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Bladder CancerLiver CancerMelanomaNSCLC (Non-Small Cell Lung Cancer)Other CancersOvarian CancerPancreatic CancerProstate CancerRCC (Renal Cell Carcinoma)TNBC (Triple Negative Breast Cancer)Combination Product: Naptumomab estafenatox (ABR-217620; NAP) and durvalumab (IMFINZI; MEDI4736)Combination Product: Obinutuzumab pretreatment (Gazyva®) Naptumomab estafenatox (ABR-217620; NAP) and durvalumab (IMFINZI; MEDI4736)ActiveNot RecruitingIsrael 0NCT03983954Phase 1
Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors

Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors

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Lymphomas and Leukemias Cancer Cells
Lymphoma

ac4C RNA Modification and Epigenetic Therapies in DLBCL

KEY TAKEAWAYS The study aimed to investigate NAT10's role and mechanisms in DLBCL using clinical samples and various assays. The results showed the essential role of ac4C RNA modification mediated by NAT10 in DLBCL and provided insights into novel epigenetic-based...

Jul 5, 2024

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Ribociclib + Letrozole in HR+ Breast Cancer: RIBECCA

KEY TAKEAWAYS

  • The phase 3b RIBECCA study aimed to investigate the real-world efficacy of ribociclib plus letrozole in postmenopausal women with HR+HER2- ABC.
  • The primary endpoint was to determine CBR.
  • Researchers concluded that in this diverse HR+HER2- ABC population, ribociclib plus letrozole demonstrated consistent efficacy and safety, mirroring pivotal trial outcomes.

In MONALEESA-2, combining ribociclib with letrozole demonstrated a substantial increase in progression-free survival (PFS) for postmenopausal women diagnosed with HR+HER2- advanced breast cancer (ABC).

Peter A Fasching and his team aimed to assess the RIBociclib for the treatment of advanCed breast CAncer (RIBECCA) study and its effectiveness of ribociclib plus letrozole in a patient population representative of routine clinical practice.

Researchers conducted an inclusive analysis in a multicenter, open-label, single-arm, phase 3b study. Patients diagnosed with HR+HER2-ABC, deemed ineligible for curative therapy, and possessing an ECOG performance status of ≤ 2, were enrolled. Ribociclib plus letrozole was administered in (cohort A: postmenopausal women and men in first-line; cohort B: pre-/perimenopausal women in first-line [B1], patients pretreated for advanced disease [B2]). 

The primary endpoint focused on clinical benefit rate (CBR) by week 24, with secondary endpoints included overall response rate (ORR), PFS, overall survival (OS), and safety. Multivariable Cox regression analysis explored the association between patient and tumor characteristics with PFS.

About 487 patients were included in the efficacy evaluation, with 502 assessed for safety. By week 24, the CBR reached 60.8% (95% CI, 56.3-65.1), and the ORR was 19.3% (95% CI, 15.9-23.1). Median PFS was 21.8 months (95% CI, 13.9-25.3) for first-line postmenopausal patients and 11.0 months (95% CI, 8.2-16.4) for premenopausal and pretreated patients. The median OS was not reached.

Factors such as higher baseline ECOG performance status, elevated histological grade, and negative progesterone receptor status had an unfavorable impact on PFS. The most common adverse events (AEs) included neutropenia (50.0%), nausea (42.0%), and fatigue (39.2%).

The study concluded that in this diverse population of patients with HR+HER2- ABC, the efficacy and safety outcomes of ribociclib plus letrozole closely mirrored those observed in pivotal trials.

This study was sponsored by Novartis Pharma GmbH, Germany.

Clinical Trial: https://clinicaltrials.gov/study/NCT03096847

Source: https://pubmed.ncbi.nlm.nih.gov/38154393/

Fasching PA, Decker T, Hartkopf A, et.al (2024). Efficacy, safety, and prognosis prediction in patients treated with ribociclib in combination with letrozole: Final results of phase 3b RIBECCA study in hormone receptor positive, human epidermal growth factor receptor-2 negative, locally advanced or metastatic breast cancer. Eur J Cancer. 2024 Feb;198:113480. doi: 10.1016/j.ejca.2023.113480. Epub 2023 Dec 15. PMID: 38154393.

HER2 in Trastuzumab Therapy: Prognostic Insights

KEY TAKEAWAYS

  • The study aimed to assess the prognostic impact of HER2 gene amplification in early-stage HER2-positive breast cancer patients treated with trastuzumab.
  • Researchers observed a nonlinear association between HER2 biomarkers and RFS; further investigation is ongoing.

Overexpression of human epidermal growth factor receptor 2 (HER2) due to HER2 gene amplification is a key driver in breast cancer tumorigenesis.

Caroline Rönnlund and her team aimed to investigate the prognostic significance of HER2 biomarkers using manual scoring and digital image analysis (DIA) algorithms, specifically assessing HER2 copy numbers, HER2/CEP17 ratios, and ERBB2 mRNA levels. The focus is on early-stage HER2-positive breast cancer patients treated with trastuzumab.

Researchers performed an inclusive analysis in a retrospective study involving 371 early HER2-positive breast cancer patients who received adjuvant trastuzumab. HER2 re-testing was conducted on whole tumor sections, and digitized tumor tissue slides underwent manual scoring and assessment using uPath HER2 Dual ISH image analysis with a breast algorithm. The Xpert® Breast Cancer STRAT4 Assay was employed to target ERBB2 mRNA levels. In situ hybridization assessed HER2 copy number and HER2/CEP17 ratio, along with ERBB2 mRNA levels, which were then explored with recurrence-free survival (RFS).

About the analysis, patients with tumors displaying the highest and lowest manually counted HER2 copy number levels experienced worse RFS compared to those with intermediate levels (HR = 2.7, CI 1.4-5.3, P = 0.003, and HR = 2.1, CI 1.1-3.9, P = 0.03, respectively). A similar trend was noted for the HER2/CEP17 ratio, and the DIA algorithm substantiated these findings. Furthermore, patients with tumors exhibiting the highest and lowest values of ERBB2 mRNA had significantly poorer prognoses (HR = 2.7, CI 1.4-5.1, P = 0.003 and HR = 2.8, CI 1.4-5.5, P = 0.004, respectively) compared to those with intermediate levels.

The study concluded that the association between any of the three HER2 biomarkers and RFS was nonlinear. Tumors with the highest levels of HER2 gene amplification or ERBB2 mRNA demonstrated a worse prognosis compared to those with intermediate levels. This finding underscores the significance of further exploration in future clinical trials focusing on HER2-targeted therapy.

The study received open-access funding from the Karolinska Institute. This study was supported by grants from Region Stockholm Sweden, the Swedish Cancer Society, MedTechLabs, the Cancer Society in Stockholm, the Swedish Breast Cancer Association, and the Swedish Society. 

Source: https://pubmed.ncbi.nlm.nih.gov/38321542/

Rönnlund C, Sifakis EG, Schagerholm C, et.al(2024). Prognostic impact of HER2 biomarker levels in trastuzumab-treated early HER2-positive breast cancer. Breast Cancer Res. 2024 Feb 7;26(1):24. doi: 10.1186/s13058-024-01779-9. PMID: 38321542; PMCID: PMC10848443.

HER2-low vs HER2-negative MBC: Improved Survival

KEY TAKEAWAYS

  • The study aimed to investigate features and outcomes of HER2-negative and HER2-low MBC using real-world data.
  • The results demonstrated that the HER2-low tumors were associated with improved survival compared to HER2-negative tumors in MBC.

Investigating real-world data, Zachary Neubauer and the team aimed to analyze characteristics and outcomes of HER2-negative and HER2-low metastatic breast cancers (MBC).

The National Cancer Database was utilized to identify MBC patients classified as HER2-low or HER2-negative via immunohistochemical staining. Demographic and clinical correlates of each subtype were identified through binomial regression analysis. Additionally, survival correlates were identified through Cox multivariable regression analysis (MVA) and propensity-match analysis.

After excluding missing data, 24,636 patients diagnosed with MBC between 2008 and 2015 were identified. Of these, 27.9% were HER2-negative, and 72.1% were HER2-low. No significant demographic differences were observed between the groups. HER2-low tumors were half as likely to exhibit concomitant hormone receptor-positive status (P < 0.01).

Among hormone receptor-negative patients, the 3-year survival rate was 33.8% for HER2-low and 32.2% for HER2-negative (P< 0.05) and among hormone receptor-positive patients, the corresponding rates were 60.9% and 55.6% for HER2-low and HER2-negative cases, respectively ( P< 0.05). HER2-low cases demonstrated improved survival in multivariable regression analysis (HR = 0.95, 95% CI 0.91-0.99) and propensity-matching (HR = 0.92, 95% CI 0.89-0.96).

 In a subset analysis focusing on hormone receptor-positive cases, HER2-low status remained associated with better survival (HR = 0.93, 95% CI 0.89-0.98) in propensity-matched multivariable regression analysis. Correlates of worse survival included older age as a continuous variable (HR = 1.02, 95% CI 1.02-1.02) and Black race (HR = 1.26, 95% CI 1.20-1.32) [all P< 0.01].

This study, the largest analysis conducted to date, revealed a statistically significant association of HER2-low tumors that exhibited improved survival compared to HER2-negative tumors in MBC. No funding was provided for the study.

Source: https://pubmed.ncbi.nlm.nih.gov/38379326/

Neubauer Z, Hasan S, Press RH, et al. (2024) ‘’Prognostic implications of HER2NEU-low in metastatic breast cancer.’’ Cancer Med. 2024 Jan;13(2):e6979. doi: 10.1002/cam4.6979.

Chidamide in HR+/HER2- MBC: Real-world Evidence

Chidamide in HR+/HER2- MBC: Real-world Evidence

KEY TAKEAWAYS

  • The study aimed to assess chidamide’s effectiveness, safety, and treatment patterns while identifying clinicopathological factors predicting its efficacy in real-world settings.
  • Real-world data supported chidamide use in HoR-positive, HER2-negative MBC patients.

Chidamide, a selective histone deacetylase inhibitor, is approved for metastatic breast cancer (MBC) patients with hormone receptor (HoR)-positive and HER2-negative status.

Doudou Li and the team spearheaded a study that aimed to assess chidamide’s efficacy, safety, and treatment patterns while identifying clinicopathological factors predicting its effectiveness in real-world scenarios.

In a multicenter retrospective design, the study enrolled consecutive MBC patients treated with chidamide from January 2020 to August 2021 across 11 institutions. Premenopausal and postmenopausal women with ER-positive, HER2-negative MBC that had been clinically or histologically proven were eligible, as long as they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Multiple primary malignancies or missing baseline characteristics were exclusion criteria. Patients received oral chidamide at 30 mg twice weekly, combined with either aromatase inhibitors (AIs) or non-AIs. Efficacy analyses encompassed progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR). Univariate and multivariate Cox regression analyses were conducted to identify potential predictors of efficacy.

About 157 patients were included for analysis, with a median of four prior treatment lines before chidamide. The median PFS for the total population was 4.2 months (95% CI 3.8-4.5). The CBR was 31.3 percent, and the ORR was 7.5%. The effectiveness of chidamide was not affected by individuals receiving different endocrine combinations or those who had previously had treatment with CDK4/6 inhibitors.

According to the multivariate analysis, patients with liver metastases (adjusted HR = 1.66, 95% CI 1.14-2.43, adjusted P = 0.008) or ≥3 prior treatment lines (adjusted HR = 1.80, 95% CI 1.17-2.77, adjusted P = 0.008) showed significantly worse PFS. The most frequent adverse events (AEs) linked to chidamide were anemia, leukopenia, neutropenia, and thrombocytopenia.

Based on real-world evidence, the study indicated that chidamide effectively cures HoR-positive and HER2-negative MBC, especially in patients who have already had treatment with CDK4/6 inhibitors and those undergoing different endocrine combinations.

Research funding was provided by the Beijing Science and Technology Innovation Medical Development Foundation, Chinese Young Breast Experts Research project, and CSCO-ROCHE Cancer Research Fund 2019.

Source: https://pubmed.ncbi.nlm.nih.gov/38457252/ 

Li D, Jin Y, Lin M, et al.(2024) ‘’Treatment patterns and clinical outcomes of chidamide combined with endocrine therapy in hormone receptor-positive, HER2-negative metastatic breast cancer: A real-world multicenter study.’’ Cancer Med. 2024 Feb;13(4):e6762. doi: 10.1002/cam4.6762. PMID: 38457252; PMCID: PMC10923034.

D-Dimer and Thrombin: Prognostic Score for Breast Cancer

KEY TAKEAWAYS

  • The HYPERCAN study observational trial aimed to investigate the predictive value of prechemotherapy hemostatic biomarkers for high-risk breast cancer pts.
  • Researchers noticed that TG and D-dimer, offer a promising tool for identifying high-risk breast cancer pts prone to early disease recurrence.

Hemostatic biomarkers have garnered attention for their potential in predicting specific cancer outcomes, such as survival, malignant disease recurrence, and progression. Despite promising results from small, single-center studies, the need for confirmatory data from large, prospective studies persists. In this context, the HYPERCAN study was initiated, focusing on a substantial cohort of high-risk breast cancer patients (pts).

Patricia Gomez-Rosas and her team aimed to investigate whether prechemotherapy hemostatic levels could serve as predictive indicators for disease recurrence (DR). The objective was to assess and generate an internally validated risk assessment model based on pre-treatment values of thrombin generation (TG) and D-dimer. This model aimed to identify subjects at higher risk of DR within the initial 2 years post tumor resection.

The HYPERCAN study conducted an inclusive analysis as part of its prospective, observational, multicenter design. Specifically focused on evaluating hemostatic biomarkers, the study aimed to elucidate their correlation with disease recurrence, disease progression, mortality response to therapy, and thrombosis in pts diagnosed with surgically resected high-risk breast cancer. The analysis encompassed pts enrolled between 2012 and 2019.

The study performed an extensive examination of blood samples collected at enrollment, prior to the initiation of anticancer treatment. TG was assessed using both the ST-Genesia system (STG-ThromboScreen reagent, with and without thrombomodulin) and the calibrated automated thrombogram (CAT) at 5 pM TF. Additionally, D-dimer, fibrinogen, prothrombin fragment 1+2 (F1+2), and proteins C and free protein S (FPS) were measured.

The primary outcome under scrutiny was early-DR (E-DR) within a 2-year timeframe. 

About 1,059 pts, with a gender distribution of 15 males and 1,044 females, and a mean age of 53 years (SD±11), were included in the analysis. Surgical procedures comprised breast-conserving resection in 53% of cases and mastectomy in 47% pts. HER-2 expression was positive in 26% of tumor specimens. Predominant molecular subtypes were Luminal B HER2 negative (32%), Luminal A (22%), Luminal B HER2 positive (19%), Triple-negative (13%), and HER2 positive (8%). The majority of tumors (86%) were classified as invasive ductal carcinoma.

All pts were eligible for systemic adjuvant chemotherapy, and those with HER-2 positivity were candidates for trastuzumab. Within 2 years from enrollment, 53 pts (5.5%) experienced early disease recurrence (E-DR), 8 died, and 92 were lost at follow-up. E-DR pts exhibited worse stage (IIIC), a higher frequency of triple-negative subtype, and less often Luminal-B/HER2-positive molecular subtypes (p<0.05).

Furthermore, E-DR subjects demonstrated elevated pre-chemotherapy levels of D-dimer (p=0.004) and peak TG measured by both Genesia (p=0.001) with and without thrombomodulin, as well as CAT assays (p<0.001). Other coagulation parameters did not significantly differ between the two groups.

A competitive multivariable proportional hazard regression model, adjusted for age and surgery status, identified D-dimer and TG peak (by both methods) as independent risk factors for E-DR. Internal validation through 1,000-bootstrapping resampling confirmed the robustness of the model. A continuous risk score incorporating D-dimer and TG achieved a ROC AUC of 0.652 (p<0.001). This risk score effectively stratified pts into high- and low-risk categories for E-DR (HR 23 vs 0%: Log-rank <0.001).

The study concluded that a validated risk model, utilizing pre-treatment TG and D-dimer values, effectively identifies high-risk breast cancer pts for early disease recurrence. If externally validated, this score could enhance clinical surveillance and guide treatment decisions, preventing overtreatment in low-risk individuals.

The study is sponsored by A.O. Ospedale Papa Giovanni XXIII

Source: https://ashpublications.org/blood/article/142/Supplement%201/5460/505075/A-D-Dimer-and-Thrombin-Generation-Based-Risk-Score

Clinical Trial: https://clinicaltrials.gov/study/NCT02622815

Rosas P G, Marchetti M, Giaccherini C, et al. (2023). “A D-Dimer and Thrombin Generation-Based Risk Score Predicts Early-Disease Recurrence in a Prospective Cohort of 1,059 High-Risk Breast Cancer Patients.” Presented at ASH 2023.

Camizestrant Study: Tailored Pre-surgical ER+ Breast Cancer Treatment

KEY TAKEAWAYS

  • The SERENA-2 and SERENA-3 phase II trials aimed to investigate the biological effects of three camizestrant dose levels in ER+ HER2- primary breast cancer post-menopausal women.
  • The results demonstrated that camizestrant achieves optimal ER degradation and Ki67 suppression, establishing it as the preferred dose for primary ER+ HER2˗ breast cancer post-menopausal patients.

Camizestrant, an advanced oral selective estrogen receptor degrader (SERD) and pure ER antagonist, exhibits substantial and clinically significant progression-free survival (PFS) advantages over fulvestrant at both 75 and 150 mg once-daily doses in the Phase 2 SERENA-2 study for post-menopausal women with ER+ HER2- advanced breast cancer.

In SERENA-3, John Robertson and his team aimed to investigate the biological impacts of three different dose levels of camizestrant in post-menopausal women with primary ER+ HER2- breast cancer.

Patients scheduled for curative intent surgery were randomly assigned to pre-surgical camizestrant treatment (75, 150, or 300 mg once daily for 5 to 7 days in Stages 1 and 2; or 75 or 150 mg once daily for 12 to 15 days in sequential Stage 3). Image-guided pre-treatment biopsies and on-treatment ultrasound-guided tumor biopsies were collected. 

The primary objective was to assess camizestrant’s effect on ER expression via immunohistochemistry (IHC) H-score, comparing pre-treatment and on-treatment biopsies. Secondary objectives included evaluating Ki67 and PgR expression, safety, and tolerability. Exploratory pharmacodynamic assessment employed various transcriptomic and proteomic technologies. Conducted across 17 centers in 3 countries (Georgia, Mexico, and the United Kingdom).

Of 135 randomized and treated patients, 76 received camizestrant for 5 to 7 days (75 mg, n=30; 150 mg, n=33; 300 mg, n=13), and 59 received it for 12 to 15 days (75 mg, n=30; 150 mg, n=29). Baseline characteristics and ER, Ki67, and PgR levels were well-balanced across arms and stages. Pharmacokinetic observations aligned with steady-state predictions. 

The results demonstrated that camizestrant consistently reduced ER H-score by approximately 65%, regardless of dose or duration. While the 75 mg dose had a milder effect on Ki67 after 5–7 days, it showed a substantial 82% reduction similar to 150 mg after 12–15 days. Additional transcriptomics and proteomics assays corroborated the IHC analyses. Adverse events (AEs) were generally mild, with no serious events reported, except for one grade 2 visual impairment and one grade 3 diarrhea. 

The study explored varied camizestrant dose levels and durations in post-menopausal women with primary ER+ HER2˗ breast cancer, established 75 mg as the optimal dose for maximal ER degradation and Ki67 suppression. Supported by SERENA-2, this robust evidence underscores the suitability of 75 mg, even in the early disease setting, emphasizing the value of a carefully crafted multi-dose pre-surgical pharmacodynamic study for optimal dose selection. Research is sponsored by AstraZeneca.

Source: https://atgproductions.net/atgclients/sabcs/2023_SABCS_Abstract_Report-12-1-23_Compressed.pdf 

Clinical Trials: https://clinicaltrials.gov/study/NCT04588298 
https://clinicaltrials.gov/study/NCT04214288 

Robertson J, Gogitidze T, Katashvili Z, et al. (2023) ’’SERENA-3: A randomized pre-surgical window of opportunity study assessing dose and duration of camizestrant treatment in post-menopausal women with ER-positive, HER2- negative primary breast cancer.’’ Presented at SABCS 2023 (RF01-01).

CtDNA Detection in Adjuvant Abemaciclib Trial for High-Risk EBC

KEY TAKEAWAYS

  • The monarchE phase III trial aimed to assess pre-treatment ctDNA detection feasibility and track ctDNA persistence/clearance in EBC patients from monarchE using SignateraTM.
  • The reported outcome suggested that early ctDNA detection predicts high recurrence risk, but decreasing levels during treatment showed promise and may indicate long-term benefit.

In the monarchE trial (NCT03155997), two years of adjuvant abemaciclib plus endocrine therapy demonstrated significant and clinically meaningful improvements in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) for patients with HR+, HER2-, node-positive, high-risk early breast cancer (EBC). Notably, the benefits of abemaciclib were sustained post-treatment, and the magnitude of improvement deepened at the 4-year mark for both IDFS and DRFS.

Sherene Loi and her research team spearheaded the study that aimed to assess the technical feasibility and dynamics of ctDNA detection pre- and during abemaciclib + ET treatment in high-risk HR+, HER2- EBC patients from monarchE.

In a subset of patients (n=178) from the monarchE trial, comprising 84 from the abemaciclib+ET arm and 94 from the ET-alone arm, blood samples were collected at two key time points: before initiating protocol-directed therapy (Visit 1; randomization + ≤ 3 days) and near the completion of the 2-year treatment period (Visit 27; 24 months +/- 5 days from Visit 1). 

This subset was enriched for overall IDFS events, excluding patients with relapses before Visit 27. Primary tumors underwent whole exome sequencing (WES), and up to 16 variants were identified. Cell-free DNA was extracted from 356 plasma samples, and a SignateraTM ctDNA assay was developed for each patient based on the identified variants from the baseline tumor sample.

Within the selected subset of 178 patients, the IDFS event rate was 39.3% % (abemaciclib+ET 34.5% [29/84] and ET alone 43.6% [41/94]). Initially, 5.6% (10 patients) were ctDNA+, and at Visit 27, 23.6% (42 patients) were either persistently (3.9%, 7 pts) or became (19.7%, 35 pts) ctDNA+.

Notably, 70% of initially ctDNA+ and 100% of persistently or newly ctDNA+ patients experienced recurrence. In contrast, none of the 3 patients who cleared ctDNA+ developed recurrence. Among persistently ctDNA-negative patients, 21.1% (28) experienced recurrence, although they had the longest median IDFS (41.7 months). Overall, 10% (7/70) of patients with IDFS events were initially ctDNA+, and 50% (35/70) had detectable ctDNA at Visit 27.

The study found that detecting ctDNA post-neoadjuvant chemotherapy is rare but linked to high recurrence risk. At the 2-year treatment end, common ctDNA positivity strongly predicts recurrence. Notably, around 30% with early ctDNA detection dropped below limits, none was recurring.

Despite persistently ctDNA-negative cases experiencing recurrence, the delay suggested potential benefits. Future analyses in a larger cohort will explore ctDNA dynamics for identifying high-risk recurrence. The study is sponsored by Eli Lilly and Company

Source: https://atgproductions.net/atgclients/sabcs/2023_SABCS_Abstract_Report-12-1-23_Compressed.pdf

Clinical Trial: https://clinicaltrials.gov/study/NCT03155997

Loi S, Graff S, Johnston S, et al. (2023) ’’Results from a pilot study exploring ctDNA detection using a tumor-informed assay in the monarchE trial of adjuvant abemaciclib with endocrine therapy in HR+, HER2-, nodepositive, high-risk early breast cancer.’’ Presented at SABCS 2023, Henry B. Gonzalez Convention Center San Antonio, Texas ( PS06-01)

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