Reqorsa Demonstrates Promising Results in Treating Patients with Small Cell Lung Cancer and Non-Small Cell Lung Cancer

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Results from the Acclaim study program found that Genprex’s Reqorsa (quaratusugene ozeplasmid) demonstrated promise in treating both Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC). According to the company, two patients in the Acclaim-1 study have had prolonged Progression Free Survival (PFS) and the first patient treated in the Acclaim-3 study attained a Partial Remission (PR) from the start of maintenance therapy.¹

"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,” said Ryan Confer, president, CEO, Genprex, in a press release.

The Acclaim-1 clinical trial evaluated Reqorsa in combination with AstraZeneca’s Tagrisso, aiming to treat patients with late-stage NSCLC who have activating EGFR mutations and disease progression after treatment with Tagrisso. Acclaim-3 evaluated the combination of Reqorsa and Genentech’s Tecentriq as a maintenance therapy for extensive-stage SCLC (ES-SCLC).

In Acclaim-1, the two patients that experienced prolonged PFS are still continuing to receive treatment from the study. In Acclaim-3, the patient that achieved a PR demonstrated a 30% reduction in tumor size. However, disease progression was later detected in an unmeasurable lesion. However, Genprex views the results as encouraging due to the patients being treated with the lower dose in the Phase 1 portion of the trial.¹

"We are very pleased with the positive early efficacy results for these patients. It is very compelling that one of the patients in our Acclaim-1 clinical trial has continued to see benefit from Reqorsa treatment for more than two years and it's been documented that the side effects of Reqorsa have diminished, rather than increased, over time,” said Mark Berger, MD, chief medical officer, Genprex, in the press release.

Regarding the Acclaim-3 patient, Berger stated that, “This patient's response was not expected during maintenance therapy with Tecentriq alone, and we believe these results are promising and a positive early indication for the study. Once ES-SCLC patients begin maintenance therapy with Tecentriq, median PFS is very short; only 2.6 months, and further tumor regression rarely occurs. The ES-SCLC patient in the Acclaim-3 clinical trial treated with our combination therapy experienced PR, but asymptomatic disease progression was diagnosed by CT scan three months after the start of maintenance therapy. We find this positive result to be promising, particularly because this patient was treated with the lower of two doses planned for the Phase 1 portion of this clinical trial, and we are hopeful that the combination of Reqorsa and Tecentriq will improve outcomes and help extend the lives of these very difficult to treat lung cancer patients."

Moving forward, Genprex stated that it intends to halt new patient enrollment in its Acclaim-2 trial, which was evaluating Reqorsa in combination with Merck's Keytruda, citing issues with recruitment and with the aim of prioritizing resources. However, patients that are currently enrolled in Phase 1 of the study will continue to receive treatment until disease progression.¹

"The decision to discontinue the Acclaim-2 clinical trial is driven in part by the fact that there are hundreds of Keytruda combination lung cancer clinical trials, which made it difficult to recruit patients and investigators due to the volume of competing trials. We thank the clinicians and patients who participated in this study and look forward to potentially reviewing this patient population again at a future time, as we fully stand behind Reqorsa’s potential to treat late-stage NSCLC patients whose disease progressed after treatment with Keytruda,” said Confer, in the press release.

Reference

1. Genprex Announces Positive Clinical Study Updates from Acclaim-1 and Acclaim-3 Phase 1/2 Clinical Trials in Lung Cancer. PR Newswire. August 14, 2024, Accessed August 14, 2024. 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