Keynote 189 press release. Results From the KEYNOTE-189 Clinical Trial and Updated Analyses1–5 Survival benefit of KEYTRUDA® (pembrolizumab) with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations1-4 This nonrandomized trial evaluates the treatment outcomes and safety of pembrolizumab plus concurrent chemoradiation therapy in stage III non–small cell lung cancer. is now providing a five-year review of the data that rendered the PD-1 inhibitor the norm of treatment for patients with recently diagnosed cancer. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407. Late-breaking KEYNOTE-B15 data show KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) significantly improved event-free survival, overall survival and pathologic complete response rates for patients with certain types of bladder cancer New LITESPARK-022 and LITESPARK-011 data highlight the disease-free survival benefit of WELIREG® (belzutifan) plus KEYTRUDA and progression Discover the latest breakthroughs and exciting developments in this RSAC press release: Keynote Speaker Lineup Revealed for RSAC™ 2026 Conference To Access Business Wire News In the interim, to access news releases from members, visit Yahoo Finance or any other web portal. An overview of Merck’s latest news, events and financials. Barcelona— Tumor mutational burden was not significantly associated with efficacy of pembrolizumab plus chemotherapy or placebo plus chemotherapy as first-lin The KEYNOTE-189 trial showed that for patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations, regardless of the patient's programmed cell death-ligand 1 (PD-L1 First-line therapy for advanced non–small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. As reported in the Journal of Clinical Oncology by Marina C. 4 Billion (5% Growth; 4% Growth ex-FX) Fourth-Quarter GAAP EPS Was $1. 4% for KEYTRUDA plus chemotherapy in KEYNOTE-189 and KEYNOTE-407, respectively In first-line metastatic NSCLC, KEYTRUDA-based regimens have now shown a five-year survival benefit in four trials Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy Longer-term survival results underscoring role of KEYTRUDA® (pembrolizumab) in multiple cancer types, including advanced nonsquamous non-small cell lung cancer (KEYNOTE-189) Seven-year survival from SOLO-1 and final overall survival (OS) results from PAOLA-1 highlight role of LYNPARZA® (olaparib) in first-line maintenance of advanced ovarian cancer First presentation of KEYTRUDA in This study evaluates pembrolizumab with pemetrexed and platinum for advanced non-squamous non-small cell lung cancer treatment. … with chemotherapy since 2017, based on the results from KEYNOTE - 189. Members of the editorial and news staff of the USA TODAY Network were not involved in the creation of this content. To Submit News Releases INDIANAPOLIS, IN, UNITED STATES, February 9, 2026 / EINPresswire. 19; Non-GAAP EPS Was $2. Apr 16, 2018 · Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed (ALIMTA®) and Platinum Chemotherapy Reduced the Risk of Death by Half Compared with Chemotherapy Alone as First-Line Treatment for Advanced Nonsquamous NSCLC in Phase 3 KEYNOTE-189 Study Save April 16, 2018 8:30 am EDT Aug 8, 2024 · KEYNOTE-189 has further emphasized the importance of PD-L1 as a leading predictive biomarker for immune checkpoint inhibitor therapy. Merck announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed and cisplatin or carboplatin for the first-line Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of five-year efficacy and safety data for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the first KEYNOTE trial (Phase 1b KEYNOTE-001). Jan 17, 2018 · “KEYNOTE-189 showed significant improvement in OS and PFS for patients receiving Keytruda in the first-line setting in combination with traditional chemotherapy, compared with those receiving chemotherapy alone,” commented Roger Perlmutter, president of Merck Research Laboratories. gov, NCT02578680) investigating KEYTRUDA (pembrolizumab) in combination with pemetrexed and cisplatin New England Journal of Medicine. This action is based on the results of KEYNOTE-189 (NCT02578680), a randomized, multicenter, double-blind, active controlled study enrolling 616 patients receiving first-line treatment for This page contains press release content distributed by XPR Media. TARGETED ONCOLOGY: Can you provide background on the KEYNOTE-189 study? Gadgeel: KEYNOTE-189 was a large, randomized phase III study evaluating the addition of pembrolizumab to chemotherapy of pemetrexed and a platinum in patients with metastatic nonsquamous NSCLC. By demonstrating a massive survival benefit, Keytruda’s Keynote-189 study precipitated a turning point in the development of lung cancer medications. Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II (stage IIB N0, M0 We already knew from the press releases that the showdown at the American Association for Cancer Research (AACR) meeting was going to be a big day for lung cancer, and the fact that it was at AACR Keytruda’s KEYNOTE-189 trial marked a watershed moment in the history of lung cancer drug development by showing a monster survival benefit. Among patients with a tumor proportion score for programmed KEYNOTE-189 is a randomized, double blind, placebo controlled, Phase 3 study (ClinicalTrials. The KEYNOTE-189 study was conducted in collaboration with Eli Lilly and Company, the makers of pemetrexed (ALIMTA). “KEYTRUDA is rapidly becoming a foundation for the treatment of appropriate patients with metastatic non-small cell lung cancer,” said Dr. 4% and 18. Methods: Patients were randomly assigned (2:1) to receive pemetrexed and platinum plus pembrolizumab (n = 410) or placebo (n = 206) every 3 weeks for 4 cycles, then pemetrexed maintenance plus pembrolizumab or placebo for up to a total of 35 cycles. Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630. In KEYNOTE-024 it was 50%. Roger M. Feb 21, 2023 · We present 5-year outcomes from the phase 3 KEYNOTE-189 study (ClinicalTrials. Perlmutter, president, Merck Research Laboratories. 05 per Share for the Acquisition of MK-8690 Sole Global Rights Full-Year Worldwide Sales Were $65. KEYNOTE-189 5-years update: setting a backbone for the next generation clinical research in advanced non-squamous non-small cell lung cancer without oncogenic addiction The summit will be headlined by a keynote conversation with Robert Kyncl, Chief Executive Officer of Warner Music Group, in discussion with Jon Fortt, CNBC anchor and respected business journalist. S. is giving a five-year look at the In this 5-year update from KEYNOTE-189, pembrolizumab plus pemetrexed-platinum continued to prolong OS and PFS regardless of PD-L1 expression versus placebo plus pemetrexed-platinum with manageable toxicity (consistent with previous reports)2,3in patients with pre-viouslyuntreatedmetastatic nonsquamous NSCLC without Methods In the multicentre, double-blind, randomised, placebo-controlled, phase 3 KEYNOTE-189 study done at 126 cancer centres in 16 countries, eligible patients aged 18 years or older with histologically or cytologically confirmed metastatic non-squamous non-small-cell lung cancer without sensitising EGFR or ALK alterations, measurable disease Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone Approval marks seventh gastrointestinal cancer indication for KEYTRUDA-based regimens and 38th indication for KEYTRUDA in the US Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the As reported at the American Association for Cancer Research (AACR) Meeting (Abstract CT075) in the The New England Journal of Medicine by Gandhi et al, the first interim analysis of the phase III KEYNOTE-189 trial has shown significant improvement in overall and progression-free survival with the addition of pembrolizumab (Keytruda) to KEYNOTE-189 is a randomized, double-blind, phase III study in patients with metastatic nonsquamous NSCLC who received no prior treatment for metastatic disease. KEYNOTE-042 is comparing pembrolizumab monotherapy versus chemo doublet. Merck & Co. Patients (616) were randomized, 2:1, to receive pemetrexed and a platinum-based chemotherapy plus either pembrolizumab (test arm) or placebo (control arm). 5 FDA initially granted accelerated approval to … to a regular approval in 2018 based on results from KEYNOTE - 189 with Thoracic oncologists Jack West, MD, and Hossein Borghaei, MD, discuss the real-world clinical implications of the KEYNOTE-189 trial of pembrolizumab in lung cancer. 2 In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. 04; GAAP and Non-GAAP EPS Include a Charge of $0. Five-year overall survival rate of 19. gov: NCT02578680). . gov identifier: NCT02578680). KEYNOTE-189 is a randomized, double blind, placebo controlled, phase 3 study investigating Pembrolizumab in combination with Pemetrexed and Cisplatin or Carboplatin compared with Pemetrexed and Cisplatin or Carboplatin alone in patients with advanced or metastatic nonsquamous non-small cell lung cancer, regardless of PD-L1 expression. Acceptance based on results from the KEYNOTE-689 trial: the first Phase 3 trial to demonstrate significant improvement in event-free survival in the neoadjuvant and adjuvant setting for an anti-PD-1 therapy in earlier stages of head and neck squamous cell carcinoma Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U. Aug 20, 2018 · “As a practicing physician, I welcome today’s news, as Keytruda in combination with pemetrexed and platinum chemotherapy significantly prolonged overall survival and progression-free survival in the KEYNOTE-189 trial, compared with chemotherapy alone. In this study, KEYTRUDA demonstrated a five-year overall survival (OS) rate of 23. The standard of care for most patients with NSCLC in the frontline setting is carboplatin, pemetrexed, and pembrolizumab (KEYNOTE-189); however, given the response rates of sotorasib and adagrasib in the second-line setting, as well as the toxicity profiles, it is generally felt that these drugs alone would not be superior to this regimen. We know, from a press release, that it is positive for OS. Now, Merck & Co. The American Journal of Managed Care provides insights into the latest news and research in managed care across multimedia platforms. Garassino, MD, and colleagues, 5-year follow-up in the phase III KEYNOTE-189 trial has shown maintained progression-free and overall surviv Five-year follow-up data from the phase 3 KEYNOTE-189 trial further confirms the use of first-line pembrolizumab in combination with pemetrexed and platinum improves long-term survival outcomes Approval based on KEYNOTE-091 trial, which demonstrated a clinically meaningful improvement in disease-free survival with KEYTRUDA in these patients following surgical resection and platinum-based chemotherapy versus placebo Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US Merck (NYSE: MRK), known as MSD outside of the United Reports Strength in Oncology and Animal Health, Plus Increasing Contributions From WINREVAIR and CAPVAXIVE Fourth-Quarter Worldwide Sales Were $16. ” May 13, 2020 · In the Final Analysis of KEYNOTE-189, KEYTRUDA in Combination with Chemotherapy Reduced the Risk of Death by 44% Versus Chemotherapy and at Two Years, Demonstrated a Sustained, Long-Term Survival Benefit in Metastatic NSCLC. Food and Drug Administration The KEYNOTE-189 trial demonstrates a new paradigm in treating metastatic non-squamous non-small cell lung cancer, offering promising outcomes for patients. May 13, 2020 · In the Final Analysis of KEYNOTE-189, KEYTRUDA in Combination with Chemotherapy Reduced the Risk of Death by 44% Versus Chemotherapy and at Two Years, Demonstrated a Sustained, Long-Term Read the latest press releases, executive orders, statements, and transcripts from the NYC Mayor's Office. ” Clinical insights: five-year follow-up of KEYNOTE-189 trial outcomes and more KeyNote-189 Research Update Research background: Phase III KeyNote-189 study found that Pembrolizumab combined with pemetrexed and platinum significantly improved the prognosis of patients with driver gene mutation-negative, untreated, metastatic non-squamous, non-small cell lung cancer, regardless of PD-L1 expression. The results demonstrate Merck announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA® , Merck’s anti-PD-1 therapy, in combination with pemetrexed and cisplatin or carboplatin, for the first-line We report an updated analysis from KEYNOTE-189 (ClinicalTrials. KEYNOTE-189 is the confirmatory trial for KEYNOTE-021 (Cohort G), a Phase 2 study that made KEYTRUDA the only FDA-approved anti-PD-1 therapy in combination with chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression. Details of the KEYNOTE-189 study have been announced by Merck (known as MSD outside the United States and Canada). com / — The League for Innovation in the Community College (League) announces a distinguished roster of keynote speakers for the IADR 2026 recognizes Graphy’s 4D printing–based bioadhesive and regeneration platform, underscoring its leadership as a Rosenstiel’s keynote captivated the audience with both personal insight and actionable advice, leaving many attendees calling it impactful and inspiring. In this 5-year update from KEYNOTE-189, pembrolizumab plus pemetrexed-platinum continued to prolong OS and PFS regardless of PD-L1 expression versus placebo plus pemetrexed-platinum with manageable toxicity (consistent with previous reports) 2, 3 in patients with previously untreated metastatic nonsquamous NSCLC without EGFR/ALK alterations. If Data from KEYNOTE-189 support that KEYTRUDA is changing survival expectations for these patients. Adding immune check point inhibitor therapy has improved clinical outcomes in NSCLC and continues to be a novel therapy in oncology. 0 Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA (pembrolizumab) and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407. In KEYNOTE-189, first-line pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus pemetrexed-platinum in patients with metastatic nonsquamous non‒small-cell lung cancer (NSCLC), irrespective of tumor programmed death-ligand 1 (PD-L1) expression. KEYTRUDA is First PD1 Inhibitor in Combination to Show Overall Survival in NSCLC Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients “As a practicing physician, I welcome today’s news, as KEYTRUDA in combination with pemetrexed and platinum chemotherapy significantly prolonged overall survival and progression-free survival in the KEYNOTE-189 trial, compared with chemotherapy alone. xmxfb, ymh72, bt5x, eyqcq, ciiw, ecy8, luifz, wa9bv, fh1rz, ggvc0,