Geron Announces First Patient Dosed in IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis

Rhea-AI Summary

Geron Corporation (Nasdaq: GERN) has initiated dosing for the first patient in its Phase 3 clinical trial, IMpactMF, studying imetelstat for refractory myelofibrosis (MF), with overall survival as the primary endpoint. This trial, targeting 320 patients, addresses a significant unmet need given the median overall survival of 14-16 months for those unresponsive to JAK inhibitors. Interim results are anticipated in 2024, with final results expected in 2025. Imetelstat is also Fast Track designated by the FDA for certain patient populations, enhancing its development prospects.

Positive

• First patient dosed in Phase 3 trial IMpactMF for refractory myelofibrosis.
• Overall survival is the primary endpoint, addressing a significant unmet medical need.
• Imetelstat received Fast Track designation from the FDA, potentially expediting its development.

Negative

• Enrollment for IMpactMF may face delays due to the ongoing impacts of the COVID-19 pandemic.
• Uncertainties regarding the benefit-risk profile of imetelstat could affect its development.
• Geron may need substantial capital to complete imetelstat's development and commercialization.

Geron Corporation (Nasdaq: GERN) today announced that the first patient has been dosed in IMpactMF, the Phase 3 clinical trial evaluating imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF).

“As the only study in refractory MF with overall survival as the primary endpoint, dosing of the first patient in IMpactMF is an important step in developing imetelstat as a potential treatment for these patients,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “With a median overall survival of only approximately 14 – 16 months for patients who fail or no longer respond to JAK inhibitor treatment, there is a significant unmet medical need for therapies that will improve survival.”

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

The final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died (referred to as an event). An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. Under current planning assumptions, the Company expects the interim analysis for IMpactMF to occur in 2024 and the final analysis in 2025. Because these analyses are event-driven, the results may be available at different times than currently expected.

IMpactMF is currently enrolling patients. The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia and Asia. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

About Geron

Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis. For more information about Geron, visit www.geron.com.

Use of Forward-Looking Statements

Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that imetelstat has potential disease-modifying activity; (ii) that Geron plans to engage over 180 sites for IMpactMF; (iii) that under current planning assumptions for IMpactMF, Geron expects to conduct an interim analysis in 2024 and a final analysis in 2025; (iv) that the final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died (i.e., an event) and that an interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred; and (v) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether the current or evolving effects of the COVID-19 pandemic and resulting global economic and financial disruptions will materially and adversely impact Geron’s business and business prospects, its financial condition and the future of imetelstat; (b) whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic, and overcomes all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timelines and planned milestones in (ii), (iii) and (iv) above; (c) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (d) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (e) whether imetelstat actually demonstrates disease-modifying activity in patients; (f) that Geron will need to raise substantial capital in order to complete the development and commercialization of imetelstat, including to meet all of the expected timelines and planned milestones in (ii), (iii) and (iv) above; (g) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials in a timely manner, whether due to the current or evolving effects of the COVID-19 pandemic or otherwise; and (h) whether Geron is able to enroll IMpactMF at a pace that would enable an interim analysis in 2024 and a final analysis in 2025. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s annual report on Form 10-K for the year ended December 31, 2020 and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

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FAQ

What is the purpose of the IMpactMF trial by Geron Corporation?

The IMpactMF trial aims to evaluate imetelstat for improving overall survival in patients with refractory myelofibrosis.

When is the interim analysis for the IMpactMF trial expected?

The interim analysis for the IMpactMF trial is anticipated to occur in 2024.

What is the primary endpoint of the IMpactMF trial?

The primary endpoint of the IMpactMF trial is overall survival among patients receiving imetelstat.

How many patients will be enrolled in the IMpactMF trial?

The IMpactMF trial is designed to enroll approximately 320 patients with refractory myelofibrosis.

What designation has the FDA granted to imetelstat?

Imetelstat has received Fast Track designation from the FDA for certain patient populations.