Onc Daily: Lung Cancer Drug Approval, Practice Struggles

Nick Mulcahy

May 07, 2020

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

FDA Approves New Lung Cancer Drug

The US Food and Drug Administration (FDA) has granted capmatinib (Tabrecta, Novartis) accelerated approval for the treatment of metastatic nonsmall cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations, as detected by an FDA-approved test.

Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and the first FDA-approved treatment for NSCLC with these mutations.

The approval is based on an overall response rate of 68% in treatment-naive patients and 41% in previously treated patients, and median duration of responses of 12.6 and 9.7 months, respectively, in the phase 2, GEOMETRY mono-1 trial, the FDA said. Results from this trial were recently presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting I.

Medscape commentator Jack West, MD, has called capmatinib's benefits "significant" for patients with these mutations, which are about 3% of all lung cancers.

Community Oncology Struggles

Over the past decade, community oncology clinics and practices have struggled with closings, acquisitions, mergers, and finances. Recently, clinics have had substantial declines in-office visits and new patients because of the COVID-19 pandemic.

But there is good news, says Ted Okon, MBA, executive director of the Community Oncology Alliance. The latest report from the organization shows that "the number of treatment sites closing appears to be plateauing," he said.

"We are still seeing acquisition of physician practices by hospitals, but what we are also seeing now are mergers among practices and acquisition by physician-run organizations," Okon told Medscape Medical News, suggesting that the latter two entities/actions are much preferable to the former.

Major Cancer Center's Sale Stopped by COVID-19

The sale of Philadelphia's Fox Chase Cancer Center, a member of the National Comprehensive Cancer Network and a National Cancer Institute-designated center, to Thomas Jefferson University, a regional health system with 14 hospitals, has been canceled.

"This transaction is the latest casualty of COVID-19," said Stephen Klasko, MD, MBA, president of Thomas Jefferson University, in the Philadelphia Inquirer.

"There is no question that but for the catastrophic economic impact of the virus, both institutions were prepared to move forward to complete this transaction," said Richard Englert, president of Temple University, which currently owns Fox Chase, having bought it for $84 million in 2012. Due to the COVID-19 downturn, Temple's healthcare entities are reportedly losing $40 million a month.

After 6 months of negotiation, the initial deal was announced in July 2019 and was followed by a nearly year-long review of operations and finances.

A Quick COVID-19 Vaccine Means Skipping "Major Steps"

Calls to develop a COVID-19 vaccine in 12 to 18 months mean that the process will have to skip "major steps," said Paul Offit, MD, of Children's Hospital of Philadelphia.

The "typical" length of time to research and develop a vaccine is about 20 years, said Offit in an interview with John Whyte, MD, chief medical officer, WebMD.

First, a proof-of-concept trial is needed, after the type of vaccine is decided upon (from a number of options such as whole, killed virus like the inactivated polio vaccine).

Larger and larger trials then follow, such as a dose-ranging study and a phase 3 trial, the definitive FDA licensure trial that usually is placebo-controlled.

The Ebola virus vaccine presents a different model, said Offit, which was "rolled out" in the African population to determine safety and efficacy. Even that process took a couple of years, he added.

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