The combination regimen will be assessed as a maintenance therapy to treat extensive stage small cell lung cancer patients. Credit: Jo Panuwat D/Shutterstock.

Genprex has dosed the first subject in the Phase II expansion portion of its Acclaim-3 trial of the Reqorsa gene therapy (quaratusugene ozeplasmid) for extensive-stage small-cell lung cancer (ES-SCLC) patients.

The trial will assess the gene therapy as a maintenance therapy, along with Genentech’s Tecentriq (atezolizumab).

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This expansion cohort is set to recruit 50 subjects across ten to 15 sites in the US.

Subjects will receive the combination regimen until they experience either disease progression or intolerable toxicity.

Determining the 18-week progression-free survival rate from the commencement of maintenance therapy is the primary endpoint of this part of the trial.

Subjects’ survival will also be monitored, with an interim analysis scheduled after the 25th patient reaches 18 weeks of follow-up.

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Enrolment for this interim analysis is anticipated to conclude in the second half of this year.

Genprex chief medical officer Mark Berger said: “We are excited to begin the Phase II expansion portion of Acclaim-3, which will determine the 18-week progression-free survival (PFS) rate of REQORSA and Tecentriq combination maintenance therapy.

“Those patients receiving Tecentriq as maintenance therapy have a median PFS of 2.6 months after the start of maintenance therapy. We look forward to studying the combination of REQORSA and Tecentriq as we work to advance our innovative gene therapy.”

The US Food and Drug Administration (FDA) previously granted fast track status to the combination therapy for treating the Acclaim-3 subjects. The gene therapy has also been granted orphan drug designation to treat SCLC.

In May 2024, the company enrolled and dosed the first subject in the Phase I/II trial to assess this combination therapy for ES-SCLC.

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