Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: pooled analysis of phase I and phase II trials.

What was studied

This study looked at a new drug called Iza-bren, also known as BL-B01D1. The drug targets EGFR and HER3 on cancer cells. The people had advanced lung cancer with a change in the EGFR gene. Their cancer had grown despite earlier EGFR drugs, called TKIs. The team pooled data on each person from an early trial and a mid-stage trial. The early trial tested rising doses. A main dose was later set at 2.5 mg/kg. It was given on days 1 and 8 of each 3-week cycle. In total, 171 people took part, followed for a median of 20.5 months.

What they found

Tumors shrank or stopped growing in many people. When tumors shrank, this lasted a median of 8.5 months. The cancer did not grow for a median of 6.9 months. People lived for a median of 24.8 months. Results were alike in the 121 people on the main dose. Among them, 50 had not had chemo before. In this group, the cancer did not grow for a median of 12.5 months. Nearly all people had side effects, and many were serious. These were mostly blood problems. A lung problem called interstitial lung disease was rare and mild. Few people stopped the drug due to side effects. No deaths were linked to the drug.

What it means for patients

The authors say the drug showed activity against this lung cancer. They say its side effects could be managed. This was in people who had already had many treatments. The authors see these results as ideas to test, not firm proof.

Why it is not certain yet

This was an exploratory look back at pooled trial data. The abstract does not describe a comparison group. Not all people got the same dose. Randomized trials are still testing the drug. Until those end, the true effect is not known.

Source

Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: pooled analysis of phase I and phase II trials.

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