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Noted This Week

April 12–18, 2024

MyProstateScore 2.0 (MPS2) proved more accurate at detecting prostate cancer than PSA and other biomarkers, researchers reported, sparing men more invasive testing, such as prostate biopsies and MRI (JAMA Oncol 2024 Apr 18). The test was designed to specifically identify higher-grade disease by measuring expression of 18 genes most often found in the presence of significant cancers. In 743 men with elevated PSA levels, using MPS2 would have avoided 35% to 42% of prostate biopsies without missing diagnoses of clinically significant disease, whereas existing biomarker testing could have avoided only 15% to 30% of biopsies. The improvement was more dramatic in men who previously had negative biopsies—the rate of unnecessary biopsies dropped to between 46% to 51% compared with 9% to 21% for existing tests. One key limitation of the trial, however, was that only 13% of participants were African American, a population known to have a higher prevalence of prostate cancer.

The FDA’s Oncology Drug Advisory Committee unanimously recommended that the agency consider using minimal residual disease (MRD) as an acceptable endpoint in granting accelerated approval of therapies for multiple myeloma instead of overall response rate (ORR). With more than 90% of patients responding to a new drug, demonstrating its clinical superiority using progression-free survival (PFS) or overall survival (OS) as endpoint for full approval can take many years, whereas clinicians can start to see improvement in MRD within months. Studies have shown that MRD negativity correlates with clinical improvement using PFS and OS. The FDA usually—although not always—follows the recommendation of its advisory committee.

Genentech’s alectinib (Alecensa) received FDA approval for adjuvant treatment of non–small cell lung cancer (NSCLC) in patients with ALK-positive disease. The decision was based on the phase III ALINA trial, in which 257 patients with stage IB to IIIA NSCLC received either alectinib or platinum-based chemotherapy following surgery (N Engl J Med 2024;390:1265–76). Researchers reported that median disease-free survival (DFS) among patients with stage II to IIIA disease who received the ALK inhibitor was not reached, whereas median DFS was 44.4 months among those who received chemotherapy. In the overall study population, median DFS was not reached with alectinib and was 41.3 months with chemotherapy.

In collaboration with several organizations, the College of American Pathologists (CAP) has released recommendations for testing of immunotherapy biomarkers, including PD-L1 and tumor mutation burden, in patients with NSCLC. The guidelines, developed with the International Association for the Study of Lung Cancer, Pulmonary Pathology Society, Association for Molecular Pathology, and LUNGevity Foundation, outline the challenges associated with PD-L1 testing and assessment, including the development of nonuniform companion diagnostic tests (Arch Pathol Lab Med 2024 Apr 16 [Epub ahead of print]). It also explains the rationale for the use of tumor mutation burden and the limitations of these tests for patients with NSCLC. CAP noted that the development of the guidelines was “driven by production of PD-L1 assays and scoring criteria that have evolved with individual therapies. At the same time, for reasons of cost and access, PD-L1 IHC antibodies and assays developed outside of the scope of randomized controlled trials have garnered widespread use.”

BioSpace reported that the FDA will require an update to boxed warnings on all six approved chimeric antigen receptor (CAR) T-cell products to alert physicians and patients to the increased risk of developing secondary T-cell cancers and the need for life-long follow-up. Drug makers had been voluntarily adding boxed warnings to their CARs since the FDA announced late last year that it was investigating reports of secondary cancers (Cancer Discov 2024 Jan 9 [Epub]). In addition, the FDA will require updates to specific parts of the product labels—notably the sections on warnings and precautions, post-marketing experience, patient counseling information, and medication guide sections, according to the media outlet.

Interplay between macrophages and pancreatic cancer cells seems to promote cachexia, researchers reported (Cancer Cell 2024 Apr 11 [Epub ahead of print]). The crosstalk between the cell types prompts the tumor cells to secrete TNF-like weak inducer of apoptosis, or TWEAK, which binds to receptors on muscle cells, causing inflammation and muscle wasting. However, the researchers noted that “depletion of macrophages reverses muscle degradation induced by tumor cells.” The finding provides potential therapeutic targets to reduce incidence and severity of muscle atrophy in patients with pancreatic cancer.

Research Watch

Locoregional Delivery of IL-13Rα2–CAR-T cells Is Safe in High-Grade Glioma
March 25,

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