• Roy S. Herbst, MD, PhD, discusses findings from the overall survival analysis of the phase 3 ADAURA trial of adjuvant osimertinib in patients with stage IB to IIIA resected non-small cell lung cancer harboring EGFR mutations. (onclive.com)
  • assistant dean for translational research, Yale School of Medicine, discusses findings from the overall survival (OS) analysis of the phase 3 ADAURA trial (NCT02511106) of adjuvant osimertinib (Tagrisso) in patients with stage IB to IIIA resected non-small cell lung cancer (NSCLC) harboring EGFR mutations. (onclive.com)
  • On December 18, 2020, osimertinib was approved for adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) with tumors with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test. (ascopost.com)
  • In cultured cells and animal tumor implantation models, osimertinib exhibited antitumor activity against NSCLC lines with EGFR mutations (T790M/L858R, L858R, T790M/exon 19 deletion, and exon 19 deletion) and, to a lesser extent, those with wild-type EGFR amplifications. (ascopost.com)
  • Osimertinib was approved for adjuvant therapy after tumor resection in patients with NSCLC with tumors with EGFR exon 19 deletions or exon 21 L858R mutations. (ascopost.com)
  • Tasso 80 mg targets specific genetic mutations associated with NSCLC, potentially revolutionizing treatment outcomes. (saifpharma.com)
  • First-generation EGFR TKIs, binding competitively and reversibly to the ATP-binding site of the EGFR tyrosine kinase domain, have resulted in a significant improvement in outcome for NSCLC patients with activating EGFR mutations (L858R and Del19). (researchgate.net)
  • The third-generation EGFR TKIs selectively and irreversibly target EGFR T790M and activating EGFR mutations, showing promising efficacy in NSCLC resistant to the first- and second-generation EGFR TKIs. (researchgate.net)
  • Currently, the first-generation gefitinib and erlotinib and second-generation afatinib have been approved for first-line treatment of metastatic NSCLC with activating EGFR mutations. (researchgate.net)
  • In this review, we summarize the available post-progression therapies including third-generation EGFR inhibitors and combination treatment strategies for treating patients with NSCLC harboring EGFR mutations and address the known mechanisms of resistance. (researchgate.net)
  • Here we report efficacy and safety data of an Asian subset of the phase III FLAURA trial ( NCT02296125 ), which compares osimertinib with standard of care (SoC) EGFR tyrosine kinase inhibitors (TKIs) in patients with previously untreated advanced NSCLC with tumors harboring exon 19 deletion (Ex19del)/L858R EGFR TKI-sensitizing mutations. (daancancer.com)
  • Osimertinib essentially works by blocking the effects of common EGFR mutations, according to the new report. (livescience.com)
  • Tagrisso was first approved by the U.S. Food and Drug Administration in 2017 , when the pill was cleared as a treatment for patients with advanced NSCLC whose tumors carried certain EGFR mutations. (livescience.com)
  • It is mainly used to treating cases of NSCLC that harbour mutations in the epidermal growth factor receptor (EGFR) gene. (wikipedia.org)
  • Molecular testing is of paramount importance in NSCLC, given the increased number of actionable mutations and the knowledge that immunotherapy may be less effective in oncogene-addicted tumors. (medscape.com)
  • Boehringer Ingelheim) as first-line treatment of metastatic non-small-cell lung cancer (NSCLC) and nonresistant EGFR mutations as identified by an FDA-approved test. (ahdbonline.com)
  • Afatinib was previously approved for patients with metastatic NSCLC and EGFR exon 19 deletions or exon 21 ( L858R ) substitution mutations, and for patients with metastatic squamous NSCLC that progressed with platinum-based chemotherapy. (ahdbonline.com)
  • This approval was based on durable responses in 32 patients with metastatic NSCLC and nonresistant EGFR mutations other than exon 19 deletions or exon 21 L858R substitutions. (ahdbonline.com)
  • When you think about NSCLC, there are those cases that are driven by driver mutations and those that are not. (ajmc.com)
  • EGFR mutations are quite common at NSCLC and drive some of the therapeutic decisions particularly those with EGFR predominant related pathology. (ersnet.org)
  • Osimertinib, a third-generation oral EGFR-TKI, potently and selectively inhibits both EGFR-TKI sensitizing and EGFR p.Thr790Met resistance mutations. (ersnet.org)
  • BACKGROUND: Lung cancer patients with sensitizing epidermal growth factor receptor (EGFR) mutations treated with osimertinib will eventually develop progressive disease (PD). (au.dk)
  • METHODS: We analyzed blood samples drawn from non-small cell lung cancer patients harboring EGFR mutations that were treated with osimertinib. (au.dk)
  • There are a host of treatments available for non-small cell lung cancer (NSCLC) these days, and for patients, perhaps the most crucial step in choosing one is to make sure a pathologist genetically sequences the tumor, so that doctors will know which mutations are driving the cancer. (curetoday.com)
  • Deeper understanding of the pathobiology of non-small cell lung cancer (NSCLC) has led to the development of small molecules that target genetic mutations known to play critical roles in the progression to metastatic disease. (medscape.com)
  • Mutations in epidermal growth factor receptor ( EGFR ), KRAS, and anaplastic lymphoma kinase ( ALK ) are mutually exclusive in patients with NSCLC, and the presence of one mutation in lieu of another can influence response to targeted therapy. (medscape.com)
  • [ 9 , 10 ] KRAS G12C accounts for approximately 50% of KRAS mutations in NSCLC, and approximately 14% of patients with NSCLC have a KRAS G12C mutation. (medscape.com)
  • EGFR mutations are also important predictive markers in NSCLC, occurring in 10 percent of cases, and there are now multiple precision treatment options for this subset of patients. (genomeweb.com)
  • The 2021 NCCN Guidelines now list osimertinib as an option for adjuvant therapy in patients with resectable stage IIB-IIIA or high-risk stage IB-IIA NSCLC harboring EGFR mutations who received previous adjuvant chemotherapy or are ineligible to receive platinum-based chemotherapy. (jnccn.org)
  • Among all BRAF mutations, BRAF V600E is the most common, accounting for approximately 50% of all BRAF mutations in NSCLC. (jnccn.org)
  • An interview with Dr. Gregory Masters discussing the latest guidelines treating non-small cell lung cancer (NSCLC) with gene mutations. (lcfamerica.org)
  • The most important components of this updated guideline confirm that osimertinib is the best first-line option for patients with standard activating EGFR mutations , such as L858R and deletion 19 mutations. (lcfamerica.org)
  • In general, for the additional mutations you mention, we recommend treatment according to the other NSCLC guideline for patients without driver mutations. (lcfamerica.org)
  • Compound epidermal growth factor receptor ( EGFR ) mutations are less responsive to tyrosine kinase inhibitors (TKIs) than single EGFR mutations in non-small cell lung cancer (NSCLC). (biomedcentral.com)
  • We retrospectively studied the next-generation sequencing (NGS) data of treatment-naïve tumors from 1025 NSCLC patients with compound EGFR mutations, which were sub-categorized into different combinations of common mutations (19-Del and EGFR exon 21 p.L858R), rare mutations, and variants of uncertain significance (VUSs). (biomedcentral.com)
  • Short in-frame deletions in exon 19 (19-Del) and point mutations in EGFR exon 21 p.L858R are the most common activating mutations in EGFR , accounting for approximately 90% of all EGFR mutations in NSCLC [ 5 , 6 ]. (biomedcentral.com)
  • Besides 19-Del and EGFR exon 21 p.L858R, extensive research has uncovered a wide array of rare EGFR activating or resistant mutations in NSCLC, including EGFR exon 18 p.G719X, EGFR exon 20 p.S768I, EGFR exon 21 p.L861Q, EGFR exon 20 p.T790M, and EGFR exon 20 insertions (20ins). (biomedcentral.com)
  • BDTX-1535, a fourth-generation, brain-penetrant epidermal growth factor receptor (EGFR) MasterKey tyrosine kinase inhibitor (TKI), is under investigation for the treatment of NSCLC harboring intrinsic driver and/or acquired resistance (post-osimertinib) EGFR mutations and glioblastoma multiforme (GBM) with multiple EGFR alterations. (drug-dev.com)
  • The BDTX-1535 expansion cohort portion of the study will assess single-agent objective response rate (ORR) in a second- or third-line setting in NSCLC patients with EGFR intrinsic driver and/or acquired resistance mutations, who have received prior treatment with approved EGFR TKI. (drug-dev.com)
  • The dosing of the first patients in the expansion cohorts follows the company's initial data readout from the dose escalation portion of the BDTX-1535 Phase 1 clinical study, which demonstrated clinical proof of activity through radiographic responses in NSCLC patients harboring diverse types of EGFR mutations including intrinsic driver and post-osimertinib acquired resistance EGFR mutations. (drug-dev.com)
  • The Phase 1 expansion cohorts will assess objective response rate and durability of response in NSCLC patients whose disease has progressed after prior EGFR inhibitor therapy, including prior osimertinib, and who have evidence of a variety of EGFR driver or resistance mutations that are targeted by BDTX-1535," said Sergey Yurasov, MD, PhD, Chief Medical Officer of Black Diamond Therapeutics. (drug-dev.com)
  • Emergence of intrinsic driver and acquired resistance EGFR mutations to osimertinib represents a significant unmet need for patients with EGFR-mutant lung cancer. (drug-dev.com)
  • Thirteen percent of patients in the US with EGFR mutation-positive NSCLC show presence of intrinsic driver mutations, which are associated with worse clinical outcomes when treated with currently approved EGFR TKIs. (drug-dev.com)
  • Fifteen percent of patients in the US whose disease has progressed after osimertinib therapy show evidence of acquired resistance EGFR mutations (eg, C797S) for which currently there is no approved EGFR TKI. (drug-dev.com)
  • The company is advancing BDTX-1535 as a potential targeted therapy option for patients with this broad spectrum of EGFR mutations in second-line NSCLC, and plans to investigate safety and efficacy in a first-line setting in NSCLC patients with intrinsic driver EGFR mutations after discussion with the US FDA. (drug-dev.com)
  • The trial is evaluating BDTX-1535 in patients with advanced/metastatic NSCLC harboring EGFR mutations with or without central nervous system (CNS) disease, or with recurrent GBM expressing EGFR alterations. (drug-dev.com)
  • Interim analysis results from the double-blind, phase 3 ADAURA trial demonstrated that among patients with stage IB to IIIA EGFR -positive non-small cell lung cancer (NSCLC), disease-free survival was significantly longer among those who received osimertinib (Tagrisso) than among those who received placebo. (cgtlive.com)
  • Made by the biopharmaceutical company AstraZeneca, Tagrisso, also known as osimertinib, reduced the five-year risk of death in lung cancer patients by 51%, according to a study published Sunday (June 4) in The New England Journal of Medicine . (livescience.com)
  • AZN - Free Report ) Tagrisso (osimertinib) for patients with late-stage non-small cell lung cancer (NSCLC). (zacks.com)
  • Tagrisso is already approved for the treatment of NSCLC. (zacks.com)
  • The first study she discusses, the ADAURA study, looked at the targeted therapy osimertinib (Tagrisso) to treat NSCLC with an EGFR mutation. (cancer.net)
  • For example, Tagrisso (osimertinib) is approved by the Food and Drug Administration to treat patients with NSCLC with an EGFR mutation. (curetoday.com)
  • Once-a-day use of the targeted cancer pill Tagrisso (osimertinib) cut the five-year death rate in half for a subset of patients with early-stage lung cancer, a new clinical trial shows. (upi.com)
  • According to ASCO, Tagrisso is also being studied at other stages of NSCLC, including its use before surgery. (upi.com)
  • In the July 13, 2023, issue of The New England Journal of Medicine , data on the use of osimertinib in the adjuvant setting were published, and there was a focus on survival. (medscape.com)
  • The updated DFS analysis, published in January 2023, showed a median DFS of 65.8 months with osimertinib vs 28.1 months with placebo, with an HR of 0.27. (onclive.com)
  • Osimertinib is an EGFR tyrosine kinase inhibitor that binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) at approximately ninefold lower concentrations than to wild-type EGFR . (ascopost.com)
  • AZ7550 showed a similar potency to osimertinib, whereas AZ5104 showed greater potency against exon 19 deletion and T790M mutants (approximately 8-fold) and wild-type EGFR (approximately 15-fold). (ascopost.com)
  • In AURA3 ( NCT02151981 ), osimertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), significantly prolonged progression-free survival and improved response in patients with EGFR T790M advanced non-small-cell lung cancer (NSCLC) and progression on prior EGFR-TKI treatment. (nih.gov)
  • In patients with T790M advanced NSCLC, no statistically significant benefit in OS was observed for osimertinib versus platinum-pemetrexed, which possibly reflects the high crossover rate of patients from platinum-pemetrexed to osimertinib. (nih.gov)
  • Although they exhibited promising anti-T790M activity in the laboratory, their clinical activity among T790M+ NSCLC was poor mainly because of dose-limiting toxicity due to simultaneous inhibition of wild-type EGFR. (researchgate.net)
  • Among the third-generation EGFR TKIs, osimertinib is today the only drug approved by the Food and Drug Administration and the European Medicines Agency to treat metastatic EGFR T790M NSCLC patients who have progressed on or after EGFR TKI therapy. (researchgate.net)
  • In spite of the initial effectiveness of EGFR-TKI therapies in patients with EGFR m advanced NSCLC, many patients develop acquired resistance and approximately 60% of these patients possess the EGFR T790M resistance mutation. (cancertherapyadvisor.com)
  • Osimertinib, a third-generation EGFR TKI that works by irreversibly binding to both EGFR TKI-sensitizing and T790M resistance-mutant forms while sparing wild-type EGFR, has demonstrated superiority compared with standard platinum-based doublet therapy in previous trials. (oncologynurseadvisor.com)
  • It was approved in 2015 by the US Food and Drug Administration (FDA) for the treatment of patients with NSCLC who are EGFR T790M mutant positive and have progressed after first-line EGFR TKI therapy. (oncologynurseadvisor.com)
  • However, it is not active against the T790M mutation which generally requires third generation drugs like osimertinib. (wikipedia.org)
  • To compare the efficacy and toxicity of osimertinib versus docetaxel-bevacizumab as third-line treatment in EGFR T790M mutated NSCLC. (nih.gov)
  • In a subgroup of these patients we identified an association between selection of EGFR T790M -negative but EGFR G724S -positive subclones and osimertinib resistance. (nature.com)
  • Third-generation EGFR inhibitors such as osimertinib have been designed to overcome acquired resistance induced by the EGFR T790M gatekeeper mutation 10 . (nature.com)
  • Clinical results show that patients treated with osimertinib respond in up to 71% in the background of an acquired EGFR T790M mutation 11 , 12 . (nature.com)
  • Patient P1 (UICC stage IIIA, 59 years old, female) received osimertinib within the AURA trial (NCT01802632) after progression on erlotinib and the detection of an acquired EGFR T790M mutation (T1) (Fig. 1a ). (nature.com)
  • The latest accelerated approval from the FDA was for AstraZeneca's Tegrisso (osimertinib) for advanced NSCLC patients who have the EGFR resistance mutation T790M and who have progressed despite receiving other EGFR inhibitors. (genomeweb.com)
  • We found that first-line treatment with osimertinib was associated with significantly longer overall survival than treatment with comparator EGFR-TKIs in patients with EGFR mutation-positive, locally advanced or metastatic NSCLC and had a similar safety profile," the authors write. (physiciansweekly.com)
  • According to the authors, the results of the study suggest that "osimertinib is an effective treatment approach as initial therapy for treatment-naive patients with advanced EGFR mutation-positive NSCLC. (cancertherapyadvisor.com)
  • In the study, researchers randomly assigned patients with completely resected EGFR mutation-positive NSCLC 1:1 to receive either 80 mg of osimertinib once daily or placebo for 3 years. (cgtlive.com)
  • The main message from this study is that patients with resected EGFR mutation-positive NSCLC who received osimertinib had significantly longer disease-free survival than those who received placebo. (ersnet.org)
  • Despite significant recent advances in treating lung cancer, there is a large unmet medical need for a targeted therapy for these EGFR mutation-positive NSCLC patients, for whom chemotherapy is still the most common treatment option. (drug-dev.com)
  • The population of EGFR mutation-positive NSCLC is genetically heterogeneous - which has presented challenges in the development of effective therapies. (drug-dev.com)
  • NCT01802632 ) demonstrated that osimertinib retains a high level of activity, delays resistance, and inhibits tumor growth in EGFRm tumors, and may be effective as first-line therapy for this patient population. (cancertherapyadvisor.com)
  • Five years after having their tumors surgically removed, 88% of patients who took osimertinib were still alive, compared with 78% of the placebo patients, according to the study. (livescience.com)
  • In January 2015, a Phase III trial in people with NSCLC suggested the drug extended life expectancy in stage IV NSCLC adenocarcinoma with EGFR Mutation type del 19-positive tumors, compared to cisplatin-based chemotherapy by a year (33 months vs. 21 months). (wikipedia.org)
  • The FDA last week granted accelerated approval to Genentech's Alecensa (alectinib) for metastatic NSCLC patients with ALK-positive tumors who no longer respond to Pfizer's Xalkori (crizotinib). (genomeweb.com)
  • Pfizer announced last week that the agency had granted priority review for its supplemental new drug application for Xalkori as an option for metastatic NSCLC patients whose tumors have ROS1 rearrangements. (genomeweb.com)
  • Of the approximately 1.5 million new cases of NSCLC each year globally, between 3 percent and 7 percent have tumors with ALK fusions, while 1 percent have ROS1 fusions. (genomeweb.com)
  • Telisotuzumab vedotin is an investigational antibody-drug conjugate that targets c-Met, a receptor tyrosine kinase that is overexpressed in tumors, including in NSCLC. (pharmacytimes.com)
  • Stereotactic body radiotherapy (SBRT) may be used in early-stage NSCLC tumors that are smaller than 5 cm without lymph node involvement. (medscape.com)
  • In ADAURA, 682 patients with completely resected stage IB, II, or IIIA NSCLC were randomly assigned 1:1 to receive either osimertinib or placebo. (onclive.com)
  • The current study is a phase 3, randomized trial which actually assessed the efficacy and safety of osimertinib as compared with placebo in patients with completely resected stage IB to IIIA NSCLC. (ersnet.org)
  • What I could see in there was very clear proof of the usefulness of chemotherapy with osimertinib. (medscape.com)
  • If you gave chemotherapy with osimertinib, there was a clear improvement over osimertinib alone. (medscape.com)
  • The benefit of chemotherapy was there, comparing either patients with placebo or osimertinib, demonstrating that by giving chemotherapy, you further improve survival. (medscape.com)
  • Well, I think today's guidelines would say that you could give them standard chemotherapy, followed by surgery, followed by osimertinib. (medscape.com)
  • You could take the patient right to surgery and give chemotherapy and then osimertinib. (medscape.com)
  • But extrapolating from the data on giving a checkpoint inhibitor with chemotherapy and knowing about the safety of chemotherapy with osimertinib, I think we're going to see more and more that you're going to want to give chemotherapy with osimertinib upfront. (medscape.com)
  • 2,3 In the trial, 682 patients with complete tumor resection, with or without prior adjuvant chemotherapy, were randomly assigned to receive oral osimertinib at 80 mg once daily (n = 339) or placebo (n = 343) following recovery from surgery and standard adjuvant chemotherapy, if given. (ascopost.com)
  • Rami Manochakian, MD , of Mayo Clinic Florida, offers his perspective on the new phase III findings on osimertinib, a third-generation, central nervous system EGFR tyrosine kinase inhibitor, which demonstrated an unprecedented overall survival benefit for patients with EGFR -mutated, stage IB-IIIA non-small cell lung cancer (NSCLC) after complete tumor resection, with or without adjuvant chemotherapy (Abstract LBA3). (ascopost.com)
  • The disease-free survival benefit with osimertinib was observed irrespective of whether patients received adjuvant chemotherapy or not," added the authors. (cgtlive.com)
  • The standard of care for patients with non-small cell lung cancer (NSCLC) is transitioning away from traditional platinum-based chemotherapy towards genotype-targeted therapy with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) such as erlotinib, gefitinib, and afatinib. (oncologynurseadvisor.com)
  • Post operative chemotherapy is recommended in patients with NSCLC with stages II to IIIA. (ersnet.org)
  • 16:49] Next, she discusses the CheckMate 9LA study, which looked at a combination of 2 immunotherapy drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), plus chemotherapy to treat metastatic or recurrent NSCLC. (cancer.net)
  • After promising phase 1 data , Dr. Yu and colleagues conducted a phase 2 trial in patients with advanced EGFR-mutated NSCLC who had progressed on systematic therapy and had received EGFR TKI and platinum-based chemotherapy. (mdedge.com)
  • Overall, the findings suggest that "HER3-DXd provided clinically meaningful and durable efficacy" in patients with advanced EGFR-mutant NSCLC that has progressed after EGFR TKI and platinum-based chemotherapy, Dr. Yu said. (mdedge.com)
  • The combination of a bispecific antibody against EGFR and MET with a tyrosine kinase inhibitor (TKI) in patients with TKI-relapsed, chemotherapy-naive, EGFR-mutated advanced NSCLC is safe and shows preliminary efficacy. (nature.com)
  • Dosing of the first patients in the BDTX-1535 dose expansion cohorts represents an important step towards offering an oral therapeutic with manageable side effects as a potential alternative to chemotherapy-based regimens following progression on osimertinib for patients with treatment-resistant lung cancer," said David Epstein, PhD, President and Chief Executive Officer of Black Diamond Therapeutics. (drug-dev.com)
  • With chemotherapy for stage I or II NSCLC, the goal is to complete four cycles. (medscape.com)
  • Tyrosine kinase inhibitors (TKIs) against the human epidermal growth factor receptor (EGFR) are now standard treatment in the clinic for patients with advanced EGFR mutant non-small-cell lung cancer (NSCLC). (researchgate.net)
  • Suresh S. Ramalingam, M.D., from the Emory University School of Medicine in Atlanta, and colleagues randomly assigned 556 patients with previously untreated advanced NSCLC with an EGFR mutation to receive either osimertinib or one of two other EGFR-TKIs (gefitinib or erlotinib) combined into a single comparator group. (physiciansweekly.com)
  • The trial randomized the patient to either osimertinib, which is a third generation tyrosine kinase inhibitor, anti-EGFR, or placebo for three years. (ascopost.com)
  • Serious AEs were reported in 54 patients (16%) in the osimertinib group and in 42 patients (12%) in the placebo group.No fatal adverse events were reported in the osimertinib group and only 1 event (a pulmonary embolism) occurred in the placebo group. (cgtlive.com)
  • Results from ASCO 23 provide confidence that adjuvant osimertinib should be considered the standard of care for patients with resected EGFRm stage IB-IIIA NSCLC. (bpno.dk)
  • The totality of the data from his team's research "instills confidence that adjuvant osimertinib is the standard of care for patients with resected EGFR[-mutated] stage IB-IIIA non-small-cell lung cancer," Herbst said. (upi.com)
  • For instance, stage IV NSCLC and MET exon 14 skipping mutation may be treated with MET -targeted therapy - capmatinib (Tabrecta) or tepotinib (Tepmetko) - in the first-line setting, while for patients with stage IV NSCLC and driver alterations in RET, first-line setting, selpercatinib (Retevmo) is an option. (lcfamerica.org)
  • There was a 40% or more improvement in 3-year progression-free survival by adding osimertinib. (medscape.com)
  • Osimertinib has potent central nervous system activity, and patients could receive the agent for 3 years while enrolled in the ADAURA trial because of its tolerability and survival benefits, Herbst concludes. (onclive.com)
  • THURSDAY, Dec. 5, 2019 (HealthDay News) - For patients with previously untreated advanced non-small cell lung cancer (NSCLC) with an EGFR mutation, overall survival is longer for treatment with osimertinib rather than comparator tyrosine kinase inhibitors of the epidermal growth factor receptor (EGFR-TKIs), according to a study published online Nov. 21 in the New England Journal of Medicine . (physiciansweekly.com)
  • The major efficacy outcome measure was investigator-assessed, disease-free survival among the 233 osimertinib vs 237 placebo patients with stage II to IIIA disease. (ascopost.com)
  • The five-year survival was 85% for the patient who received osimertinib versus 73% for patient who received placebo. (ascopost.com)
  • This overall survival data means that osimertinib increase the chance of a cure. (ascopost.com)
  • Osimertinib in combination with platinum-based therapy and pemetrexed demonstrated a statistically significant and clinically meaningful improvement in progression-free survival vs osimertinib monotherapy in patients with EGFR-mutated advanced non-small cell lung cancer. (onclive.com)
  • More recent data indicate that osimertinib treatment is even superior to single agent first-generation inhibitors such as erlotinib or gefitinib in terms of PFS and overall survival (OS) in the first-line setting 13 . (nature.com)
  • In phase 1 and 2 clinical trials in patients with ROS1-positive NSCLC,) the overall response rate with entrectinib was about 75 percent, with a comparable response rate in the central nervous system and a progression-free survival (PFS) of 19 months. (curetoday.com)
  • This is because numerous lines of evidence show that patients with stage IV NSCLC and a targetable mutation typically have improved overall survival (OS) when treated with a targeted therapy. (jnccn.org)
  • The ADAURA trial found that the third-generation EGFR tyrosine kinase inhibitor (TKI) osimertinib improved 3-year disease-free survival in stage IB-III, EGFR -positive NSCLC. (jnccn.org)
  • In a first for the lung cancer field, adjuvant osimertinib unequivocally improves survival in people with resected [surgically treated] EGFR-mutated non-small cell lung cancer," Pennell said in a news release from the American Society of Clinical Oncology (ASCO). (upi.com)
  • Although advanced treatments including targeted therapy and immunotherapy have developed, such as Crizotinib, Osimertinib, Pembrolizumab, and Atezolizumab, the 5-year overall survival rate of patients with NSCLC is still less than 20% [ 2 ]. (medsci.org)
  • Non-small Cell Lung Cancer The ADAURA trial confirmed that in patients with early-stage (stage II to IIIA) NSCLC, adjuvant treatment with osimertinib after surgical resection of the tumor significantly improved overall survival. (medscape.com)
  • 15 March 2019), 188 patients (67%) receiving osimertinib versus 93 (66%) receiving platinum-pemetrexed had died. (nih.gov)
  • In the patients with stage II and IIIA NSCLC, osimertinib provided an OS benefit compared with placebo. (onclive.com)
  • Another change in the guidelines is a strong push toward testing in resectable stage IB-IIIA NSCLC. (jnccn.org)
  • These study results suggest that osimertinib as adjuvant therapy is an effective treatment strategy for patients with stage IB to IIIA EGFR-positive non-small cell lung cancer following complete tumor resection. (cgtlive.com)
  • The study, published in The New England Journal of Medicine , suggests that osimertinib as adjuvant therapy is an effective treatment strategy for this patient population following complete tumor resection. (cgtlive.com)
  • The adoption of third-generation tyrosine kinase inhibitors (TKIs) to treat non-small cell lung cancer (NSCLC) for EGFR positive patients has led to acquired resistance pathways in approximately 40 percent of EGFRT790M-positive NSCLC patients. (lcfamerica.org)
  • The NeoADAURA (NCT04351555) and LAURA (NCT03521154) trials are also currently under way to investigate the efficacy and safety of neoadjuvant osimertinib in patients with EGFR -positive resectable NSCLC and osimertinib after chemoradiation in stage III unresectable EGFR -positive NSCLC, respectively. (cgtlive.com)
  • However, for several years, Pfizer has been studying Xalkori's efficacy and safety in other molecularly defined NSCLC subsets, and the fruit of that work has finally resulted in a new regulatory filing with the FDA. (genomeweb.com)
  • This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. (uchicagomedicine.org)
  • In the primary DFS analysis of ADAURA, published in October 2020, adjuvant osimertinib led to a statistically significant DFS improvement compared with placebo. (onclive.com)
  • These DFS data supported the 2020 FDA approval of adjuvant osimertinib in patients with EGFR -mutant NSCLC. (onclive.com)
  • Dr. Jyoti Patel, the 2020 Cancer.Net Associate Editor for Lung Cancer , discusses 3 studies that explored different treatment options for non-small cell lung cancer (NSCLC) . (cancer.net)
  • His leadership in targeted therapeutics resulted in a 2020 ASCO plenary talk and publication of results of the third-generation EGFR-inhibitor osimertinib for the treatment of resected EGFR-mutant NSCLC in the New England Journal of Medicine. (yale.edu)
  • For this review, the authors present findings and results from previous trials, methods for identifying patients for whom osimertinib treatment would be appropriate based on mutation status, mechanisms of resistance, as well as current clinical studies and the optimal sequence of osimertinib in treatment of NSCLC. (oncologynurseadvisor.com)
  • Patients with NSCLC require a complete staging workup to evaluate the extent of disease, because stage plays a major role in determining the choice of treatment. (medscape.com)
  • Because most lung cancers cannot be cured with currently available therapeutic modalities, the appropriate application of skilled palliative care is an important part of the treatment of patients with NSCLC. (medscape.com)
  • The Biodesix process of generating molecular profiling of cell-free DNA and RNA in the blood of patients with NSCLC using next generation sequencing (NGS) was demonstrated as an effective diagnostic tool, with reduced risk to patients as compared to more invasive tissue biopsy. (lcfamerica.org)
  • Recent studies have demonstrated that integrating plasma-based multiplex gene sequencing into routine clinical care can help more patients with NSCLC receive effective molecularly guided therapies . (medscape.com)
  • In this episode, we spoke with Andrew Ciupek, manager of clinical research at the Go2 Foundation for Lung Cancer, to learn more about biomarker testing and the various treatment options available for patients with NSCLC. (curetoday.com)
  • Fusion between echinoderm microtubule-associated proteinlike 4 ( EML4 ) and ALK is seen in approximately 2-7% of patients with NSCLC adenocarcinomas. (medscape.com)
  • ROS-1 gene alterations are present in approximately 1% of patients with NSCLC. (medscape.com)
  • This has been well illustrated and it makes testing critically important for patients with NSCLC," she continued. (jnccn.org)
  • We believe that all patients with NSCLC should be tested, and that molecular testing should be considered for squamous cell lung cancer. (jnccn.org)
  • An OS benefit with osimertinib was also observed across all prespecified patient subgroups analyzed, Herbst notes. (onclive.com)
  • Biodesix ® will release new data demonstrating the potential diagnostic utility of a blood-based test for patients with resistance to osimertinib, and on the precision of liquid biopsy in comparison to tissue biopsy. (lcfamerica.org)
  • Data shows that the Biodesix assay may be of utility in diagnosing patients who have developed resistance to osimertinib, and could save valuable time to treatment. (lcfamerica.org)
  • The median DFS was not yet reached in the osimertinib arm vs 27.5 months in the placebo arm, with a hazard ratio (HR) of 0.20. (onclive.com)
  • The 5-year OS rates with osimertinib and placebo were 85% and 73%, respectively, and the HR was 0.49. (onclive.com)
  • Additionally, in patients with stage IB, II, or IIIA disease, the 5-year OS rate with osimertinib was 88% vs 78% with placebo, translating to an HR of 0.49. (onclive.com)
  • 0001). The proportion of patients with central nervous system involvement at the time of disease recurrence was 1.5% (n = 5) in the osimertinib group and 10% (n = 34) in the placebo group. (ascopost.com)
  • The other point also I'd like to bring up, which was brought up by many, is that in the placebo arm, there are some patients when their disease recurred, did not get osimertinib for a lot of different reasons. (ascopost.com)
  • In total, 682 patients were randomized, including 339 to the osimertinib group and 343 to the placebo group. (cgtlive.com)
  • OS data were immature at the time of analysis, though 29 patients had died, including 9 in the osimertinib group and 20 in the placebo group. (cgtlive.com)
  • Adverse events (AEs) were reported in 329 patients (98%) in the osimertinib group and in 306 patients (89%) in the placebo group. (cgtlive.com)
  • AEs of grade 3 or higher were reported in 68 patients (20%) in the osimertinib group and in 46 patients (13%) in the placebo group. (cgtlive.com)
  • Patients in the trial received either a placebo or osimertinib. (livescience.com)
  • 339 received osimertinib g and 343 placebo. (ersnet.org)
  • 90% of the patients of the patients with stage II to IIIA disease in the osimertinib group vs 44% of those in the placebo group were alive and disease-free. (ersnet.org)
  • Interestingly, in the overall population at 24 months 98% in the osimertinib group vs 85% in the placebo group were alive and did not have central nervous system disease. (ersnet.org)
  • Finally, 29 patients died (9 in the osimertinib group and 20 in the placebo group). (ersnet.org)
  • Patients who are to receive SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to Durvalumab or placebo. (uchicagomedicine.org)
  • Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. (medscape.com)
  • Approximately 80% to 85% of all lung cancers are NSCLC. (livescience.com)
  • As the most common mutation in NSCLC, KRAS accounts for 25%-30% of all such cancers. (medscape.com)
  • The drug's sales are growing from continued strong momentum in metastatic indications, including some types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma cancers, and a rapid uptake across recent earlier-stage launches. (zacks.com)
  • ROS-1 gene alterations, thought to lead to abnormal cells, have been identified in various cancers, including NSCLC. (medscape.com)
  • The new trial involved 682 patients with stages IB, II or IIIA non-small cell lung cancers (NSCLC). (upi.com)
  • It represents a new era of precision therapy, meticulously tailored to the unique needs of patients with metastatic NSCLC. (saifpharma.com)
  • 20:26] Finally, she discusses a study that looked at the use of an antibody-drug conjugate, trastuzumab deruxtecan (Enhertu), to treat metastatic NSCLC with a HER2 mutation. (cancer.net)
  • One group received oral osimertinib (80 mg/day) and the other group received intravenous infusion docetaxel (75 mg/m 2 ) and bevacizumab (7.5 mg/kg) every 21 days until disease progression, unacceptable toxic effects or patient death. (nih.gov)
  • A total of 279 patients were randomly assigned to receive osimertinib and 140 to platinum-pemetrexed (136 received treatment). (nih.gov)
  • For this cohort of the AURA study, researchers assigned 60 treatment-naive patients to receive osimertinib 80 mg or 160 mg once daily, and blood samples were collected from patients whose disease progressed to assess osimertinib resistance mechanisms. (cancertherapyadvisor.com)
  • Eligible Asian patients (enrolled at Asian sites) who were at least 18 years of age (≥20 years in Japan) and had untreated EGFR-mutated advanced NSCLC were randomized 1:1 to receive osimertinib (80 mg, orally once daily) or an SoC EGFR TKI (gefitinib, 250 mg, or erlotinib, 150 mg, orally once daily). (daancancer.com)
  • In addition, a study cohort with a sufficient number of patients harboring an EGFR mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. (uchicagomedicine.org)
  • Patients could crossover to osimertinib on progression confirmed by blinded independent central review. (nih.gov)
  • The results were evaluated with Gene Ontology (GO) enrichment analysis to reveal patterns of protein expression at progression while on osimertinib treatment. (au.dk)
  • The FDA has granted breakthrough therapy designation (BTD) to investigational telisotuzumab vedotin (Teliso-V, AbbVie) for the treatment of individuals with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small-cell lung cancer (NSCLC), with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. (pharmacytimes.com)
  • Among them, 74 were enrolled in the osimertinib group and 73 were in the docetaxel-bevacizumab group. (nih.gov)
  • The main grade 3 or 4 toxic effects were diarrhea (2.7%) and interstitial lung disease (1.4%) in the osimertinib group and alopecia (15.3%), anorexia (12.5%), neutropenia (9.7%) and nausea (8.3%) in the docetaxel-bevacizumab group. (nih.gov)
  • Osimertinib had higher response rate, longer PFS and milder side effects than docetaxel-bevacizumab in third-line therapy in patients with EGFR T790 M positive advanced NSCLC. (nih.gov)
  • Key secondary endpoint of the Phase I AURA study, enrolling EGFR -mutated NSCLC patients who had developed resistance to treatment with EGFR TKIs, included determination of the PK of osimertinib. (oncologynurseadvisor.com)
  • Two bispecific antibodies in development, amivantamab for NSCLC and teclistamab for multiple myeloma, have some similarities, but one is being developed for a solid tumor and the other for hematologic cancer. (ajmc.com)
  • Osimertinib has warnings/precautions for interstitial lung disease/pneumonitis, QTc interval prolongation, cardiomyopathy, keratitis, Stevens-Johnson syndrome and erythema multiforme major, cutaneous vasculitis, and embryofetal toxicity. (ascopost.com)
  • Preliminary clinical PK analysis on a small number of NSCLC patients indicated that osimertinib and its active metabolites, AZ5104 and AZ7550, have a half-life of at least 50 h, longer than would be predicted from the preclinical data, which resulted in a desirable flat PK profile after multiple once daily dosing. (oncologynurseadvisor.com)
  • Liquid biopsy is increasingly utilized for non-invasive clinical testing, as 30 percent of advanced NSCLC patients are not eligible for tissue biopsy. (lcfamerica.org)
  • Información confiable y compasiva para personas con cáncer, sus familiares y sus cuidadores, de parte de expertos de la American Society of Clinical Oncology (la Sociedad Estadounidense de Oncología Clínica, ASCO por sus siglas en inglés), la voz de los médicos del cáncer y los profesionales oncológicos del mundo. (cancer.net)
  • A year ago, ASCO released a clinical practice guideline on systemic therapy for patients with stage IV non-small cell lung cancer (NSCLC) without driver alterations. (lcfamerica.org)
  • Black Diamond Therapeutics, Inc. recently announced the first patients dosed in mutation matched expansion cohorts of non-small cell lung cancer (NSCLC) in the ongoing Phase 1 clinical study evaluating BDTX-1535. (drug-dev.com)
  • and new immunotherapy agents are recommended for advanced NSCLC without a driver oncogene. (jnccn.org)
  • An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation. (uchicagomedicine.org)
  • the median OS was 26.8 months (95% CI 23.5-31.5) versus 22.5 months (95% CI 20.2-28.8) for osimertinib and platinum-pemetrexed, respectively. (nih.gov)
  • The median central nervous system PFS was not calculable for the osimertinib group and was 13.8 months for the SoC EGFR TKI group (hazard ratio = 0.55, 95% confidence interval: 0.25-1.17, p = 0.118). (daancancer.com)
  • The median time to maximum plasma concentration (C max ) of osimertinib after single oral dosing was 6 h (range 3-24 h) across all doses. (oncologynurseadvisor.com)
  • In this Asian population, first-line osimertinib demonstrated a clinically meaningful improvement in PFS over an SoC EGFR TKI, with a safety profile consistent with that for the overall FLAURA study population. (daancancer.com)
  • Non-small cell lung cancer (NSCLC) is a formidable adversary, but a ray of hope now shines through with Tasso 80 mg (Osimertinib). (saifpharma.com)
  • Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. (cgtlive.com)
  • Lung cancer is the leading cause of cancer-related deaths in the U.S. , with NSCLC being the most commonly diagnosed subtype. (lcfamerica.org)
  • The study was the result of a 682-patient trial that included participants diagnosed with non-small cell lung cancer (NSCLC), one of two main types of primary lung cancer. (livescience.com)
  • This includes non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC). (imarcgroup.com)
  • During ASCO, Janssen presented results from the CHRYSALIS study on amivantimab, a bispecific antibody being developed to treat non-small cell lung cancer (NSCLC). (ajmc.com)
  • While the treatment landscape for non-small cell lung cancer (NSCLC) continues to evolve, there is a heavy emphasis on discovering new targeted therapies for patients. (curetoday.com)
  • Updates to the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) for 2021 include recommendations for biomarker testing in all appropriate patients with newly diagnosed advanced lung cancer, including squamous cell lung cancer. (jnccn.org)
  • SINGAPORE - Heavily pretreated patients with EGFR-mutated non-small cell lung cancer (NSCLC) may experience a clinically meaningful benefit with the antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd), new phase 2 trial results suggest. (mdedge.com)
  • NSCLC is defined as any type of epithelial lung cancer other than SCLC, which can include adenocarcinoma, large-cell carcinoma, and squamous cell carcinoma, as well as less common types of cancer. (pharmacytimes.com)
  • Non-small cell lung cancer (NSCLC) accounts for 85-90% of cases, while lung adenocarcinoma (LUAD) is the most common subtype [ 2 ]. (medsci.org)
  • Surgery is recommended for patients with stage I or II non-small cell lung cancer NSCLC) and may provide the best possibility for a cure. (medscape.com)