OBR Daily Commentary

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Update on PALLAS, an International Academic Breast Cancer Study Evaluating Adjuvant Palbociclib Second Interim Analysis of Adjuvant

(PrECOG) May 29, 2020 - Study for HR+, HER2- Early Breast Cancer demonstrates that there is little chance of palbociclib reducing the risk of recurrence. The Austrian Breast & Colorectal Cancer Study Group (ABCSG), Alliance Foundation Trials (AFT), the Breast International Group (BIG), PrECOG, LLC, the German Breast Group, and the NSABP Foundation today announced that the independent Data Monitoring Committee (IDMC) for the global Phase 3 early breast cancer PALbociclib CoLlaborative Adjuvant Study (PALLAS) trial determined that the study is unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival (iDFS) following a preplanned interim analysis.

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Debu Tripathy, MD (Posted: June 01, 2020)

quotesThe interim analysis of the very large PALLAS trial testing the addition of 2 years of palbociclib to standard adjuvant endocrine therapy is truly a disappointment not only as negative trial, but as a rejection of the conceptual framework – that a drug known to double progression-free survival in the metastatic setting has no impact in the adjuvant setting. These results will force us to re-evaluate the fundamental biology of micrometastatic disease, in some cases dormant cells that lie in hiding without even dividing for years, that for unknown reasons can reawaken and cause clinical recurrence. Anti-proliferative drugs may not be the answer, and a better understanding of dormancy will be critical. Finally, it remains possible that longer duration of therapy, or one of the other two cyclin-dependent kinase 4/6 inhibitors (both of which are being tested) could yield a positive result.quotes

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Seattle Genetics Announces U.S. FDA Approval of TUKYSA™ (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

(Seattle Genetics) Apr 17, 2020 - Approved for patients with HER2-positive metastatic breast cancer who have received one or more prior anti-HER2 therapies in the metastatic setting. First HER-2 tyrosine kinase inhibitor in combination to improve overall and progression-free survival in patients with metastatic HER2-positive breast cancer with or without brain metastases.

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Debu Tripathy, MD (Posted: April 17, 2020)

quotesThe approval of tucatinib is a first in many ways. Most importantly, it demonstrated a survival improvement in later lines of therapy – following on notable successes with pertuzumab and T-DM1 in first and 2nd+ lines. Also, it is the first HER2-specific agent in the clinic – targeting the proven HER2 “driver” without side effects due to blockade of closely related HER1 (EGFR). Importantly, it is the first trial to demonstrate improvements in outcome in patients with a history of CNS involvement that constituted about half of the enrolled patients, with 18% actually progressing in the CNS as allowed on the study. It will now be a new standard beyond first line therapy (depending on agents previously received). Many trials are now ongoing or planned to test tucatinib such as a trial in the most aggressive form of CNS disease – with leptomeningeal involvement (HER2+), as well is in early stage breast cancer for patients who have residual HER2+ breast following neoadjuvant therapy. quotes

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Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC)

(Merck) Feb 12, 2020 - In pivotal phase 3 KEYNOTE-355 study, KEYTRUDA plus chemotherapy significantly improved PFS compared to chemotherapy alone in patients with mTNBC whose tumors expressed PD-L1 (CPS ≥10). Data to be presented at an upcoming medical congress and discussed with regulatory authorities.

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Debu Tripathy, MD (Posted: February 12, 2020)

quotesThis is a notable finding as the first potentially practice-changing results for the use of immunotherapy in early stage breast cancer. It has already been shown that pembrolizumab can improve pathological complete response (pCR) rates when added to standard chemotherapy for triple negative breast cancer from this same trial (and in the previously reported I-SPY2 trial for hormone receptor-positive breast cancer as well). We also know that pCR is a reasonably good surrogate for disease-free survival. While the FDA has evaluated pCR rate as a possible approvable endpoint, additional data is still needed for the relatively new field of immunotherapy (at least “new” for breast cancer). This is the data that is needed for ultimate approval and entry into clinical use. We eagerly await the details of the trial results – it will be a welcome addition to our treatment protocols designed to prevent metastatic recurrences if the short and long-term toxicities are acceptable.quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Associate Clinical Professor, Medical Oncology Executi...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics Professo...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Steven Spielberg Family Chair in Hematology Oncology P...

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Stephen M. Schleicher, M.D., MBA

Community Oncology, Medical Oncologist, OneOncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Health Policy
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William McGivney, PhD

National Health Policy Expert...