A First-of-its-Kind Initiative with Leading Oncologists Hopes to Usher in the Allogeneic Cell Therapy Revolution by Broadening and Expediting Access

This year celebrates the five-year anniversary of the first approval of an autologous CAR T therapy in a hematologic malignancy. Since then, the field has benefited from additional successes – promising datasets reaffirming the treatment benefit coming from a single infusion, approval of new CAR T therapies, and use of these innovative treatments earlier in a patient’s course of disease. 

Yet one thing has not changed – the challenges associated with delivery and access of autologous CAR T.

A recently published Journal of Clinical Oncology (JCO) article discussed real-world access constraints with autologous CAR T in part due to individualized patient manufacturing. The reported median waiting time for an FDA-approved CAR T for triple refractory multiple myeloma patients was 6 months, with only 25% of patients eventually receiving CAR T therapy.[1] While the focus in this study was multiple myeloma, long wait times and supply limitations related to cell therapy have also been documented in non-Hodgkin lymphoma. As a result, these extensive wait times require frontline physicians to make unfathomably hard decisions – which of their eligible patients will get a scarce cell-manufacturing slot versus who can survive time on a waiting list as their disease continues to progress.

Allogene was formed with the goal of addressing the limitations associated with the delivery of autologous CAR T therapy. Together we are advancing the next revolution in cell therapy – an “off-the-shelf” (allogeneic) product with the potential to make CAR T readily available to all eligible patients.  

We recently conducted our own study to even better understand access challenges associated with the real-world delivery of autologous CAR T therapies. Our research reaffirms the results of JCO article, while also bringing even more clarity to the access barriers.

• While a vast majority of late-stage cancer patients are eligible for CAR T treatment, only half of them receive treatment.[2]
•  While 82% of respondents agree that CAR T therapies have changed how they manage aggressive cancers, extensive wait times and manufacturing limitations keep many eligible patients from receiving these life-extending treatments.[2]
•  Of those patients eligible for treatment, 12% were able to receive treatment within one month, with approximately 40% waiting three to six months or longer to receive treatment as their disease worsens.[2]
•  In late-stage diseases where time and access to therapy is of the essence, disease progression, manufacturing capacity, and comorbidities were the top barriers.[2]

These findings shed light on what may lie ahead for the market. While the global CAR T market is expected to expand dramatically as more patients become eligible, respondents noted increased patient demand, manufacturing capacity and time to treatment as the top three challenges facing CAR T adoption in the future.[2] A ‘Catch-22’ that comes with the success of CAR T but leaves patients hanging in the balance.

To help bring about a solution to this access bottleneck in CAR Ts and support the work being done across the industry in clinical trials, we at Allogene launched CAR T Together™. This first-of-its-kind effort with oncologists from preeminent research institutions nationwide aimed at supporting the development of “off-the-shelf” (allogeneic) CAR T products to make CAR T therapy scalable and more accessible to patients with certain cancers.

CAR T Together is meant to inspire physicians and scientists to move cancer treatment forward through collaboration, innovation and compassion – including the advancement of science, supporting the development of more potent cells, next-generation therapies that address limitations such as the emergence of resistance, addresses graft rejection, and forming alliances with investigators and institutions in an effort to expedite clinical trial enrollment and product approval.

Inaugural members of this initiative include lead investigators from Moffitt Cancer Center, the Sarah Cannon Colorado Blood Cancer Institute, the Mayo Clinic, and the City of Hope. These dedicated physicians, and the many more who are part of our clinical trials and other industry trials, are leading the vanguard of scientific innovation.

Four years into the Allogene journey, we are on a path to transform the future of CAR T therapy from a complex individualized procedure to an off-the-shelf, on demand pharmaceutical product. We are driven to serve patients, families, and health care providers, who are in urgent need of improved therapies for advanced cancers now. They are our inspiration.

But this cannot be done alone. Much like how generations of brilliant, dedicated people have collaborated to optimize and transform all forms of technology, now it’s time that we do the same with CAR T – CAR T Together.

Cautionary Note on Forward-Looking Statements

This post contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The post may, in some cases, use terms such as "believe," “designed,” "potential," "proposed," "estimate," "anticipate," "expect," "plan," "intend," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: expectations regarding the future demand for CAR T products and the supply of autologous CAR T products; the ability to develop allogeneic CAR T products; the ability to enroll patients in clinical trials of allogeneic CAR T products; the results from the survey, which may not be representative of all CAR T treatment providers and may change as the treatment landscape evolves; and the potential benefits of allogeneic CAR T. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 8-K filed on September 21, 2022, Form 8-K filed on October 6, 2022 and Form 10-Q for the quarter ended June 30, 2022. Any forward-looking statements that are made in this post speak only as of the date of this post. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this post.

[1] JCO. Ethical challenges with CAR T slot allocation with idecabtagene vicleucel manufacturing access. LINK

[2] Allogene data on file.