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In Brief This Week: AstraZeneca, Merck, Stemline Therapeutics, Caris Life Sciences, Artios Pharma

NEW YORK – Health Canada this week approved AstraZeneca and Merck's PARP inhibitor Lynparza (olaparib) as adjuvant treatment for high-risk, early-stage HER2-negative breast cancer patients harboring germline BRCA1/2 mutations. The agency granted the drug accelerated approval based on the results of the Phase III OlympiA trial, in which patients receiving adjuvant Lynparza experienced a 42 percent reduction in risk of invasive breast cancer recurrence, second cancers, or death versus patients receiving a placebo. Lynparza is also approved as adjuvant therapy for this patient population in the US and Europe

The Menarini Group said this week that the US Food and Drug Administration has accepted a new drug application from its subsidiary, Stemline Therapeutics, for elacestrant in estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer. The agency is expected to make a decision by Feb. 17, 2023. 

Caris Life Sciences said this week that OU Health Stephenson Cancer Center has joined its Precision Oncology Alliance, a network of cancer centers that collaborate to advance precision oncology and biomarker-driven research. Located on the University of Oklahoma Health Sciences Center campus, Stephenson is the state's only National Cancer Institute-designated cancer center. In the Caris POA, it joins about 70 other institutions. Members enjoy early access to Caris' database and artificial intelligence platform, as well as a growing network of clinical trials. 

Artios Pharma said this week that it has expanded an ongoing Phase I/II basket trial of its Pol theta inhibitor ART4215 into a cohort for BRCA1/2-mutated breast cancer patients. In the new cohort, Artios is evaluating ART4215 plus Pfizer's PARP inhibitor Talzenna (talazoparib) for BRCA1/2-deficient breast cancer. Roughly 120 HER2-negative, BRCA1/2-positive breast cancer patients will be randomized 1:1 to receive either ART4215 and Talzenna or Talzenna alone. The Cambridge, UK-based firm expects to report Phase I safety and tolerability data from the basket trial during the first half of 2023. Data from the Phase II expansion portion in BRCA1/2-deficient breast cancer, meanwhile, is expected in 2024. Artios — a company focused on drugging DNA damage response pathways — is also evaluating an ATR inhibitor, ART0380, alone and together with chemotherapy in a Phase I/II trial for solid cancer patients, including those with ATM protein loss. 

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.