Celldex starts phase 1/2 study of glembatumumab vedotin in squamous cell lung cancer

The open-label study will assess the safety and tolerability of the drug in patients with unresectable stage IIIB or IV, gpNMB-expressing, advanced or metastatic squamous cell carcinoma (SCC) of the lung, who have progressed on prior platinum-based chemotherapy.

Glembatumumab vedotin targets gpNMB, a protein overexpressed by several tumor types such as SCC of the lung.

Overexpression of gpNMB is associated with metastasis and poor clinical outcome.

A cancer research network, dubbed PrECOG, will carry out the study across 10 sites in the US.

Glembatumumab vedotin will be administered once every three weeks until disease progression or intolerance.

The primary endpoint of the phase 2 portion, which will enroll about 20 subjects, is objective response rate (ORR). A second stage may enroll a further 15 patients if nearly two patients achieve a partial response or complete response.

Secondary objectives include analyses of safety and tolerability and further assessment of anti-tumor activity across a range of endpoints.

Celldex Therapeutics executive vice president and chief medical officer Thomas Davis said: "gpNMB, the target of glembatumumab vedotin, is strongly expressed in the vast majority of squamous cell lung cancers.

"Glembatumumab vedotin has consistently induced notable response rates in other difficult to treat cancers that overexpress gpNMB. We hope to elicit similar activity in squamous cell carcinoma and look forward to completing this study."

The drug is currently being assessed in patients with metastatic triple negative breast cancers that overexpress gpNMB as well as in patients with advanced melanoma who have progressed after at least one checkpoint inhibitor therapy and, if applicable, BRAF- or MEK-targeted therapy.

It has earlier been evaluated in a phase 2 study in advanced breast cancer and a Phase 1/2 trial in patients with unresectable stage III or IV melanoma.