Ivonescimab Plus Chemotherapy Demonstrates a Statistically Significant Benefit in Overall Survival with a Hazard Ratio of 0.74 in 2L+ Treatment of Patients with EGFRm NSCLC in HARMONi-A Study Conducted by Akeso in China The First Phase III Study Testing Ivonescimab Now Represents the First Statistically Significant OS Benefit Achieved by an Ivonescimab-Containing Regimen Ivonescimab Plus Chemotherapy Demonstrates Median OS of 16.8 Months vs. 14.1 Months, Respectively, for Patients Receiving Ivonescimab Plus Chemotherapy vs. Chemotherapy Alone; OS HR of 0.74 (p=0.019) Favorable Risk-Benefit Profile Observed in This Phase III Study Full Press Release Here: https://lnkd.in/g72yaVXR #SMMTNewERA #TeamSummit #Ivonescimab #OncologyResearch *Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).
More Relevant Posts
-
A survey by ISMP and ECRI highlights the severe impact of drug and equipment shortages on healthcare. Conducted from June 29 to July 27, 2023, it gathered insights from practitioners about shortages affecting medications, single-use supplies, and durable medical equipment. Notably, 44% of respondents reported shortages in hematology and oncology drugs, leading to altered chemotherapy regimens, increased medication error risks, and strained clinical resources. These disruptions compromise patient care quality and pose significant challenges to healthcare operations, underscoring the urgent need for solutions to address supply chain issues.
💊 ISMP Insights on Patient Safety Risks from Drug Shortages In a recent Cancer Journal article, ISMP’s Shannon Bertagnoli, Pharm.D., Ann Shastay, and Rita Jew underscore how ongoing shortages continue to compromise patient safety and care quality. Almost half of practitioners responding to ISMP and ECRI’s national survey on drug, supply, and equipment shortages reported impact on hematology and oncology medications. Other effects discussed in the article include: • Frequent chemotherapy delays and dose adjustments due to shortages • Medication error risks when substituting or compounding alternative treatments • Strain on clinical resources as teams work to manage limited supplies • Need for system-wide collaboration to strengthen supply chain resilience 👉 https://lnkd.in/ei6eJApE #MedicationSafety #DrugShortages #OncologySafety #ISMP #PatientSafety
To view or add a comment, sign in
-
-
Alkermes has announced positive topline results from the Vibrance-2 phase 2 study evaluating alixorexton in patients with narcolepsy type 2 (NT2). Alixorexton, formerly referred to as ALKS 2680, is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development for the treatment of narcolepsy type 1 (NT1), NT2 and idiopathic hypersomnia (IH). – Alixorexton is the First Oral Orexin 2 Receptor Agonist to Demonstrate Efficacy in a Large Phase 2 Study in Patients With Narcolepsy Type 2, Supporting Advancement to Phase 3 – Alixorexton Met the Study's Dual Primary Endpoints, Demonstrating Statistically Significant and Clinically Meaningful Improvements in Wakefulness and Excessive Daytime Sleepiness Compared to Placebo in Patients With Narcolepsy Type 2 – Alixorexton Was Generally Well Tolerated at All Doses Tested Learn more: https://lnkd.in/g8GNYXmY #narcolepsy #orexin #orexinagonist #Alkermes
To view or add a comment, sign in
-
-
MASH is at another turning point. With its first-ever approved treatment (Rezdiffra) now established, and GLP-1, Wegovy, recently FDA-approved for patients with moderate-to-advanced fibrosis, MASH care is moving upstream – towards earlier identification and management. Ipsos’ latest PoV explores the new imperatives for pharma companies operating in this space: Monitor the evolution of the MASH patient flow, from timings and methods of diagnosis to HCPs involved in patient care Understand how the use of available treatment options is unfolding Align drug benefits to the unique requirements of specific patient types Read our full PoV: https://lnkd.in/ec7Sgfwm Ipsos has tracked MASH treatment since 2017; the next wave of our MASH Therapy Monitor will assess Wegovy’s impact and Rezdiffra’s evolving role. #MASH #Hepatology #GLP1 #PharmaInsights
To view or add a comment, sign in
-
MSD has secured an updated FDA label for its breakthrough PAH therapy, WINREVAIR™ (sotatercept-csr k) — now including reduction in hospitalization, lung transplant, and death. Why it matters: This move strengthens Merck’s clinical and strategic edge in pulmonary hypertension. For competitors like Gilead, United Therapeutics, and Janssen, the benchmark just shifted — from improving exercise capacity to demonstrating survival benefit. The update will likely reshape pricing dynamics, reimbursement frameworks, and partnering priorities in rare cardiovascular markets. At Medifirm Intelledge Global, we track such shifts through real-time competitive intelligence, pipeline analytics, and launch strategy insights — helping pharma teams anticipate the next move before it happens. #Merck #CompetitiveIntelligence #PharmaStrategy #PAH #Winrevair #MarketAccess #DrugLaunch #MedifirmIntelledgeGlobal
To view or add a comment, sign in
-
LucidQuest YouTube > Trending in Respiratory Research: CAL101, LTI-03, Taladegib and More: In this edition of Respiratory Research Updates, we highlight key breakthroughs in pulmonary health. Calluna Pharma’s CAL101 received FDA Orphan Drug Designation for IPF, while Rein Therapeutics resumes its Phase 2 trial of LTI-03 in IPF. Endeavor BioMedicines' Taladegib gained EMA PRIME Designation for IPF treatment. Hanmi Pharma’s partnership with Boehringer Ingelheim expands COPD treatment access in Korea. Otsuka’s Phase 3 trial for MDR-TB begins, and GSK Korea launches the Nucala Auto Injector. MannKind discontinues its NTM lung disease trial, focusing on new formulations. Plus, CalciMedica’s promising data for PAH therapy. Stay tuned for more updates! http://dlvr.it/TPH4BT Subscribe for more! #LucidQuest #PharmaCI
To view or add a comment, sign in
-
-
LucidQuest YouTube > Trending in Respiratory Research: CAL101, LTI-03, Taladegib and More: In this edition of Respiratory Research Updates, we highlight key breakthroughs in pulmonary health. Calluna Pharma’s CAL101 received FDA Orphan Drug Designation for IPF, while Rein Therapeutics resumes its Phase 2 trial of LTI-03 in IPF. Endeavor BioMedicines' Taladegib gained EMA PRIME Designation for IPF treatment. Hanmi Pharma’s partnership with Boehringer Ingelheim expands COPD treatment access in Korea. Otsuka’s Phase 3 trial for MDR-TB begins, and GSK Korea launches the Nucala Auto Injector. MannKind discontinues its NTM lung disease trial, focusing on new formulations. Plus, CalciMedica’s promising data for PAH therapy. Stay tuned for more updates! http://dlvr.it/TPGl2r Subscribe for more! #LucidQuest #PharmaCI
To view or add a comment, sign in
-
-
LucidQuest YouTube > Trending in Respiratory Research: CAL101, LTI-03, Taladegib and More: In this edition of Respiratory Research Updates, we highlight key breakthroughs in pulmonary health. Calluna Pharma’s CAL101 received FDA Orphan Drug Designation for IPF, while Rein Therapeutics resumes its Phase 2 trial of LTI-03 in IPF. Endeavor BioMedicines' Taladegib gained EMA PRIME Designation for IPF treatment. Hanmi Pharma’s partnership with Boehringer Ingelheim expands COPD treatment access in Korea. Otsuka’s Phase 3 trial for MDR-TB begins, and GSK Korea launches the Nucala Auto Injector. MannKind discontinues its NTM lung disease trial, focusing on new formulations. Plus, CalciMedica’s promising data for PAH therapy. Stay tuned for more updates! http://dlvr.it/TPGl2m Subscribe for more! #LucidQuest #PharmaCI
To view or add a comment, sign in
-
-
LucidQuest YouTube > Trending in Respiratory Research: CAL101, LTI-03, Taladegib and More: In this edition of Respiratory Research Updates, we highlight key breakthroughs in pulmonary health. Calluna Pharma’s CAL101 received FDA Orphan Drug Designation for IPF, while Rein Therapeutics resumes its Phase 2 trial of LTI-03 in IPF. Endeavor BioMedicines' Taladegib gained EMA PRIME Designation for IPF treatment. Hanmi Pharma’s partnership with Boehringer Ingelheim expands COPD treatment access in Korea. Otsuka’s Phase 3 trial for MDR-TB begins, and GSK Korea launches the Nucala Auto Injector. MannKind discontinues its NTM lung disease trial, focusing on new formulations. Plus, CalciMedica’s promising data for PAH therapy. Stay tuned for more updates! http://dlvr.it/TPH4B0 Subscribe for more! #LucidQuest #PharmaCI
To view or add a comment, sign in
-
-
Encouraging update for the ALK+ lung cancer community—looking forward to topline ALKOVE-1 data on investigational neladalkib for TKI-pretreated advanced ALK+ NSCLC. Gratitude to the patients, caregivers, and researchers; results will need careful, peer-reviewed evaluation. Learn why biomarker testing matters: https://lnkd.in/ggsz29en #ALKpositive #NSCLC #ClinicalTrials #PrecisionOncology #LungCancer
⚡ TUNE IN ON MONDAY: Topline pivotal data for TKI pre-treated patients with advanced ALK+ NSCLC from our ALKOVE-1 clinical trial of investigational candidate neladalkib are coming. Join our live webcast & conference call on November 17, 2025 at 8:00am ET. Learn more: https://lnkd.in/ejyAWgkE
To view or add a comment, sign in
-