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21 Diseases |  |
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- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors. (Hall A; Poster Bd #: 307a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2135;
P2
The primary endpoint for each cohort is ORR by investigator per RECIST version 1.1. Secondary endpoints include safety and tolerability, DOR, DCR, PFS, overall survival, pharmacokinetics, and the correlation between HER3 IHC protein expression and efficacy.
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
Journal: ERBB3 overexpression is enriched in diverse patient populations with castration-sensitive prostate cancer and is associated with a unique AR activity signature. (Pubmed Central) - Feb 2, 2024
Mechanistic studies demonstrated a direct link between HER3 and enzalutamide resistance. ERBB3 OE as a biomarker could thus stratify patients for intensification of therapy in castration-sensitive disease, including targeting HER3 directly to improve sensitivity to AR-targeted therapies.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
A phase 2 study of HER3-DXd in patients (pts) with metastatic breast cancer (MBC). () - Jan 22, 2024 - Abstract #YIR2024YIR_124;
P2
HER3-DXd had an acceptable safety profile, and the data further confirm the clinical activity in MBC in heavy pre-tx MBC across the broad range of HER3 expression levels. Parts B and Z are ongoing and data from this report support the potential entry of HER3-DXd into the therapeutic paradigm in MBC
- A multivariate biomarker to guide antibody-drug conjugate selection and provide insight on response differences across breast cancer subtypes (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_583;
P=N/A
We have developed and validated TRS, a multivariate RNA based tumor tissue algorithm that predicts observed ORRs across tumor types and approved/late-stage ADCs. More than 75% of all patients with metastatic breast cancer are predicted to be responsive to one or more ADCs, including those approved in other tumor types.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo
Antitumor effect of HER3-DXd, an antibody-drug conjugate targeting HER3, in gastric cancer cell lines. (LEVEL 2, EXHIBIT HALL D) - Sep 16, 2023 - Abstract #AACRNCIEORTC2023AACR_NCI_EORTC_609;
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo
A phase 2 study of HER3-DXd in patients (pts) with metastatic breast cancer (MBC). (Live Stream | Hall B1) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3348;
P2
Parts B and Z are ongoing and data from this report support the potential entry of HER3-DXd into the therapeutic paradigm in MBC. Clinical trial information: NCT04699630.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo
The impact of HER3 dynamics on the efficacy of HER3-DXd, a novel HER3 directed antibody-drug conjugate (Section 19; Poster Board #19) - Mar 14, 2023 - Abstract #AACR2023AACR_6070;
HER3 expression was dynamically changed by HER3-DXd dosing regimen and by RTKi treatment, resulting in a substantial impact on payload release. These findings support our strategy of clinical studies using HER3-DXd after drugs that increase HER3 expression including EGFR TKI and indicate that HER3 dynamics may play a key role in achieving optimal efficacy of HER3-DXd.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen, Daiichi Sankyo
HERTHENA-Lung02: A randomized Phase 3 study of patritumab deruxtecan vs platinum-based chemotherapy in locally advanced or metastatic EGFR-mutated NSCLC after progression with a third-generation EGFR tyrosine kinase inhibitor (Section 46; Poster Board #24) - Mar 14, 2023 - Abstract #AACR2023AACR_3693;
P1, P3
Patients are stratified by prior third-generation EGFR TKI treatment (osimertinib vs other), line of prior third-generation EGFR TKI use (first vs second line), region (Asia vs rest of world), and presence of stable brain metastases (yes vs no)...Other secondary endpoints include investigator-assessed progression-free survival, objective response rate, duration of response, clinical benefit rate, disease control rate, time to response (all assessed by investigator and BICR per RECIST 1.1), safety, and patient-reported outcomes. Enrollment began May 2022 and is ongoing, with sites in Asia, Australia, Europe, and North America.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen, Daiichi Sankyo
Targeting ATR enhances the antitumor efficacy of patritumab deruxtecan (HER3-DXd)in tamoxifen-resistant ER+ breast cancer cells by inducing DNA damage and apoptosis (Section 36; Poster Board #9) - Mar 14, 2023 - Abstract #AACR2023AACR_2097;
Background: HER3, a member of the ERBB family of receptor tyrosine kinases that activates multiple oncogenic signaling pathways, is overexpressed in 50-70% of breast cancers (BC). The combination of HER3-DXd plus ATR inhibitors has therapeutic potential for overcoming tamoxifen resistance in HER3+/ER+ BC.
- | PHA665752 / Pfizer, patritumab (U3-1287) / Amgen, Daiichi Sankyo
Journal: Dual-targeting therapy against HER3/MET in human colorectal cancers. (Pubmed Central) - Feb 9, 2023
We established HER3-and/or MET-KO SW1116 cell lines, and HER3/MET-double KO resulted in the inhibition of in vitro cell proliferation and in vivo tumor growth in nude mice by SW1116 cells. Furthermore, the combination of patritumab, an anti-HER3 fully human mAb, and PHA665752, a MET inhibitor, markedly inhibited in vitro cell proliferation, 3D-colony formation, and in vivo tumor growth in nude mice by SW1116 cells The dual targeting of HER3/MET has potential as CRC therapy.
- Correlation between antibody-drug conjugate (ADC) targetable antigen expression and occurrence of interstitial lung disease (ILD) (Hall Bordeaux) - Jan 31, 2023 - Abstract #ESMOTAT2023ESMO_TAT_126;
This may imply and further provide support to ILD being a bystander effect rather than true on-target toxicity with ADCs. Further ADC development should focus on reducing bystander effects via selection of linker and payload classes least likely to cause ILD while optimizing dose and drug-to-antibody ratio.
- || Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Tagrisso (osimertinib) / AstraZeneca, patritumab (U3-1287) / Amgen, Daiichi Sankyo
Patritumab is a first world drug not available here .Maybe enhertu can be tried along osimertinib (Twitter) - Jan 13, 2023
- || patritumab (U3-1287) / Amgen, Daiichi Sankyo
Continue CP until progression , candidate for Patritumab trial. Else off label T- Dxd , esp given high copy number , though less ORR compared to her2 mutant https://t.co/yqizO6rgFy (Twitter) - Jan 12, 2023
- | MK-2206 / Merck (MSD), patritumab (U3-1287) / Amgen, Daiichi Sankyo
Journal: Targeting HER3-dependent activation of nuclear AKT improves radiotherapy of non-small celllung cancer. (Pubmed Central) - Oct 4, 2022
IR-induced activation of nuclear AKT occurs inside the nucleus that is mainly dependent on HER3 expression in NSCLC. These findings suggest that targeting HER3 in combination with radiotherapy may provide a logical treatment option for investigation in selected NSCLC patients.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen, Daiichi Sankyo
HERTHENA-Lung02: A Randomized Phase 3 Study of Patritumab Deruxtecan vs Platinum-Based Chemotherapy in Locally Advanced or Metastatic EGFR-Mutated NSCLC After Progression with a Third-Generation EGFR TKI (Ballroom FGH) - Sep 14, 2022 - Abstract #IASLCNACLC2022IASLC_NACLC_82;
P1, P3
Pts are stratified by prior 3rd-gen EGFR TKI treatment (osimertinib vs other), line of prior 3rd-gen EGFR TKI use (first vs second line), region (Asia vs rest of world), and presence of stable brain metastases (yes vs no)...Enrollment began May 2022 and is ongoing, with sites in the US, Canada, EU, Asia, and Australia. This trial in progress was previously presented at ESMO 2022.
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
Targeting nuclear HER3-AKT cascade improves radiotherapy of non-small cell lung cancer (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_264;
Thus, targeting HER3 in combination with radiotherapy may provide a logical treatment option for investigation in selected NSCLC patients. No
- |||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
patritumab is a HER3 ADC with the same toxin. it is being developed in NSCLC now, a lot of competition in breast cancer with deruxtecan ADCs! (Twitter) - Aug 15, 2022
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen, Daiichi Sankyo
HERTHENA-Lung02: A randomized phase III study of patritumab deruxtecan vs platinum-based chemotherapy in locally advanced or metastatic EGFR-mutated NSCLC after progression with a third-generation EGFR TKI (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2914;
P1, P3
Pts are stratified by prior 3rd-gen EGFR TKI treatment (osimertinib vs other), line of prior 3rd-gen EGFR TKI use (first vs second line), region (Asia vs rest of world), and presence of stable brain metastases (yes vs no)...Other secondary endpoints include investigator-assessed PFS, objective response rate, duration of response, clinical benefit rate, disease control rate, time to response (all per BICR per RECIST v1.1), safety, and patient-reported outcomes. Enrollment into the trial is starting in Q2 2022.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen, Daiichi Sankyo
Pharmacokinetics, efficacy, and safety of patritumab deruxtecan (HER3-DXd) in EGFR inhibitor-resistant, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2158;
P1
The primary objective of cohort 4 is to evaluate the PK of this formulation during the first treatment cycle. Secondary objectives include the evaluation of PK, safety, tolerability, immunogenicity, and efficacy.
- ||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Will be fascinating where Patritumab and Datopotamab Dxd falls in Rx sequelae of nsclc .Looks like they work irrespective of genomic drivers , some impressive responses seen in TROPION lung trial in refractory nsclc. . (Twitter) - Jul 8, 2022
- || patritumab (U3-1287) / Amgen, Daiichi Sankyo
Wont Patritumab work in these? (Twitter) - Jun 7, 2022
- | Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, patritumab (U3-1287) / Amgen, Daiichi Sankyo
Third instalment of a triple whammy, after patritumab and Enhertu. $DSNKY making a bid to consolidate its status as the winner of #ASCO22 (Twitter) - Jun 7, 2022
- ||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Head-to-Head: Waiting head to head with Patritumab…. (Twitter) - Jun 5, 2022
- ||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, patritumab (U3-1287) / Amgen, Daiichi Sankyo
Clinical: HER3 expression noted in very similar population, HR+ HER2- MBC, by T-DXd and Sacituzumab. Also we need to remember that patritumab alone did not have any clinical activity, the efficacy of this ADC, linker and payload dependent. #ASCO22 @OncoAlert (Twitter) - Jun 4, 2022
- || patritumab (U3-1287) / Amgen, Daiichi Sankyo
May have to start testing for Her3 also if patritumab keep showing responses - (Twitter) - Jun 3, 2022
- ||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
$DSNKY's forgotten ADC? @ByAmyBrown take on patritumab in Her3-expressing cancers (interestingly, not NRG1) https://t.co/qvlAN1G2nx #ASCO22 $MRUS $ELEV (Twitter) - Jun 3, 2022
- || patritumab (U3-1287) / Amgen, Daiichi Sankyo
Patritumab is a somewhat under-the-radar asset (Daiichi [ex U3 Pharma] / $AMGN); update at an #ASCO22 oral session $MRUS (Twitter) - Apr 27, 2022
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo
A Phase II Study of HER3-DXD in Patients (pts) with Metastatic Breast Cancer (MBC) (Exhibition area) - Mar 19, 2022 - Abstract #ESMOBC2022ESMO_BC_401;
P2
Part B will enroll ∼60 pts (20 pts in up to 3 subgroups) as defined from the biomarker expression pattern and preliminary efficacy findings from Part A. Pts from the same biomarker subgroups in Parts A and B will be pooled for the final efficacy analysis. Enrollment to Part A was initiated in November 2020.
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
HER3 expression is associated with cold tumor immune microenvironment and the regulation of its signal in humanized breast cancer patient derived xenograft models converts to hot tumor (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_7714;
Thus, inhibition of HER3 signal might be of interesting concept for both regulation of oncologic signal and immunological modulation in HER3-expressing breast cancer. Further HER3 related immune modulation exploration in breast cancer treatment strategy needs to be clarified in the future.
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen, Daiichi Sankyo
HER3 is an actionable target in advanced prostate cancer (Section 32) - Mar 9, 2022 - Abstract #AACR2022AACR_4583;
HER3 is commonly expressed in advanced PC and has clinical relevance in this setting. Our data indicate that HER3 is a valid target for clinical trials for men suffering from high HER3 expressing advanced PC.
- ||||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Tagrisso (osimertinib) / AstraZeneca, patritumab (U3-1287) / Amgen, Daiichi Sankyo
Clinical: Nice publication from @KAZUHIKONAKAGA2 and Kimio Yonesaka in @CCR_AACR showing HER3 expression goes up in patients with EGFR mutant cancer treated with EGFR TKI. Additional data support studying combination of patritumab (U3-1402) and osimertinib https://t.co/VhPsZAmtss (Twitter) - Jan 19, 2022
- | Biomarker, Trial completion date, Trial primary completion date: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Aug 27, 2021
P2, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Our data indicate that HER3 is a valid target for clinical trials for men suffering from high HER3 expressing advanced PC. Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030
- || patritumab (U3-1287) / Amgen
Patritumab Dx won’t work? (Twitter) - Apr 6, 2021
- |||| Avastin (bevacizumab) / Roche, patritumab (U3-1287) / Amgen
Drugs for CTNNB1 1) Niclosamide ( Drug repurposing) 2) MEK i 3) Bevacizumab Her3 mutations- Patritumab Her2 mutations (V842I ) Not much literature for this mutations (Twitter) - Mar 26, 2021
- |||| patritumab (U3-1287) / Amgen
T- Dxd or even better Patritumab given her3 mutation. (Twitter) - Mar 26, 2021
- | Biomarker, Phase classification: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Feb 16, 2021
P2, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030 Phase classification: P1 --> P2
- ||||||| patritumab (U3-1287) / Amgen
Clinical: #WCLC20 @IASLC @OncoAlert Efficacy of Patritumab-Dx in #EGFRMT #NSCLC. HER3 was expressed in nearly all tumors. Efficacy was observed in EGFR C797S, MET amplification, HER2 MT BRAF fusion, and PIK3CA MT. @HelenaYu923 @EGFRResisters (Twitter) - Jan 28, 2021
- |||| Opdivo (nivolumab) / Ono Pharma, BMS, patritumab (U3-1287) / Amgen
More on #SABCS20 Keep an 👀 on these abstracts: 👉first report of T-Dxd+nivo in #HER2-expressing BC ➡️strong rationale for the combo, important to check ILD rate 👉update of patritumab DxD in #HER3-expressing BC ➡️ 43% ORR previously reported, survival outcomes pending #bcsm (Twitter) - Nov 30, 2020
- ||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
Patritumab Deruxtecan Poised for Phase 2 Exploration in HER3+ Advanced CRC @GillesJAGallant #crcsm https://t.co/hIDuk9obZD (Twitter) - Oct 27, 2020
- | Biomarker, Phase classification, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Oct 14, 2020
P1, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Phase classification: P1 --> P2 Phase classification: P2 --> P1
- ||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
既治療のEGFR遺伝子変異陽性の進行NSCLCに抗HER3抗体薬物複合体patritumab deruxtecanが有望 https://t.co/eGbQzH9EvL #ADC @DaiichiSankyoJP (Twitter) - Sep 25, 2020
- || patritumab deruxtecan (U3-1402) / Daiichi Sankyo
Clinical, Journal: A Novel HER3-Targeting Antibody-Drug Conjugate, U3-1402, Exhibits Potent Therapeutic Efficacy through the Delivery of Cytotoxic Payload by Efficient Internalization. (Pubmed Central) - Sep 23, 2020
U3-1402 demonstrated promising antitumor activity against HER3-expressing tumors with tolerable safety profiles. The activity of U3-1402 was driven by HER3-mediated payload delivery via high internalization into tumor cells.
- ||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
New data on patritumab deruxtecan data was presented at #ESMO20 by @HelenaYu923. This is an interesting molecule and mechanism of action - wanted to go through this great presentation. Also kudos to @MLJohnsonMD2 @ConorSteuerMD and others! #LCSM (Twitter) - Sep 20, 2020
- |||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Trodelvy (sacituzumab govitecan-hziy) / Immunomedics, Everest Medicines, patritumab (U3-1287) / Amgen
With this ADC,the treatment of many orphan&Common tumors will soon find a solution, and it seems that all the standard treatment options we know of for most tumors will change. Sacituzumab govitecan, patritumab deruxtecan (U3-1402) and others. This ESMO Theme is ADC&Hope (Twitter) - Sep 20, 2020
- ||||| patritumab (U3-1287) / Amgen
#ESMO20 HER3 is expressed in 80% of #EGFR mutant NSCLC hence this ADC approach. Patritumab is an ADC with HER3 Ab linked to a topoisomerase I payload. Here, data from escalation (n=12) and expansion (n=45) in EGFR+ NSCLC after TKI (expansion was post chemo as well). #LCSM (Twitter) - Sep 20, 2020
- |||||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
Clinical: #ESMO20 Dr. @HelenaYu923 presents data on patritumab deruxtecan (U3-1402), a HER3-ADC for patients with #EGFR mutant NSCLC. #LCSM @OncoAlert (Twitter) - Sep 20, 2020
- |||| #ESMO20 We are seeing promising activity with mobocertinib in EGFRex20, patritumab deruxtecan in sensitizing #EGFR, and tarloxotinib and poziotinib in #HER2, but some toxicity concerns with poziotinib at this dose schedule. Nice discussion @ZerAlona #LCSM #OncoAlert (Twitter) - Sep 18, 2020
- |||| #ESMO20 Nice discussion of the #EGFR / #HER2 #NSCLC abstracts from @ZerAlona covering poziotinib, tarloxotinib, mobocertinib, and patritumab deruxtecan. #LCSM #OncoAlert (Twitter) - Sep 18, 2020
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
[VIRTUAL] Efficacy and safety of patritumab deruxtecan (U3-1402), a novel HER3 directed antibody drug conjugate, in patients (pts) with EGFR-mutated (EGFRm) NSCLC (On-Demand) - Aug 27, 2020 - Abstract #ESMO2020ESMO_3512;
P1
Funding: Daiichi Sankyo. Clinical trial identification: NCT03260491.