OBR Daily Commentary

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Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

(Takeda) Apr 27, 2021 - Takeda Pharmaceutical Company Limited today announced that that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy. Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.

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H. Jack West, MD (Posted: April 28, 2021)

quotesThough the activity of this targeted therapy isn't at the same level as that of osimertinib vs. an activating EGFR exon 19 or 21 mutation, or as that of alectinib vs. ALK-positive NSCLC, there remains a real unmet need for a targeted therapy against EGFR exon 20 mutations. We'd certainly welcome mobocertinib into the clinic for these patients.quotes

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Immune-boosting Drug May Help Before Lung Cancer Surgery

(ABC News/AP) Apr 12, 2021 - A drug that helps the immune system fight cancer gave dramatic results when used with chemotherapy before surgery in patients with operable lung tumors, doctors report. One out of 4 patients given chemo and the Bristol Myers Squibb drug Opdivo had no signs of cancer remaining once they ultimately had surgery, a study of about 350 such people found.

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H. Jack West, MD (Posted: April 18, 2021)

quotesThese data are extremely encouraging for this setting, with a remarkable increase in the rate of pathologic complete response associated with the addition of nivolumab to chemo, compared to chemotherapy alone. We don't have event-free survival, let alone overall survival yet, and I would say we need to see these results before getting ahead of ourselves and declaring this approach a new standard of care, but the early data are about as encouraging as you could ever hope to see at this point. This is especially true when patients on the neoadjuvant chemo/nivolumab arm had only received three cycles to achieve the marked improvements seen here -- this wasn't as if it entailed an extra year or more of treatment.quotes

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Second Drug Targeting KRAS G12C Shows Benefit in Mutated Non-Small-Cell Lung Cancer

(ELCC 2021 Virtual) Mar 25, 2021 - Clinical activity with a second drug inhibiting KRASG12C confirms its role as a therapeutic target in patients with advanced non-small-cell lung cancer (NSCLC) harbouring this mutation, according to results from a study with the KRASG12C inhibitor adagrasib reported at the European Lung Cancer Virtual Congress 2021. “As we strive to identify the oncogenic driver in more and more of our patients with NSCLC, it becomes critical that we develop therapies that can target these identified oncogenic drivers,” said lead author Gregory Riely, from Memorial Sloan Kettering Cancer Center, New York, USA.

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H. Jack West, MD (Posted: March 25, 2021)

quotesImportant work, especially data on co-mutations with KRAS G12C. There's a great deal more to learn in coming years. For now, these data with adagrasib look slightly superior to what we've seen with sotorasib, but we await far more data on combinations and in different settings in NSCLC in the coming years. I'm very hopeful that KRAS G12C is poised to become a large molecular subset for whom we'll have a greater understanding and steadily improving treatment options in the coming years.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...