Allogene Therapeutics Activates Three Community Cancer Centers as First Sites for the Pivotal Phase 2 ALPHA3 Trial Evaluating Cemacabtagene Ansegedleucel (cema-cel) as First Line (1L) Consolidation Treatment for Patients with Large B-Cell Lymphoma (LBCL)

2024-07-02

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免疫疗法引进/卖出

Patient Screening is Underway at Rocky Mountain Cancer Centers, Part of the US Oncology Network and Sarah Cannon Research Institute; Astera Cancer Care, Part of the OneOncology Network; and Norton Cancer Institute

ALPHA3 Will be the First Pivotal Trial to Offer CAR T as Part of First Line (1L) Treatment at Community Cancer Centers, Where 80% of Patients Receive Care

ALPHA3 Expected to Complete Enrollment in 1H 2026; Potential BLA Submission in 2027

July 01, 2024 -- Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that Rocky Mountain Cancer Centers (RMCC), part of the US Oncology Network and Sarah Cannon Research Institute (SCRI); Astera Cancer Care (ACC), a multi-specialty community oncology practice and part of the OneOncology network; and Norton Cancer Institute, are open for enrollment in the pivotal Phase 2 ALPHA3 trial.

The ALPHA3 trial is evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) consolidation treatment regimen for newly diagnosed and treated large B-cell lymphoma (LBCL) patients who remain positive for minimal residual disease (MRD). Detection of MRD will be done using the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. When given as a “7th cycle” of frontline treatment to eligible patients with MRD, consolidation treatment with cema-cel has the potential to meaningfully improve 1L cure rates for patients with LBCL who are likely to relapse.

“We believe community physicians have been waiting for a trial like ALPHA3 that offers cutting-edge CAR T without the inherent complexities associated with autologous therapies,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “The differentiated attributes of cema-cel eliminate many of the complex logistics that have hindered CAR T adoption in the community setting. The fact that community-based practices are the first sites to open for enrollment in the ALPHA3 trial is a significant symbolic step forward in expanding patient access to this powerful modality and will serve as a catalyst for our cema-cel development program.”

RMCC is the largest multidisciplinary practice in Colorado with 19 locations across the state dedicated solely to providing care for patients with cancer and diseases of the blood. RMCC is a part of SCRI, a combination of two nationally recognized oncology research institutes – US Oncology and SCRI. This combination creates a leading oncology research organization participating in community-based clinical trials. Patients undergoing treatment for newly diagnosed LBCL throughout the RMCC network will be considered for enrollment in ALPHA3.

“Current 1L chemoimmunotherapy is effective in most patients, but the reality is that 30% will relapse,” said John M. Burke, M.D., a Blood Cancer Specialist at RMCC. “The ALPHA3 trial will be answering two key questions. First, can measuring circulating tumor DNA in the blood be used to select lymphoma patients destined to relapse for early intervention? And second, does treating these high-risk lymphoma patients with cema-cel increase cure rates compared with conventional surveillance? These are critically important questions that have the potential to change the lymphoma treatment paradigm.”

ACC is an independent and physician-owned multi-specialty community oncology practice serving more than 22,000 new patients annually in Central New Jersey. The practice is part of the OneOncology platform which is a partnership of over 20 independent community oncology practices nationally. Astera’s specialists practice at 13 distinct locations in Middlesex, Somerset, Bergen, Hudson, Hunterdon, Mercer and Monmouth counties in New Jersey and Langhorne, Pennsylvania and have a robust clinical trial platform for cancer therapy with one of the only community-based clinical trial programs in CAR T cell therapies in the nation. Patients undergoing treatment for newly diagnosed LBCL throughout the ACC network will be considered for enrollment in ALPHA3.

According to Edward J. Licitra, M.D., PhD, oncologist and Chairman and Chief Executive Officer at ACC, relapsed LBCL is much more difficult to treat, and physicians often consider enrollment in clinical trials to allow access to promising therapies. “I have watched with interest the acceleration of CAR T research in LBCL, but because most patients live more than two hours from the nearest treatment center, it’s not feasible for them to participate. Having access to an “off-the-shelf” CAR T product with a manageable safety profile changes that equation dramatically for me, and my patients. We are excited to help define a new treatment standard in LBCL. An approved “off-the-shelf” CAR T product would allow for greater access to cutting edge technologies for patients in their local communities and this could improve outcomes for many more cancer patients.”

With more than 21 locations serving Louisville, Kentucky and Southern Indiana, Norton Cancer Institute (NCI) treats more than 4,000 newly diagnosed cancer patients each year. NCI’s network of multidisciplinary clinics offers patients the latest treatments and access to more than 100 clinical trials.

“Kentucky has one of the highest cancer death rates in the United States1 and a big contributor to this is lack of patient access to cutting-edge treatments,” said Don A. Stevens, M.D., a hematologist-oncologist at Norton Cancer Institute. “Offering investigational cema-cel to our first line patients has the potential to improve cure rates for the 30% we know will relapse after chemoimmunotherapy. This could change how we treat these patients in the future.”

About Cemacabtagene Ansegedleucel (cema-cel)

Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T™ investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in third line (3L) r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About the ALPHA3 Trial

Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to “watch and wait” to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD.

About Allogene Therapeutics

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X (formerly Twitter) and LinkedIn.

1 US News & World Report. You’re More Likely to Die of Cancer if You Live in This State (usnews.com). Accessed 25June2024.

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