Ifinatamab deruxtecan
- Generic Name
- Ifinatamab deruxtecan
- Drug Type
- Biotech
- CAS Number
- 2484870-92-8
- Unique Ingredient Identifier
- C6I0GC0GX5
Merck and Daiichi Sankyo Launch Phase 3 Trial of Novel B7-H3 Targeted ADC for Advanced Esophageal Cancer
• The IDeate-Esophageal01 Phase 3 trial has begun evaluating ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody-drug conjugate, against standard chemotherapy in advanced esophageal squamous cell carcinoma.
• Esophageal squamous cell carcinoma accounts for 90% of global esophageal cancers with dismal survival rates of 15-20%, highlighting the urgent need for new treatment approaches after first-line therapy failure.
• The trial follows promising early-phase results and will enroll approximately 510 patients across Asia, Europe, and North America, with overall survival as the primary endpoint.
Durvalumab Shows Breakthrough Results in Limited-Stage Small Cell Lung Cancer Treatment
• Durvalumab demonstrated significant survival benefits as consolidation therapy after chemoradiation in limited-stage small cell lung cancer patients, establishing a potential new standard of care.
• The FDA granted breakthrough therapy designation to durvalumab for limited-stage small cell lung cancer treatment, following compelling data from the phase 3 ADRIATIC trial.
• The ADRIATIC study showed improved progression-free and overall survival with durvalumab, regardless of prior prophylactic cranial irradiation or concurrent chemoradiotherapy use.
GSK's GSK'227 Receives FDA Breakthrough Therapy Designation for Relapsed Osteosarcoma
• The FDA granted Breakthrough Therapy Designation to GSK'227 for relapsed or refractory osteosarcoma after two prior lines of therapy.
• The designation aims to expedite the development of GSK'227, a B7-H3-targeted antibody-drug conjugate, for this rare bone cancer.
• The FDA's decision was based on promising data from the ARTEMIS-002 trial, which evaluated GSK'227 in osteosarcoma patients.
• GSK'227 represents a potential new treatment option for osteosarcoma patients with limited alternatives after chemotherapy failure.
Global Clinical Trial Landscape Shows Asia-Pacific Leading SCLC Research with Over 1,200 Studies Since 2019
• Small cell lung cancer affects approximately 400,000 new patients globally, with Asia reporting the highest case numbers, followed by Europe and North America.
• First-line treatment protocols vary by stage, with limited-stage SCLC receiving platinum-based chemotherapy with radiotherapy, while extensive-stage cases require additional immunotherapy.
• The Asia-Pacific region leads in clinical trial activity since 2019, with China emerging as a prominent research hub, while innovative therapies including immune checkpoint inhibitors and antibody-drug conjugates show promising advances.
DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer
• DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy.
• The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months.
• This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.
Datopotamab Deruxtecan Granted FDA Breakthrough Therapy Designation for EGFR-Mutated NSCLC
• The FDA granted Breakthrough Therapy Designation to datopotamab deruxtecan (Dato-DXd) for EGFR-mutated non-small cell lung cancer (NSCLC).
• The designation is based on Phase 2 TROPION-Lung05 data, indicating a potential benefit in previously treated patients.
• Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate being jointly developed by AstraZeneca and Daiichi Sankyo.
• AstraZeneca and Daiichi Sankyo withdrew their BLA for Dato-DXd in advanced or metastatic nonsquamous NSCLC based on Phase 3 data from the TROPION-Lung01 trial.
WCLC 2024: Novel Therapies and Biomarkers Advance Lung Cancer Treatment
• Perioperative nivolumab demonstrates superior event-free survival compared to neoadjuvant nivolumab in resectable NSCLC, showing benefit even in PD-L1 negative cases.
• Amivantamab plus lazertinib shows improved overall survival versus osimertinib in first-line EGFR-mutated advanced NSCLC, with a favorable trend in intracranial progression-free survival.
• Ivonescimab significantly prolongs progression-free survival compared to pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC in a Chinese patient cohort.
• Zongertinib demonstrates a high objective response rate in HER2-mutated NSCLC, paving the way for combination regimens with ADCs or use as second-line therapy.
Enhertu Wins 2024 Prix Galien USA Award for Best Biotechnology Product
• Enhertu, developed by Daiichi Sankyo and AstraZeneca, received the 2024 Prix Galien USA Award for Best Biotechnology Product, recognizing its impact on improving human health.
• The award acknowledges Enhertu's innovative HER2-directed antibody-drug conjugate (ADC) technology and its role in redefining metastatic breast cancer treatment.
• Enhertu has received multiple approvals globally for HER2-positive and HER2-low breast cancer, NSCLC with HER2 mutations, and HER2-positive gastric or GEJ adenocarcinoma.
• Ongoing clinical trials are evaluating Enhertu's efficacy and safety across various HER2-targetable cancers, both as monotherapy and in combination with other treatments.
Ifinatamab Deruxtecan Shows Promise in Extensive-Stage Small Cell Lung Cancer
• Ifinatamab deruxtecan (I-DXd) demonstrated promising activity in patients with extensive-stage small cell lung cancer (ES-SCLC) at the World Congress on Lung Cancer.
• The antibody-drug conjugate (ADC) I-DXd showed a dose-response relationship, with higher doses yielding improved overall response rates in ES-SCLC.
• Combination strategies involving ADCs like I-DXd with immunotherapy are being explored due to the potential for immunogenic cell death induction.
• Protein engineering advancements are enabling the development of targeted therapies with improved clinical responses in lung cancer.
Antibody-Drug Conjugates for Cancer Show Promise with Multiple FDA Approvals Anticipated by 2027
• The cancer antibody-drug conjugate (ADC) market is experiencing substantial growth, driven by the demand for targeted therapies that improve efficacy and reduce side effects.
• Over 600 ADCs are currently in clinical trials, with more than 20 in Phase 3, indicating a robust pipeline of potential new cancer treatments.
• Several ADC candidates are in late-stage clinical trials, targeting various malignancies, including lung, breast, and urogenital cancers.
• ADCs combine monoclonal antibodies with cytotoxic agents, enabling targeted drug delivery to cancer cells, improving patient outcomes and diagnostic accuracy.
Ifinatamab Deruxtecan Shows Promise in Extensive-Stage Small Cell Lung Cancer
• Interim data from the IDeate-Lung01 trial reveal a 54.8% objective response rate with ifinatamab deruxtecan (I-DXd) at 12 mg/kg in patients with extensive-stage small cell lung cancer (ES-SCLC).
• The disease control rate (DCR) reached 90.5% in the 12 mg/kg arm, indicating a substantial proportion of patients experienced disease stabilization.
• The 12 mg/kg dose of I-DXd has been selected for further evaluation in the second part of the IDeate-Lung01 trial and the phase 3 IDeate-Lung02 study.
• Further research is needed to fully assess the toxicity profile of I-DXd and to analyze the complete data from the IDeate-Lung01 study.
I-DXd Antibody-Drug Conjugate Shows Promise in Extensive-Stage Small Cell Lung Cancer
• Interim analysis of the Phase 2 IDeate-Lung01 study reveals that I-DXd demonstrates clinically meaningful responses in pretreated patients with extensive-stage small cell lung cancer (ES-SCLC).
• The study evaluated two doses of I-DXd (8 mg/kg and 12 mg/kg) in patients who had received prior platinum-based chemotherapy, with the 12 mg/kg dose showing a higher overall response rate.
• The 12-mg/kg dose demonstrated a confirmed objective response rate of 54.8%, approximately twice that of the 8-mg/kg dose, which had a 26.1% response rate.
• Based on these findings, the 12-mg/kg dose has been selected for further study in the extension part of IDeate-Lung01 and in the Phase 3 IDeate-Lung02 study.
Ifinatamab Deruxtecan Shows Promise in Treating Small Cell Lung Cancer
• Interim Phase 2 trial results indicate that ifinatamab deruxtecan (I-DXd) demonstrates notable activity against small cell lung cancer (SCLC).
• The 12 mg/kg dose of I-DXd achieved an objective response rate (ORR) of approximately 55% in SCLC patients, while the 8 mg/kg dose showed an ORR of ~26%.
• Median overall survival reached 11.8 months with the 12 mg/kg dose and 9.4 months with the 8 mg/kg dose, with preliminary intracranial responses also observed.
• Merck and Daiichi Sankyo have selected the 12 mg/kg dose for further expansion in the trial, based on efficacy and safety data.
Ifinatamab Deruxtecan Shows Promise in Extensive-Stage Small Cell Lung Cancer
• Interim analysis of the IDeate-Lung01 phase II trial reveals that ifinatamab deruxtecan (I-DXd) demonstrates promising activity in pretreated patients with extensive-stage small cell lung cancer (SCLC).
• Patients treated with I-DXd 12 mg/kg showed a confirmed objective response rate (ORR) of 54.8%, more than double the 26.1% ORR in the 8 mg/kg cohort.
• The disease control rate was also higher in the 12-mg/kg group, at 90.5% versus 80.4% in the 8-mg/kg group, showcasing the potential of I-DXd in managing this aggressive cancer.
• I-DXd at 12 mg/kg is currently being evaluated in the ongoing phase III IDeate-Lung02 trial, building on the encouraging phase II results.
Ivonescimab and IBI363 Show Promise in Advanced Solid Tumors at ESMO 2024
• Ivonescimab demonstrates encouraging Phase II data in advanced triple-negative breast cancer, recurrent/metastatic head and neck squamous cell carcinoma, and metastatic microsatellite-stable colorectal cancer.
• IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein combined with bevacizumab, shows promising anti-tumor activity in advanced colorectal cancer.
• Updated Phase 3 MARIPOSA study results reveal significant overall survival improvement with amivantamab plus lazertinib over osimertinib in EGFR-mutant advanced NSCLC.
• Sacituzumab govitecan and ifinatamab deruxtecan demonstrate activity in extensive-stage small cell lung cancer, offering potential new treatment options.
Merck Discontinues Phase 3 KeyVibe-008 Trial of Vibostolimab and Pembrolizumab in Extensive-Stage Small Cell Lung Cancer
• Merck halted the Phase 3 KeyVibe-008 trial after an independent review showed the vibostolimab/pembrolizumab combination with chemotherapy did not meet futility criteria for overall survival in ES-SCLC.
• Patients receiving the vibostolimab and pembrolizumab fixed-dose combination experienced a higher rate of adverse events and immune-related adverse events compared to the control arm.
• The trial evaluated vibostolimab, an anti-TIGIT antibody, combined with pembrolizumab (KEYTRUDA®), an anti-PD-1 therapy, plus chemotherapy versus atezolizumab plus chemotherapy as a first-line treatment.
• Merck is currently notifying study investigators to stop treatment with the vibostolimab/pembrolizumab combination and offer patients the option to switch to atezolizumab.
Daiichi Sankyo and Merck Expand Collaboration to Develop Novel DLL3-Targeting T-Cell Engager for Small Cell Lung Cancer
• Daiichi Sankyo and Merck have expanded their existing partnership to include MK-6070, an investigational DLL3-targeting T-cell engager, with Merck receiving $170 million upfront in the agreement.
• MK-6070 targets delta-like ligand 3 (DLL3), which is highly expressed in small cell lung cancer and neuroendocrine tumors, and has received FDA Orphan Drug Designation for SCLC treatment.
• The companies plan to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in patients with small cell lung cancer, addressing an aggressive cancer with significant unmet treatment needs.
Phase 3 Trial of Ifinatamab Deruxtecan Launched for Relapsed Small Cell Lung Cancer
• Daiichi Sankyo and Merck have initiated the IDeate-Lung02 Phase 3 trial to evaluate ifinatamab deruxtecan (I-DXd) versus chemotherapy in relapsed small cell lung cancer (SCLC).
• The trial will assess the efficacy and safety of I-DXd, a potential first-in-class B7-H3 directed antibody-drug conjugate, in patients who have progressed after one prior line of platinum-based chemotherapy.
• The primary endpoints of the study are objective response rate (ORR) and overall survival, with secondary endpoints including progression-free survival and duration of response.
• Approximately 460 patients across multiple continents will be enrolled in the IDeate-Lung02 trial, with the aim of addressing the unmet need for effective treatments in relapsed SCLC.
Merck and Daiichi Sankyo Form $22 Billion Alliance for Three Novel Antibody-Drug Conjugates
• Merck will pay Daiichi Sankyo $4 billion upfront plus $1.5 billion in continuation payments, with potential additional milestone payments reaching a total of $22 billion.
• The collaboration focuses on three investigational antibody-drug conjugates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), targeting multiple solid tumors.
• Patritumab deruxtecan has received Breakthrough Therapy Designation for EGFR-mutated non-small cell lung cancer, with a biologics license application planned by March 2024.
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