On December 2, 2015 Novartis reported that it will present data that highlight advancements in targeted combination therapy research, and underscore the company’s continued commitment to bringing innovative treatments to patients living with advanced breast cancer at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), December 8-12 (Press release, Novartis, DEC 2, 2015, View Source [SID:1234508378]). Novartis will present 55 abstracts showcasing key real-world data from Afinitor (everolimus), Tykerb (lapatinib) and several investigational compounds in advanced breast cancer [1].

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"These data presented at SABCS reinforce the current focus toward combination therapies as the standard treatment for hormone receptor-positive, HER2 negative advanced breast cancer," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "Given the breadth of our portfolio, we are well positioned to explore innovative treatment combinations with the goal of providing the greatest benefit for patients living with advanced breast cancer."

Key Afinitor presentations show real-world data that add to the growing body of evidence demonstrating the benefit of staying on treatment:

BOLERO-2: cfDNA analysis from BOLERO-2 plasma samples identifies a high rate of ESR1 mutations: Exploratory analysis for prognostic and predictive correlation of mutations reveals different efficacy outcomes of endocrine therapy-based regimens (SABCS Oral Poster: #S2-07; December 9, 4:45 PM CST)

EVEREXES: Clinical effectiveness of everolimus and exemestane in advanced breast cancer patients from Asia and Africa: First efficacy and updated safety results from the phase IIIb study (SABCS Abstract #P4-13-09; December 11, 7:30 AM CST)

Evaluation of miracle mouthwash (MMW) plus hydrocortisone versus prednisolone mouth rinses as prophylaxis for everolimus-associated stomatitis: Preliminary results of a randomized phase II study (SABCS Abstract #P1-15-06; December 9, 5:00 PM CST)

BALLET: Stomatitis following everolimus (EVE) plus exemestane (EXE) in patients with hormone receptor-positive (HR+), HER2-advanced breast cancer (ABC) in the BALLET trial (SABCS Abstract #P4-13-10; December 11, 7:30 AM CST)

BRAWO: Stomatitis in patients treated with everolimus and exemestane – Results of the 3rd interim analysis of the non-interventional trial (SABCS Abstract #P4-13-08; December 11, 7:30 AM CST)

BRAWO: Impact of physical activity/exercise on adverse events and quality of life during treatment with everolimus and exemestane for ER+ women – Results of the 3rd interim analysis (SABCS Abstract #P4-13-07; December 11, 7:30 AM CST)

BRAWO: Results of the third interim analysis – Sub-analysis of patients < 70 years and >= 70 years (SABCS Abstract #P4-13-06; December 11, 7:30 AM CST)

Investigational data in PI3K/mTOR and CDK 4/6 pathways demonstrate value of inhibiting multiple targets via dual or triplet therapy:

BELLE-2: PIK3CA status in circulating tumor DNA predicts efficacy of buparlisib plus fulvestrant in postmenopausal women with endocrine-resistant HR+/HER2- advanced breast cancer: First results from the randomized, Phase III BELLE-2 trial (SABCS Oral Presentation #S6-01; December 11, 3:15 PM CST)

NeoPHOEBE: Phase II, randomized, parallel-cohort study of neoadjuvant buparlisib (BKM120) in combination with trastuzumab and paclitaxel in women with HER2-positive, PIK3CA mutant and PIK3CA wild-type primary breast cancer (SABCS Abstract #P1-14-01; December 9, 5:00pm CST)

Triplet therapy with ribociclib, everolimus, and exemestane in women with HR+/HER2- advanced breast cancer (SABCS Abstract #P6-13-01; December 12, 7:30 AM CST)

Phase Ib/II study of ribociclib and alpelisib and letrozole in ER+, HER2- breast cancer: Safety, preliminary efficacy and molecular analysis (SABCS Abstract #P3-14-01; December 10, 5:00 PM CST)

Data from the Make Your Dialogue Count (MYDC) survey, which sought to better understand how to improve communications among advanced breast cancer patients, caregivers and health care professionals, explore emotional effects of advanced breast cancer on caregivers:

The experience of caregivers of women with metastatic breast cancer: Insights from the MYDC survey (SABCS Abstract #P1-11-06; December 9, 5:00 PM CST)
Other noteworthy data to be presented at SABCS on Tykerb (lapatinib) and Sandoz proposed biosimilar pegfilgrastim:

NeoALTTO: Whole exome sequencing of pre-treatment biopsies to identify DNA aberrations associated with response to HER2-targeted therapies in breast cancer (SABCS Oral Poster #S5-01; December 11, 9:30 AM CST)

NeoALTTO (BIG 1-06): Breast ultrasound (US) and mammography (Mx) and response to neoadjuvant LAP, TRAS and their combination in HER2+ breast cancer (SABCS Abstract #P6-01-04; December 12, 7:30 AM CST)

ALTTO: The impact of early LAP-induced rash on DFS and OS (SABCS Abstract # PD5-07; December 10, 5:00 PM CST)
Results from PROTECT 1; A randomized, double-blind trial comparing the efficacy and safety of a proposed biosimilar pegfilgrastim (LA-EP2006) with reference pegfilgrastim in patients with breast cancer (SABCS Abstract #P1-10-01; December 9, 5:00 PM CST)
To read more about the Novartis research approach and perspectives on current trends in the breast cancer treatment landscape, visit www.novartisoncology.com/stories.