Quaratusugene Ozeplasmid Receives FDA Fast Track Designation in ES-SCLC

Investigators of the Acclaim-3 trial will enroll patients who have achieved a complete or partial response or stable disease following initial treatment with 3 to 4 cycles of carboplatin, etoposide, and atezolizumab. The dose-escalation phase will include up to 12 patients, and the efficacy evaluation phase will include up to 50.

Quaratusugene ozeplasmid (Reqorsa) has received fast-track designation from the FDA in combination with atezolizumab (Tecentriq) for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who did not experience tumor progression following initial therapy with atezolizumab and chemotherapy, according to a press release from Genprex.

Quaratusugene ozeplasmid expresses tumor suppressor gene TUSC2, with nearly all cases of SCLC having a lower expression of TUSC2 tumor suppressor protein and 41% of cases lacking the protein expression entirely. The agent will be assessed in combination with atezolizumab as part of the phase 1/2 Acclaim-3 trial (NCT05703971), which will include both a dose escalation phase and an efficacy evaluation phase.

“This fast track designation for the Acclaim-3 patient population is another validation of quaratusugene ozeplasmid’s potential to treat lung cancer,” Mark Berger, MD, chief medical officer at Genprex, said in the press release.

“We are very excited to soon begin treating patients in the Acclaim-3 clinical trial, which positions quaratusugene ozeplasmid as a component of initial standard therapy for SCLC rather than as treatment for relapse. Based on our experience in other trials, we have reduced the phase 1 portion of the study to 2 dose levels instead of the 3 dose levels in our Acclaim-1 and Acclaim-2 clinical trials. We believe this will shorten the phase 1 portion of the trial.”

Investigators of the Acclaim-3 trial will enroll patients who have achieved a complete or partial response or stable disease following initial treatment with 3 to 4 cycles of carboplatin, etoposide, and atezolizumab. The dose-escalation phase will include up to 12 patients, and the efficacy evaluation phase will include up to 50.

During the study’s first phase, patients will receive intravenous quaratusugene ozeplasmid plus intravenous atezolizumab at a dose of 1200 mg once every 21 days until disease progression or unacceptable toxicity. The starting quaratusugene ozeplasmid dosage will be 0.09 mg/kg and 0.12 mg/kg.

The primary end point of the study’s second phase will be 18-week progression-free survival (PFS). The secondary end points of the Acclaim-3 trial will include the safety profile and pharmacokinetics of the experimental agent, as well as overall survival.

A futility analysis will occur during the second phase of the trial after the twenty-fifth patient treated reaches a follow-up time of 18 weeks.

To be eligible for inclusion, patients must have an ECOG performance status of 0 or 1 and be 28 days or more beyond any major surgical procedures, including thoracotomy, laparotomy, or joint replacement. They must also have adequate renal and hepatic function, and a stable cardiac condition.

Exclusion criteria include any inability to tolerate atezolizumab, any prior gene therapy, and any prior prophylactic cranial irradiation or consolidation thoracic radiation. Any active systemic viral, bacterial, or fungal infection requiring treatment, as well as any serious concurrent illness, are also among the exclusion criteria.

“We are very pleased to receive a third fast track designation from the FDA for quaratusugene ozeplasmid, this time for patients with ES-SCLC in combination with the checkpoint inhibitor atezolizumab,” Rodney Varner, president, chairman, and chief executive officer at Genprex, said in the press release. “We look forward to accelerating the clinical development of quaratusugene ozeplasmid, and potentially providing a new treatment option for patients with SCLC.”

Reference

Genprex receives U.S. FDA fast track designation for REQORSA® immunogene therapy in combination with Tecentriq® for the treatment of small cell lung cancer. News Release. Genprex, Inc. June 28, 2023. Accessed June 28, 2023. https://bit.ly/3NsdZfP