First Patient Dosed in Phase II Expansion Portion of Acclaim-3 Trial of Reqorsa in Combination With Tecentriq
In the Phase I dose escalation portion, which evaluated the combination in participants with small cell lung cancer, the first patient treated attained partial remission.
Genprex announced that the first patient has been enrolled and dosed in the Phase II expansion portion of its Acclaim-3 clinical trial. The study program is evaluating Reqorsa (quaratusugene ozeplasmid) in combination with Genentech’s Tecentriq (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC).1
In a press release, Mark Berger, MD, chief medical officer at Genprex 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. ES-SCLC has a poor prognosis with a median PFS of 5.2 months. 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 expansion portion of the open-label, multi-center Acclaim-3 trial will enroll 50 patients across 10-15 sites in the United States. The primary endpoint of the Phase II expansion portion is to determine the 18-week PFS rate from the time of the start of maintenance therapy with Reqorsa and Tecentriq. Patients will be treated with the combination until disease progression or unacceptable toxicity is experienced. Once the 25th patient is enrolled, treated, and reaches 18 weeks of follow up, an interim analysis, expected in the second half of 2025, will be performed.
Earlier in August 2024, Genprex provided updates on its studies of Reqorsa. In the Phase I dose escalation portion of Acclaim-3, the first patient treated experienced an initial positive response after enrollment and dosing commenced in May by attaining partial remission. Additionally, the company observed positive results from its Acclaim-1 study, which is evaluating Reqorsa in combination with AstraZeneca’s Tagrisso in patients with late-stage, non-small cell lung cancer.2
In a press release from the time, Ryan Confer, president and chief executive officer of Genprex said, “We are excited by these early and promising patient responses to Reqorsa treatment, particularly as these patients represent some of the most difficult to treat lung cancer patient populations. There is significant unmet medical need for patients afflicted with lung cancer, as nearly all patients' disease progresses following treatment, even when treated with today's most advanced targeted therapies and immunotherapies. This leaves patients with limited therapeutic options. We are thrilled our novel gene therapy treatment for lung cancer, Reqorsa, is demonstrating early evidence of efficacy with a favorable safety profile. We look forward to continuing to evaluate Reqorsa in our lung cancer clinical trials while we advance our efforts to bring new therapies to those battling cancer."
The Reqorsa-Tecentriq combination previously received FDA Fast Track Designation for the treatment of the Acclaim-3 patient population. Additionally, the FDA granted Orphan Drug Designation to Reqorsa for the treatment of SCLC.
References
1. Genprex Announces First Patient Dosed in Phase 2 Expansion Portion of Acclaim-3 Clinical Study of Reqorsa® Gene Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer. News release. Genprex. January 23, 2025. Accessed January 23, 2025. https://www.prnewswire.com/news-releases/genprex-announces-first-patient-dosed-in-phase-2-expansion-portion-of-acclaim-3-clinical-study-of-reqorsa-gene-therapy-in-combination-with-tecentriq-to-treat-small-cell-lung-cancer-302358445.html
2. Genprex Announces Positive Clinical Study Updates from Acclaim-1 and Acclaim-3 Phase 1/2 Clinical Trials in Lung Cancer. News release. Genprex. August 14, 2024. Accessed January 23, 2025. https://www.prnewswire.com/news-releases/genprex-announces-positive-clinical-study-updates-from-acclaim-1-and-acclaim-3-phase-12-clinical-trials-in-lung-cancer-302221892.html
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