#United States #San Diego #CAR-T therapy #Nektar Therapeutics #NKTR-255

Exciting Developments from Nektar Therapeutics at ASH 2024

Nektar Therapeutics made headlines at the 66th Annual American Society of Hematology (ASH) Meeting in San Diego, presenting groundbreaking findings from its Phase 2 proof-of-concept study on NKTR-255. This investigational therapy has shown promising results as an adjunct to CD19-directed CAR-T therapy in patients suffering from relapsed or refractory large B-cell lymphoma (LBCL).

Following the trial involving multiple sites and a total of fifteen participants, the results demonstrated a significant 73% complete response rate (CRR) at six months for those treated with NKTR-255, contrasting sharply with the 50% rate observed in the placebo group. What’s particularly noteworthy is that two patients treated with NKTR-255 progressed from stable or partial responses to complete responses at the six-month mark—a transition not seen in the placebo cohort.

Dr. Sairah Ahmed, a prominent figure in the field and Associate Professor at the University of Texas MD Anderson Cancer Center, emphasized the importance of these findings, stating, "The majority of patients currently receiving CAR-T therapies fail to achieve durable disease remission. The results of this study demonstrated that NKTR-255 enhanced CAR T-cell counts, increasing the number of patients achieving a complete response at six months post-infusion." She noted that patients achieving such responses in prior pivotal trials were highly likely to remain in complete response beyond two years, indicating improved progression-free survival.

The NKTR-255 therapy, a polymer-conjugated IL-15 agonist, is designed to activate and enhance the body’s natural killer (NK) and CD8+ T-cells, which has potential benefits in extending both response duration and intensity for CAR-T and other cellular therapies. Interestingly, the kinematics of CAR T-cells were notably improved, with an observed 5.8-fold increase in the area under the curve for CD8+ CAR-T cells in those receiving NKTR-255, compared to those given a placebo.

Beyond these immediate results, the reported clinical benefits surpass established benchmarks for CAR-T cell therapies, previously documented with 6-month CRR figures ranging from 41% to 44%. Mary Tagliaferri, Chief Medical Officer of Nektar, referred to this as a significant contribution to the growing body of evidence supporting NKTR-255’s utility alongside standard CAR T-cell therapies. Tagliaferri stated, "This study is the first randomized trial demonstrating that adjuvant treatment with NKTR-255 can enhance the durability of responses to standard-of-care commercial CAR T-cell therapy by modifying CAR T-cell kinetics."

Nektar's NKTR-255 therapy was reported to be safe and well-tolerated in the trial participants, reinforcing its feasibility for those battling relapsed/refractory LBCL when paired with FDA-approved CD19 CAR T-cell products.

In addition to its primary study, NKTR-255 is being evaluated in other contexts, such as its combination with various immunotherapies, including ongoing trials for other significant conditions, including non-small cell lung cancer and urothelial carcinoma.

Nektar Therapeutics, headquartered in San Francisco, continues to push the boundaries in treating autoimmune and chronic inflammatory diseases, with a robust pipeline that includes its lead candidate, rezpegaldesleukin (NKTR-358), aimed at addressing regulatory T-cell functionality. For more details on the NKTR-255 presentation and Nektar's comprehensive portfolio, interested individuals can visit their official site at www.nektar.com.

The implications of these findings are substantial, marking a potential shift in treatment strategies for lymphoma patients and expanding opportunities for improved patient outcomes in the realm of immunotherapy.

As Nektar progresses, it underscores a pivotal movement in biotech focused on innovative treatments that enhance cellular therapies, paving the way for a future where more patients can achieve lasting remissions and improved quality of life.