NEW YORK – Kura Oncology this week received breakthrough therapy designation from the US Food and Drug Administration for tipifarnib in HRAS-mutated head and neck cancer. The designation was based on data from the Phase II RUN-HN trial studying tipifarnib in HRAS-mutant head and neck cancer patients with recurrent or metastatic disease. Among 18 evaluable patients taking tipifarnib, the objective response rate was 50 percent, the median progression-free survival was 5.9 months, and the median overall survival was 15.4 months. Kura licensed tipifarnib from Janssen in 2015. The company is conducting a registrational Phase II trial called AIM-HN, involving more than 200 HRAS-mutant head and neck cancer patients.
Innovent Biologics and Iaso Biotherapeutics said this week that the China National Medical Products Administration's Center for Drug Evaluation has granted breakthrough therapy designation for the firms' jointly developed CAR T-cell therapy for relapsed or refractory multiple myeloma. The autologous therapy, IBI326, is designed to target BCMA, an antigen found on the surface of multiple myeloma cells. China's Center for Drug Evaluation granted the treatment breakthrough therapy designation based on the results of a Phase I/II study, which is ongoing in the country. The trial results to date suggest that the treatment has a positive safety profile and can lead to durable responses among patients with relapsed or refractory multiple myeloma, including those with disease progression following previous anti-BCMA CAR T-cell therapy.
Invitae said this week it has added tools from digital health AI firm Medneon to its clinical workflow, to make it easier for clinicians to determine which patients need genetic testing to assess their cancer risk and how to use the results to guide treatment. Medneon's Predictive Risk Assessment synthesizes current guidelines, real-world evidence, and patients' personal and family history of cancer to estimate their lifetime and short-term risk. Based on this, doctors can decide if patients should receive genetic testing and imaging. The platform can also help determine if patients meet insurers' coverage criteria for testing. After results are returned, Medneon's Personalized Genetic Insights service draws on information in the published literature and the AI knowledgebase ASK2ME and issues customized reports to help doctors treat patients.
Hologic this week completed its previously announced acquisition of molecular oncology test company Biotheranostics for approximately $230 million. Biotheranostics develops and markets two molecular diagnostic tests for breast and metastatic cancers — Breast Cancer Index (BCI) and CancerType ID (CTID).
Hologic noted that the National Comprehensive Cancer Network revised its clinical practice guidelines last month to include BCI as a gene expression assay that predicts the benefits from extended endocrine therapy for patients with early-stage hormone-receptor positive breast cancer.
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.