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In Brief This Week: Merck, Taiho Oncology, Guardant Health, City of Hope, Bluestar Genomics

NEW YORK –  Merck said this week that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the European label for pembrolizumab (Keytruda) in urothelial carcinoma be updated to include data from the Phase III Keynote-361 trial, which investigated whether adding chemotherapy to pembrolizumab improved outcomes in patients but failed to meet key endpoints. Pembrolizumab is currently available in Europe as a single agent for the treatment of advanced or metastatic urothelial cancer patients who are not eligible for cisplatin-based chemo and whose tumors express PD-L1 with a combined positive score of at least 10. This indication will remain unchanged. Although Keynote-361 failed to show that adding chemo to pembrolizumab improved progression-free survival and overall survival compared to chemotherapy alone, CHMP has taken the position that the risk-benefit profile in the study is nonetheless positive and that physicians should have access to the study data on pembrolizumab's label so they can make decisions about whether to give patients additional chemo on a case-by-case basis.

Taiho Oncology this week said that it has received breakthrough therapy designation from the US Food and Drug Administration for its FGFR inhibitor futibatinib for patients with previously treated, locally advanced, or metastatic cholangiocarcinoma characterized by FGFR2 rearrangements. The agency granted futibatinib this designation based on data from the Phase II FOENIX-CCA2 study, which Taiho will present at the American Association for Cancer Research's annual meeting later this month. Last year, based on earlier data on 67 patients with FGFR2 fusion-positive tumors, there was a 34 percent objective response rate to futibatinib in this trial and the median duration of response was a little more than six months. Futibatinib also has orphan drug designation from the FDA as a cholangiocarcinoma treatment.

Guardant Health said this week that the Centers for Medicare and Medicaid Services has granted Advanced Diagnostic Laboratory Test (ADLT) status to its Guardant360 CDx test. Obtaining ADLT status — which is reserved for FDA-approved tests or other innovative products that provide novel clinical information that cannot be otherwise obtained — triggers a specific, market-based approach to test pricing for the Medicare-covered population. Over the course of nine months, Guardant will collect and submit private-payor payment rates for its test and CMS will then use the median to determine a new price, which will go into effect on Jan. 1, 2022. In the meantime, Guardant360 CDx will be reimbursed at the test's $5,000 list price for Medicare patients.

City of Hope this week said it has received a $50 million gift from the Lennar Foundation that it will put toward its $1 billion plans to develop a comprehensive cancer campus in Irvine, California, and build an advanced cancer care and research network in Orange County. The 190,000-square foot Lennar Foundation Cancer Center is currently under construction and is slated to open its doors in 2022. With the new cancer center, City of Hope is aiming to provide the region's 3.2 million residents with better access to clinical trials; the latest treatments for aggressive cancers; genomic and precision medicine interventions for preventing cancer or treating it in earlier stages; and a range of supportive care programs. City of Hope Irvine will also open a hospital dedicated only to treating cancer patients in 2025. Additionally, a portion of the gift will fund translational research between City of Hope and the University of Miami's Sylvester Comprehensive Cancer Center aimed at advancing precision medicine approaches and eliminating health disparities. 

Bluestar Genomics said this week that it has received US Food and Drug Administration breakthrough device designation for its pancreatic cancer liquid biopsy assay in patients with new-onset diabetes. The test uses a patient's blood sample to identify abnormal epigenomic and genomic signatures linked to pancreatic cancer.  

Cancer Genetics said this week that it has closed its previously announced merger of StemoniX. As part of the transaction, Cancer Genetics was renamed Vyant Bio, effective March 30. StemoniX will operate as a wholly owned subsidiary of the firm. Vyant Bio will be traded on the Nasdaq under the symbol VYNT. 

Angle said this week that it has completed fitting out and staffing its clinical service laboratories in Guildford, UK, and Plymouth Meeting, Pennsylvania. The labs will enable the UK-based firm to accelerate deployment of the Parsortix system for use in cancer drug trials. When the labs are accredited and the firm's tests are validated, they will also offer laboratory-developed tests, Angle added. The company plans to seek ISO15189 accreditation in the US, as well as CLIA accreditation. Angle said the first LDT it anticipates making available is the Ovarian Cancer Pelvic Mass Triage assay. In September, the company said it had filed a de novo submission with the US Food and Drug Administration for the Parsortix system for use with metastatic breast cancer 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.