On November 19, 2021 Seagen, Inc. (Nasdaq:SGEN) reported upcoming data presentations for TUKYSA (tucatinib) at the San Antonio Breast Cancer Symposium (SABCS), taking place December 7-10, 2021 (Press release, Seagen, NOV 19, 2021, View Source [SID1234595839]). Seven abstracts – including three spotlight posters – highlight the company’s commitment to addressing unmet needs in advanced breast cancer.

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"Data to be presented at this year’s SABCS add to the breadth of evidence supporting the use of TUKYSA in patients with HER2-positive metastatic breast cancer, including long term data from the pivotal HER2CLIMB trial, which continues to demonstrate clinical benefit in patients including those with active and stable brain metastases after an additional 15.6 months of follow up," said Roger Dansey, M.D., Chief Medical Officer at Seagen.

"When a patient has leptomeningeal metastases, it is a difficult-to-treat situation with a very poor prognosis, so I’m very encouraged by results from a trial that showed clinically meaningful activity of the TUKYSA regimen in these patients," said Rashmi Murthy, M.D., Associate Professor, Department of Breast Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

Two abstracts featured in spotlight poster presentations show:

Continued Clinical Benefit in HER2-Positive Metastatic Breast Cancer Patients (MBC) with Active and Stable Brain Metastases

Updated exploratory results from the pivotal HER2CLIMB trial showed that TUKYSA combined with trastuzumab and capecitabine resulted in a robust and durable prolongation of overall survival (OS) that was consistent with results from the primary analysis for HER2-positive metastatic breast cancer patients with brain metastases after an additional 15.6 months of follow-up. The benefit was maintained in patients with active and stable brain metastases. These results will be featured in a spotlight poster (Abstract #PD4-04) presented by Nancy U. Lin, M.D., Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber in Boston, MA.

Promising Activity of TUKYSA Regimen in HER2-Positive MBC Patients with Leptomeningeal Metastases

A single-arm, investigator-sponsored phase 2 trial (n=17) of TUKYSA combined with trastuzumab and capecitabine represents the first prospective evidence of a systemic regimen demonstrating clinical benefit for HER2-positive breast cancer patients with leptomeningeal metastases, cancer that has spread to the membranes lining the brain and spinal cord. The findings showed a median OS of nearly one year (11.9 months [95% Confidence Interval: 4.1, NR]). Patients with leptomeningeal disease have a historically poor prognosis with median survival of four to five months.1,2 The most common treatment for leptomeningeal metastases is radiation therapy. These results will be featured in a spotlight poster (Abstract #PD4-02) presented by Rashmi Murthy, M.D., University of Texas MD Anderson Cancer Center.

Presentations of Company-Sponsored Trials:

Abstract Title

Abstract #

Presentation

Lead Author

Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with previously treated HER2-positive metastatic breast cancer with brain metastases (HER2CLIMB)

PD4-04

Spotlight Poster Discussion 4
Wed, Dec. 8, 2021:
5 pm – 6:30 pm CT

N. Lin

Trials-in-Progress

SGNTUC-019: Phase 2 basket study of tucatinib and trastuzumab in previously treated solid tumors with HER2 alterations: HER2-mutated breast cancer cohort (ongoing clinical trial)

OT1-15-01

Ongoing Trials Poster Session 1
Wed, Dec. 8, 2021:
5 pm – 6:30 pm CT

A. Okines

HER2CLIMB-04: phase 2 trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (trial in progress)

OT1-13-01

Ongoing Trials Poster Session 1
Wed, Dec. 8, 2021:
5 pm – 6:30 pm CT

E. Hamilton

Enfortumab vedotin 202: Phase 2 study of enfortumab vedotin for previously treated advanced solid tumors, including breast cancer

OT1-02-04

Ongoing Trials Poster Session 1
Wed., Dec. 8, 2021:
5 pm – 6:30 pm CT

M. Ono

Presentations of Investigator-Sponsored TUKYSA Trials:

Abstract Title

Abstract #

Presentation

Lead Author

Safety and efficacy of a tucatinib-trastuzumab-capecitabine regimen for treatment of leptomeningeal metastasis (LM) in HER2+ breast cancer: Results from TBCRC049, a phase 2 non-randomized study

PD4-02

Spotlight Poster Discussion 4
Wed, Dec. 8, 2021:
5 pm – 6:30 pm CT

R. Murthy

Intracranial efficacy of tucatinib, palbociclib and letrozole combination in patients with HR+/HER2+ breast cancer and brain metastases

P1-18-26

Poster Session 1
Wed, Dec. 8, 2021:
7 am – 8:30 am CT

E. Shagisultanova

Evaluation of Tucatinib + (Paclitaxel + Pertuzumab + Trastuzumab) followed by AC in high-risk HER2 positive (HER2+) stage II/III breast cancer: Results from the I-SPY 2 TRIAL

PD8-07

Spotlight Poster Session 8
Thu, Dec. 9, 2021:
7 am – 8:30 am CT

D. Potter

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.3,4,5 In 2020, more than two million new cases of breast cancer were diagnosed worldwide.6 Between 15 and 20 percent of breast cancer cases are HER2-positive.7

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

TUKYSA is approved in 36 countries. It was approved by the U.S. FDA in April 2020 and by the European Medicines Agency and the U.K. Medicines and Healthcare Products Regulatory Agency in February 2021. Merck, known as MSD outside the U.S. and Canada, has exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.

U.S. Indication and Important Safety Information

TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Warnings and Precautions

Diarrhea – TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Hepatotoxicity – TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.
Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Strong CYP3A or Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.
Use in Specific Populations

Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

On November 19, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to transform disease management and improve patient outcomes, reported the publication of a study of patients with stage I-III cutaneous melanoma (Press release, Castle Biosciences, NOV 19, 2021, View Source [SID1234595855]). Data demonstrated that DecisionDx-Melanoma is a significant independent predictor of metastatic recurrence.

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DecisionDx-Melanoma is Castle’s gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node (SLN) positivity, independent of traditional staging factors. The study, titled "The 31-gene expression profile stratifies recurrence and metastasis risk in patients with cutaneous melanoma," analyzed 438 patients who were tested with DecisionDx-Melanoma as part of their clinical care. The study can be accessed here.

"This study reinforced one of the primary reasons why I order DecisionDx-Melanoma for my patients as soon as they receive a melanoma diagnosis," said first author Abel Jarell, M.D., dermatologist and dermatopathologist at Northeast Dermatology Associates, Portsmouth, N.H. "It’s designed to provide personalized, prognostic information that I use to determine the likelihood that the cancer will spread, which helps inform decisions for treatment to ensure the best possible outcome for each patient’s disease."

Study background and highlights:

The study’s primary purpose was to show risk stratification by DecisionDx-Melanoma in patients with stage I–III cutaneous melanoma. A secondary end point was to demonstrate the added prognostic value of DecisionDx-Melanoma when combined with complete American Joint Committee on Cancer (AJCC) staging (including SLN status) or with SLN status alone, for recurrence detection.
438 patients with stage I–III melanoma consecutively tested with DecisionDx-Melanoma were analyzed and stratified as low risk (Class 1A), intermediate risk (Class 1B/2A) or high risk (Class 2B) of recurrence or metastasis.
DecisionDx-Melanoma significantly stratified five-year melanoma survival prognoses for patients, including recurrence-free survival (RFS) (p<0.001), distant metastasis-free survival (DMFS) (p<0.001) and melanoma-specific survival (MSS) (p<0.001).
Patients with a DecisionDx-Melanoma low-risk result (Class 1A) had higher five-year survival outcomes and were less likely to experience a recurrence than patients with a high-risk result (Class 2B).
Multivariable analysis showed that DecisionDx-Melanoma is a significant, independent predictor of metastatic recurrence (hazard ratio=5.38, p=0.014).
DecisionDx-Melanoma increased prognostic survival accuracy over sentinel lymph node status alone.
Consistent with previous validation and performance studies, the study demonstrated that DecisionDx-Melanoma added independent prognostic value to current staging guidelines for cutaneous melanoma to identify patients with a high and low recurrence or metastasis risk to improve patient management.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through Sept. 30, 2021, DecisionDx-Melanoma has been ordered 84,195 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

On November 19, 2022 Betta Pharmaceutical Co., Ltd. reported that the company received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration (NMPA) (Press release, Betta Pharmaceuticals, NOV 19, 2021, View Source [SID1234610680]). Ensatinib Hydrochloride Capsules (trade name: Bemena ) was officially approved for marketing , becoming the first domestic class 1 new drug for the treatment of ALK-mutated advanced non-small cell lung cancer in China.

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Lung cancer is the malignant tumor with the highest mortality and morbidity in China, of which non-small cell lung cancer (NSCLC) accounts for about 80%-85% of lung cancers. Anaplastic lymphoma kinase (ALK) is one of the important oncogenic drivers of NSCLC, and ALK mutations are found in 5%-7% of NSCLC patients . Because this mutation is more common in young, non-smoking or light-smoking lung adenocarcinoma patients, it is easier to achieve 5-year survival after using targeted drugs than other gene mutations. ALK fusion mutation is also known as "diamond mutation".

△Mechanism of action of Ensatinib

Ensatinib hydrochloride is a new-generation, potent and highly selective new-generation ALK inhibitor. It is a brand-new innovative drug with completely independent intellectual property rights jointly developed by Betta Pharmaceuticals and its holding subsidiary Xcovery. In December 2018 , the drug registration application of ensatinib for patients with ALK -positive locally advanced or metastatic non-small cell lung cancer who had progressed after receiving crizotinib treatment or who were intolerant to crizotinib received national approval. Accepted by the Food and Drug Administration. In February 2019 , ensatinib was included in the priority review list by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration. Since then, the clinical verification and registration on-site inspection organized by the Center for Food and Drug Inspection and Inspection ( CFDI ) of the State Food and Drug Administration have been completed successively .

The domestic phase II registration clinical study of ensatinib hydrochloride was led by Professor Zhang Zhang from Sun Yat-sen University Cancer Center, and a total of 27 domestic medical centers participated. The results of the study were published in full in the internationally renowned medical academic journal "The Lancet Respiratory Medicine" in October 2019 . Subsequent updated data showed that the overall ORR of crizotinib-resistant patients treated with ensatinib was 52.6% , the disease control rate was 87.8% , the median PFS was 11.2 months, the intracranial ORR was 71.4% , and the intracranial disease was 71.4%. The control rate was 95.2% . Studies have shown that ensatinib has more advantages compared with similar imported drugs in efficacy, especially in patients with intracranial metastasis, it has a higher response rate and has a good and controllable safety.

36BD9EA4-860C-4D7A-BF10-EC1D3BDFF35A.jpeg

△The full text of the ensatinib clinical study was published in The Lancet Respiratory Medicine

International oncology authoritative expert – Professor Ross Camidge from the University of Colorado in the United States commented in the editor’s note of The Lancet Respiratory Medicine that ensatinib is effective and safe, and is the second-line treatment for patients with ALK-mutated advanced non-small cell lung cancer The new option , and as the first-line treatment research progresses, may become the first-line treatment drug. Professor Zhang Li said when ensatinib was awarded the "Top Ten Original Researches in China’s Oncology Field in 2019" for its registered clinical study : " Ensatinib has outstanding efficacy and safety, and it can be said to be the ‘J-20’ in China’s ALK field . We hope to continue to work with Betta to create more new drugs to better meet the needs of patients and contribute to China’s pharmaceutical innovation. "

As the second targeted new drug approved by Betta Pharmaceuticals after icotinib, ensatinib, like icotinib , fills the domestic blank of similar drugs. Promoting international multi-center head-to-head, first-line Phase III clinical research ( eXalt3 ) overseas. In August 2020 , Dr. Leora Horn of Vanderbilt University in the United States released the interim analysis results of the eXalt3 study to the world at the World Conference on Lung Cancer ( WCLC ) Bureau Symposium . Results showed that patients with ALK -positive non-small cell lung cancer ( NSCLC ) treated with ensatinib had significantly longer median progression-free survival ( mPFS ) than patients treated with crizotinib.

Professor Mao Li, Senior Vice President and Chief Medical Officer of Betta Pharmaceuticals and CEO of Xcovery in the United States, said: "I am very pleased to see ensatinib emerge as a dark horse in the field of ALK-TKI . The R&D process is the first step for Betta Pharmaceuticals to "base itself in China and go global". The company is also actively preparing for the listing application for first-line indications in China and the United States. It is believed that after successful listing in the future, it will launch a full-scale attack in the whole process of ALK-positive NSCLC patients. In the management, the patient’s life is fully protected."

Dr. Ding Lieming, Chairman and Chief Executive Officer of Betta Pharmaceuticals, said: " I am delighted that ensatinib has been approved for marketing, providing patients with a new treatment option. Ensatinib is confident that it will be the second icotinib, continued The next story of icotinib , and it is expected to become the first targeted new drug for lung cancer to be simultaneously marketed globally by a Chinese company, benefiting not only Chinese patients, but also patients in other countries in the world. Betta will focus on ‘ becoming a The vision of a multinational pharmaceutical company headquartered in China is to strive to develop more affordable Best-in-class and First-in-class new drugs and good drugs, so that people can live a better life. "

On November 19, 2021 Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) reported that updated safety and efficacy data from the Phase 1 dose escalation trial of ARV-471, a novel oral estrogen receptor (ER)-targeting PROteolysis TArgeting Chimera (PROTAC) protein degrader, will be presented in a spotlight poster-discussion session at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-10, 2021 (Press release, Arvinas, NOV 19, 2021, View Source [SID1234595840]). ARV-471 is being jointly developed by Arvinas and Pfizer for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

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Presentation details are as follows:

Abstract Title: First-in-human safety and activity of ARV-471, a novel PROTAC estrogen receptor degrader, in ER+/HER2- locally advanced or metastatic breast cancer
Session Title: Spotlight Session 13
Abstract Number: 2343
Session Type: Spotlight Poster-Discussion Session
Session Date: Friday, December 10, 2021
Session Time: 7:00 a.m. – 8:30 a.m. CT

For a copy of the abstract, please visit the official SABCS website here.

Investor Call & Webcast Details
A conference call and webcast will be held at 8:30 a.m. ET on Friday, December 10, 2021, with Arvinas and Pfizer Oncology executives to discuss these data. Participants are invited to listen by dialing (844) 467-7654 (domestic) or (602) 563-8497 (international) five minutes prior to the start of the call and providing the passcode 9122219.

Supporting materials for the conference call and webcast will be available on Arvinas’ website at www.arvinas.com under Events + Presentations. A replay of the webcast will be archived on the Arvinas website following the presentation.

About ARV-471
ARV-471 is an investigational orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of ARV-471; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

On November 19, 2021 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported the release of 9 abstracts that will be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 7-10, 2021 (Press release, Puma Biotechnology, NOV 19, 2021, View Source [SID1234595856]). Abstracts are available to the public online on the SABCS website at www.sabcs.org.

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Oral Presentation:

Abstract:

GS4-10

Title:

Neratinib + fulvestrant + trastuzumab for hormone receptor-positive, HER2-mutant metastatic breast cancer and neratinib + trastuzumab for triple-negative disease: Latest updates from the SUMMIT trial

Presenter:

Komal Jhaveri, MD, FACP

Session:

Friday, Dec. 10, 11:00-11:15 a.m. CT

Poster Presentations:

Abstract:

P2-10-08

Title:

Assessment of risk factors for HER2+ breast cancer recurrence: A literature review

Presenter:

Joyce O’Shaughnessy, M.D.

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-11-02

Title:

Subsequent breast cancer among women with HER2+ disease in a large integrated healthcare system

Presenter:

Reina Haque, PhD, MPH

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-11-19

Title:

Estimating the long-term risk of recurrence in patients receiving HER2-targeted agents in HER2+ early-stage breast cancer (ESBC)

Presenter:

David Leroy Veenstra, PharmD, PhD

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-13-05

Title:

Central nervous system metastases as a site of first recurrence in adjuvant therapy trials of HER2+ early breast cancer (EBC)

Presenter:

Nancy U. Lin, MD

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-13-21

Title:

Improved central nervous system outcomes in patients with early-stage HER2-positive breast cancer who receive neratinib for the recommended duration: Findings from the phase 3 ExteNET trial

Presenter:

Frankie Ann Homes, MD, FACP

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P3-12-20

Title:

Outcomes of patients with pathologic complete response following neoadjuvant HER2-targeted therapy in patients with HER2+ early stage breast cancer

Presenter:

Joyce O’Shaughnessy, M.D.

Session:

Poster Session 3, Thursday, Dec. 9, 7:00-8:30 a.m. CT

Abstract:

P3-16-01

Title:

Population effectiveness model of the consequences of recurrence after trastuzumab emtansine (T-DM1) treatment among U.S. patients with high-risk HER2+ early-stage breast cancer (ESBC)

Presenter:

David Leroy Veenstra, PharmD, PhD

Session:

Poster Session 3, Thursday, Dec. 9, 7:00-8:30 a.m. CT

Abstract:

P5-18-02

Title:

Final findings from the CONTROL trial of diarrheal prophylaxis or neratinib dose escalation on neratinib-associated diarrhea and tolerability in patients with HER2+ early-stage breast cancer

Presenter:

Arlene Chan, MBBS, FRACP, MMED

Session:

Poster Session 5, Friday, Dec. 10, 7:00-8:30 a.m. CT