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In Brief This Week: Mirati Therapeutics, Gilead, Natera, Actinium Pharmaceuticals, Myriad Genetics

NEW YORK – Results presented during the European Lung Cancer Virtual Congress this week demonstrated that 45 percent of 51 evaluable non-small cell lung cancer patients treated with Mirati Therapeutics' investigational KRAS G12C inhibitor adagrasib exhibited partial responses to the treatment, and 24 patients had stable disease. The results are from Mirati's multi-cohort Phase I/II KRYSTAL-1 study, which evaluated adagrasib as a treatment for 79 advanced NSCLC patients whose tumors harbored KRAS G12C mutations. In the trial, patients whose tumors harbored STK11 mutations in addition to KRAS G12C mutations experienced an even greater response. 


Gilead said this week that the European Medicines Agency (EMA) has granted accelerated assessment to the marketing authorization application for sacituzumab govitecan-hziy (Trodelvy) as a treatment for previously treated, locally advanced, or metastatic triple-negative breast cancer (TNBC). The EMA will now review data from the Phase III ASCENT trial and decide whether to approve the agent for use in the EU. Sacituzumab govitecan-hziy, which is designed to deliver an anti-tumor payload to cancer cells by binding to Trop-2 proteins on the cell surface, had previously received accelerated approval from the FDA for the same TNBC indication.  


Natera said this week that the US Food and Drug Administration has granted it two Breakthrough Device Designations covering new intended uses for its Signatera molecular residual disease test. The new BDDs, which support the development of Signatera through Phase III clinical trials as a companion diagnostic to two unnamed cancer therapies, add to another BDD for Signatera that Natera received in 2019. 


Actinium Pharmaceuticals this week said it has completed initial patient enrollment in the second-dose cohort of the Phase I portion of a Phase I/II trial investigating Actimab-A in combination with venetoclax (AbbVie/Genentech's Venclexta) in fit and unfit, refractory acute myeloid leukemia patients. The aim in the Phase I portion is to determine the maximum-tolerated Phase II dose of Actinium's Actimab-A, which comprises the anti-CD33 monoclonal antibody lintuzumab linked to the alpha-emitting radioisotope Actinium-225.  

The three patients in the first-dose cohort in the Phase I portion had a high-risk biomarker, including a FLT3-internal tandem duplication, antecedent JAK2-positive myelofibrosis, or a TP53 mutation. One patient with mutations in IDH2, RUNX1, TP53, and other genes experienced complete remission with incomplete blood count recovery on the Actimab-A/venetoclax combination. Next-generation sequencing analysis after the first cycle showed the patient was negative for IDH2 and RUNX1 mutations. Another patient also experienced partial response after one cycle of the combination. The New York-based drugmaker expects to complete the Phase I portion and present proof-of-concept data in the second half of the year. 


Myriad Genetics said this week that its myChoice Diagnostic System will be reimbursed in Japan when it is used to determine which advanced ovarian cancer patients have homologous recombination repair deficiency and may benefit from first-line maintenance treatment with olaparib (AstraZeneca's Lynparza). In November, Japan’s Ministry of Health, Labor, and Welfare approved myChoice as a companion diagnostic for olaparib in this setting. The test is also approved and reimbursed in Japan as a companion diagnostic to identify ovarian cancer patients who are likely to benefit from niraparib (GlaxoSmithKline's Zejula). Myriad has a deal with SRL, a subsidiary of HU Group Holdings, to commercialize myChoice in Japan. 


Inspirata this week announced a multiyear extension of its partnership with Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. The partnership was initiated in 2016 and has resulted in more than 1.75 million whole-slide images being scanned and the first primary diagnosis sign-out through digital in the US, according to the Tampa, Florida-based digital pathology firm. 


Molecular diagnostics firm PreludeDx said this week that it has entered into an agreement with MultiPlan to participate in the healthcare cost management company's primary and complementary networks. Under the terms of the agreement, more than 60 million members and nearly 1 million providers will have access at discounted rates to the PreludeDx genomic test DCISionRT, which predicts recurrence risk and radiation therapy benefits for patients with ductal carcinoma in situ (DCIS), an early form of breast cancer confined to the milk ducts. MultiPlan's clients, their members, and network providers will have access to DCISionRT, which determines whether surgery alone or surgery coupled with radiation therapy is appropriate for DCIS, PreludeDx said. The companies did not disclose the financial and other terms of their deal.


Caris Life Sciences said this week that the Cancer Center at California Pacific Medical Center (CPMC) has joined its Precision Oncology Alliance, a collaborative network of cancer centers working to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology through research on predictive and prognostic markers that improve clinical outcomes. The alliance now includes 49 cancer centers and academic institutions, which have early access to the company’s database and artificial intelligence platform to establish evidence-based standards for cancer profiling and molecular testing in oncology, as well to the Caris CODEai data solution, which contains cancer treatment information and clinical outcomes data for more than 244,000 patients.


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.