Onc Daily: Selpercatinib Approved, ASCO Goes Virtual

Sharon Worcester

May 11, 2020

Here are the most important stories that Medscape Oncology's editors picked for you to read today.

FDA Approves Selpercatinib

The US Food and Drug Administration today approved selpercatinib (Retevmo, Loxo/Lilly), making it the first targeted therapy approved for the treatment of certain tumors with an RET gene alteration.

The drug received an accelerated approval that was based on response rates from the open-label phase 1/2 LIBRETTO-001 study. It was approved for three indications: the treatment of RET-positive tumors in adults with non–small cell lung cancer that has spread; the treatment of advanced medullary thyroid cancer (MTC) or MTC that has spread in adults and children older than 12 years who require systemic therapy; and for thyroid cancer in adults and children older than 12 years who require systemic therapy and whose disease has stopped responding, as well as in cases that are not appropriate for radioactive iodine therapy.

ASCO Meeting Goes On ― Online

The annual meeting of the American Society of Clinical Oncology (ASCO) is going virtual this year. The McCormick Place convention center in Chicago, where the meeting was scheduled to take place, currently serves as a field hospital amid the ongoing COVID-19 pandemic.

"We have to remember that even though there's a pandemic going on and people are dying every day from coronavirus, people are still dying every day from cancer," Richard Schilsky, MD, PhD, chief medical officer of ASCO, told Medscape Medical News.

"This pandemic will end, but cancer will continue, and we need to be able to continue to get the most cutting edge scientific results out there to our members and our constituents so they can act on those results on behalf of their patients," he said.

Find more details here about the timing and content of the virtual scientific program, which will be "compressed a little bit," Schilsky said.

Conclusions: Read the Fine Print

If you attend the ASCO meeting ― or any scientific meeting, for that matter ― consider that "researchers sometimes spin negative results in an ambiguous, or even positive, light in their conclusion sections," according to a study published in JAMA Oncology.

The authors reviewed oral presentations of more than 200 phase 3 randomized controlled trials presented at ASCO and ESMO meetings from 2017 through 2019 and found that 29% of 91 studies with negative results had nonnegative conclusions, and half of those emphasized a numerically better outcome in the experimental arm despite a nonsignificant P value.

The authors warn that conclusions that are not justified by the study results could be misleading and harmful in clinical practice. They said that practicing physicians should question authors' conclusions and should always look carefully at the study design, the primary objectives, and the hypothesis.

Defining SOC: No Easy Task

As approvals for new antineoplastic agents increase, defining the standard of care in clinical oncology is neither simple nor straightforward, according to Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia.

In a Medscape commentary, he shares his vision for "pragmatic clinical trials...in real-world clinical practice settings" that are encouraged and supported by groups such as ASCO, the National Cancer Institute, and insurers.

New Guidelines for Head and Neck Cancers

Medscape has updated its reference content with new information on the management of head and neck mucosal melanomas during the COVID-19 pandemic. The guidelines were published in the April 28 issue of Otolaryngology–Head and Neck Surgery.

Cancer Surgery: "For Now, We Wait"

With so many surgeries being postponed during the COVID-19 crisis, the question of how to determine which should be performed right away and which can be safely delayed makes for some heart-wrenching decisions. In an article in the New Yorker, Alessandra Colaiann, MD, a chief resident in otolaryngology and head-and-neck surgery at Harvard Medical School, shares her experience and that of her colleagues in navigating the complexity and pain of the process and of telling cancer patients, who have upended their lives to schedule a surgery, that their procedure has been delayed indefinitely.

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