In support of Breast Cancer Awareness month, Ferma.AI is here with a snapshot of HER2-negative Breast Cancer clinical trials intelligence from October, 2022.

Here is an overview of key events during the month.

9 new trials introduced

Stemline Therapeutics | Elacestrant; Alpelisib; Everolimus; Ribociclib; Palbociclib | Advanced ER-Positive HER2-Negative Metastatic Breast Cancer | Phase 1/2 | Primary Endpoint: RP2D

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, AE

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 | Primary endpoints: DLTs, TEAEs

Stemline Therapeutics | Elacestrant | CDK4/6i-Naive ER-positive HER2-negative Advanced Metastatic Breast Cancer | Phase 2 | Primary endpoint: PFS  

143 trials modified

  • NCT05306340 (evERA Breast Cancer): The trial sponsored by Genentech has the following updates:

  - Outcome measures will be determined in both ESR1m subpopulation                     and ITT population

  - TTCD in pain severity has been added as a secondary outcome measure

  - Criteria has been updated to include unresectable patient population

  • NCT04192331: Study type has been changed from observational to a phase 2 interventional study with randomized allocation and parallel assignment interventional model
  • NCT03328026: One of the combination drugs, Epacadostat, will not be considered as an intervention. Expansion cohort will be randomized into two arms with differences in initial treatment sequences
  • NCT04683679: The trial sponsored by Memorial Sloan Kettering Cancer Center has the following updates,

    - ER-Positive/Her2-negative BC patients will also be enrolled in the study       along with the TNBC population

  - Allocation has been changed to non-randomized and a new arm (Arm C)             was added to the trial, which includes ER-positive mBC patients treated               with pembrolizumab, SBRT and Olaparib

  - The study was amended to pause Arm B

6 Press Releases and 18 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
  • An analysis from the PALLAS trial presented during the 2022 ASCO Plenary Series, demonstrated that addition of palbociclib to endocrine therapy did not prolong iDFS in patients with ER+/ HER2- early BC. Also, secondary endpoints failed to improve. Source:Onclive, 20-Oct-2022
  • FDA authorized the initiation of the first Phase 2 study of Atossa’s proprietary (Z)-endoxifen in premenopausal women with ER+/HER2- breast cancer thereby lifting the clinical hold. Source: AtossaTherapeutics, 24-Oct-2022
  • Preliminary results of the phase 3 CAPItello-291 trial showed that capivasertib plus fulvestrant generated a statistically significant improvement in PFS, thereby meeting its primary endpoint in patients with HR-positive, HER2-low or negative locally advanced or mBC. Source: Astrazeneca, 26-Oct-2022
  • Updated results from the phase 2 SERENA-II trial showed that camizestrant led to a statistically significant improvement in PFS when compared to fulvestrant in advanced ER-positive HER2-negative BC. Source: Astrazeneca, 26-Oct-2022
  • Preliminary results from a Phase 1/2 trial, NCT04505826 presented at 34th EORTC-NCI-AACR Symposium highlighted that OP-1250-001 had favorable tolerability, high drug exposure and strong anti-tumor activity in advanced ER-positive, HER2-negative mBC. Source: Olema Oncology, 26-Oct-2022

21 Publications from Pubmed and ScienceDirect

  • PMID: 36194623: Assessing sacituzumab govitecan in HR+/HER2- breast cancer (News in Brief)
  • 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.
  • PMID: 36239405: Palbociclib with fulvestrant or letrozole in endocrine-sensitive patients with HR+/HER2- advanced BC: Safety analysis of the randomized PARSIFAL trial. Cosimo et al.

Social Analysis

  • 17 LinkedIn posts, 5 Facebook posts, 1 Instagram post and 2 tweets collectively highlighted that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental biologics license application (sBLA) for sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer.

This sBLA is based on data from the registrational phase 3 TROPiCS-02 clinical trial (NCT03901339), which met its primary endpoint of progression-free   survival (PFS) and key secondary endpoint of overall survival (OS) compared to physician’s choice of chemotherapy.

  • 2 LinkedIn posts, 1 Facebook, 1 Instagram post and 1 tweet 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
  • 10 tweets, 2 LinkedIn posts and 2 Facebook posts collectively highlighted the results from ELAINE- 2 clinical trial (NCT04432454) and stated that lasofoxifene, when combined with abemaciclib (Verzenio), a CDK 4/6 inhibitor, demonstrated promising clinical activity and had a favorable risk-to-benefit ratio for the treatment of pre- and postmenopausal patients with ER-positive/HER2-negative metastatic breast cancer who harbor an ESR1 mutation and whose disease had progressed on prior therapies
  • 3 LinkedIn posts, 3 Facebook posts, 1 Reddit post and 1 tweet collectively highlighted the announcement by Atossa Therapeutics and mentioned that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and authorized initiation of the phase 2 neoadjuvant clinical study of (Z)-endoxifen in premenopausal women with early-stage estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This is the first study of Atossa’s proprietary (Z)-endoxifen in the United States
  • 3 LinkedIn posts, 1 Facebook post and 1 Instagram post discussed the positive high-level results from the CAPItello-291 Phase III trial and mentioned that AstraZeneca’s capivasertib (AZD5363) in combination with fulvestrant (Faslodex) showed statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with placebo plus fulvestrant in patients with hormone receptor (HR)-positive, HER2-low or negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy

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