Non-small cell lung cancer stage III

Pictured: AstraZeneca signage outside of its office in Sweden/iStock, Wirestock AstraZeneca on Monday released high-level results from the Phase III LAURA study, demonstrating clinical benefit for Tagrisso (osimertinib) as a maintenance treatment for patients with unresectable, stage III, EGFR-mutated non-small cell lung cancer. The pharma did not reveal specific data in its announcement but said that Tagrisso led to a “statistically significant and highly clinically meaningful improvement” in progression-free survival (PFS) in the treatment setting when given to patients who had been treated with chemoradiotherapy. Tagrisso also showed a “favorable trend” in terms of overall survival (OS), a key secondary outcome, though data for this endpoint were not yet mature at the time of the analysis. The study will continue to collect OS data. AstraZeneca will present LAURA data at an upcoming medical congress. Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, in a statement called LAURA’s findings “highly impactful” while noting that these results “further entrench Tagrisso as the backbone therapy for EGFR-mutated lung cancer.” LAURA is a randomized, double-blinded and placebo-controlled trial that enrolled 216 patients with unresectable stage III NSCLC with mutations in the EGFR gene. All patients had not progressed after platinum-based chemoradiotherapy. Tagrisso was given at 80-mg, once-daily oral maintenance doses, while those in the placebo arm were allowed to take Tagrisso after their cancers had progressed. In terms of Tagrisso’s safety pro this earlier setting, LAURA found that adverse events were consistent with what had previously been established. The study documented no new safety concerns. Monday’s readout follows Tagrisso’s recent approval for the treatment of advanced EGFR-mutated NSCLC in combination with chemotherapy, which further expands treatment options for NSCLC patients, especially those with a “poorer prognosis, including patients whose cancer has spread to the brain,” Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in a statement. Tagrisso is an EGFR tyrosine kinase inhibitor (TKI) that works by binding to specific mutated forms of EGFR, which would otherwise promote cell growth and proliferation, and which have been correlated with poor prognosis. According to its website, Tagrisso is designed to target sensitizing EGFR mutations, including exon 19 deletions and exon L858R mutations, as well as acquired resistance mutations. Besides its most recent approval, Tagrisso has three other indications in NSCLC: as a first-line treatment option in patients with metastatic disease, as adjuvant therapy following resection and as treatment for metastatic disease that had progressed after prior EGFR-TKI therapy. In all three cases, Tagrisso is only approved for patients harboring specific EGFR mutations, as determined by an FDA-approved test. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Dive Brief:AstraZenecas targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally advanced or metastatic lung tumor, following a Food and Drug Administration approval Friday.The FDA cleared Tagrisso together with chemotherapy based on results showing the combination reduced the risk of disease progression or death versus Tagrisso alone, which is currently the first-line standard for non-small cell lung cancer that harbors mutations in a gene known as EGFR.Over the weekend, meanwhile, AstraZeneca reported new clinical trial data showing Tagrisso outperformed placebo following chemoradiotherapy for Stage 3 EGFR-mutated non-small cell lung cancer that couldnt be surgically removed. The results, which AstraZeneca will share with regulators, could further support early use of Tagrisso.Dive Insight:Tagrisso is at the center of AstraZenecas oncology resurgence. The drug, which first won approval in the U.S. in 2015, is the companys second highest selling product, after the diabetes and kidney disease treatment Farxiga.It has become a go-to treatment for EGFR-mutated lung cancers, which make up about 15% of the estimated 165,000 or so people who are diagnosed with non-small cell lung cancer each year. Over time, AstraZeneca has secured expanded clearance for its use earlier in metastatic treatment, as well as a role in the adjuvant, or after surgery, setting.The latest approval, announced late Friday, could establish a new standard in the first-line metastatic setting. Adding chemo to Tagrisso extended progression-free survival by about nine months over Tagrisso monotherapy, results showed. The combination also appeared to work better in lowering the risk of cancer growth in the central nervous system.The OK is also notable for Johnson & Johnson, which recently reported trial results showing a drug combination its developed beat Tagrisso monotherapy. Following Fridays approval, physicians may now see Tagrisso plus chemo as the relevant comparator.In the adjuvant setting, meanwhile, AstraZeneca recently shared data that proved Tagrisso used this way can considerably extend patient survival. The results mandate testing for EGFR mutations in patients with early-stage non-small cell lung cancer, said Benjamin Solomon, a medical oncologist at the Peter MacCallum Cancer Center in Australia, during a discussion of the data at a medical meeting last June.For patients whose lung cancer is unresectable, new trial data AstraZeneca shared Monday show Tagrisso could help, too. Treatment resulted in a statistically significant and highly clinically meaningful improvement in progression-free survival versus placebo when given following chemoradiotherapy for Stage 3 non-small cell lung cancer.Overall survival data favored Tagrisso, AstraZeneca said, but the results from the trial, called Laura, were not yet final.These highly impactful results for the Laura trial in this potentially curative early lung cancer setting further entrench Tagrisso as the backbone therapy for EGFR-mutated lung cancer, said Susan Galbraith, head of oncology R&D at AstraZeneca, said in a statement. '

First EGFR inhibitor and targeted treatment to demonstrate progression-free survival benefit in Stage III setting WILMINGTON, DE, USA I February 19, 2024 I Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO ® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) compared to placebo after CRT. Overall survival (OS) data showed a favorable trend for TAGRISSO , although data were not mature at the time of this analysis. The trial will continue to assess OS as a secondary endpoint. Each year an estimated 2.4 million people are diagnosed with lung cancer globally with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer. 1-3 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR mutations. 4-7 More than one in six patients with NSCLC are diagnosed with unresectable Stage III disease (15%). 8 Suresh Ramalingam, MD, Executive Director of Winship Cancer Institute of Emory University, Atlanta, US, and principal investigator in the trial, said: “These results represent a major advance for patients with Stage III EGFR-mutated lung cancer who have a high propensity for early progression and spread to the brain, and where no targeted therapy is available. LAURA shows osimertinib can provide impactful clinical benefit and could become the first targeted treatment option for patients with Stage III disease.” Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These highly impactful results for the LAURA trial in this potentially curative early lung cancer setting further entrench TAGRISSO as the backbone therapy for EGFR-mutated lung cancer. These data together with the ADAURA data, reinforce the imperative to diagnose and treat patients with lung cancer as early as possible.” The safety and tolerability of TAGRISSO in the LAURA trial was consistent with its established profile and no new safety concerns were reported with TAGRISSO maintenance treatment following CRT. The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial with results expected later this year, and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial. IMPORTANT SAFETY INFORMATION INDICATIONS Please see complete Prescription Information , including Patient Information for TAGRISSO. You may report side effects related to AstraZeneca products by clicking here . Notes Lung cancer Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 1 Lung cancer is broadly split into NSCLC and small cell lung cancer. 2 The majority of all NSCLC patients are diagnosed with advanced disease. 6 Patients with EGFRm NSCLC are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the cell-signaling pathways that drive the growth of tumor cells. 10 LAURA LAURA is a randomized, double-blind, placebo-controlled, multi-center, global Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum‑based CRT. Patients were treated with TAGRISSO 80mg once daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met. Upon progression, patients in the placebo arm were permitted to be treated with TAGRISSO. The trial enrolled 216 patients in more than 145 centers across more than 15 countries, including in the US, Europe, South America and Asia. This is the analysis of the primary endpoint of PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS. TAGRISSO TAGRISSO ® (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than 800,000 patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC. TAGRISSO is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan. These include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC, where TAGRISSO recently demonstrated a statistically significant and clinically meaningful OS benefit. There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC. TAGRISSO is the only targeted therapy to improve patient outcomes in both early-stage disease in the ADAURA Phase III trial and late-stage disease in the FLAURA Phase III trial and FLAURA2 Phase III trial . The Company is also researching ways to address tumor mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test TAGRISSO plus savolitinib, an oral, potent and highly selective MET TKI, as well as other potential new medicines. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including TAGRISSO and gefitinib; durvalumab and tremelimumab-aclt; fam-trastuzumab deruxtecan-nxki and datopotamab deruxtecan in collaboration with Daiichi Sankyo; savolitinib in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca . References SOURCE: AstraZeneca