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Noted This Week: March 8–14, 2024

March 18, 2024

The FDA approved tislelizumab (Tevimbra; BeiGene), a humanized immunoglobulin G4 anti–PD-1 monotherapy to treat adults with inoperable or metastatic esophageal squamous cell carcinoma who have already received systemic chemotherapy but no PD-1 or PD-L1 checkpoint inhibitors. In the phase III RATIONALE 302 trial, researchers randomly assigned 512 patients from 11 countries to receive either tislelizumab or physician’s choice of chemotherapy. Median overall survival among patients who received tislelizumab was 8.6 months compared with 6.3 months among those who received chemotherapy. Researchers reported that tislelizumab was also less toxic than chemotherapy.

Researchers reported encouraging efficacy of a CAR T-cell therapy in patients with recurrent glioblastoma that targets EGFR and IL13 receptor alpha 2 (IL13Rα2; Nat Med 2024 Mar 13 [Epub ahead of print]). In a phase I trial, six patients received one of two doses of the therapy, which was associated with immune effector cell–associated neurotoxicity, which was managed with dexamethasone and an anti-IL1R agent. “Reductions in enhancement and tumor size at early magnetic resonance imaging timepoints were observed in all six patients,” the researchers wrote, although none of them experienced an objective radiographic response. However, all the patients experienced “substantial CAR T-cell abundance and cytokine release in the cerebrospinal fluid,” demonstrating the preliminary safety and efficacy of the EGFR–IL13Rα2 CAR T-cell therapy.

Separately, another group of researchers reported dramatic tumor regression in patients with recurrent glioblastoma who received CAR “T cells engineered to target the EGFR variant III tumor-specific antigen, as well as the wild-type EGFR protein, through secretion of a T-cell engaging antibody molecule” (TEAM; N Engl J Med 2024 Mar 13 [Epub ahead of print]). In the phase I INCIPIENT trial, three patients received an intraventricular infusion of CARv3-TEAM-E T cells and experience dramatic tumor shrinkage within a few days without causing any grade 4 or 5 adverse events. However, the effects were short-lived in two of the patients, but the third patient experienced a durable response that has lasted more than 150 days.

In a first, the FDA granted accelerated approval to the CD19-directed chimeric antigen-receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already received a BTK inhibitor and a BCL2 inhibitor. The decision was based upon results of the phase I/II TRANSCEND CLL 004 study, in which 20% of patients experienced a complete response; the overall response rate was 45%. The median duration of response was not reached and 35.3 months, respectively. Patients with CLL or SLL often relapse or become refractory to approved medications, and there is no established standard of care for these patients.

U.S. President Joe Biden released his budget requests for fiscal year (FY) 2025, proposing only modest increases in spending—which do not keep pace with inflation—for the NIH, NCI, and Centers for Disease Control and Prevention. If approved by Congress, the NIH would receive a 1.8% increase over FY 2023, the NCI would receive a bump of $500 million, and the CDC would receive $100 million more for cancer prevention programs. (Congress has not yet approved spending levels for FY 2024, so FY 2023 levels are provided for comparison). The budget also proposed $1.45 billion to support the Cancer Moonshot. The budget offers insight into the president’s priorities but does not reflect what Congress will eventually authorize.

Boston, MA–based Dana-Farber Cancer Institute launched the Neuro-Inclusive Oncology Care and Empowerment Program for adults with cancer and intellectual and/or developmental disabilities (IDD), such as autism-spectrum disorder, Down syndrome, cerebral palsy, epilepsy, and fragile X syndrome. Patients with IDDs are typically diagnosed with cancer at later stages, experience delays in receiving care, given fewer treatment options, and die from cancer at a greater rate than patients without IDDs. The program aims to improve how these patients fare and reduce their stress by, for example, developing visual aids to depict what might happen during treatment, making sensory and/or physical accommodations to the treatment environment, and offering counseling.

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