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- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trends in the management of small HER2-positive breast cancers. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5189;
Although NAT witnessed an upward trend from 2018 to its peak in 2021, its utilization declined again in 2022. A balance between the most effective treatment and minimizing toxicities should be ensured.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Efficacy and safety of recombinant humanized anti-HER2 antibody-MMAE conjugate (RC48) in neoadjuvant for HER2-positive breast cancer: A single-arm phase II study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5171;
P2
Although the pCR rate was lower than the traditional chemotherapy combined with targeted therapy, the effect of rapid reduction of tumor volume was better (the moderate-severe remission rate was 82. 6%).
- Irene (pyrotinib) / Jiangsu Hengrui Pharma, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trastuzumab, pertuzumab and nab-paclitaxel plus pyrotinib or not in neoadjuvant treatment of HER2-positive breast cancer: A multi-center, randomized, open-label, phase II study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5168;
P2
Concurrent pyrotinib treatment with TP was associated with a high rate of severe diarrhea. Further biomarker analyses are needed to identify which population would receive great benefit with neoadjuvant pyrotinib therapy in HER2+ breast cancer.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Unveiling the relationship between the UGT2B gene family and neoadjuvant treatment response in patients with HER2-positive breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5128;
The UGT2B family genes encode enzymes involved in glucuronidation and metabolic pathways associated with drug detoxification and elimination. Our findings suggest that variations in the UGT2B15 expression may impact the metabolism rate of specific drugs, underscoring the necessity for additional research in this area.
- Irene (pyrotinib) / Jiangsu Hengrui Pharma, Cipterbin (inetetamab) / 3SBio
A prospective, open-label, single-arm phase II clinical study of inetetamab in combination with pyrotinib and albumin-bound paclitaxel for the neoadjuvant treatment of patients with HER2+ early and locally advanced breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5113;
7%, and even 72. 7% in HR+ patients.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
A retrospective, single-center study comparing two neoadjuvant protocols for patients with HER2-positive breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5111;
In this study, pCR rates were numerically better in the ACTHP regimen vs. DCHP, though not statistically significant. Dose reductions were more common in the DCHP but had less cardiotoxicity.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Optimal neoadjuvant treatment and prognostic factors in patients with HR-positive/HER2-positive early or locally advanced breast cancer: A national real-world study in China. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5105;
Prognostic factors for improved tpCR and bpCR included T+P and platinum NAT, whereas ? 65 yrs and post-surgery ER+ were predictive of decreased tpCR and bpCR.
- AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Efficacy, safety, and predictive biomarkers of dalpiciclib combined with letrozole, pertuzumab and trastuzumab as neoadjuvant therapy in HR+/HER2+ breast cancer: A phase II study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5100;
The predictive value of genetic alterations and ctDNA status for treatment efficacy warrants further investigation. Clinical trial information: ChiCTR2200062114.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
A prospective phase II study of neoadjuvant therapy guided by personalized drug-testing on patient-derived tumor-like cell clusters for early breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5096;
P1/2
Our results demonstrate that personalized drug testing on PTCs can effectively guide the choice of neoadjuvant therapy for early TNBC and HER2-positive breast cancer patients. Clinical trial information: NCT04750122, NCT04836156.
- Perjeta (pertuzumab) / Roche
Neoadjuvant pertuzumab, docetaxel, carboplatin, and trastuzumab (PTCH) regimen in patients with HER2 positive early, locally advanced, and oligometastatic breast cancer: Real-world Indian experience. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5095;
In a real-world context, PTCH is an effective and safe anthracycline-free regimen for use in curative (adjuvant and neoadjuvant) setting for HER2 positive breast cancer in Indian women Using neoadjuvant PTCH may improve pCR and obviate the need for adjuvant T-DM1 after surgery making it a cost-effective strategy in limited recourse setting. The survival outcomes were significantly better among those with node-negative disease and among those who achieved a pCR.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Continuous glucose monitoring and rates of hyperglycemia during chemotherapy for early-stage breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4879;
P
The survival outcomes were significantly better among those with node-negative disease and among those who achieved a pCR. The most common chemotherapy regimens included docetaxel/cyclophosphamide (25%), weekly paclitaxel
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Peony exploratory analyses of biomarker changes: From baseline to surgical samples in patients with HER2+ breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4698;
P3
In pooled analyses, we only observed a trend of PIK3CA mutation detected in surgical samples with a worse DFS, which is in line with the association observed with baseline PIK3CA mutation status. No other associations were found between surgical biomarkers and DFS.
- ADC2122 / ZovaBio, Adcoris, Perjeta (pertuzumab) / Roche
Phase 1 study of ZV0203, a first in class pertuzumab ADC, in patients with HER2 positive advanced solid tumors. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4692;
P1
ZV0203 was well tolerated and showed clinically encouraging anti-tumor activity in heavily pretreated pts with HER2 positive cancer. Clinical trial information: NCT05423977.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Pilot evaluation of portable scalp cooling for chemotherapy-associated alopecia in early-stage breast cancer. (Hall A; Poster Bd #: 270) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2888;
P, P=N/A
Point estimates of efficacy were like those reported for PAXMAN (Dean's 0-2: 50%) and DigniCap (66%). A follow-up clinical trial is planned with a primary outcome of efficacy in patients receiving taxane-based chemotherapy (NCT06215469, PI: Rugo).
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Deciphering tumor microenvironment dynamics in HER2-amplified refractory metastatic colorectal cancer in the TRIUMPH trial. (Hall A; Poster Bd #: 227) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2633;
Notably, dynamic reorganization of fibroblast and endothelial cells into stromal regions suggest complex treatment responses. Identification of angio-TAM expressing SPP1 and VEGFA adds depth to understanding the contribution of tumor microenvironment to the resistance mechanism.
- Perjeta (pertuzumab) / Roche, inavolisib (GDC-0077) / Roche
INAVO122: A phase III study of maintenance inavolisib or placebo + pertuzumab + trastuzumab following induction with pertuzumab + trastuzumab + a taxane in patients (pts) with PIK3CA-mutated, HER2-positive advanced breast cancer (HER2+ aBC). (Hall A; Poster Bd #: 100a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2553;
P3
Target randomization is ~230 pts; this study is currently recruiting (15 pts enrolled). Encore from SABCS 2023 (PO2-19-09).
- Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche, trastuzumab imbotolimod (BDC-1001) / Bolt Biotherap
Phase 2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 (trastuzumab imbotolimod) +/- pertuzumab (P) in patients (pts) with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (T-DXd). (Hall A; Poster Bd #: 98b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2550;
P2
Li B, et al. ASCO 2023, Abstract 2538.
- Comparison of expert treatment recommendations versus community healthcare providers: Analysis from an online decision support tool for metastatic breast cancer. (Hall A; Poster Bd #: 31) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2483;
Data from an online IDST demonstrate discordance of expert recommendations and community HCPs Tx selection in MBC, which is made challenging by a number of variables that that must be assessed during the care continuum. Expert recommendations in the IDST often reinforced or changed HCP's Tx plan, highlighting the need for ongoing education and the potential of an online tool to improve optimal Tx decisions for MBC, particularly when HCPs must consider current guidelines and tumor-specific biomarkers across multiple tumor types they may see.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Multiple alternative splicing of HER2 transcripts and exon skipping with potential consequences on function and antibody-based therapy. (Hall A; Poster Bd #: 11) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2464;
The percentage of skipped transcripts is low. However, since these isoforms have deficiency in critical domains for membrane anchoring and for dimerization, the biological effects might be more significant than that expected from percentage of abnormal protein.
- Kadcyla (ado-trastuzumab emtansine) / Roche, Perjeta (pertuzumab) / Roche
The subgroup analysis by age and geriatric assessment in a phase III study comparison of trastuzumab emtansine with trastuzumab, pertuzumab, and docetaxel in older patients with advanced stage HER2-positive breast cancer (JCOG1607 HERB TEA study). (Hall A; Poster Bd #: 9) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2462;
No subgroups benefiting from T-DM1 as first-line treatment were identified. HPD remains the standard for advanced HER2-positive breast cancer, regardless of age (even in ?75 years) G8 score, or IADL.
- imlunestrant (LY3484356) / Eli Lilly, Verzenio (abemaciclib) / Eli Lilly
Imlunestrant, an oral selective estrogen receptor degrader (SERD), in combination with human epidermal growth factor receptor 2 (HER2) directed therapy, with or without abemaciclib, in estrogen receptor (ER) positive, HER2 positive advanced breast cancer (aBC): EMBER phase 1a/1b study. (Hall A; Poster Bd #: 5) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2458;
P1
2 prior HER2 directed regimens, no prior CDK4/6i or fulvestrant; (Part E): received 1 st line induction taxane chemotherapy (any duration) + H + P, without disease progression and ?1 prior therapy for aBC. Imlunestrant in combination with trastuzumab
- TQB2930 / Sino Biopharm
Preliminary safety and efficacy of TQB2930, a HER2-targeted bispecific antibody in patients with advanced breast cancer: Results from a phase 1b study. (Hall A; Poster Bd #: 4) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2457;
P1/2
TQB2930 is well tolerated and has demonstrated promising single-agent anti-tumor activity in HER2-positive breast cancer who have failed standard anti-HER2 therapies, including multiple lines of prior HER2 targeted agents. These early signs of activity support the further exploration of combination therapy of TQB2930 and the study is ongoing.
- Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Real world experience of trastuzumab deruxtecan for the treatment of metastatic breast cancer in the UK. (Hall A; Poster Bd #: 2) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2455;
However, the majority (80%) of these patients were treated in the third line and beyond. The rates of drug interruption and reduction were higher in the real-world data set than in DB02, which may impact on efficacy in the real-world setting.
- Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
DESTINY-Breast07: Dose-expansion interim analysis of T-DXd monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ mBC. (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2452;
P1/2
Early data showed promising efficacy in both modules. The DESTINY-Breast07 study is ongoing; analyses from the Phase 3 DESTINY-Breast09 clinical trial will provide definitive data on TDXd
- Halaven (eribulin mesylate) / Eisai, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trastuzumab and pertuzumab in combination with eribulin mesylate or a taxane as first-line chemotherapeutic treatment for HER2-positive, locally advanced or metastatic breast cancer: Results of a multicenter, randomized, non-inferiority phase 3 trial in Japan (JBCRG-M06/EMERALD). (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2450;
P3
This is the first study to show non-inferiority of eribulin to taxane when used in combination with dual HER2 blockade. As a less toxic but equally effective alternative to the taxane-containing regimen, eribulin combined with HP could be first-line treatment of locally advanced or metastatic HER2+ BC.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Pertuzumab plus trastuzumab (P+T) in patients (pts) with solid tumors with ERBB2 or ERBB3 amplification (amp) or mutations (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study. (Hall A; Poster Bd #: 287) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2113;
P2
P+T showed antitumor activity in pts with advanced solid tumors with ERBB2/3amp. Additional study is warranted to confirm the efficacy of P+T in this population.
- Rozlytrek (entrectinib) / Roche
MyTACTIC: Activity of targeted therapy in patients (pts) with advanced solid tumors harboring specific biomarkers. (Hall A; Poster Bd #: 245) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2072;
P2
At data cut-off (Jan 12, 2024), 252 pts were enrolled into one of 14 arms; no pts were enrolled into arm A (entrectinib in ROS1fusion-positive tumors)... Targeted therapies yielded responses across tumor types in most treatment arms; testing for actionable molecular alterations is warranted for pts with limited treatment options.
- Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) / Roche, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Phase II/III study of paclitaxel/carboplatin alone or combined with either trastuzumab and hyaluronidase-oysk or pertuzumab, trastuzumab, and hyaluronidase-zzxf in HER2 positive, stage I-IV endometrial serous carcinoma or carcinosarcoma (NRG-GY026). (Hall A; Poster Bd #: 502a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1953;
P2/3
Key exclusion criteria include severe heart disease or interstitial lung disease. The phase II portion of this study is open and enrolling.
- Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Perjeta (pertuzumab) / Roche
Neoadjuvant dynamic marker-adjusted personalized therapy comparing trastuzumab-deruxtecan versus pacli-/docetaxel + carboplatin + trastuzumab + pertuzumab in HER2+ early breast cancer: WSG-ADAPT-HER2-IV. (Hall A; Poster Bd #: 213a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1359;
P2
treatment, and at recurrence. ctDNA/ctRNA from optional blood samples will be assessed for mutations and gene expression relevant in HER2+ EBC.
- Herceptin (trastuzumab) / Roche, azeliragon (TTP488) / Cantex Pharma, Perjeta (pertuzumab) / Roche
RAGE inhibition to decrease cancer therapy related cardiotoxicity in women with early breast cancer (RAGE). (Hall A; Poster Bd #: 207a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1347;
P1/2
In Cohort 4, 6 patients will receive dose dense doxorubicin and cyclophosphamide (ddAC)...As of 2/1/24, 4 patients have been enrolled, with 4 undergoing screening. At the completion of this trial, we plan a randomized trial to evaluate the role of TTP488 to decrease cardiotoxicity, cancer related cognitive decline and disease recurrence.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Interim FDG-PET/CT for predicting response of HER2-positive breast cancer to neoadjuvant therapy: ECOG-ACRIN EA1211/DIRECT trial. (Hall A; Poster Bd #: 204b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1342;
P2
The EA1211/DIRECT trial is the first step in implementing a Response-Guided Treatment Strategy by validating the ?SULmax threshold of 40% as the optimum cut point across standard of care HER2-directed neoadjuvant regimens. If EA1211/DIRECT meets its objectives, the results will be used to design clinical utility studies, thus hoping to change practice.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
The predictive value of the mature B cell signature in early Her2-positive breast cancer treated with neoadjuvant therapy. (Hall A; Poster Bd #: 198) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1334;
103 patients were treated with trastuzumab-based NAT and 85 patients were treated with dual-blockade (trastuzumab plus pertuzumab) based NAT. Our result suggested that the mature B cell signature was more strongly associated with the pCR and recurrence-free survival than TILs.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Neoadjuvant pegylated liposomal doxorubicin-containing chemotherapy in combination with trastuzumab and pertuzumab in patients with HER2-positive early breast cancer: A randomized phase II study (METIS). (Hall A; Poster Bd #: 188) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1324;
P2
Our result suggested that the mature B cell signature was more strongly associated with the pCR and recurrence-free survival than TILs. Patients aged 18 to 70 years old with previously untreated stage II
- Keytruda (pembrolizumab) / Merck (MSD), Perjeta (pertuzumab) / Roche
Multiomic factor analysis for pathologic complete response (pCR) after 12 weeks of pembrolizumab + trastuzumab + pertuzumab in HER2-enriched (HER2-E) early breast cancer (eBC) in the Keyriched-1 trial. (Hall A; Poster Bd #: 182) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1318;
P2
Our multiomic analysis uncovered potential biomarkers for pCR in HER2-E eBC treated with immune therapy and dual-HER2 blockade alone. These results together with the results from the ADAPT translational research program support validation in larger trials investigating chemotherapy-free regimens in selected patients with HER2+ eBC.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Prevalence and dynamics of circulating tumor DNA (ctDNA) among patients (pts) with HER2+ breast cancer (BC) receiving neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP) in the DAPHNe trial. (Hall A; Poster Bd #: 180) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1316;
P1
In this population of moderate risk (mostly stage II) HER2+ BC pts, 92% were ctDNA+ at BL. Neoadjuvant THP was very effective at clearing MRD, regardless of whether there was residual disease in the breast/nodes or not, consistent with the absence of any BC recurrence in the cohort to date.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Comparing 18 F-FDG positron emission tomography (PET) and breast magnetic resonance imaging (MRI) to predict pathological complete response (pCR) and 3-year invasive disease-free survival (3-y iDFS) in patients (pts) with HER2+ early breast cancer (EBC): An unplanned exploratory analysis of PHERGain trial. (Hall A; Poster Bd #: 178) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1314;
P2
Although PET is the recommended imaging technique for early treatment response, these data suggest that MRI-assessed tumor shrinkage could alternatively guide NAT after the first 2 HP cycles in HER2+ EBC pts following the PHERGain strategy when PET is not available. 1.
- Irene (pyrotinib) / Jiangsu Hengrui Pharma, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Patient-derived tumor cell clusters (PTC) guiding-neoadjuvant therapy of HER2-positive breast cancer: A prospective randomized phase II clinical trial. (Hall A; Poster Bd #: 173) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1309;
P2
1. Yin et al., Sci.Transl.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
RNA-Seq based gene expression profiling of baseline and on-treatment breast tumors to predict response to HER2-directed therapy, without chemotherapy (TBCRC026). (Hall A; Poster Bd #: 122) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1258;
P2
In this unique cohort with ER-negative, HER2-positive breast cancer treated with neoadjuvant HP without chemotherapy, HER2-E tumors and those with increased immune signaling were more likely to respond to HER2-directed therapy. Combining C1D15 SULmax on PET/CT and a B cell signature provided improved prognostic information and should be further explored as candidate biomarkers in this setting.
- Genomic landscape and therapeutic implications in advanced solid cancers: KOSMOS-II (KOrean Precision Medicine Networking Group Study of MOlecular profiling guided therapy based on genomic alterations in advanced Solid tumors, KCSG AL-22-09). (Hall A; Poster Bd #: 356) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1090;
ERBB2 alterations were most frequently led to MGT; trastuzumab emtansine (n = 75, 20.8%; ERBB2 AMP n=36; ERBB2 Mut n=20; ERBB2 AMP & Mut n=17; NA n=2), or trastuzumab plus pertuzumab (n = 17, 7.5%), followed by EGFR gain to bevacizumab plus erlotinib (n = 18, 5%) and high TMB (?20 mut/Mb) to atezolizumab (n= 46, 12.8%). The KOSMOS-II study demonstrated the feasibility of a pragmatic, nationwide precision medicine approach using diverse real-world NGS panels and favorable clinical outcomes.
- || Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (clinicaltrials.gov) - Apr 22, 2024
P2, N=138, Active, not recruiting, Sponsor: University of Texas Southwestern Medical Center
The KOSMOS-II study demonstrated the feasibility of a pragmatic, nationwide precision medicine approach using diverse real-world NGS panels and favorable clinical outcomes. Recruiting --> Active, not recruiting
- | Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Journal, Metastases: Trastuzumab plus pertuzumab for HER2-amplified advanced colorectal cancer: Results from the drug rediscovery protocol (DRUP). (Pubmed Central) - Apr 22, 2024
Recruiting --> Active, not recruiting The results of this study confirm a clinically significant benefit of trastuzumab plus pertuzumab treatment in patients with HER2+mCRC.
- || Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Review, Journal: HER2 targeted therapy in colorectal Cancer: Current landscape and future directions. (Pubmed Central) - Apr 22, 2024
Although many unknowns remain, an improved understanding of these anti-HER2 agents will be essential for advanced CRC. In this review, we provide an overview of the role of HER2 in CRC as an oncogenic driver, a prognostic and predictive biomarker, and a clinically actionable target, as well as the current progress and challenges in the field.
- || Trial completion date, Trial primary completion date: BIS-Program: Impact of Neoadjuvant Immunotherapy in Early Stage Breast Cancer Before Standard Therapy (clinicaltrials.gov) - Apr 18, 2024
P2, N=185, Recruiting, Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
In this review, we provide an overview of the role of HER2 in CRC as an oncogenic driver, a prognostic and predictive biomarker, and a clinically actionable target, as well as the current progress and challenges in the field. Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2024 --> Feb 2025
- | Tukysa (tucatinib) / Pfizer, Kisqali (ribociclib) / Novartis, Perjeta (pertuzumab) / Roche
Phase classification, Trial completion date, Trial primary completion date, Metastases: UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov) - Apr 17, 2024
P1/2, N=18, Recruiting, Sponsor: Jonsson Comprehensive Cancer Center
Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2024 --> Feb 2025 Phase classification: P1b --> P1/2 | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2025
- | Perjeta (pertuzumab) / Roche
Journal: Exploring the Combined Action of Adding Pertuzumab to Branded Trastuzumab versus Trastuzumab Biosimilars for Treating HER2+ Breast Cancer. (Pubmed Central) - Apr 17, 2024
The observed increase suggests a potential synergistic effect between these antibodies, which could enhance their therapeutic efficacy in HER2-positive cancers. These findings underscore the importance of understanding the complex interplay between therapeutic antibodies and their target antigens, providing valuable insights for the development of more effective treatment strategies.
- || Review, Journal, PD(L)-1 Biomarker: Targeting HER2 in Gastroesophageal Adenocarcinoma: Molecular Features and Updates in Clinical Practice. (Pubmed Central) - Apr 17, 2024
Recently, the combination of trastuzumab with pembrolizumab, along with chemotherapy, and the development of trastuzumab deruxtecan, with its specific bystander activity, demonstrated improved outcomes, renewing attention in the treatment of this disease. This review will summarise historical and emerging therapies for the treatment of HER2-positive GEA, with a section dedicated to the HER2 molecular pathway and the use of novel blood biomarkers, such as circulating tumour DNA and circulating tumour cells, which may be helpful in the future to guide treatment decisions.
- | Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Biomarker, Journal, BRCA Biomarker, Metabolomic study: Metabolomics assisted by transcriptomics analysis to reveal metabolic characteristics and potential biomarkers associated with treatment response of neoadjuvant therapy with TCbHP regimen in HER2?+?breast cancer. (Pubmed Central) - Apr 17, 2024
Serum-metabolomics could be used as a powerful tool for exploring informative biomarkers for predicting or monitoring treatment efficacy. Metabolomics integrated with transcriptomics analysis could assist in obtaining new insights into biochemical pathophysiology and might facilitate the development of new treatment targets for insensitive patients.
- |||| Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trial completion, HEOR, Combination therapy: PH002-TP-II: Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients (clinicaltrials.gov) - Apr 17, 2024
P2, N=257, Completed, Sponsor: Palleos Healthcare GmbH
Metabolomics integrated with transcriptomics analysis could assist in obtaining new insights into biochemical pathophysiology and might facilitate the development of new treatment targets for insensitive patients. Active, not recruiting --> Completed
- ||||| PERT-IJS (pertuzumab biosimilar) / Biocon
Trial initiation date, Metastases: Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta (clinicaltrials.gov) - Apr 16, 2024
P3, N=382, Not yet recruiting, Sponsor: Biocon Biologics UK Ltd
Active, not recruiting --> Completed Initiation date: Mar 2024 --> Sep 2024
- ||||| HLX11 (pertuzumab biosimilar) / Fosun Pharma, Organon
Enrollment closed, Metastases: A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta (clinicaltrials.gov) - Apr 16, 2024
P3, N=900, Active, not recruiting, Sponsor: Shanghai Henlius Biotech
Initiation date: Mar 2024 --> Sep 2024 Recruiting --> Active, not recruiting