NEW YORK – Janssen this week said its CAR T-cell therapy, ciltacabtagene autoleucel (cilta-cel), will undergo accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) as a treatment for relapsed or refractory multiple myeloma. The company expects to submit the marketing authorization application for the dual-binding BCMA autologous CAR T-cell therapy to CHMP in the first half of 2021, which will include data from the Phase Ib/II CARTITUDE-1 study presented at the 2020 American Society for Hematology annual meeting.
That trial produced an overall response rate of 95 percent among heavily pretreated, relapsed, or refractory multiple myeloma patients receiving cilta-cel, with a stringent complete response rate of 56 percent, a six-month progression-free survival rate of 87 percent, and an overall survival rate of 94 percent. Last month, Janssen began a rolling submission of its biologics license application for cilta-cel for the same relapsed or refractory multiple myeloma indication with the US Food and Drug Administration.
Hologic this week announced a multi-year strategic collaboration to integrate Google Cloud's machine learning technologies with its Genius Digital Diagnostics System. Genius Digital Diagnostics is a digital cytology platform that combines artificial intelligence with advanced digital imaging to help identify pre-cancerous lesions and cancer cells in women.
Hologic said Google Cloud enhances the system's deep learning component. With Google Cloud, the Genius Digital Diagnostics System is expected to derive more actionable insights from cytology slides for cytotechnologists and pathologists, Hologic said.
Financial terms of the collaboration were not disclosed.
The Access to Comprehensive Genomic Profiling Coalition this week appointed NeoGenomics and Tempus to its coalition of diagnostic firms and laboratory service providers to advocate for appropriate broad US health insurance coverage of comprehensive genomic profiling for patients living with advanced cancer.
Guardant Health’s Asia, Middle East & Africa division this week submitted its application to Japan’s Ministry of Health, Labour and Welfare for regulatory approval of the Guardant360 CDx assay for comprehensive genomic profiling in patients with advanced solid tumors and as an unspecified companion diagnostic.
Guardant360 CDx, a blood-based liquid biopsy test, analyzes circulating tumor DNA and identifies genetic alterations that may inform treatment decisions. Last August, the US Food and Drug Administration approved the test for comprehensive genomic profiling across solid tumors and as a companion diagnostic to identify non-small cell lung cancer patients with EGFR alterations who may benefit from treatment with osimertinib (AstraZeneca’s Tagrisso).
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.