OBR Daily Commentary

forumImage

FDA Approves Cemiplimab-rwlc For Non-Small Cell Lung Cancer With High PD-L1 Expression

(FDA.gov) Feb 22, 2021 - On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations. Efficacy was evaluated in Study 1624 (NCT03088540), a multi-center, randomized, open-label trial in 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or with metastatic NSCLC.

H. Jack West, MD (Posted: February 23, 2021)

quotesThis approval now gives us a third option for the same clinical setting in which we already have pembrolizumab as a clear standard of care since it demonstrated significant superiority to chemotherapy alone in 2016. We also have atezolizumab that showed the same thing and currently serves as a rarely used understudy to pembrolizumab here, with no incremental benefit. Cemiplimab provides only further redundancy here. We should also reflect on the questionable ethics of running a trial that assigns half of the patients to a treatment that had been proven inferior to single agent immunotherapy from KEYNOTE-024 before the new trial started. Unfortunately, history has shown us that we should not expect the addition of more agents in the same setting to lead to improvements in pricing. I strongly suspect Regeneron will fail to price cemiplimab significantly lower than pembrolizumab or atezolizumab, which is the only factor that could differentiate it from better established competition in this market.quotes

Read Article arrow
Add Comment 1 Comment
forumImage

Neoadjuvant Combination Immunotherapy Improves Outcomes For Early Stage Non-small Cell Lung Cancer

(MD Anderson) Feb 18, 2021 - The first randomized Phase II clinical trial to report on single and combined neoadjuvant immune checkpoint inhibitor therapy in stage I-III non-small cell lung cancer (NSCLC) found combination therapy produced a significant clinical benefit, as assessed by major pathologic response (MPR) rate, as well as enhanced tumor immune cell infiltration and immunological memory. Researchers from The University of Texas MD Anderson Cancer Center published the study results today in Nature Medicine.

H. Jack West, MD (Posted: February 20, 2021)

quotesThough there is a lot of focus on neoadjuvant immunotherapy for lung cancer, many if not most practicing oncologists will be seeking more established endpoints like a significant improvement in overall survival, or at least disease-free survival, rather than focusing on relatively newer variables like major pathological response that have been "retrofitted" as an endpoint of choice because they show a benefit quickly. Neoadjuvant immunotherapy or chemoimmunotherapy should generate great enthusiasm and become a new standard of care if and when it produces improvements in established endpoints in prospective, randomized phase 3 trials -- not before that. Immunologic endpoints don't counterbalance the side effects and costs of immunotherapy.quotes

Read Article arrow
Add Comment 1 Comment
forumImage

First Opinion: The Biden Administration Needs to Look Beyond ICER for Evaluating Drug Therapies

(STAT) Feb 9, 2021 - As breakthrough drugs stream out of biopharmaceutical laboratories, how much they should cost and who will get access to them remain thorny issues.

William McGivney, PhD (Posted: February 15, 2021)

quotesIt is extremely disconcerting to think that ICER could be thought of as possibly playing a significant role in evaluating and determining what appropriate pricing should be for therapeutic drugs and biologics in Oncology; and even worse playing the lead or only role. Concepts developed by those who generally have sprung from academia without ever having the sole responsibility for making patient care decisions are often flights of fancy that threaten great real-world accomplishments. For example, the FDA record for approvals of therapeutics for cancer has been exemplary under the leadership of Rick Pazdur, MD, an Oncologist who came to the FDA after years of practice and treating patients at MD Anderson. The FDA approval process is now a model for evaluation and efficiency in drug approval. What if the availability of FDA-approved innovative agents to patients in need had to wait a time period for some esoteric “cipherin” (to use Jethro Bodine’s technical term) to grant permission for general availability and access. Again, one needs to sit in the “Chair” and, actually, carry out and apply the policies that one writes for patients in need. In doing so, one quickly realizes that many of those patients look line one’s mother, brother, daughter, etc. The ICER Policy Paper, Unsupported Prices Increases, seems to communicate an aloof, academic view that the only good evidence is ICER-accepted evidence. In a cited Boston Globe article, ICER was referred to as the “Boston Watchdog”. This reminds me of my book, “On the Road to Kick-Ass Healthcare”. Is that the Road that we want to be on when in need of innovative, effective agents to address the serious healthcare needs of loved ones or even ourselves. Esoteria are ok in theoretical decision-making, I guess, but I still cannot find the model that applies to the following: “Dr. McGivney: My name is Jane Smith and I am the mother of two little boys, one is 23 months old and one is 9 months. About 5 years ago I was diagnosed with a precancerous lesion on my tongue. I had the lesion surgically excised. I have had three subsequent lesions all removed surgically. I am starting to experience some difficulty in my speech. I have just been diagnosed again with such a lesion. My doctor prescribed a well-known drug called Accutane. Two of the medical directors at your insurance company have denied coverage for the drug. I cannot afford it myself. I was referred to you. If I have to have surgery, my speech will only get worse. I beg of you, I plead with you to cover the drug so that I do not need to get surgery again. I need to try the drug because all that I want to be able to do is to teach my two little boys how to talk!!" I sat there numb!! There is a story as to how I covered that drug but too long for these electronic pages. The story is true and, as such, I ask as one sits alone in a room with eight other cases all marked “urgent”, trying to make that decision for Ms. Smith: How does one model that decision-making process? quotes

Read Article arrow
Add Comment 1 Comment

Meet the Editorial Board

Prostate Cancer
member photo
Tomasz M. Beer, MD, FACP

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

Community Oncology
member photo
Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
member photo
Debu Tripathy, MD

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

Lung Cancer
member photo
H. Jack West, MD

Associate Clinical Professor, Medical Oncology Executi...

Gastrointestinal Cancers
member photo
Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
member photo
Howard Sandler, MD, MS, FASTRO

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

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

Steven Spielberg Family Chair in Hematology Oncology P...

member photo
Stephen M. Schleicher, M.D., MBA

Community Oncology, Medical Oncologist, OneOncology...

Health Policy
member photo
Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
member photo
Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Health Policy
member photo
William McGivney, PhD

National Health Policy Expert...