd-line EGFRm NSCLC (post-EGFR TKI) | Monotx, vs chemo | To start Oct 2025 |
| BL-B01D1-301 | Sichuan Baili (SystImmune) | 2nd-line EGFRm NSCLC (post-EGFR TKI) | Monotx, vs chemo | Completes May 2026 |
| BL-B01D1-302 | Sichuan Baili (SystImmune) | 2nd-line EGFRwt NSCLC (post-PD-L1 + chemo) | Monotx, vs docetaxel | Completes May 2026 |
| BL-B01D1-304 | Sichuan Baili (SystImmune) | 2nd-line SCLC (post-PD-L1 + chemo) | Monotx, vs topotecan | Completes Jul 2026 |
| BL-B01D1-308 | Sichuan Baili (SystImmune) | 1st-line EGFRm NSCLC | + Tagrisso, vs Tagrisso | Completes Dec 2028 |
Source: OncologyPipeline.
SystImmune also has phase 3 trials of iza-can ongoing in breast, platinum-resistant ovarian, bladder, oesophageal and nasopharyngeal cancers. The last is the most advanced, with the company claiming a pivotal win in China last month, although details are scant.
Meanwhile Bristol, which licensed iza-can from for $800m up front in December 2023, recently began its first pivotal study, Izabright-Breast01, in first-line triple-negative breast cancer patients ineligible for PD-L1 inhibitors plus chemo.
According to Bristol’s second-quarter presentation, readout of Izabright-Breast01 is expected in 2028.
Both Bristol pivotal trials have a phase 2/3 design, designed to find a recommended phase 3 dose before testing progression-free survival as their primary endpoints.
Meanwhile, a Bristol-sponsored phase 1/2 study of iza-can plus Tagrisso or Keytruda in solid tumours is under way, with data due in 2027; a SystImmune-funded but US-based phase 1 in NSCLC and other cancers will read out next year.
SystImmune is set for another $250m payout on the start of Bristol’s second pivotal study, according to an IPO document from its parent company, Biokin (which is also the holding company of Baili Pharmaceutical). Biokin doesn’t appear to have yet floated in Hong Kong, as planned.
Other EGFR x HER3 ADC rivals include Avenzo Therapeutics, which licensed AVZO-1418 from DualityBio in January and recently began a phase 1/2 study; and Junshi Biosciences, whose JS212 is in phase 1/2 in China.
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