Ferma.AI is back with a snapshot of HER2-negative Breast Cancer clinical trials intelligence from last week, October 7-13, 2022.

Here is an overview of the key events:

4 new trials introduced

Pfizer | ARV-471; Ribociclib | ER-Positive HER2-Negative Advanced or Metastatic Breast Cancer | Phase 1/2 | Primary Endpoints: DLTs, OR

Ellipses Pharma | EP0062 | Relapsed Locally Advanced or Metastatic AR-Positive HER2-Negative ER-Positive Breast Cancer | Phase 1/2 | Primary Endpoints: DLTs, MTD, AEs

Peking University People's Hospital | Collaborator: Jiangsu Hengrui Pharmaceutical | Fluzoparib; Camrelizumab | gBRCA-Mutated HER2-negative Early Breast Cancer | Phase 2 | Primary Endpoint: tpCR

ProfoundBio | PRO1184 | Locally Advanced and/or Metastatic HR+ HER2-negative Breast Cancer; Locally Advanced and/or Metastatic ST (Ovarian Cancer; Endometrial Cancer; NSCLC; TNBC; Mesothelioma) | Phase 1/2 | DLTs, TEAEs

42 trials modified

  • NCT04191499: Phase 2 has been included to this Hoffmann-La Roche sponsored trial and now focuses both on phase 2 and phase 3
  • NCT02285179 (Poseidon): Genentech collaborated phase 1/2 trial was completed on October 12, 2022
  • NCT01625286 (BEECH): AstraZeneca’s phase 1/2 trial was completed on October 13, 2022
  • NCT05262400: Phase 1 has been included to this Pfizer sponsored trial and now focuses both on phase 1 and phase 2
  • NCT04192331: Study type has been changed from observational to a phase 2 interventional study with randomized allocation and parallel assignment interventional model

2 press releases and 7 news articles

  • Gilead's sBLA application for Trodelvy was accepted for priority review by the FDA for adult unresectable locally advanced HR-positive HER2-negative mBC based on the results from the phase 3 TROPiCS-02 study. PDUFA target action date is currently set for February 2023. Source: Gilead, 11-Oct-2022
  • Olema Oncology would present the updated clinical results of phase 1/2 NCT04505826, a study of OP-1250, in subjects with advanced metastatic ER-positive, HER2-negative BC at ENA 2022. Source: Olema Oncology, 12-Oct-2022
  • Adverse event analysis of Eli Lilly sponsored monarchE, MONARCH 1, MONARCH 2, and MONARCH 3 trials using abemaciclib demonstrated a manageable safety profile for HER2 negative BC. Also, dose reductions may be a key aspect of appropriate symptom management. Source: Onclive, 13-Oct-2022

9 Publications from Pubmed and ScienceDirect

  • ScienceDirect: Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early BC. Geyer Jr. et al.
  • PMID: 36207609: Outcomes of patients with HER2-negative mBC after first-line chemotherapy among patients with and without pathogenic gBRCA1/2 mutations. Jacot et al.
  • ScienceDirect: Randomized, open-label, non-inferiority clinical trial for evaluating the clinical and pathological response rates to NHT and CT in patients with luminal-subtype breast tumors. Maria Carolina et al. (Study Protocol)
  • PMID: 36220852: Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2- mBC. Rugo et al.

Social Analysis

  • 10 LinkedIn posts, 3 Facebook posts and 1 tweet collectively highlighted that the FDA has granted priority review to Sacituzumab Govitecan-hziy (Trodelvy) for patients with unresectable locally advanced or metastatic HR–positive, HER2-negative breast cancer who have previously received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. The priority review is based on results from the phase 3 TROPiCS-02 trial (NCT03901339)
  • 1 tweet and 1 Facebook post discussed the second interim analysis results of OlympiA clinical trial (NCT02032823) and mentioned that, with 3.5 years of median follow-up, OlympiA demonstrated statistically significant improvement in overall survival (OS) with adjuvant olaparib compared with placebo for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 and high-risk, HER2-negative early breast cancer. The findings were published in the Annals of Oncology journal on 10th October 2022
  • 1 LinkedIn post highlighted the result of clinical trial “Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor” (NCT05361655) sponsored by Pfizer. The post mentioned that palbociclib demonstrated a median overall survival (OS) of 49.1 months which is significantly longer compared to aromatase             inhibitor recipients, who showed OS of 43.2 months. The post also highlighted   that the progression-free survival (PFS) is 19.3 months and 13.9 months with palbociclib and aromatase inhibitor, respectively. These findings were published in NPJ breast cancer journal on 11th October 2022.

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