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In Brief This Week: Daiichi Sankyo, AstraZeneca, Mary Bird Perkins Cancer Center, Guardant Health

NEW YORK – The European Medicines Agency this week validated Daiichi Sankyo and AstraZeneca's Type II Variation Application for trastuzumab deruxtecan (Enhertu) for the treatment of patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer who have received an anti-HER2-based regimen. Now, EMA's Committee for Medicinal Products for Human Use will begin its review of the application, which includes data from the DESTINY-Gastric01 and DESTINY-Gastric02 Phase II studies. In those trials, 51 percent and 38 percent of patients responded to treatment with trastuzumab deruxtecan, respectively.

Mary Bird Perkins Cancer Center, which provides cancer care throughout southeast Louisiana and southwest Mississippi, this week announced a partnership with OneOncology aimed at enhancing patients' access to clinical trials, lowering the cost of infusion drugs and medical supplies, migrating to a new electronic medical records platform, and adopting new treatments and services based on advancing research, including precision cancer care. The collaboration with OneOncology, an organization that helps improve community oncology care at lower costs compared to the hospital setting, will officially launch next year. As an example of the benefits of partnering with OneOncology, Mary Bird Perkins highlighted in a statement that OneOncology's research into biomarkers and next-generation sequencing testing patterns can help improve its patients' ability to get tested and receive biomarker-matched personalized therapies. For the remainder of the year, the partners will implement clinical programs and identify opportunities for further collaboration.

Guardant Health and the Royal Marsden NHS Foundation Trust said this week that they have partnered to establish an in-house liquid biopsy testing service for cancer diagnostics at the Royal Marsden that will use Guardant's sequencing test technology. The service is expected to become operational at the end of 2022 and will be available for clinical care and clinical research.

Menarini Group this week said the US Food and Drug Administration has granted orphan drug designation to its dual PIM/FLT3 inhibitor SEL24/MEN1703 for the treatment of acute myeloid leukemia. SEL24/MEN1703 is being studied as a single agent in a Phase I/II trial of relapsed or refractory AML. In early data, the drug showed efficacy in patients with IDH-mutant disease, who were either treatment-naïve or previously treated with IDH inhibitors. Researchers are currently recruiting AML patients with IDH1 or IDH2 mutations in the study to further explore the drug's activity in this patient group. The FDA grants orphan designation to drugs for rare diseases, which provides sponsors tax credits for clinical trials, exemption from user fees, and seven years of market exclusivity for the drug after regulatory approval.

Veracyte this week said its Immunoscore Colon Cancer Test has been included in the pan-Asian adapted European Society for Medical Oncology Clinical Practice Guidelines, which were recently published in the Annals of Oncology and will be discussed at an upcoming medical conference. The Immunoscore test, which came under Veracyte earlier this year through its acquisition of HalioDx, measures patients' immune response at the site of colon tumors and informs the use of chemotherapy. ESMO adapted the 2020 version of its "Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer" for patients in Asian countries based on the consensus opinions of 14 experts from cancer societies in Japan, China, India, Korea, Malaysia, Singapore, and Taiwan. The guidelines state that tumor recurrence risk estimates and predictions about chemo benefit are both important considerations when deciding on therapy and recommend taking into account ethnic differences associated with the treatment of Asian patients with localized colon cancer. "In this context, the Immunoscore Colon Cancer test is recommended for its ability to refine the prognosis of stage II and stage III colon cancer patients, in conjunction with standard cancer staging known as TNM (Tumor, Node, Metastasis)," Veracyte said in a statement.

Mount Sinai Health System and BronxCare Health System this week held a ribbon-cutting ceremony for a new cancer facility in New York City, called BronxCare Mount Sinai Comprehensive Cancer Care. The cancer center has dedicated chemotherapy and immunotherapy infusion suites, a specialized oncology pharmacy, and advanced radiation oncology care services. The new site will bring together the cancer care expertise of Mount Sinai and BronxCare, and precision oncology will be a focus. "At BronxCare, we strive to bring individualized cancer care and precision oncology to the community," Kevin Jain, the new cancer center's director and the section chief of medical oncology and hematology at BronxCare Health System, said in a statement. "This new facility will help us continue our goal of achieving the best possible patient outcomes."

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.