Treatment with lisocabtagene maraleucel led to strong and durable response rates with little serious adverse effects in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma.
Administration of lisocabtagene maraleucel (liso-cel; Breyanzi) in patients with relapsed or refractory follicular lymphoma (FL) and mantle cell lymphoma (MCL) led to deep and durable responses in the TRANSCEND clinical trials, Bristol Meyers Squibb announced in a press release.
“Results from TRANSCEND FL and TRANSCEND NHL 001 further underscore Breyanzi’s potential best-in-class and best-in-disease profile for a CD19-directed CAR T cell therapy in lymphomas,” the press release stated.
In the TRANSCEND FL trial, patients with relapsed or refractory indolent non-Hodgkin lymphoma were treated with lisocabtagene maraleucel in the second- and third-line plus settings, according to the press release.
In the third-line plus setting, the overall response rate (ORR) was 97% (95% CI, 91.6-99.4; one-sided P < 0.0001), the investigators found. A complete response (CR) was seen in 94% (95% CI, 87.5-97.8; one-sided P < 0.0001) of patients.
These responses were found to be durable; a median duration of response was not reached at a follow-up point of 16.6 months, and at 12 months, 81.9% of participants had an ongoing response, the results of the study show. At a further follow-up at 17.5 months, median progression-free survival (PFS) was also not reached, with 12-month PFS reached in 80.7% of participants, the results show.
In addition to its efficacy, lisocabtagene maraleucel was found to have a manageable safety profile in patients, with a low rate of severe cytokine release syndrome (CRS) or any neurological events (NE), the results show.
The TRANSCEND NHL 001 trial, which featured participants who had relapsed or refractory MCL after 2 or more lines of therapy, resulted in an ORR of 86.5% (95% CI, 76.5-93.3; one-sided P < 0.0001). The study found that 74.3% (95% CI, 62.8-83.8; one-sided P < 0.0001) of patients achieved a CR.
Additionally, researchers say that lisocabtagene maraleucel was well-received in this cohort of patients, and there were no new safety signals that were observed in the group.
In patients with relapsed or refractory FL, historical outcomes are poor, despite high initial responses to front-line treatment, the press release stated. Many patients experience relapses, and with each additional relapse, a patient’s prognosis worsens. Durability of responses with current treatment options also wanes after each subsequent line of treatment.
“In TRANSCEND FL, the overall and complete response rates achieved with liso-cel were very high, and appear mostly durable at 12 months, and, importantly, the safety profile was favorable,” said lead investigator Franck Morschhauser, MD, PhD, professor of Hematology at Centre Hospitalier Universitaire de Lille, Groupe de Recherche sur les forms Injectables et les Technologies Associées in Lille, France, in the release. “[These] data shows the potential of liso-cel as a promising treatment option for patients with relapsed or refractory follicular lymphoma.”
Similarly, patients with MCL commonly experience a relapse and there are no curative options available, according to the release. Patients tend to develop resistance to initial lines of treatment, which leads to weakening responses and duration of responses and an overall worsening prognosis.
“Despite advances in treatment, there remains a critical unmet need for additional therapies that offer deep and durable responses in patients with high-risk, aggressive relapsed or refractory mantle cell lymphoma,” said lead investigator Michael Wong, MD, professor at the Department of Lymphoma and Myeloma, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center in Houston, in the release.
The results of the clinical trials were presented at the 2023 International Conference on Malignant Lymphoma (ICML) on June 17, and will be discussed with relevant health authorities, Bristol Meyers Squibb said in their press release.
Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) Delivers Deep and Durable Responses in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma in TRANSCEND Clinical Trials Presented at ICML 2023. Bristol Meyers Squibb (2023). News release. Available at https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibbs-Breyanzi-lisocabtagene-maraleucel-Delivers-Deep-and-Durable-Responses-in-Relapsed-or-Refractory-Follicular-Lymphoma-and-Mantle-Cell-Lymphoma-in-TRANSCEND-Clinical-Trials-Presented-at-ICML-2023/default.aspx. Accessed on June 20, 2023.