NEW YORK – Myriad Genetics said this week it will start receiving reimbursement in Japan for its BRACAnalysis Diagnostics System as a companion test to identify which metastatic pancreatic or metastatic castration-resistant prostate cancer patients harbor germline BRCA1/2 mutations and are likely to benefit from the PARP inhibitor olaparib (AstraZeneca/MSD's Lynparza). Following the test's approval in these settings by Japan's Ministry of Health, Labor, and Welfare in October, the government will now reimburse the test. The latest approval and reimbursement of BRACAnalysis expands the test's utility beyond the BRCA1/2-mutated breast and ovarian cancer setting where it is already approved as a companion test for olaparib.
Diagnostics data analytics company Diaceutics said this week that it is working with Canadian Pathology Quality Assurance (CPQA) to advance NTRK immunohistochemistry proficiency testing. With the availability of precision oncology drugs that target NTRK fusions, there is a growing need to test for these biomarkers and to establish proficiency testing programs in this area, Diaceutics said. The CPQA will use Diaceutics' recently launched DXRX platform to work with labs to source formalin-fixed paraffin-embedded tissue blocks and build a small tissue microarray for NTRK IHC proficiency testing and test validation assistance. The CPQA is particularly interested in getting access to breast and salivary mammary analogue secretory carcinoma tissue blocks, which are more likely to have NTRK fusions.
During the American Society of Clinical Oncology's virtual Gastrointestinal Cancers Symposium on Jan. 17, Cambridge, Massachusetts-based Agios Pharmaceuticals reported mature overall survival data from the Phase III ClarIDHy trial comparing ivosidenib (Tibsovo) against placebo in IDH1-mutated cholangiocarcinoma. In the study, median overall survival was 10.3 months for patients randomized to receive ivosidenib, compared to 7.5 months for those on placebo, an outcome that did not achieve statistical significance. More than 70 percent of patients in the placebo arm crossed over to the ivosidenib arm, and researchers reported a median overall survival of 5.1 months for patients on placebo after adjusting for crossover.
As previously reported, Agios will still submit a supplementary new drug application for ivosidenib in this indication based on the drug’s demonstrated ability to improve median progression-free survival, the primary endpoint of the ClarIDHy trial. In September, the company had reported that median progression-free survival was 2.7 months versus 1.4 months on ivosidenib and placebo, respectively. The company said that CalrIDHy is the first and only Phase III trial in IDH1-mutant, advanced bile duct cancer and that the survival, progression-free survival, and safety data are "compelling" for patients with a difficult-to-treat tumor type.
Twist Bioscience this week announced licensing deals with Serotiny and Applied StemCell for its biopharma division. Financial details of the deals were not disclosed.
Twist will provide Serotiny with custom DNA libraries that encode chimeric antigen receptors (CAR). Serotiny will screen receptor designs for improved therapeutic properties as part of CAR T-cell therapies that may target solid tumors. Twist will have the right to license the technology resulting from the collaboration. Twist will use Applied StemCell's Targatt CHO cell lines to screen, select, and characterize novel antibodies for its internal and partnered therapeutics development programs.
Cancer diagnostics firm Precipio said this week that two oncology practices, West Cancer Center in Tennessee and New York Cancer & Blood Specialists, will be implementing its HemeScreen cancer mutation profiling panel in their internal labs. In December, the company announced it was working with an unnamed oncology distributor to launch the HemeScreen Physician Office Lab (POL) program to make its molecular profiling technology for hematologic malignancies available to community practices. By bringing the HemeScreen test in-house, these practices will be able to "significantly improve" the turnaround time for molecular test results for hematologic malignancies, such as myeloproliferative neoplasms, chronic lymphocytic leukemia, and acute myeloid leukemia, Precipio said. The company had previously estimated that an average practice in the HemeScreen POL program could generate $100,000 in reagent sales, depending on its size.
Lantern Pharma this week closed a previously announced public offering, in which it raised nearly $69 million in gross proceeds from the sale of 4,928,571 shares of common stock at a price of $14 per share. The company also sold 642,856 shares that the underwriter had the option to purchase. The Dallas, Texas-based precision oncology firm plans to use the funds for working capital, general corporate purposes, improving its RADR artificial intelligence platform, advancing therapeutic candidates in its pipeline, and acquiring and in-licensing other drug development candidates and intellectual property.
Guardant Health and the Vall d’Hebron Institute of Oncology said this week that they are working together to establish an in-house cancer genomic testing service at VHIO's Barcelona facility using Guardant's proprietary digital sequencing liquid biopsy platform.
Vall d’Hebron's new service is expected to become operational before the end of this year and will be available for both research and clinical care. According to the partners, testing will be limited to private-paying patients at first, though the institute expects to be able to gain coverage for patients in the public healthcare system over time.
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.