Guardant Health and Blueprint Medicines present real-world data identifying the EGFR C797X mutation as the most common mechanism of resistance to osimertinib therapy at the IASLC 2022 World Conference on Lung Cancer

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PALO ALTO, Calif., & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Guardant Health Inc. (Nasdaq: GH), a leader in precision oncology, and Blueprint Medicines Corporation (Nasdaq: BPMC) today announced that they are presenting new data demonstrating that the EGFR C797X mutation is the most common Mechanism of resistance to osimertinib therapy is for patients with advanced non-small cell lung cancer (NSCLC). That Results were presented today at the World Conference on Lung Cancer 2022 of the International Association for the Study of Lung Cancer (IASLC) in Vienna.

“This real-world study enhances our understanding of how osimertinib resistance mutations emerge over time with new insights into when EGFR-C797X mutations overtake MET amplifications as the most commonly acquired resistance mechanism,” said Suresh Ramalingam, MD, FACP, FASCO, Executive Director of Emory University’s Winship Cancer Institute, who served as the lead investigator for the study. “The analysis characterizes the increased frequency of EGFR-C797X mutations when patients are treated longer with first-line osimertinib, reinforcing the need for next-generation EGFR inhibitors to combat C797X-driven resistance.”

The study, conducted in collaboration by Guardant Health, Blueprint Medicines and the Winship Cancer Institute, analyzed de-identified clinical and genomic data using GuardantINFORM’s real-world evidence platform, which includes more than 65,000 adults with advanced NSCLC. The analysis evaluated genomic data from the Guardant360 circulating tumor DNA (ctDNA) test from more than 2,000 patients harboring an EGFR mutation and treated with osimertinib, a third-generation EGFR TKI (tyrosine kinase inhibitor), and the current one Standard of care for patients treated with EGFR mutation were advanced-stage NSCLC with frequent EGFR mutations. The study included ctDNA results up to five years after the start of osimertinib therapy.

Cumulatively, the analysis showed that EGFR-C797X mutations occurred 1.25-fold more frequently than MET amplifications when osimertinib was used as first-line therapy and 2.4-fold more frequently when used as second-line therapy. In patients with probable disease progression after first-line treatment with osimertinib, the cumulative incidence of EGFR C797X mutations was 12.5 percent. MET amplifications were the most common resistance mutation in the first year of osimertinib treatment, and EGFR C797X mutations exceeded the rate of MET amplifications at years two to five.

“This study is an excellent example of how real-world data from the GuardantINFORM platform can be used to shed new light on resistance mechanisms in lung cancer therapy,” said Helmy Eltoukhy, Chairman and Co-CEO of Guardant Health. “The analysis provided important insights into resistance mutations that may contribute to the development of more effective therapies against lung cancer.”

“We are committed to developing transformative precision therapies that prevent or overcome treatment resistance, which represents an important unmet medical need for patients with EGFR-mutated non-small cell lung cancer,” said Becker Hewes, MD, chief medical officer at Blueprint Medicines. “Our collaboration with Guardant Health advances our efforts to characterize dynamic treatment resistance patterns in lung cancer and helps inform therapeutic strategies, including novel combinations, that may prolong patient benefit.”

About GuardantINFORM

The GuardantINFORM clinical genomics platform is designed to help accelerate research and development of next-generation cancer therapeutics by offering biopharma partners an in silico platform that combines de-identified longitudinal clinical information and genomic data generated from the Guardant360 -Liquid biopsy test were collected. With data from more than 225,000 patients diagnosed with locally advanced and metastatic cancer, this robust dataset offers real-world insight into the use of anti-cancer therapies in the clinic, tumor development, and treatment resistance throughout each patient’s treatment course for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping fight cancer worldwide through the use of its proprietary tests, extensive dataset and advanced analytics. Guardant Health’s oncology platform leverages capabilities to drive commercial acceptance, improve patient clinical outcomes and reduce healthcare costs across all phases of cancer care. Guardant Health has commercially launched Guardant360®Guardant360® CDx, Guardant360 TissueNext™, Guardant360 Response™ and GuardantOMNI® Tests for advanced cancer patients and Guardant Reveal™ for early cancer patients. Guardant Health’s screening portfolio, including the ShieldTM Test, aims to address the needs of individuals who are eligible for cancer screening. For more information visit guardanthealth.com and continue to follow the company LinkedIn and Twitter.

About Blueprint drugs

Blueprint Medicines is a global precision therapy company developing life-changing therapies for people living with cancer and blood disorders. With a precise and agile approach, we develop drugs that selectively target genetic drivers with the aim of staying one step ahead across disease states. Since 2011, we have leveraged our research platform, including our molecular targeting expertise and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we supply approved medicines directly to patients in the United States and Europe, and we are advancing multiple programs worldwide in systemic mastocytosis, lung cancer and other genomically defined cancers, and cancer immunotherapy. For more information visit www.BlueprintMedicines.com and keep following us Twitter (@BlueprintMeds) and LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements regarding the potential benefits, values, advantages and advantages of Guardant Health’s liquid biopsy tests or assays; Statements regarding Blueprint Medicines’ plans, strategies, timelines and expectations for clinical trials, study cohorts and indications; the anticipated benefits of Blueprint Medicines’ joint study with Guardant Health, which identified the EGFR C797X mutation as the most common mechanism of resistance to osimertinib; the potential benefit of Blueprint Medicines’ current or future approved drugs or drug candidates in the treatment of patients; and Blueprint Medicines strategy, business plans and focus. The words “aim”, “may”, “will”, “could”, “would”, “should”, “expect”, “plan”, “anticipate”, “intend”, “believe”, “estimate”, “Forecast”, “forecast”, “potential”, “continue”, “goal” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All forward-looking statements in this press release are based on the current expectations and beliefs of the respective management of Guardant Health and Blueprint Medicines and are subject to a number of risks, uncertainties and important factors that could cause actual events or results to differ materially from those expressed or implied by any forward-looking statements in this press release, including without limitation risks and uncertainties related to the impact of the COVID-19 pandemic on each company’s business, operations, strategy, goals and anticipated milestones, including Blueprint Medicines’ ongoing and planned research and discovery activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future to approved products and the introduction, marketing and sale of current or future approved products; Blueprint Medicines’ ability and plans to build a commercial infrastructure and successfully launch, commercialize and sell current or future approved products, including AYVAKIT® (avapritinib) and GAVRETO® (pralsetinib); the ability of Blueprint Medicines to successfully expand the approved indications for AYVAKIT and GAVRETO or to receive marketing and reimbursement approvals for AYVAKIT and GAVRETO in additional regions in the future; delays in ongoing or planned clinical trials or the development of current or future drug candidates by Blueprint Medicines; Blueprint Medicines’ advancement of several early-stage efforts; Blueprint Medicines’ ability to successfully demonstrate the safety and efficacy of its drug candidates and to obtain approval of its drug candidates in a timely manner, if at all; Blueprint Medicines’ pre-clinical and clinical results for drug candidates, which may not support the further development of such drug candidates, either as monotherapies or in combination with other compounds, or may impact the expected timing of data or regulatory filings; the timing of initiation of clinical trials and study cohorts at clinical trial sites and patient recruitment rates; actions by regulatory authorities that may affect the initiation, timing and progress of clinical trials and marketing applications; Blueprint Medicines’ ability to develop and commercialize companion diagnostic tests for its current and future drug candidates; Blueprint Medicines’ ability to successfully expand its business, research platform and portfolio of therapeutic candidates, and the timing and costs thereof; Blueprint Medicines’ ability to realize the anticipated benefits of its leadership transition plan; and the success of Blueprint Medicines’ current and future acquisitions, collaborations, partnerships or licensing agreements. These and other risks and uncertainties are described in more detail in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the companies’ most recent annual reports on Form 10-K and all others current and periodic reports thereafter filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release represent the views of Guardant Health and Blueprint Medicines only as of the date of this release and should not be construed as representing their views as of a later date. Except as required by law, Guardant Health and Blueprint Medicines expressly disclaim any obligation to update any forward-looking statements.

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