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By Nancy Lapid, Health Science Editor

Hello Health Rounds readers! With thousands of researchers sharing new data at the American Society of Clinical Oncology meeting in Chicago, our special ASCO edition on Monday didn’t seem like enough coverage of the interesting and potentially practice-changing studies. So in today’s newsletter, we feature three more studies from the year’s biggest cancer conference.

In breaking news, see these stories from our Reuters journalists: Merck sues to halt Medicare drug price negotiation; Texas seeks $1.8 bln from Planned Parenthood in fraud claim; White House promises improved drug overdose efforts; EU backs WHO’s COVID vaccine advice; and Novavax expects COVID shot to work against rising variants.

Reuters’ industry news stories cover Sanofi-AstraZeneca’s preventive RSV therapy; Novocure‘s lung cancer device; GSK‘s cancer drug Jemperli; Illumina’s appeal to the FTC; Neuralink’s valuation; Stelara’s patent deal; Bayer’s contraceptive pill shortage; General Electric’s stake in GE HealthCare; SpringWorks Therapeutics’ tumor treatment; and Akero’s NASH drug.

Collecting a cancer patient’s DNA for genetic testing – for example, in cheek swab kits such as this one – can help identify the best treatment for that person, but very few patients undergo these tests. REUTERS/Sarah Lynch.

Only a small fraction of U.S. cancer patients receive recommended genetic testing that could help determine the best course of treatment for them, new data suggest.

Among more than 1.3 million adults diagnosed with cancer between 2013 and 2019 in two U.S. states, only 6.8% underwent the recommended tests, researchers reported on Monday at the annual meeting of the American Society of Clinical Oncology.

So-called germline genetic testing, which looks for inherited changes in a person’s genes, can help determine the cancer treatment most likely to be effective and whether family members might also be at risk. Medical guidelines recommend the tests for people with cancers of the breast, colon and rectum, endometrium, ovaries, pancreas, and prostate.

When researchers reviewed data from the four laboratories that perform the most germline genetic testing in California and Georgia, they found significant under testing for the various cancers. Ovarian cancer patients had the genetic testing at 38.6%, with endometrial at 6.4%; colorectal 5.6%; pancreatic, 5.6%; and prostate, a mere 1.1%. The testing rate for patients with breast cancer was 50% among men and 26% among women, according to a report of the study published in JAMA.

“Genetic testing for inherited cancer syndromes has become an integral component of cancer care because it directly affects management and therapy,” the authors of an accompanying editorial wrote.

“Identification of gene variants associated with increased cancer susceptibility can improve outcomes for both cancer patients and family members,” they said, calling its underuse “a missed opportunity to decrease the population-level burden of cancer.”

Rather than taking immunotherapy drugs indefinitely, patients with an advanced form of the most common type of lung cancer might be able to stop after two years, according to new research.

Introduced over the past decade, these drugs that unleash the immune system to attack cancer, such as Merck’s Keytruda and Opdivo from Bristol Myers Squibb, have revolutionized treatment for advanced non-small cell lung cancer, but how long patients must keep taking them has not been clear.

Researchers reviewed data on 1,091 patients whose lung cancer had not progressed after receiving one of these drugs, either alone or with chemotherapy, as part of their initial treatment.

One-in-five had stopped immunotherapy at two years, the researchers reported on Monday in JAMA Oncology and at ASCO.

When they compared these patients to the majority who had continued treatment beyond two years, they found similar survival rates in the two groups. An average of 38 months after starting therapy, 79% of those who stopped after two years and  81% of those who continued therapy were still alive.

A randomized controlled trial would be needed to confirm the safety of stopping the drugs after two years, but that will take years, study leader Dr. Lova Sun of the Perelman School of Medicine at University of Pennsylvania said in a statement.

“Our goal was to use real-world observational data to provide guidance on this important clinical question,” Sun said. “We hope this data provides reassurance that stopping treatment at two years is a valid treatment strategy that does not seem to compromise overall survival.”

An editorial published with the study noted that discontinuing the therapy  after two years means “lower risk of toxic effects, less time in treatment for patients, and considerably lower costs for our healthcare system.”

For a significant proportion of new cancer drugs approved for use in the United States, the optimal dosage remains unknown for years, U.S. Food and Drug Administration researchers say.

On Monday at the ASCO meeting, they presented more than a decade’s worth of data to bring the problem to light and reported on the agency’s efforts to reform its processes.

The FDA’s reform initiative, dubbed Project Optimus, is working with drug manufacturers and other stakeholders to advance a dose optimization paradigm that occurs early in the drug testing process “to ensure an optimized recommended dosage at the time of approval,” they said.

From 2010 through 2022, 15% of new cancer drug approvals were granted with a requirement that manufacturers conduct further “dose optimization” studies after the products became commercially available, FDA researchers reported.

Although the recommended dosages possessed a favorable benefit/risk profile, there were significant safety concerns that required evaluation of alternative dosages, they said in a brief summary of their presentation.

During the study period, the FDA required manufacturers of 21 of 138 newly approved cancer drugs conduct an additional 18 randomized trials and six other types of studies, with enrollment requirements ranging from 100 to 500 patients.

So far, only 11 of the required “post-marketing” investigations have been completed, including eight that led to dosage changes for five new drugs.

“This process was slow,” with half of the completed demands taking more than six years to be fulfilled, the researchers said in making the case for reform. 

This newsletter was edited by Bill Berkrot.

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