Data presented at this year’s ASCO conference reinforced the importance of patient identification. Dedham Partners Matthew Cunningham and Aaron McKeon-Fish provided an overview of the conference and the Merck Moderna readouts for PharmaLive. Check out their insights here: https://ow.ly/oZsk50SileP
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Onco-This-Week (OTW) is here with bite-size updates on Oncology Clinical Development. 📁Subscribe to get the free newsletter directly in your inbox at: https://lnkd.in/e3WDGyVz 💊DRUG APPROVALS 📌USA: Pfizer TIVDA in Cervical Cancer; Novartis Lutathera in pediatric gastroenteropancreatic neuroendocrine tumors; Accelerated approval for Day One Biopharmaceuticals OJEMDA in R/R BRAF-altered pLGG 📌EU: Astellas Pharma XTANDI in Prostate Cancer; Legend Biotech CARVYKTI in R/R MM; Beigene Tislelizumab in NSCLC 📌China: Apollomics Vebreltinib in Gliomas 🔬REGULATORY NEWS 📌EU: AstraZeneca Truqap Faslodex for approval in Breast Cancer 📌HOOKIPA Pharma Inc. Ph2/3 design of HB-200 pembrolizumab in HPV16 OPSCC aligned with FDA feedback 📌Positive CHMP Opinion: BMS Opdivo Cisplatin, & Gemcitabine as 1L in Unresectable or mUC; Jansen and Jansen RYBREVANT chemo as 1L in NSCLC 📌FDA FTD: Compass Therapeutics Inc. CTX-009 Paclitaxel in BTC; Deverra Therapeutics DVX101 in AML 📌GSK FDA PR sBLA of Jemperli chemo in Endometrial Cancer 📌Encouraging FDA feedback for Evexta Bio rupitasertib in Breast Cancer 📌IND application cleared: OncoC4, Inc. SIGLEC 10 ICI ONC-841 in Solid Tumors 📌Breakthrough Therapy Designation: Kura Oncology, Inc. Ziftomenib in NPM1-Mutant AML 📌FDA Approves CT for GenFleet Therapeutics GFH925 in Ph3 CT for mCRC 📢TRIAL RESULTS 📌Significant PFS in DESTINY-Breast06 Ph3 CT of AstraZeneca Enhertu in Breast Cancer following endocrine therapy 📌Positive OS for ImmunityBio, Inc. Anktiva ICI in NSCLC; Talks with FDA for Registration of ANKTIVA in LC 📌Immutep Limited: Positive Results from TACTI-003 Cohort B 📌AIM ImmunoTech First Dose Well-Tolerated in Ph1b/2 of Ampligen Imfinzi in Pancreatic Cancer 📊TRIAL/PROGRAM STATUSES 📌Enrollment Completed: Starton Therapeutics STAR-LLD Ph1b CT in MM 📌First Patient Dosed: Compass Therapeutics Inc. Ph1 of CTX-8371 in Solid Tumors 📌IDEAYA Biosciences selects Ph2 Dose for IDE397 Monotherapy in MTAP-Deletion sNSCLC 📌Nykode Therapeutics initiate Ph2 of VB10.16 in HPV16 ve, PD-L1 ve Cervical Cancer 📌SELLAS Life Sciences Group, Inc. Positive Recommendation of Data Monitoring Committee after Enrollment in REGAL Ph3 📌INmune Bio Inc. Completes First, & initiates Second Cohort of Ph1/2 of INKmune NK Cell Therapy in mCRPC 💼BUSINESS NEWS 📌Allogene Therapeutics $15M CIRM Grant to support Ph1 TRAVERSE CT for ALLO-316 in RCC 📌Collaboration: Hanmi Pharmaceuticals & MSD for BH3120 KEYTRUDA; Ono & PRISM BioLab for Novel Drug Candidates in Oncology 📌Endeavor BioMedicines Raise $132.5M for Transformational Medicines 📌Tharimmune, Inc. Announce Option Agreement to Generate HER2/HER3 ADCs 📌Flindr Therapeutics €20M financing for first-in-class small molecule inhibitors 📌Acquisition: ONO PHARMA USA gets Deciphera Pharmaceuticals ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur & Himanshi Agarwal, PhD, Social Media Managers
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Join Richa Tewari, as she highlights comprehensive oncology clinical development weekly updates with Onco-This-Week (OTW) 📁Subscribe to get your OTW newsletter directly weekly to your inbox at: https://lnkd.in/e3WDGyVz 🔬REGULATORY NEWS 📌EMA validated Type II Application for Bristol Myers Squibb Opdivo Yervoy for 1L HCC 📌Sumitomo Pharma America, Inc. DSP-5336 Received FDA FTD for R/R AML 📌End-of-Phase-2 Meeting Outcomes and Topline Interim Ph 2 Data for Agenus BOT/BAL in MSS CRC announced 📌U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SELLAS Life Sciences Group, Inc. SLS009 for pediatric AML 📌FDA FTD for Diakonos Oncology Pancreatic Cancer Dendritic Cell Vaccine 📌sNDA accepted for Shanghai Junshi Biosciences Co Ltd Toripalimab Bevacizumab for 1L HCC 📢TRIAL RESULTS 📌Bayer Darolutamide meets PE in Ph3 ARANOTE trial in prostate cancer 📌FAILED TRIAL: AVEO Oncology Ph 3 TiNivo-2 didn’t meet PE from rechallenging RCC patients with immunotherapy after receiving ICI beyond progression on previous ICIs 📊TRIAL STATUSES 📌BioSyngen BRG01 Enters Ph2 CT For Solid Tumors On Recurrent/Metastatic Nasopharyngeal Carcinoma 📌Revolution Medicines RMC-6236 to advance to Ph3 testing in pancreatic cancer following encouraging results from a Ph1 study 💼BUSINESS NEWS 📌SOTIO Biotech Enters into Multi-Target Antibody Agreement with Biocytogen to Expand ADC Pipeline 📌Scorpion Therapeutics Announces $150 M Series C Financing to Advance Leading Clinical-stage Precision Oncology Pipeline 📌CatalYm GmbH Announces New Financing of $150M to Support Broad Ph2b Development Program for Visugromab 📌Full-Life Technologies, SK Biopharmaceuticals Enter Licensing Agreement for Novel Therapeutic Targeting Multiple Solid Tumors 📌GC Cell and Checkpoint Therapeutics Inc Advance Collaborative Cancer Research 📌Sermonix Pharmaceuticals Receives U.S. Patent for Lasofoxifene as Method for Aromatase-Resistant ER Breast Cancer in the Absence of ESR1 Mutations 📌ORIC Pharmaceuticals Inc. Announces Multiple Clinical Collaborations for Evaluating ORIC-944 AR Inhibitors for Prostate Cancer ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD and Anusha Jayaraman, PhD, Managing Editors Himanshi Agarwal, PhD and Siftjit Kaur, PhD, Social Media Managers
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The blog titled Unmasking the Silent Danger: The Unseen Perils of Prescription Drugs discusses the often overlooked risks of prescription drug misuse, calling it a silent epidemic that transcends demographic and socio-economic boundaries. It emphasizes the critical role healthcare providers play in monitoring drug use, identifying harmful patterns, and educating patients while urging personal responsibility in using medications as directed and exercising caution with online purchases. The article advocates for a multi-level approach to prevent misuse and accidental ingestion, asking if enough is being done policy-wise to address the evolving landscape of drug usage and misuse.
Decoding Cancer: The Multidisciplinary Approach Transforming Diagnosis and Treatment
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Pharmacists play a crucial role in guiding the complexities of treatment eligibility, administration, and toxicity management of bispecific antibody therapy in patients with relapsed or refractory multiple myeloma (RRMM). In a recent Pharmacy Times Clinical Forum panel discussion in New York, pharmacists addressed the unmet needs of RRMM patients, discussed trends in bispecific antibody therapy management, and shared actionable insights. Some key strategies highlighted included staff education, treatment guidelines, and improved communication with community care centers to elevate patient care. Check out the full recap article below. If you are interested in our clinical forums, please feel free to reach out! #Pharmacists #PatientCare #RRMM #BispecificAntibodyTherapy #HealthcareDiscussion https://lnkd.in/eaDwrFef
Navigating Bispecific Antibodies for Multiple Myeloma: Best Practices and Clinical Implementation
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Onco-This-Week (OTW) brings this week's bite-size updates in Oncology Clinical Development. 📁Never miss an update by subscribing to the free newsletter at https://lnkd.in/e3WDGyVz 💊DRUG APPROVALS 📌BMS Opdivo Cisplatin Gemcitabine in mUC 📌BeiGene BRUKINSA in R/R FL 📌Janssen Inc. RYBREVANT Chemo in NSCLC 📌Pfizer Inotuzumab ozogamicin in pediatric ALL 📌EMD Serono, Inc. tepotinib in mNSCLC 🔬REGULATORY NEWS 📌Iovance Biotherapeutics, Inc. Clinical Hold lifted on IOV-LUN-202 CT in NSCLC 📌TransThera | 药捷安康 EU authorizes Ph3 CT for Cholangiocarcinoma; EMA ODD for Tinengotinib 📌DaichiiSankyo EU validates Datopotamab Deruxtecan Applications for NSCLC or Breast Cancer 📌Janssen applies to EMA for DARZALEX-based quadruplet therapy in MM 📌Janssen expands IMBRUVICA label in US to include Oral Suspension 📌TME Pharma IND cleared for NOX-A12 Ph2 in brain cancer 📌PhotonPharma FDA clears Human CT of Innocell in Stage 3/4 Ovarian Cancer 📌FDA ODD: a2bio2 A2B530 in CC; iOnctura for Autotaxin Cancer Therapy; Verastem Oncology Avutometinib in LGSOC 📌China NMPA accepts NDA for AnHeart Therapeutics Taletrectinib as 1L in ROS1 ve NSCLC 📌Oncolytics Biotech Inc. files amendment for Pan Cancer GOBLET Cohort 📢TRIAL RESULTS 📌Positive results from DREAMM-8 Ph3 CT of BMS Blenrep in R/R MM 📌Cardiff Oncology Positive update from 2L ONSEMBLE CT of onvansertib FOLFIRI/bev in RAS-mutated mCRC 📌Mustang Bio publishes Ph1 data for MB-101 IL13Rα2-targeted CAR T-Cells in HGG 📌FAILED TRIAL: Ultimovacs ASA INITIUM Study for UV1 Vaccination Added to Ipilimumab & Nivolumab in Malignant Melanoma 📌Positive data for Alligator Bioscience AB ALG.APV-527 Ph1 CT in Solid Tumors 📌Ultimovacs ASA publishes NIPU Ph2 CT with UV1 for mesothelioma in EJC 📌Immutep Limited announces First Clinical Data from 90mg Dosing of Efti 📌MAIA Biotechnology, Inc. THIO shows efficacy as 3L in NSCLC 📊TRIAL/PROGRAM STATUSES 📌First patient dosed: Cardiff Oncology 1L-RAS-mutated mCRC Trial 📌Verismo Therapeutics opens 2nd Clinical Site for STAR-101 Ph1 CT 📌Debiopharm expands Debio0123 CT to Gynecological Cancers & Solid Tumors 📌MaaT Pharma completes patient recruitment for Ph2a of MaaT013 ICI in Metastatic Melanoma 📌Innate Pharma Ph1/2 of IPH6501 in R/R DLBCL 💼BUSINESS NEWS 📌AVANTGEN gets Milestone Payment for First Patient Dosed in Ph1 with Kite Pharma Investigational CAR-T Therapy 📌BriaCell Therapeutics Corp. executes Letter of Intent to advance Breast & Prostate Cancer Immunotherapies 📌Collaboration: Gilead Sciences-Merus for Ab-Based Trispecific T-Cell Engagers; Transgene-NEC-BostonGene for Ph1/2 CT of Neoantigen CV TG4050; C4 Therapeutics, Inc.-Merck against Critical Oncogenic Proteins 📌Taiho Pharmaceutical Co., Ltd., Enters ELA with Haihe Biopharma for Gumarontinib ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur & Himanshi Agarwal, PhD, Social Media Managers
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Onco-This-Week (OTW) is here with comprehensive updates on Oncology Clinical Development. 📁Subscribe to get the free weekly newsletter directly in your inbox at: https://lnkd.in/e3WDGyVz 💊DRUG APPROVALS 📌China: Astellas Pharma XTANDI in mHSPC 📌EU: AstraZeneca Tagrisso chemo as new 1L for EGFR-mutated advanced lung cancer; Johnson & Johnson RYBREVANT chemo as 1L in NSCLC with activating EGFR ex 20 insertion mutations 🔬REGULATORY NEWS 📌FDA grants FTD to Full-Life Technologies 225Ac-FL-020 for mCRPC 📌Checkpoint Therapeutics Inc completes BLA resubmission to FDA for cosibelimab in cSCC 📌CHMP recommends AstraZeneca Lynparza Imfinzi combo for approval in EU in MMR-proficient endometrial cancer 📌NMPA accepts NDA with Priority Review for HUTCHMED Tazemetostat in R/R FL 📌FDA clears IND: KaliVir Immunotherapeutics Oncolytic Immunotherapy VET3-TGI for Solid Tumors; SCG Cell Therapy SCG142 in HPV-associated solid tumor; Signet Therapeutics Inc. sigx1094 for Diffuse Gastric Cancer 📌CHMP adopts positive opinion for Janssen Inc. BALVERSA in mUC with susceptible FGFR3 genetic alterations 📌Japan’s PMDA clears Henlius CTN for Ph 3 MRCT of Serplulimab Combo in 1L mCRC 📢TRIAL RESULTS 📌FAILED TRIAL: Primary endpoints of PFS and OS not met for Ph2/3 SKYSCRAPER-06 trial of Roche tiragolumab, Tecentriq chemo 📌MaaT Pharma announces First DSMB Positive Review of Ph2 Trial for MaaT033 in Patients Receiving Allo-HSCT 📌Janssen CARVYKTI shows improvement in OS in landmark CARTITUDE-4 study 📌Henlius announces Successful Completion of Ph1 Study of Daratumumab HLX15 📊TRIAL/PROGRAM STATUSES 📌TRACON Pharmaceuticals to terminate Development of envafolimab in sarcoma 📌Allogene Therapeutics activates Three Community Cancer Centers as First Sites for Ph2 ALPHA3 Trial of Cemacabtagene Ansegedleucel as 1L in LBCL 📌First Patient dosed: Ph1/1b Clinical Trial of Quanta Therapeutics QTX3046 📌Apollomics announces focus on vebreltinib study enrollment for NSCLC 📌Atossa Therapeutics, Inc. announce updated Protocol for Trial Evaluating (Z)-Endoxifen Abemaciclib in ER /HER2- Breast Cancer 💼BUSINESS NEWS 📌Collaboration: Radionetics Oncology with Eli Lilly and Company; Boehringer Ingelheim & OSE Immunotherapeutics to advance clinical development of BI 770371; IASO BioTherapeutics(驯鹿生物)& Innovent Biologics for Cell Therapy 📌Exclusive License Agreement: Ubix Therapeutics & Yuhan for UBX-103 in mCRPC; Merck & Orion for Opevesostat in mCRPC; Ipsen for development of Cabometyx in advanced NET based on CABINET Ph3 trial; TuHURA Biopharma for Kineta KVA12123 Novel anti-VISTA Checkpoint Inhibitor 📌Eisai US & Bristol Myers Squibb end global strategic collaboration for the co-development and co-commercialization of farletuzumab ecteribulin; now all rights with Eisai ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur & Himanshi Agarwal, PhD, Social Media Managers
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Join Richa Tewari, PhD as she brings Onco-This-Week (OTW) newsletter with updates on oncology clinical development. 🖐️ Subscribe to get the free weekly newsletter directly in your inbox at: https://lnkd.in/e3WDGyVz ♻️Share with your network to get the conversation going! 💊DRUG APPROVALS 📌FDA: Adaptimmune TECELRA in MAGE-A4 synovial sarcoma; GSK Jemperli chemo in endometrial cancer; Janssen Inc. DARZALEX FASPRO-based regimen in MM 🔬REGULATORY NEWS 📌FDA ODD: Cellectis CLLS52 for ALL; Verastem Oncology Avutometinib & Defactinib for Pancreatic Cancer 📌FDA FTD: BioAlta Ozuriftamab Vedotin for SCCHN; Corvus Pharmaceuticals Soquelitinib for R/R PTCL 📌FDA Clears IND: Umoja Biopharma UB-VV111 for Heme Malignancies 📌Immorta Bio files IND for Senolytic Immunotherapy SenoVax for Lung Cancer 📌FDA Priority Review for Novartis Scemblix for CML based on ASC4FIRST Ph3 data 📌PDUFA Date extended for Syndax Pharmaceuticals Revumenib NDA in R/R KMT2Ar Acute Leukemia 📢TRIAL RESULTS 📌Positive Topline Data: Improved Tumor Response in ALX Oncology ASPEN-06 Ph2 Trial of Evorpacept in HER2 ve Gastric Cancer; Ph2 Results for BioNTech SE mRNA Immunotherapy BNT111 in Melanoma 📌FAILED TRIAL: Primary endpoint not met in FibroGen, Inc. Late-Stage Pamrevlumab Pancreatic Cancer Studies 📌Increased OS for IMUNON IMNN-001 in OVATION 2 Ph2 trial for Ovarian Cancer 📌Henlius Completes Ph1 Study of Daratumumab HLX15 📊TRIAL/PROGRAM STATUSES 📌Merck initiates IDeate-Lung02 Ph3 Trial of Ifinatamab Deruxtecan in SCLC 📌Moleculin Biotech, Inc. designs MIRACLE Ph3 Trial for Annamycin cytarabine approval in R/R AML 📌PDS Biotechnology aligns with FDA on Ph3 Trial in HPV16 ve 1L Head & Neck Cancer 📌Geovax Inc Announces Ph2 Plans for Gedeptin Cancer Therapy 📌MacroGenics, Inc. provides Vobramitamab Duocarmazine Update; discontinues treatment for TAMARACK mCRPC 📌First Patient Dosed: Ph1/2 Trial of Estrella Biopharma, Inc EB103 in B-cell NHL; Nuvalent, Inc. HEROEX-1 Ph1a/1b Trial of NVL-330 📌Cue Biopharma deprioritizes CUE-101 & CUE-102 programs, enhances focus on autoimmune CUE-401 📌Myeloid Therapeutics initiates patient dosing for MT-303 in Ph1 Study for HCC 📌Notable progresses Ph2 volasertib program following FDA Clearance 💼BUSINESS NEWS 📌Collaboration: Vir Biotechnology, Inc.-Sanofi for Multiple Clinical-Stage T-cell Engagers; Instil Bio-Immune Oncology Research Institute to Develop IMM2510 & IMM27M; IDEAYA Biosciences-Biocytogen to Announce Option & License Agreement for B7H3/PTK7 Topo-I-Payload Bispecific ADC Program 📌Boehringer Ingelheim acquires Nerio Therapeutics, secures novel ICIs 📌Incyte to re-prioritize Cancer Drugs In R&D portfolio Refocus 📌中外製薬 / Chugai Pharmaceutical Co., Ltd. In-Licenses PI3K Inhibitor Inavolisib for Breast Cancer with PIK3CA Mutation ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD, & Anusha Jayaraman, PhD Jayaraman, Managing Editors Siftjit Kaur, & Himanshi Agarwal, PhD Agarwal, Social Media Managers
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Onco-This-Week (OTW) is here with the latest updates on Oncology Clinical Development in bite-size amounts. 📁Subscribe to get your weekly OTW fix directly in your inbox at: https://lnkd.in/e3WDGyVz 💊DRUG APPROVALS 📌EU: Merck KEYTRUDA Chemo as Neoadjuvant Treatment then as Monotherapy in NSCLC 📌Japan: AstraZeneca Truqap Faslodex in HR ve breast cancer; Astellas Pharma VYLOY in Gastric Cancer 🔬REGULATORY NEWS 📌Syndax Pharmaceuticals FDA Priority Review of NDA for Revumenib in R/R KMT2Ar Acute Leukemia 📌Allarity Therapeutics Stenoparib Accelerates Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer 📌China NMPA: sBLA accepted for Astellas Pharma enfortumab vedotin KEYTRUDA as 1L in Advanced Bladder Cancer; IND application approved for IASO BioTherapeutics(驯鹿生物)Equecabtagene Autoleucel as 2nd & 3rd L in MM; sNDA for HUTCHMED Savolitinib in mMET Exon14 NSCLC 📢TRIAL RESULTS 📌Primary endpoint met: Bristol Myers Squibb KRYSTAL-12 CT of KRAZATI in KRAS G12C-Mutated Locally Advanced or mNSCLC; Novocure METIS Ph3 CT, Extended Time to Intracranial Progression in Brain Mets from NSCLC 📊TRIAL STATUSES 📌Cantargia AB nears start of DOD-sponsored CT of nadunolimab in leukemia 📌Enrollment completed: Syndax Pharmaceuticals AUGMENT-101 CT in R/R mNPM1 AML; Syros in SELECT-MDS-1 Ph3 CT 📌SELLAS Life Sciences Group, Inc. updates on Ph3 REGAL CT & Positive Topline Data from Ph2a of SLS009 in R/R AML 📌Enrollment initiated: MEI Pharma Ph1, 12-Patient Expansion Cohort for Voruciclib Venetoclax 📌Actinium Pharmaceuticals, Inc. announce CT to Study Iomab-ACT Targeted Radiotherapy Conditioning with Commercial CAR T-Cell Therapy 📌First Patient Dosed: InnoCare Pharma 诺诚健华(HKEX: 09969; SSE: 688428) CT of ICP-189 Furmonertinib combo; PMV Pharmaceuticals, Inc. Global Tumor-Agnostic Ph2 PYNNACLE CT for Rezatapopt in TP53 Y220C ve Solid Tumors; Immuneering Corporation Ph1/2a CT of IMM-6-415 in Solid Tumors with RAF or RAS Mutations; Innovent Biologics Ph3 CT of IBI310 Sintilimab in MSI-H/dMMR Colon Cancer Neoadjuvant Therapy 💼BUSINESS NEWS 📌Genfleet & BeiGene Initiate Ph1b/2 of GFH009 & BRUKINSA in DLBCL 📌Gilead Sciences & Xilio Therapeutics, Inc. ELA For Tumor-Activated IL-12 Program 📌Nuvation Bio acquires AnHeart Therapeutics in All-Stock Transaction; 📌Edgewood Oncology raises $20M to Advance BTX-A51 in Hematologic Malignancies & Genetically-Defined Solid Tumors ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur & Himanshi Agarwal, PhD, Social Media Managers
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We are excited to announce that our partner Zai Lab has dosed its first patient in a global Phase 2 clinical trial evaluating the efficacy and safety of the IL-17 targeted therapy ZL-1102 for the topical treatment of chronic plaque psoriasis. Crescendo granted Zai Lab an exclusive global license for ZL-1102 in May 2018. The preceding Phase 1b study resulted in the declaration of clinical proof-of-concept, where Humabody® VH became the first biologic to penetrate psoriatic skin and result in a clinical benefit. This topical immune-modulating therapy highlights opportunities for new treatment modalities for patients, and further supports the strength of Crescendo’s Humabody® platform beyond systemic administration. We look forward to closely following the Phase 2 trial’s progress. Read the full press release here: https://lnkd.in/eXG_y7a4 #Immunology #Biotech #Therapeutics #Partnership
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Healthcare Management Consulting I Health Insurance | Clinical Data Aggregation I Digital Health I Pharma Market Research and CI I Expert Vetted Freelancer at Upwork
🚀Is Novartis' Scemblix poised to become the next standard of care in 1L CML? Groundbreaking news from Novartis' Phase 3 ASC4FIRST trial on Scemblix® (asciminib), showcasing significant advancements in the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph CML) in the chronic phase. Key Highlights from the ASC4FIRST Trial: 📊 Scemblix demonstrated superior major molecular response (MMR) rates at week 48 compared to standard-of-care (SoC) TKIs (imatinib, nilotinib, dasatinib, bosutinib). 💊 MMR rates: Scemblix 67.7% vs. SoC TKIs 49.0%, and Scemblix 69.3% vs. imatinib alone 40.2%. 🛡️ Superior safety and tolerability profile with fewer grade ≥3 adverse events (AEs) and treatment discontinuations. Current Treatment Landscape for Ph CML: 🔬 First-Line Treatments: Tyrosine Kinase Inhibitors (TKIs) like imatinib, dasatinib, nilotinib, and bosutinib. 🔄 Second-Line Treatments: For patients resistant or intolerant to first-line TKIs, options include ponatinib and the novel allosteric inhibitor asciminib. 🧬 Combination and Experimental Therapies: Ongoing research explores combinations with other targeted therapies and new-generation TKIs. How Scemblix Addresses Unmet Needs: ✅ Resistance and Mutations: Effective against the T315I mutation and other resistant mutations due to its novel mechanism of action. 🌟 Long-term Safety: Demonstrates a favorable safety profile with fewer severe side effects, improving patient quality of life and adherence to therapy. 💊 Adherence and Tolerability: Better tolerability and fewer dose adjustments reduce the burden on patients, particularly the elderly and those with comorbid conditions. 🎯 Achieving Deep Responses: Higher rates of major molecular response (MMR) and deeper molecular responses (MR4 and MR4.5) improve long-term outcomes. 🛡️ Quality of Life: Reduced adverse events and treatment discontinuations enhance overall patient well-being. 🌍 Access and Affordability: Ongoing studies and regulatory approvals aim to make Scemblix more accessible, addressing the high costs of current therapies. Competitive Landscape: 🔎 Several companies are developing competitor molecules targeting similar pathways, including BMS with dasatinib, Pfizer with bosutinib, and Ariad Pharmaceuticals (part of Takeda) with ponatinib. Additionally, Astex Pharmaceuticals is developing ASTX727 for newly diagnosed CML. Regulatory Submission: 📅 Novartis has submitted Scemblix for review under the FDA’s Oncology Center of Excellence Real-Time Oncology Review (RTOR) program and has been granted Breakthrough Therapy Designation, highlighting its potential to significantly improve patient outcomes. FDA approval is anticipated soon, potentially within the next few months. Source: https://lnkd.in/gUAehb2r
Novartis Scemblix® Phase III data first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CML
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