Farletuzumab ecteribulin, a folate receptor alpha (FRα) antibody-drug conjugate, in select advanced cancers: An open-label, multicenter, phase 1/2 dose-finding study.

What was studied

This phase 1/2 study tested farletuzumab ecteribulin (FZEC) in patients with advanced solid tumors. FZEC is an antibody-drug conjugate that targets folate receptor alpha. The patients had measurable disease and earlier treatment. Dose escalation included ovarian, endometrial, triple-negative breast and lung cancers. Later parts included ovarian and endometrial cancers. The study tested several dose plans to find a safer dose.

What they found

Lung inflammation (ILD/pneumonitis) was a major problem in dose escalation. It was also seen in dose confirmation. Dosing was changed to body surface area. At 25 mg/m2, all ILD/pneumonitis events were grade 1-2. Tests of 33 mg/m2 were stopped for ILD/pneumonitis. At 8 mg/m2 on days 1, 8 and 15, no ILD/pneumonitis occurred. That plan also gave more responses, but groups were small. With steroids, ILD/pneumonitis was similar, but it seemed to start later.

What it means for patients

The authors say FZEC given in split doses lowered the risk of ILD/pneumonitis. They say it showed preliminary antitumor activity. They say the next part will test more split doses, alone and with lenvatinib.

Why it is not certain yet

The groups that did better were small. This was an open-label study without a control group. The antitumor activity was preliminary. The steroid result was based on timing that only seemed delayed.

Source

Farletuzumab ecteribulin, a folate receptor alpha (FRα) antibody-drug conjugate, in select advanced cancers: An open-label, multicenter, phase 1/2 dose-finding study.

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