Ifinatamab Deruxtecan (I-DXd) Receives FDA Breakthrough Therapy Designation for Heavily Pretreated Extensive-Stage Small Cell Lung Cancer
Daiichi-Sankyo
Pharmaceutical R&D Developer
8Month18Day, Ifinatamab deruxtecan（I-DXd) has been approved by the U.S. Food and Drug Administration (FDA) Granted Breakthrough Therapy Designation (BTD), for the treatment of adult patients with extensive-stage small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy.
Ifinatamab deruxtecanIs a potential first-in-class targeted drug designed with unique technologyB7-H3Antibody-drug conjugates (ADC）, by Daiichi Sankyo (TSE: 4568）Developed, and co-developed by Daiichi Sankyo and Merck.
FDABreakthrough Therapy Designation aims to expedite the development and regulatory review of new drugs for serious diseases with significant unmet medical needs. Drugs granted this designation must demonstrate encouraging efficacy in early clinical studies, achieving substantial improvement over existing treatment options in clinically significant endpoints.
This timeFDABreakthrough Therapy Designation Based onIDeate-Lung01 IIData from the phase trials, and obtainIDeate-PanTumor01 I/IIData from the phase trial support.IDeate-Lung01The main analysis results of the study will be presented at the conference hosted by the International Association for the Study of Lung Cancer (IASLC).2025World Lung Cancer Conference (#WCLC25) was announced in the form of an oral presentation of the latest重磅 research. This isifinatamab deruxtecanThe First ObtainedBTD, which is also the first one obtained since the launch of the collaboration between Daiichi Sankyo and Merck.BTD。
Global Head of R&D at Daiichi SankyoKen TakeshitaDr. stated:“FDAGrantifinatamab deruxtecanThe breakthrough therapy designation underscores the urgent need for new treatment options among patients with previously treated extensive-stage small cell lung cancer. We will continue to advance the development of this drug, aiming to deliver the first targetedB7-H3TheADCBring to patients, fundamentally improving the treatment prognosis for those with this aggressive disease.”
Senior Vice President of Merck Laboratories, Global Head of Clinical Research and Chief Medical OfficerEliav BarrDr. said:“For patients with extensive-stage small cell lung cancer, treatment options are often very limited once disease progression occurs after standard treatment. This Breakthrough Therapy Designation further strengthens our...ifinatamab deruxtecanConfidence in playing an important role in the treatment of extensive-stage small cell lung cancer. We look forward to the upcoming2025Shared research data at the World Lung Cancer Conference, showcasing the potential of this innovative therapy.”
AboutIDeate-Lung01Research
IDeate-Lung01Is a global, multicenter, randomized, open-labelIIPhase research, to evaluateifinatamab deruxtecanTreatmentPatients with Extensive-Stage Small Cell Lung CancerSafety and efficacy. Patients had previously received at least one line of treatment.Platinum-based Chemotherapy, having received up to three lines of treatment at most.Patients with asymptomatic brain metastases (treatment-naïve or previously treated) are eligible for enrollment.
In the first part of the study (dose optimization), patients were assigned by1:1Proportional Randomization8mg/kgOr12mg/kg ifinatamab deruxtecanTreatment, every3Once weekly intravenous infusion (Q3W). In the second part of the study (dose expansion), patients received12mg/kgOfifinatamab deruxtecanTreatment, every3Once weekly intravenous infusion.
The primary endpoint of the study was the objective response rate (ORR), as assessed by the blinded independent central review (BICR) BasisRECIST v1.1Perform the calculation. Secondary endpoints include duration of response, progression-free survival, disease control rate, time to response, overall survival, pharmacokinetics, and safety.ThroughBICRIntracranial AssessmentORRPerform exploratory analysis.
IDeate-Lung01The study has enrolled participants from Asia, Europe, and North America.187Number of patients. For more information about this study, please visitClinicalTrials.gov。
AboutIDeate-PanTumor01Research
IDeate-PanTumor01Is a global, multi-center, first-in-human, open-label I/IIPhase clinical trial to evaluateifinatamab deruxtecanIn advanced cases where there is no response or intolerance to standard treatment, or where no standard treatment regimen exists,/Safety and efficacy in patients with unresectable or metastatic solid tumors.
The trialIPhase (Dose Escalation) Evaluationifinatamab deruxtecanSafety and tolerability of escalating doses to determine the maximum tolerated dose and recommended expansion dose (RDE）。IIPhase (Dose Expansion) Evaluation in12 mg/kg RDEBelow,ifinatamab deruxtecanSafety and efficacy in patients with squamous non-small cell lung cancer, metastatic castration-resistant prostate cancer, and esophageal squamous cell carcinoma.
The dose-escalation phase of the trial evaluates dose-limiting toxicity and safety; the dose-expansion phase assesses objective response rate, duration of response, disease control rate, progression-free survival, overall survival, and safety. The trial will also evaluate pharmacokinetic endpoints, exploratory biomarkers, and immunogenicity endpoints.
IDeate-PanTumor01The study has enrolled approximately250Number of patients. For more information about this study, please visitClinicalTrials.gov。
About Small Cell Lung Cancer
2022More than cases of lung cancer diagnosed worldwide in248Ten Thousand Cases1. Small Cell Lung Cancer (SCLC) is the second largest type of lung cancer, accounting for approximately15%2。SCLCHighly aggressive, prone to rapid progression to advanced metastatic stages, with a low five-year survival rate.3,4Although the existing standard treatment for advanced small cell lung cancer can improve prognosis to a certain extent, there is still an urgent need for additional subsequent treatment options.5,6,7,8。
AboutB7-H3
B7-H3It is a transmembrane protein that belongs toB7Protein family, which includesPD-1IncludingCD28Receptor Family Binding9,10。B7-H3It is overexpressed in various types of cancer, including small cell lung cancer, and its overexpression has been shown to be associated with poor prognosis, thereforeB7-H3Is one of the most promising therapeutic targets.11,12,13, 14. There is currently no targetedB7-H3The drug has been approved for the treatment of any cancer.
AboutIfinatamab Deruxtecan
Ifinatamab deruxtecan(I-DXd)Is a potential first targeted experimentalB7-H3TheADC。Ifinatamab deruxtecanUsing Daiichi Sankyo's proprietaryDXd ADCTechnical design, by humanized anti-B7-H3 IgG1Monoclonal antibodies are linked to multiple topoisomerases through a cleavable tetrapeptide linker.IInhibitor payload (a derivative of exatecan,DXd) Connection composition.
Ifinatamab deruxtecanApproved in the United StatesFDA, the European Commission, Japan's Ministry of Health, Labour and Welfare, and Taiwan's Food and Drug Administration have granted orphan drug designation for the treatment ofSCLC。
AboutIfinatamab DeruxtecanClinical Development Plan
A comprehensive clinical development program is underway globally to evaluateifinatamab deruxtecanEfficacy and Safety of Monotherapy and Combination Therapy with Other Anticancer Drugs in Various Cancers.
Regarding the Collaboration between Daiichi Sankyo and Merck
Daiichi Sankyo and Merck &2023Year10Monthly achievement of global cooperation, joint development and commercializationpatritumab deruxtecan (HER3-DXd)、ifinatamab deruxtecan (I-DXd)Andraludotatug deruxtecan (R-DXd), and Daiichi-Sankyo has exclusive rights in the Japanese market. Daiichi-Sankyo will be fully responsible for production and supply.2024Year8Month, the cooperation agreement was extended toMK-6070, both parties will jointly develop and commercialize the drug globally, with Merck having exclusive rights in the Japanese market. Merck will be fully responsibleMK-6070Production and supply.
About Daiichi-SankyoADCProduct Series
Daiichi-Sankyo'sADCProduct Portfolio Includes7Products in the clinical development stageADC, theseADCBased on two different internal developments of Daiichi SankyoADCTechnology Platform.
The most advanced in clinical developmentADCThe platform belongs to Daiichi Sankyo Company Limited.DXd ADCTechnical platform, each modelADCBy monoclonal antibodies through a cleavable tetrapeptide linker with multiple topoisomerasesIInhibitor payload (a derivative of exatecan,DXd) Connection composition.DXd ADCThe current product portfolio includes targetedHER2TheADCTrastuzumab deruxtecan, and targetedTROP2TheADCDatozumab. The two products mentioned above are currently being co-developed by Daiichi Sankyo and AstraZeneca and commercialized globally.Patritumab deruxtecan（HER3-DXd, TargetedHER3OfADC）、ifinatamab deruxtecan（I-DXd, TargetedB7-H3TheADC）、raludotatug deruxtecan（R-DXd, TargetedCDH6OfADC) is currently being handled by Daiichi Sankyo andMerck & Co., Inc（Rahway, NJ, USA) Co-develop and commercialize globally.DS-3939is a targetedTA-MUC1OfADC, currently developed by Daiichi Sankyo.
Daiichi Sankyo's SecondADCThe platform consists of monoclonal antibodies and modifications pyrrolobenzodiazepine（PBD) Payload connection composition.DS-9606Is targetedCLDN6ThePBD ADC, which is planned to be used for clinical development on this platform.ADCThe first one in China.
Ifinatamab deruxtecan、patritumab deruxtecan、raludotatug deruxtecan、DS-3939AndDS-9606All are investigational drugs and have not been approved in any country./The region has been approved for any indication. Safety and effectiveness have not been established.
About Daiichi Sankyo
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