Flatiron Health, Inc.

NEW YORK, Oct. 29, 2024 /PRNewswire/ -- Canopy, the first Continuous Care Platform for oncology, today announced the strategic expansion of its leadership team with the appointments of Josh Neiman as President and Chief Commercial Officer and Geoff Calkins as Chief Product and Strategy Officer. With these strategic appointments, Canopy is poised to strengthen its leadership position in the oncology space and deliver on its mission to provide comprehensive, continuous care solutions that empower practices and improve patient outcomes. Josh Neiman brings extensive U.S. and global oncology experience to Canopy. Most recently, as Chief Commercial Officer for North America and Europe at BeiGene, Josh led the commercialization of innovative cancer therapies, building and scaling the organization from initial commercial sales to an annual run rate of over $2B. Josh also brings invaluable startup experience from his tenure as Vice President of Marketing at Flatiron Health, where he was instrumental in integrating technology with oncology care. Josh also held leadership roles at Onyx Pharmaceuticals and Genentech, contributing to the successful market launches of multiple therapies, including Kyprolis®, Rituxan®, Gazyva®, and Herceptin®. "Oncology innovation is evolving at an unprecedented pace and so are the demands being placed on practices and the patients they serve," said Josh Neiman. "With its approach, Canopy is at the forefront of transforming oncology care. I'm honored to join the team during this exciting period of growth and contribute to its mission of enhancing patient outcomes." Geoff Calkins was previously the first employee at Flatiron Health, where he served as Senior Vice President, Product and Operations. Geoff was instrumental in developing and scaling oncology-focused solutions, including electronic health record (EHR) software and a repository of real-world cancer evidence, used by more than 250 oncology practices. At Canopy, Geoff will lead product vision and strategy, driving continuous innovation to meet the evolving needs of oncology practices. "Canopy is uniquely positioned to change the way that cancer care is delivered," said Geoff Calkins. "I'm excited to join this incredible team and move quickly to build products that will improve the lives of providers and patients." This announcement follows a series of significant milestones for Canopy over the past year, including growing its provider base by 4X and exceeding 1,200 providers across prominent practices such as New York Cancer & Blood Specialists, Highlands Oncology, Oncology Consultants, and more. "We're thrilled to welcome Josh and Geoff to the team," said Lavi Kwiatkowsky, CEO and Founder of Canopy. "Their combined expertise and leadership will be pivotal as we rapidly grow and unlock new paradigms of care for patients and their providers." About Canopy Canopy provides oncology practices with a comprehensive platform for all the care that happens between visits. Canopy's multi-channel ePRO and remote triage system enable practices to identify and prioritize patients who need help, resolve their issues using intelligent software, and generate new reimbursement streams from programs like PCM, CCM, EOM, and more. For more information, visit . Media Contact Kaitlin Hemric Canopy [email protected] SOURCE Canopy WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Myriad’s MyRisk® test is the first hereditary cancer test integrated into Flatiron’s OncoEMR® SALT LAKE CITY, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced a collaboration with Flatiron Health, a leading health tech company dedicated to expanding the possibilities of point of care solutions in oncology. This collaboration allows physicians to order Myriad’s MyRisk® Hereditary Cancer Test and view the results of the test directly in Flatiron’s cloud-based Electronic Medical Record (EMR) platform, OncoEMR®. MyRisk is the first hereditary cancer test to be incorporated into Flatiron’s OncoEMR. The integration allows 4,200 providers at over 800 community-based cancer care locations across the U.S. in Flatiron’s network to conveniently order, receive, and review MyRisk testing results directly through their daily OncoEMR system. By creating a streamlined, end-to-end workflow for germline testing in OncoEMR, clinicians have access to the results they need at point-of-care, facilitating personalized treatment decisions for patients while reducing administrative burdens and improving turnaround times for results. “Our collaboration with Flatiron integrates MyRisk testing with practicing clinicians’ current workflows, potentially enhancing access to and usability of germline testing for more personalized patient care,” said George Daneker Jr, MD, President and Chief Clinical Officer of Oncology, Myriad Genetics. “By making germline testing interoperable with OncoEMR, we aim to simplify the ordering experience for clinicians in Flatiron’s extensive network and provide important health information that may help improve patient care and outcomes. We look forward to expanding the availability of our other genomic testing solutions onto the OncoEMR platform in the future, addressing the needs of even more patients.” “As we continue to advance personalized medicine, the importance of germline testing at the point of care is critical to improving patient outcomes,” said Stephen Speicher, MD, Senior Medical Director, Head of Clinical Oncology and Patient Safety at Flatiron Health. “By giving physicians the ability to order Myriad’s MyRisk Hereditary Cancer Test and to view the results directly within OncoEMR, we're offering clinicians a seamless way to access the information they need to practice precision medicine, facilitating better patient outcomes, more time with patients, and a better care experience for physicians and their patients.” The integration is available now to all OncoEMR users. About Myriad GeneticsMyriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com. Safe Harbor Statement This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to how the company’s collaboration with Flatiron may facilitate personalized treatment decisions for patients while reducing administrative burdens and improving turnaround times for results and how by making germline testing interoperable with OncoEMR, the company aims to simplify the ordering experience for clinicians in Flatiron’s extensive network and provide important health information that may help improve patient care and outcomes. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law. About Flatiron HealthFlatiron Health is a healthtech company expanding the possibilities for point of care solutions in oncology and using data for good to power smarter care for every person with cancer. Through machine learning and AI, real-world evidence, and breakthroughs in clinical trials, we continue to transform patients’ real-life experiences into knowledge and create a more modern, connected oncology ecosystem. Flatiron Health is an independent affiliate of the Roche Group. Myriad Genetics Investor Contact Matt Scalo (801) 584-3532 IR@myriad.com Myriad Genetics Media Contact Glenn Farrell (385) 318-3718 PR@myriad.com Flatiron Health Media ContactNina Toorpress@flatiron.com

The FDA wants to narrow the use of popular cancer drugs in stomach cancer. An expert meeting on Thursday will consider its arguments. The FDA is having second thoughts about the broad labels it has granted PD-1 inhibitors in newly diagnosed stomach cancer, questioning whether restrictions should be placed on products from Bristol Myers Squibb and Merck & Co. plus a stomach cancer hopeful from BeiGene.In a briefing document prepared for an Oncologic Drugs Advisory Committee meeting slated for Thursday, the FDA suggested that PD-1 inhibitors may not be suitable for certain patients with HER2-negative gastric cancer who have low PD-L1 expression, even though these immunotherapies have shown life-extension benefits in broad study populations.After picking apart PD-L1 subgroup data from separate phase 3 trials of BMS’ Opdivo, Merck’s Keytruda and BeiGene’s Tevimbra, the FDA found that the drugs’ benefit-risk profiles “appeared not favorable” in PD-L1-negative patients and only “intermediate” in patients with tumors with PD-L1 combined positive scores or tumor area positivity scores below 10.“Although these results are exploratory ... strong evidence does not appear to support the use of anti-PD-L1 drugs in patients with low PD-L1 expression,” the FDA said in its briefing document.In 2021, Bristol’s Opdivo became the first PD-1 inhibitor approved, alongside chemo, as a front-line treatment for stomach cancer. Merck’s Keytruda followed suit in November 2023, and BeiGene’s application for the same indication for Tevimbra is currently under FDA review. Opdivo and Keytruda won broad FDA approvals in the disease covering patients regardless of their PD-L1 expression, and BeiGene is seeking the same for Tevimbra.If the FDA gets its way, the agency’s stance would significantly reduce the number of stomach cancer patients that PD-1 drugs may target. Based on patient distribution patterns in its phase 3 trial, Merck noted that a selection cut-off at PD-L1 expression scores below 10 would exclude about 65% of new patients with HER2-negative stomach cancer, according to the company’s own briefing document. Although the FDA’s existing approvals may be inclusive, the real-world use of PD-1 inhibitors in HER2-negative stomach cancer may not be as broad. The National Comprehensive Cancer Network guidelines give the highest category 1 recommendations to Opdivo only in tumors with PD-L1 expression scores of at least 5, and to Keytruda in cases with scores of 10 or above. Nevertheless, pointing to health records by Flatiron Health, Merck noted that about 25% of first-line stomach cancer patients were not being tested for PD-L1 expression before treatment.The phase 3 trials the companies used to support their HER2-negative stomach cancer bids all showed statistically significant improvements in overall survival (OS) when all patients with various levels of PD-L1 expressions were counted. In the CheckMate-649 trial, adding Opdivo to chemotherapy cut the risk of death by 20%. In KEYNOTE-859, Keytruda’s addition to chemo led to a 22% reduction in the risk of death. The OS benefit was 20% for Tevimbra’s addition to chemo in the final analysis of RATIONALE-305.However, the FDA found the OS benefit observed in the overall population “appears to be predominantly attributable to subgroups of patients with higher PD-L1 expression.”The three trials enrolled patients with different characteristics. For its analysis, the FDA focused on HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma cases that are microsatellite stable or mismatch repair proficient.Among patients with PD-L1-negative disease and PD-L1 scores below 10, the FDA analyses showed a death-risk reduction of 8% and 6%, respectively, for Opdivo; 8% and 14% for Keytruda; and 2% and 9% for Tevimbra.The problems with the analyses were obvious, and the FDA didn’t shy away from their shortfalls: None of the trials were prospectively designed to measure the PD-1 inhibitors’ efficacy specifically in those PD-L1-negative or -low patients. Besides, the relatively small sample size for each trial’s subgroup also means their results may not be reliable.“[H]owever, consistency of subgroup effects over multiple trials as well as biological plausibility can increase confidence in the subgroup results,” the FDA argued. To add to the FDA’s doubts in the HER2-negative indication, Keytruda recently showed a potential detriment to OS in PD-L1-negative patients in the HER2-positive stomach cancer setting. A subgroup analysis of the phase 3 KEYNOTE-811 trial linked Keytruda’s combination with Herceptin and chemo to a higher risk of death versus Herceptin and chemo alone. Afterward, the FDA quickly limited Keytruda’s accelerated approval there to exclude PD-L1-negative patients.Still, during a recent interview with Fierce Pharma, Marjorie Green, M.D., head of oncology global clinical development at Merck Research Laboratories, pointed out that the disease biology between HER2-negative and HER2-positive gastric cancer is different. She therefore argued that the HER2-positive finding should not be used to penalize Keytruda in the HER2-negative indication.Besides, because the subgroups analysis for KEYNOTE-859 didn’t show any negative impact on OS, the results “suggest that there is a potential for benefit across all PD-L1 expression levels,” Merck argued in its own briefing document.Overall, the FDA stated that the addition of PD-1 inhibitors to chemo “does not appear to result in benefit” in PD-L1-negative stomach cancer patients, while the benefit in patients with PD-L1 expression below 10 is unclear.“If patients with low or no PD-L1 expression are not expected to benefit based on the available data, then administering anti-PD1 therapy has the potential for harm including serious immune related adverse events on top of a malignancy that can markedly affect a patient’s quality of life,” the agency said in its document.The advisory committee will convene this Thursday, and the FDA’s external experts will weigh in on whether labeling of the drugs should be limited to a certain PD-L1 level. The agency is considering a classwide action because a drug-specific approach, while statistically sound, would cause “obstacles to the consistent treatment of patients with Ga/GEJ adenocarcinoma in the United States and in the conduct of future trials to improve outcomes of patients with gastric/GEJ adenocarcinoma.”Besides stomach cancer, the FDA also raised a similar concern for PD-1 drugs in first-line esophageal squamous cell carcinoma based on findings from Merck’s KEYNOTE-590, BMS’ CheckMate-648 and BeiGene’s RATIONALE-306 trials, according to a separate briefing document for Thursday’s meeting.