CGTLive's 2024 Pillars of Progress: Top News in Oncology

For all of 2024, our team was following the clinical development of targeted and novel engineered approaches to the treatment of patients with various medical disorders. These efforts included holding in-depth conversations with experts in the clinical care of these individuals, as well as in cell and gene therapy development, culminating in our coverage of each step of progress that the most exciting cellular and genetic treatments have made along the pipeline.

From major data publications and presentations to FDA decisions and medical meetings, the team spent all year bringing the latest information to the website's front page.

Among our areas of focus in 2024 has been oncology. The major news items appeared among the top pieces our team produced—but sometimes smaller stories reach those heights as well because of their clinical impact, their inventive mechanisms, or otherwise. Whatever the reason for the attention these stories got, their place here helps provide an understanding of the themes in oncology over the course of 2024.

Here, we'll highlight some of the most-read content on CGTLive's oncology page this year. Click the buttons to read further into these stories.

First Patient With Esophageal Cancer Receives TAC101-CLDN18.2 Cell Therapy

“The patient has made good progress. We are going to, within the next couple of weeks, do the first scan to monitor for early evidence of clinical activity. So, we are very excited about it and we're looking forward to seeing the scans for the patient. We are in fact being prepared that the patient may need a booster dose.”
—Deyaa Adib, MD

In February, Triumvira Immunologics treated the first patient with Claudin 18.2+ solid tumors in its phase 1/2 TACTIC-3 trial (NCT05862324) investigating TAC101-CLDN18.2 cell therapy. Deyaa Adib, MD, Chief Medical Officer, Triumvira Immunologics, told CGTLive that the patient, who has esophageal cancer, had multiple prior lines of therapy, including chemotherapy and immune therapy.

FDA Approves Obe-Cel for Adults With R/R B-Cell Precursor Acute Lymphoblastic Leukemia

“Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need that exists in the treatment of patients with this disease once they relapse, where historically they suffer from poor outcomes. This milestone approval, based on the demonstrated clinical benefit of Aucatzyl, brings new hope for adult patients with r/r B-ALL.”
—Elias Jabbour, MD

In November, the FDA announced that it had approved obecabtagene autoleucel (Aucatzyl; Autolus Inc), known colloquially as obe-cel, a CD19-directed genetically modified autologous T-cell immunotherapy, for the treatment of adults with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). The therapy was approved based on the findings of the pivotal phase 1b/2 FELIX clinical trial (NCT04404660), which showed rates of overall complete remission (CR) above 60% and a median duration of remission beyond 12 months for those who achieved complete remission within 3 months.

Umoja Biopharma's In Situ CAR-T Therapy Cleared for US Trial in Hematologic Malignancies

“The IND clearance for UB-VV111 is a significant milestone in Umoja’s mission to develop off-the- shelf therapies that overcome the limitations of current ex vivo cellular immunotherapies. We are proud to be a leader of the in vivo space, aiming to remove many of the barriers and challenges of early- generation ex vivo CAR T-cell therapies, from the difficult, lengthy, and costly manufacturing process to the arduous administration experience. Physicians and patients have been waiting for something better and we are excited to initiate our first clinical trial.”
—Andrew Scharenberg, MD

In July, the FDA cleared an investigational new drug (IND) application for Umoja Biopharma's UB-VV111, a gene therapy product intended to create CD19-directed chimeric antigen receptor (CAR) T-cells within the body, allowing the company to go forward with a phase 1 dose escalation trial in hematologic malignancies. The trial will be open to patients with relapsed/refractory large-B-cell lymphoma and chronic lymphocytic leukemia, regardless of whether they have previously received treatment with a CAR-T product.

FDA Deems Mesoblast’s Data on Remestemcel-L Cell Therapy Sufficient for BLA Submission in Pediatric SR-aGVHD

“We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SR-aGVHD.”
—Silviu Itescu, MBBS, FRACP

In March, the FDA informed Mesoblast that the available data from the phase 3 MSB-GVHD001 clinical trial (NCT02336230) is sufficient for the submission of a biologics license application (BLA) for its allogeneic mesenchymal stromal cell therapy, remestemcel-L, for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The company noted that it planned to submit the BLA in the second quarter of 2024.

FDA Finalizes Sets of Guidelines for Both CAR-T Products and Genome Editing Products

"We first posted the draft guidance on considerations for the development of CAR T-cell products in March of 2022... [and] we received over 650 comments from approximately 85 stakeholders, and we really appreciate your thoughtful insights into where more clarity would be helpful. After consideration of each comment and with revisions as needed, the final guidance was then published at the beginning of 2024."
—Kim Schultz, PhD

After finalizing the guidance in January, in March, the FDA's Center for Biologics Evaluation and Research (CBER) hosted a webinar highlighting key points from the final version of the CAR-T guidance document on March 7, 2024. In the webinar, a recording of which is now available on the FDA's website, the speakers covered the main points from the general, CMC, nonclinical, and clinical considerations for CAR-T development from the document. The webinar also included a question-and-answer segment (which begins about 30 minutes into the presentation).