Pillars of Progress: Top News in Oncology From 2025

For all of 2025, 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 2025 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 2025.

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 Multiple Myeloma Dosed in EsoBiotec's Trial for In Vivo CAR-T ESO-T01

“ESO-T01 has the potential to offer a simplified patient journey, with several benefits over current treatments for MM that are often costly and have unfavorable side effects."
—Jean-Pierre Latere, PhD

In January, it was announced that the first patient was been dosed in an early phase 1 investigator-initiated clinical trial (NCT06691685) taking place in China for EsoBiotec's ESO-T01, an investigational BCMA-directed in vivo chimeric antigen receptor T-cell (CAR-T) therapy being evaluated for the treatment of relapsed/refractory multiple myeloma (MM).

BrainChild Bio's Pediatric Brain Tumor CAR-T BCB-276 Reels in Breakthrough Therapy Designation

“Breakthrough therapy designation gives us the possibility to accelerate the development path for BCB-276 as a CAR T-cell therapy that can potentially transform the treatment of DIPG. This designation is a major milestone for the children and families afflicted with these devastating brain tumors and represents a new paradigm for treating central nervous system brain tumors in children and adults, including a large number of patients suffering with glioblastomas and brain metastases.”
—Michael Jensen, MD

In April, BrainChild Bio's BCB-276, an investigational CAR-T therapy that targets B7-H3 and is being developed for the treatment of a type of pediatric brain tumor referred to as diffuse intrinsic pontine glioma (DIPG), received breakthrough therapy designation from the FDA.

Iovance Biotherapeutics’ Lifileucel Produces Durable Responses in 5-Year Analysis of Advanced Melanoma Data

“This 5-year analysis of the C-144-01 trial is the longest follow-up of the largest group of patients with melanoma treated with TILs in a single study. This study illustrates lifileucel’s continued durability of response and survival benefit up to 5 years after a single administration without any long-term safety concerns.”
—Theresa Medina, MD, and colleagues

Iovance Biotherapeutics’ lifileucel (marketed as Amtagvi), an FDA-approved autologous tumor infiltrating lymphocyte (TIL) therapy, produced durable responses in a 5-year analysis of data from patients with advanced melanoma treated the phase 2 C-144-01 clinical trial (NCT02360579). The analysis was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30 to June 3, in Chicago, Illinois, and was simultaneously published in The Journal of Clinical Oncology.

enGene Snags FDA RMAT Designation for Bladder Cancer Gene Therapy Detalimogene

“Detalimogene has the potential to deliver what NMIBC patients and their physicians have long needed—a nonviral option with optimized delivery to the bladder, safety in handling, and ease of administration. We’re pleased to receive this designation for detalimogene and are encouraged that we’re one step closer to potentially providing NMIBC patients a new option that may help transform the treatment landscape.”
—Ron Cooper, BSc

In June, the FDA granted regenerative medicine advanced therapy (RMAT) designation to enGene's detalimogene voraplasmid (also known as detalimogene, and previously referred to as EG-70), an investigational nonviral immuno-oncology gene therapy, for the treatment of high-risk bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle-invasive bladder cancer (NMIBC) with carcinoma in situ.

Iovance Biotherapeutics’ TIL Therapy Lifileucel Approved for Advanced Melanoma in Canada

“This approval in Canada is our first marketing authorization outside the US and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers. We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-US strategy for Amtagvi in additional markets.”
—Frederick Vogt, PhD, JD

In August, lifileucel received a Notice of Compliance with conditions (NOC/c) from Health Canada for advanced melanoma. Specifically, the market authorization applies to adults with unresectable or metastatic melanoma who have no satisfactory alternative treatment options and whose disease has progressed after or during treatment with at least 1 previous line of systemic therapy that included a PD-1–blocking antibody. Furthermore, if the patient’s disease is positive for a BRAF V600 mutation, they must also have received a BRAF inhibitor.

Also of note, at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 6 to 9, 2025, in Orlando, Florida, CGTLive interviewed ImmunoLogic cohost Janna Minehart, MD, a clinical fellow in hematology oncology (Master of Science Translational Research Program) at the University of Pennsylvania, about highlights in oncology immunotherapy from the conference. Minehart spoke about several presentations that excited her, and expressed her enthusiasm for the progress in the field.