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A Look Ahead to SABCS 2022

Sara Hurvitz, MD, FACP

Professor of Medicine
Director,
Breast Oncology Program
Division of Hematology-Oncology
Department of Medicine
David Geffen School of Medicine at UCLA
Los Angeles, California


Sara Hurvitz, MD, FACP: researcher (paid to institution): Ambrx, Amgen, Arvinas, AstraZeneca, Bayer, Cytomx, Daiichi-Sankyo, Dantari, Dignitana, Genentech/Roche, G1 Therapeutics, Gilead Sciences, Greenwich Life Sciences, GlaxoSmithKline, Immunomedics, Lilly, MacroGenics, Novartis, OBI Pharma, Orinove, Pfizer, Phoenix Molecular Designs, Pieris, PUMA, Radius, Samumed, Sanofi, Seattle Genetics/Seagen, Zymeworks; speaker: Daiichi Sankyo.


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Joyce O'Shaughnessy, MD

Celebrating Women Chair in Breast Cancer Research
Director,
Breast Cancer Research Program
Baylor University Medical Center
Texas Oncology
US Oncology Network
Dallas, Texas


Joyce O’Shaughnessy, MD: consultant/advisor/speaker: AbbVie, Agendia, Amgen Biotechnology, Aptitude Health, AstraZeneca, Athenex, Bayer, Bristol-Myers Squibb, Carrick Therapeutics, Celgene, Daiichi Sankyo, Eisai, G1 Therapeutics, Genentech, Genzyme, Gilead Sciences, GRAIL, Halozyme Therapeutics, Heron Therapeutics, Immunomedics, Ipsen Biopharmaceuticals, Lilly, Merck, Myriad, Nektar Therapeutics, Novartis, Ontada, Pfizer, Pharmacyclics, Pierre Fabre, Prime Oncology, Puma Biotechnology, Roche, Samsung Bioepis, Sandoz, Sanofi, Seagen, Syndax, Synthon, Taiho Oncology, Takeda, Theralink.


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Released: December 5, 2022

The 2022 San Antonio Breast Cancer Symposium (SABCS) will showcase important results from many clinical trials in breast cancer. Here, renowned experts have highlighted some of their most anticipated abstracts, which will be covered online as part of CCO’s Independent Conference Coverage of SABCS 2022. After the meeting, remember to check the CCO website for a downloadable highlights slideset summarizing the data from these studies and a CME-certified online expert analysis activity featuring expert commentaries on the clinical implications of the data. 

Top Picks
The monarchE trial demonstrated both invasive disease–free survival (iDFS) and distant relapse–free survival (DRFS) benefits for adjuvant abemaciclib plus endocrine therapy (ET) for patients with high-risk, hormone receptor (HR)–positive/HER2-negative early breast cancer. Further analysis of iDFS, DRFS, and overall survival (OS) from a preplanned interim analysis will be presented (GS1-09). With a median follow-up of 42 months, the benefit of abemaciclib in terms of iDFS and DRFS was maintained after patients completed 2 years of adjuvant abemaciclib. These are very important results given that the early benefits seen in the PENELOPE trial with adjuvant palbociclib disappeared by 40 months. These data confirm the benefit of abemaciclib in patients with HR-positive/HER2-negative early breast cancer who are at high risk of recurrence. Although immature at this analysis, the trend in OS benefit with abemaciclib also is encouraging. It is anticipated that this will drive more adjuvant abemaciclib use in patients meeting eligibility criteria per monarchE.

Another anticipated study is the phase II SERENA-2 trial of camizestrant (GS3-02), an oral selective estrogen receptor degrader (SERD). This study compares oral camizestrant vs ET (fulvestrant) in patients with advanced/metastatic HR-positive breast cancer previously treated with ET for advanced disease. Depending on the degree of benefit, this may be the second randomized trial to show benefit of an oral SERD vs ET in advanced/metastatic breast cancer. Earlier in 2022, the investigational oral SERD elacestrant demonstrated a significant progression-free survival benefit compared with physician’s choice of ET in the phase III EMERALD trial in advanced breast cancer. An update from the EMERALD study by duration of previous CDK4/6 inhibitor therapy will be reported (GS3-01).

It is anticipated that, if positive, the phase III CAPItello-291 trial (GS3-04) will lead to FDA approval of the first AKT inhibitor—capivasertib. This trial evaluated capivasertib in combination with fulvestrant in patients with HR-positive/HER2-negative locally advanced or metastatic breast cancer following recurrence/progression on or after ET therapy with or without a CDK4/6 inhibitor. We await the presentation to see the level of benefit from capivasertib. The safety profile of capivasertib appears more favorable than that of alpelisib, a PI3K inhibitor, but a head-to-head comparison is lacking. If the data in the molecularly altered group of CAPItello-291 are positive, then capivasertib has the potential to supplant alpelisib in patients with tumor PIK3CA mutations. This remains to be determined by analysis of the full data once available.

Young premenopausal patients with HR-positive breast cancer may need to consider the effects of treatment on fertility and pregnancy. These patients typically are offered 5-10 years of adjuvant ET. The POSITIVE trial (GS4-09) aims to evaluate whether temporary interruption of ET to attempt pregnancy is associated with a higher risk of breast cancer recurrence. These results are highly anticipated by young patients who want to know if a break in ET to achieve pregnancy will impact their breast cancer treatment or risk of recurrence. If this trial demonstrates that patients receiving ET do not have worse outcomes after an interruption of ≤2 years to attempt or have a pregnancy compared with those without breaks in therapy, this will be very welcome news for practice. However, if this study shows that taking ≤2 years off adjuvant ET does negatively impact outcomes, this also would be important data to help guide practice.

Additional Studies of Potential Interest
CCO’s Independent Conference Coverage of SABCS 2022 will include coverage of additional studies, including:

  • GS1-10: primary results from the phase II RIGHT Choice trial of ribociclib plus ET vs physician’s choice of combination chemotherapy in premenopausal patients with aggressive HR-positive/HER2-negative breast cancer
  • GS2-01: primary results from the phase III DESTINY-Breast02 trial comparing trastuzumab deruxtecan (T-DXd) vs physician’s choice in HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1)
  • GS2-02: updated survival results from the phase III DESTINY-Breast03 trial comparing T‑DXd vs T‑DM1 in HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and a taxane
  • GS2-03: neoadjuvant T-DXd with or without anastrozole for HER2-low, HR-positive early-stage breast cancer
  • GS3-06: efficacy results from the randomized phase II PACE study of fulvestrant, fulvestrant plus palbociclib, or combined fulvestrant, palbociclib, and avelumab in estrogen receptor (ER)–positive/HER2-negative metastatic breast cancer after previous ET plus a CDK4/6 inhibitor
  • GS3-09: OS from the STIC CTC trial using circulating tumor cells to inform first-line therapy selection in ER-positive/HER2-negative breast cancer
  • GS4-02: impact of omission of axillary lymph node dissection on recurrence in patients with node-positive disease downstaged to node-negative disease after neoadjuvant therapy in the OPBC-04/EUBREAST-06/OMA trial
  • GS5-11: efficacy outcomes by Trop-2 expression level from the TROPiCS-02 study of sacituzumab govitecan vs treatment of physician’s choice in HR-positive/HER2-negative advanced breast cancer
  • PD7-03: intracranial efficacy outcomes with neratinib plus T-DM1 in patients with HER2-positive breast cancer and brain metastases from the phase II Translational Breast Cancer Research Consortium trial 022
  • PD13-12: safety and efficacy of the phase Ia/b study of imlunestrant, an oral SERD, plus abemaciclib with or without an aromatase inhibitor in ER-positive breast cancer

Remember to Check Back!
Please visit the CCO website after the meeting to get more information about these interesting and important studies from SABCS 2022, including a downloadable highlights slideset, along with a CME-certified expert analysis activity where these experts will explore the clinical implications of the data.

Your Thoughts?
Which studies being presented at SABCS 2022 interest you most, and which do you think will have the biggest impact on clinical practice? Join the conversation below!

Supported by educational grants from
AstraZeneca
Daiichi Sankyo, Inc.
Gilead Sciences, Inc.
Lilly
Puma Biotechnology

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