OBR Daily Commentary

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Imfinzi Approved In The US For Less-Frequent, Fixed-Dose Use

(AstraZeneca) Nov 20, 2020 - AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This new option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.

H. Jack West, MD (Posted: November 22, 2020)

quotesAn overdue revision that will be a real help in reducing the frequency of needed visits to complete the year of consolidation durvalumab to confer the significant overall survival benefit after chemoradiation for a target of a year. Patients will welcome this, and it is change we will also welcome to minimize the risk of frequent visits during a pandemic.quotes

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Surprise Federal Drug Rule Directs Insurers to Reveal What They Pay for Prescription Drugs

(KHN) Nov 19, 2020 - Health insurance companies will have to give their customers estimated out-of-pocket costs for prescription drugs and disclose to the public the negotiated prices they pay for drugs, under an unexpected new Trump administration rule.

Dean Gesme, MD (Posted: November 19, 2020)

quotesDisruption rather than transparency. This rule, to take effect in 2022, will allow commercially insured patients to see the negotiated contractual "price" that insurers/PBMs pay to drug manufacturers but excludes rebates and other incentives which are necessary for consumers to make meaningful comparisons between insurance plans. quotes

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Results from Phase 3 CROWN Trial of Pfizer’s LORBRENA® (lorlatinib) in Previously Untreated ALK-Positive Lung Cancer Published in the New England Journal of Medicine

(Pfizer) Nov 19, 2020 - Pfizer Inc. today announced results from the Phase 3 CROWN trial of LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) were published online ahead of print in the New England Journal of Medicine. At a planned interim analysis, LORBRENA treatment resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) according to blinded independent central review (BICR), the primary endpoint, compared to XALKORI (HR 0.28: 95% CI, 0.19 to 0.41; p<0.001), corresponding to a 72% reduction in the risk of progression or death. The trial is continuing for the secondary endpoint of overall survival (OS), which was not mature at the time of analysis.

H. Jack West, MD (Posted: November 19, 2020)

quotesThe CROWN trial clearly illustrates that lorlatinib has superior overall and intracranial efficacy compared to an obviated standard we already know is significantly inferior to two other FDA approved ALK inhibitors in the first line setting -- alectinib and brigatinib. That's great, but lorlatinib has some uniquely challenging side effects, most likely potentially severe neurologic issues ranging from confusion to hallucinations and delusions, that occur in >20% of patients. In addition, lorlatinib is approved and has demonstrated good efficacy in patients with ALK+ cancer that has progressed on alectinib, brigatinib, or other ALK inhibitors, and not just on prior crizotinib. It has the best data of any ALK inhibitor in this setting, and using lorlatinib first line sacrifices our most effective second line ALK inhibitor option. Everyone likes a feel-good, positive headline, but it is damning with faint praise to see that lorlatinib achieves the same distinction as two other agents already approved in the same setting and one other (ensartinib) that has yet to be approved for first line use here. Importantly, all of these agents have clearly superior intracranial efficacy vs. crizotinib. To be clear, this work offers no compelling reason for oncologists to change our practice, which is generally to initiate first line treatment with alectinib.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...