On June 23, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported findings from a study that evaluated uveal melanoma (UM) patients’ attitudes toward prognostic testing and specifically with respect to DecisionDx-UM (Press release, Castle Biosciences, JUN 23, 2022, View Source [SID1234616215]). Highlights from the study were shared in a poster presentation at the 20th congress of the International Society of Ocular Oncology (ISOO), recently held in Leiden, The Netherlands.

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The poster, titled "Uveal Melanoma Patient Attitudes Towards Prognostic Testing Using Gene Expression Profiling" and presented by Basil K. Williams, Jr., M.D., assistant professor in the Department of Ophthalmology and Mary Knight Asbury Chair of Ocular Oncology at the University of Cincinnati College of Medicine, can be viewed here.

"Most patients impacted by the rare but quite deadly disease, uveal melanoma, want and expect to play an active role in their care to ensure the best possible outcome," said Williams. "We believe the survey data supported this sentiment and found that regardless of their overall prognosis, patients value the information provided by their DecisionDx-UM test results."

Study highlights:

An online questionnaire was distributed by the Melanoma Research Foundation’s CURE OM (Ocular Melanoma) initiative to capture anonymous information regarding patient-reported experiences following prognostic testing.
Patients were asked questions regarding the decision to undergo prognostic testing and the extent to which they felt decision regret.
Of the 177 survey participants, 90% reported wanting prognostic information at diagnosis.
Of the patients who received prognostic testing with DecisionDx-UM, there was no significant difference in decision regret levels among those receiving a low- (Class 1A), intermediate- (Class 1B) or high-risk (Class 2) test result (Kruskal-Wallis rank sum test, X2=4.1, p=0.13).
Patients tested with DecisionDx-UM reported gaining value from their test result, including:
Increased knowledge and understanding of their disease
More personalized treatment options
Information relevant to life planning
Relief from uncertainty about the future
About DecisionDx-UM

DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma. DecisionDx-UM is the standard of care in the management of newly diagnosed uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup.

On June 23, 2022 Hummingbird Diagnostics GmbH, a leader in reading blood-based microRNAs for early disease detection and characterization, reported a publication in the Journal of Thoracic Oncology Clinical and Research Reports that demonstrates their blood 5-microRNA signature (miRisk) to predict survival following immunotherapy in advanced non-small cell lung cancer (NSCLC) patients with high PD-L1 expression (Press release, Hummingbird Diagnostics, JUN 23, 2022, View Source [SID1234616214]).

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The study builds on results published in March 2022 in npj Precision Oncology [1] and addresses a current clinical dilemma; which advanced-stage NSCLC patients with high PD-L1 expression (≥ 50%) should be treated with immunotherapy (IO) alone versus immunotherapy in combination with chemotherapy (ICT)? Both are currently licensed therapies in international guidelines, yet no biomarkers exist to guide this decision. Optimizing this choice using principles of precision medicine will have significant impacts on patient survival and quality of life, by including toxic chemotherapy only when deemed necessary. Hummingbird’s results demonstrate a significant association between overall survival (OS) and the miRisk score in IO treated patients and furthermore highlight its value as a predictive biomarker for type of treatment (IO or ICT). The score could identify high-risk patients who might benefit from treatment with ICT, as opposed to IO, and support treatment decisions as a blood-based complementary diagnostics.

"Patients with advanced, non-oncogene-driven, non-small-cell lung cancer (NSCLC) with high PD-L1 expression are eligible for treatment with immunotherapy. There is, however, an urgent medical need for biomarkers identifying cases that require additional combination with chemotherapy," says Timothy Rajakumar, MD PhD, Medical Director of Hummingbird Diagnostics and first author on the study. "The miRisk score represents an immune focused biomarker that is specifically predictive of response to immunotherapy and could serve as the foundation for a complementary diagnostic to guide therapeutic decisions and thereby allow physicians to more accurately choose between treating patients with IO alone vs. ICT."

The study was performed in collaboration with Professor Petros Christopoulos from the Thoraxklinik at Heidelberg University Hospital, as well as with Professor Martin Reck, Grosshansdorf. A valuable study cohort was assembled from a total of 155 whole blood samples, prospectively collected from patients with stage IV NSCLC with PD-L1 TPS ≥50%, before they had been initiated on treatment with IO or ICT. These samples were subject to small RNA sequencing and used to train and validate a 5-microRNA model to predict OS (miRisk). This model was significantly associated with OS and, most importantly, with the type of therapy (IO or ICT) therefore offering the promise to support clinical decisions surrounding choice of therapy.

Bruno Steinkraus, PhD, Chief Scientific Officer of Hummingbird Diagnostics remarked: "We believe our analysis will provide a blueprint for host-based integrative biomarker usage in a field of pressing medical need with the emergence of more complex immunotherapy regimens. Taken together with the relatively simple use of a peripheral whole blood test that does not require pipetting at point of care, we envision applicability of this technology to non-invasive therapy guidance for the IO or ICT decision in PD-L1 high patients."

The open-access article can be found online on the journal’s website: View Source(22)00093-5/fulltext

1Rajakumar T et al. A blood-based miRNA signature with prognostic value for overall survival in advanced stage non-small cell lung cancer treated with immunotherapy. NPJ Precis Oncol 2022; 6:19

On June 23, 2022 McKesson Corporation (NYSE: MCK) and HCA Healthcare, Inc. (NYSE: HCA) reported an agreement to form a joint venture combining McKesson’s US Oncology Research (USOR) and HCA Healthcare’s Sarah Cannon Research Institute (SCRI) (Press release, McKesson, JUN 23, 2022, View Source [SID1234616213]). USOR is the research arm of McKesson’s The US Oncology Network and draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. SCRI, which is the research arm of Sarah Cannon, HCA Healthcare’s Cancer Institute, offers end-to-end clinical trial site support services with a deep expertise in early-phase oncology research and drug development as well as a specialized contract research organization (CRO).

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Together, USOR and SCRI will create a fully integrated oncology research organization aimed at expanding clinical research, accelerating drug development and increasing availability and access to clinical trials for community oncology providers and patients, including those in underserved communities. The joint venture plans to offer an expanded clinical research network, a broader portfolio of clinical trials, and enhanced data and analytics capabilities to better match patients with clinical trials.

"McKesson and HCA Healthcare share a commitment to advancing the next generation of cancer care," said Brian Tyler, chief executive officer, McKesson. "This new joint venture is an important step forward in increasing access to clinical trials, particularly within the community setting, where the majority of all cancer patients are initially treated. Additionally, the joint venture directly aligns with McKesson’s strategic growth priorities by further expanding our differentiated oncology ecosystem and improving the value proposition for provider and biopharma partners."

"Clinical research and partnerships are fundamental to how we address our communities’ most pressing healthcare needs," said Sam Hazen, chief executive officer of HCA Healthcare. "We believe this joint venture with McKesson, which unifies our oncology research experts, will promote the development of individualized therapies and provide more opportunities for cancer patients to receive new treatments."

The transaction is expected to close in 2022. Following the close of the transaction, McKesson will own 51% of the joint venture and have operating control. The joint venture will be governed by a Board of Directors with representation from both McKesson and HCA Healthcare. The new company will be led by SCRI’s Dee Anna Smith, who will serve as chief executive officer, and SCRI’s Howard A. "Skip" Burris, III, MD, who will serve as president. Additionally, USOR’s Robert Coleman, MD will become the new organization’s chief medical officer and SCRI’s David Spigel, MD will be its chief scientific officer.

"When it comes to the fight against cancer, building a network of collaborators is essential. Our impact on patients is evident through our longstanding partnerships with experts from Tennessee Oncology, Florida Cancer Specialists and many other valued oncology programs," said Dee Anna Smith, chief executive officer of Sarah Cannon. "In the last three decades, our collaborations have led to advancing treatment standards for the majority of new cancer therapies that are available to patients today. We believe that coming together with US Oncology Research will complement and strengthen our network so that we can continue to make a greater impact for people living with cancer."

Separately, McKesson will acquire Genospace, SCRI’s personalized medicine platform. Genospace is a leading innovator in precision medicine and clinical trial matching. By becoming a part of McKesson, Genospace will power the oncology data and analytics capabilities for the joint venture as well as enhance the ability of its provider partners to more efficiently identify the most appropriate therapies or clinical trials for their patients.

Research is essential to advancing cancer care from diagnosis through survivorship, and as such, the joint venture will enhance both companies’ cancer care offerings. McKesson’s The US Oncology Network and HCA Healthcare’s cancer network, Sarah Cannon Cancer Institute, are not part of the transaction and will continue to operate independently of the joint venture.

Financial terms of the agreement were not disclosed. The transaction is subject to necessary regulatory approvals and other customary closing conditions.

On June 23, 2022 Pfizer Inc. (NYSE: PFE) reported that its board of directors declared a $0.40 third-quarter 2022 dividend on the company’s common stock, payable September 6, 2022, to holders of the Common Stock of record at the close of business on July 29, 2022 (Press release, Pfizer, JUN 23, 2022, View Source [SID1234616212]). The third-quarter 2022 cash dividend will be the 335th consecutive quarterly dividend paid by Pfizer.

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On June 23, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that its investor relation team will participate in the following upcoming investor conference (Press release, Innate Pharma, JUN 23, 2022, View Source [SID1234616211]):

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Conference Portzamparc – Evenement Corporate Access, Paris (in-person event)
Event Date: June 30, 2022