patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD) 
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  • ||||||||||  Journal:  Antibodies to watch in 2024. (Pubmed Central) -  Jan 9, 2024   
    In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Journal:  Patritumab Deruxtecan Is Efficacious in EGFR-Mutant Non-Small Cell Lung Cancer. (Pubmed Central) -  Dec 17, 2023   
    These data warrant further evaluation of HER3-DXd in patients with HER3-expressing metastatic breast cancer. Patritumab deruxtecan has clinical efficacy in previously treated EGFR-mutant non-small cell lung cancer.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    New trial:  Medical Access Program for Patritumab Deruxtecan (clinicaltrials.gov) -  Oct 25, 2023   
    P=N/A,  N=0, Available, 
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Trial completion date, Trial primary completion date, Metastases:  A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer (clinicaltrials.gov) -  Sep 11, 2023   
    P2,  N=121, Recruiting, 
    Trial completion date: Jul 2024 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Jun 2024 Trial completion date: Nov 2023 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2025
  • ||||||||||  Tagrisso (osimertinib) / AstraZeneca
    Clinical Outcomes of Real-World Treatment for Metastatic EGFRm NSCLC after Osimertinib and Platinum-Based Chemotherapy (Exhibit Hall) -  Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2446;    
    These observations in patients with EGFRm NSCLC after osimertinib and PBC indicate that currently available therapies provide limited clinical benefit, highlighting a significant clinical unmet need. Moreover, these data provide important context for interpreting the results of patritumab deruxtecan as assessed in study HL-01 in this patient population.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Enrollment closed, Trial completion date:  SOLTI TOT-HER3: A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression (clinicaltrials.gov) -  Jun 23, 2023   
    P1,  N=80, Active, not recruiting, 
    As more effective strategies are needed for patients with refractory non-oncogene-addicted NSCLC, the design of novel clinical trials with ADCs targeting TROP-2 is encouraged as both a monotherapy or combination strategy with existing agents (e.g., monoclonal antibodies targeting immune checkpoint inhibitors or chemotherapy). Recruiting --> Active, not recruiting | Trial completion date: Apr 2023 --> Sep 2023
  • ||||||||||  MODULE 6: Recent Advances in the Treatment of Metastatic TNBC (mTNBC) (Hilton Chicago; Grand Ballroom (Level 2)) -  May 26, 2023 - Abstract #ASCO2023ASCO_7068;    
    This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Exact Sciences Corporation, Lilly, Merck, Natera Inc, Puma Biotechnology Inc, Seagen Inc, Stemline Therapeutics Inc, and TerSera Therapeutics LLC. Efficacy and safety findings with pembrolizumab/chemotherapy for previously untreated, PD-L1-positive mTNBC; optimal integration into practicePublished data evaluating the utility of ctDNA testing to assess immunotherapy response in patients with mTNBC; potential role of this strategyKey clinical research findings guiding the use of PARP inhibitors for mTNBCAvailable findings with and current role of PARP inhibitor monotherapy for patients with mBC harboring germline or somatic mutations in DNA damage response pathway genes beyond germline BRCA1/2Outcomes reported with T-DXd among patients with ER-negative, HER2-low mBC in the DESTINY-Breast04 study; optimal sequencing of T-DXd opposite other available treatment optionsKey efficacy and safety findings from the Phase III ASCENT trial comparing sacituzumab govitecan to physician
  • ||||||||||  MODULE 4: Novel and Emerging Strategies for ER-Positive mBC (Hilton Chicago; Grand Ballroom (Level 2)) -  May 26, 2023 - Abstract #ASCO2023ASCO_7066;    
    This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Exact Sciences Corporation, Lilly, Merck, Natera Inc, Puma Biotechnology Inc, Seagen Inc, Stemline Therapeutics Inc, and TerSera Therapeutics LLC. Biological rationale for the investigation of AKT inhibition in breast cancer; mechanism of action of capivasertibKey efficacy and safety data from the Phase III CAPItello-291 study evaluating capivasertib/fulvestrant versus placebo/fulvestrant for recurrent ER-positive, HER2-negative mBCStructural and mechanistic similarities and differences between investigational oral SERDs under development (eg, camizestrant, imlunestrant) and elacestrantEfficacy and safety results from the Phase II SERENA-2 study of camizestrant compared to fulvestrant for postmenopausal women with advanced ER-positive, HER2-negative breast cancerAvailable data with other oral SERDs; ongoing Phase III studies evaluating oral SERDs alone and in combination with other systemic therapies for ER-positive mBCEarly data with novel investigational antibody-drug conjugates, such as datopotamab deruxtecan and patritumab deruxtecan, for ER-positive mBCOther novel agents and strategies under investigation for ER-positive mBC
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  U31402-A-U103: HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer (clinicaltrials.gov) -  May 22, 2023   
    P1,  N=280, Recruiting, 
    Biological rationale for the investigation of AKT inhibition in breast cancer; mechanism of action of capivasertibKey efficacy and safety data from the Phase III CAPItello-291 study evaluating capivasertib/fulvestrant versus placebo/fulvestrant for recurrent ER-positive, HER2-negative mBCStructural and mechanistic similarities and differences between investigational oral SERDs under development (eg, camizestrant, imlunestrant) and elacestrantEfficacy and safety results from the Phase II SERENA-2 study of camizestrant compared to fulvestrant for postmenopausal women with advanced ER-positive, HER2-negative breast cancerAvailable data with other oral SERDs; ongoing Phase III studies evaluating oral SERDs alone and in combination with other systemic therapies for ER-positive mBCEarly data with novel investigational antibody-drug conjugates, such as datopotamab deruxtecan and patritumab deruxtecan, for ER-positive mBCOther novel agents and strategies under investigation for ER-positive mBC Trial completion date: Jan 2024 --> Feb 2026 | Trial primary completion date: Jan 2024 --> Jun 2025
  • ||||||||||  Review, Journal:  'Targeting' Improved Outcomes with Antibody-Drug Conjugates in Non-Small Cell Lung Cancer-An Updated Review. (Pubmed Central) -  May 19, 2023   
    Many promising ADCs are in the pipeline for clinical development in non-small cell lung cancer, including sacituzumab govitecan, patritumab deruxtecan, datopotamab deruxtecan and tusamitamab ravtansine...In this comprehensive review, we will be discussing the recent evidence including targets, efficacy and the safety of newer ADC candidates in NSCLC. We will also briefly discuss the specific toxicities, novel biomarkers, overcoming resistance mechanisms, challenges and the way forward, as these new ADCs and combinations find a way into the clinical practice.
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
    Biomarker, Enrollment change, Trial primary completion date, Metastases:  ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) -  May 18, 2023   
    P2,  N=170, Recruiting, 
    We will also briefly discuss the specific toxicities, novel biomarkers, overcoming resistance mechanisms, challenges and the way forward, as these new ADCs and combinations find a way into the clinical practice. N=100 --> 170 | Trial primary completion date: Jun 2023 --> Jan 2024
  • ||||||||||  MODULE 2: Contemporary Treatment for Localized or Metastatic NSCLC with an EGFR Mutation (Hilton Chicago, Grand Ballroom ) -  May 15, 2023 - Abstract #ASCO2023ASCO_7038;    
    This event is organized and accredited by Research to Practice and supported through educational grants provided by AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Lilly, Novocure Inc, Regeneron Pharmaceuticals Inc, and Takeda Pharmaceuticals USA Inc. Key efficacy and safety findings, including emerging overall survival data, from the Phase III ADAURA trial evaluating adjuvant osimertinib for patients with Stage IB to IIIA NSCLC with EGFR mutations; appropriate incorporation into clinical care Ongoing Phase III evaluation of osimertinib for nonmetastatic NSCLC, such as in the NeoADAURA and LAURA trials; nonresearch role, if any Optimal selection of first-line treatment for patients with metastatic NSCLC and EGFR tumor mutations, including those with CNS metastases Incidence, clinical relevance and spectrum of resistance mechanisms in patients receiving osimertinib Published findings (eg, from the SAVANNAH trial) with and ongoing studies (eg, the SAFFRON and ORCHARD trials) of osimertinib combined with other agents for patients experiencing disease progression on first-line osimertinib Mechanism of action of the novel HER3-directed antibody-drug conjugate patritumab deruxtecan; available data, ongoing evaluation and potential clinical role in metastatic EGFR tyrosine kinase inhibitor-resistant NSCLC Antitumor activity and tolerability of amivantamab/lazertinib in the CHRYSALIS-2 study for patients with progressive NSCLC with EGFR mutations Key efficacy and safety findings informing the FDA approvals of amivantamab and mobocertinib for patients with metastatic NSCLC and EGFR exon 20 mutations; appropriate selection and sequencing of these agents
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
    Characterization of diverse targetable alterations in ERBB2 and ERBB3 in 93,465 non-small cell lung cancers (NSCLC). (On Demand | Hall A; Poster Bd # 82) -  Apr 26, 2023 - Abstract #ASCO2023ASCO_3503;    
    Diverse ERBB2 and ERBB3 alt in NSCLC may predict sensitivity to anti-HER2/3 therapies, but not all classes of alts are detected/reported by all profiling assays. Utilization of comprehensive testing to guide biomarker definitions, treatment selection, and clinical trial enrollment is imperative.
  • ||||||||||  A REVOLUTION IN THE MAKING: HOW ANTIBODY-DRUG CONJUGATES ARE TRANSFORMING BREAST CANCER TREATMENT (RM 1 (Vista 1+2)) -  Apr 4, 2023 - Abstract #GBCC2023GBCC_2;    
    T-DXd does have higher levels of nausea, vomiting and fatigue compared to T-DM1 and is associated with a risk of interstitial lung disease (ILD) in 10-15% of patients, a potentially serious toxicity that requires monitoring...Sacituzumab Govitecan is an ADC with a topoisomerase I inhibitor payload and an antibody targeting Trop-2, an epithelial antigen expressed on all subtypes of breast cancer...Datopotamab deruxtecan, another ADC targeting Trop-2 and patritumab deruxtecan, targeting HER3, have both demonstrated promising levels of clinical activity in patients with pretreated MBC...These include understanding the mechanisms by which cancers develop resistance to ADCs, what makes a good target antigen and does the level of this antigen matter, how best to sequence ADCs, and lastly, how to monitor, prevent and treat ILD? With the approval of 3 ADCs for breast cancer and more in development, and substantial benefit across all subtypes and in both early and late stage disease, ADCs have revolutionized the treatment of breast cancer and their impact will increase in the years to come.