FDA Grants Fast Track Designation for Reqorsa Plus Tecentriq

The Food and Drug Administration (FDA) granted a Fast Track designation to Reqorsa immunogene therapy, Genprex announced in a June 28 press release. Reqorsa will be used along with checkpoint inhibitor Tecentriq for patients with extensive-stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after initially receiving Tecentriq and chemotherapy as standard treatment.

Extensive-stage small cell lung cancer has a median progression free survival (PFS) — the time a patient lives without disease worsening — of 5.2 months, therefore having a weaker prognosis, according to Genprex, which also stated that with the use of Tecentriq maintenance therapy alone, the median PFS for patients is only 2.6 months, counting from the beginning of maintenance therapy.

According to Genprex, nearly 100% of small cell lung cancers express less TUSC2, a tumor suppressor gene (protein), and 41% of small cell lung cancers entirely lack TUSC2 protein. However, the use of Reqorsa makes up for the lack of TUSC2 because it contains a plasmid which expresses TUSC2.

“Based on our experience in other Reqorsa trials, we have reduced the phase 1 portion of the study to two dose levels instead of the three dose levels in our Acclaim-1 and Acclaim-2 clinical trials. We believe this will shorten the phase 1 portion of the trial,” said Dr. Mark Berger, chief medical officer at Genprex. “In addition, the median PFS of only 2.6 months seen with Tecentriq maintenance treatment will also shorten the time needed to evaluate the combination of Reqorsa and Tecentriq as maintenance therapy for SCLC.”

Prospective Plan for Genprex’s Acclaim-3 Clinical Trial

With this new designation, Genprex is expected to begin its Acclaim-3 clinical trial in the third quarter of this year. Patients with ES-SCLC in this clinical trial will have already received initial treatment, which comprises three to four cycles of carboplatin and etoposide (two types of chemotherapy), along with Tecentriq. Patients in this trial will then receive maintenance therapy: a combination of Reqorsa and Tecentriq every 21 days until disease progression (when the cancer grows or spreads).

In phase 1 of the Acclaim-3 clinical trial, Genprex plans to enroll 12 patients for the dose escalation portion of the phase to identify the Maximum Tolerated Dose (MTD). The highest dose evaluated from phase 1 will be the recommended dose for phase 2 if there are no dose-limiting toxicities in the first phase. The trial will proceed with phase 2, in which 50 enrolled patients will be treated with Reqorsa and Tecentriq until an experience with unsuitable toxicity or disease progression. The goal for the end of phase 2 is to establish the progression-free survival rate from the beginning of maintenance therapy with Reqorsa and Tecentriq, which is across 18 weeks.

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